what is subject of study in research

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• Research is an Activity and a Subject of Study: A Proposed Metaconcept and Its Practical Application (76149 views)
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Research Is an Activity and a Subject of Study: A Proposed Metaconcept and Its Practical Application

Allison Hosier *

Information literacy instruction based on the ACRL Information Literacy Competency Standards for Higher Education tends to focus on basic research skills. However, research is not just a skill but also a subject of study. The ACRL Framework for Information Literacy for Higher Education opens the door to integrating the study of research into information literacy instruction via its acknowledgement of the contextual nature of research. This article introduces the metaconcept that research is both an activity and a subject of study. The application of this metaconcept in core LIS literature is discussed and a model for incorporating the study of research into information literacy instruction is suggested.

Introduction

Studies have shown that students’ confidence in their research skills often does not match their proficiency with those skills. 1 Students seem to believe that their facility with search engines is sufficient for any research-related task they may be faced with. In believing this, what students fail to realize is that while the information-seeking skills they have developed are certainly valuable in some situations, they are less so in others.

Instructors of composition courses face a similar dilemma. Students believe that writing is nothing more than a basic skill and often fail to appreciate the importance of rhetorical context to the writing process. In an effort to resolve this, instructors help students familiarize themselves with different genres of writing via the study of writing itself. As a result, students may begin to recognize that basic skills are not enough to meet the expectations for writing in every context. The most successful student writers are ones who are able to recognize themselves as novices in some of these contexts. 2 These student writers will also begin to see that writing is not just an activity but also a subject of study. 3

Students who learn about research through information literacy instruction may not have the opportunity to experience a similar epiphany about the research process. This is because common models of information literacy instruction are primarily skills-based with a particular focus on application. There is little if any time to devote to teaching students about the contextual nature of research or how to study a research product for evidence of conventions related to these contexts.

If information literacy instruction is typically skills-based, it is likely because the ACRL Information Literacy Competency Standards for Higher Education (the Standards ) is a skills-based document, as are similar documents that have shaped how information literacy has been taught until now. The Standards guidelines in particular fail to address the contextual nature of research in a meaningful way, thus limiting opportunities to introduce this important concept in the classroom.

The advent of the ACRL Framework for Information Literacy for Higher Education (the Framework ) marks a shift from skills-based thinking about information literacy to concept-based thinking. Because of this shift, information literacy instructors now have the option to expand their teaching beyond the application of basic research skills. The Framework ’s attention to context in particular can be used to create a model of instruction that involves the study of research in addition to the application of research skills. In this way, students will better recognize that research, like writing, is both an activity and a subject of study.

The purpose of this article is threefold. The first is to propose the metaconcept that research is both an activity and a subject of study. This metaconcept has long been present in the literature in the library and information science field but has been largely absent from information literacy instruction. The second goal of this study is dto discuss how the influence of the Standards led to the skills-based model of information literacy instruction while suggesting that the Framework ’s attention to context provides a path for reshaping such instruction around the study of research. Third, a model for integrating this metaconcept into information literacy instruction will be presented.

These ideas were initially inspired by Adler-Kassner and Wardle’s edited volume Naming What We Know: Threshold Concepts of Writing Studies . Just as Adler-Kassner and Wardle and their collaborators aimed to articulate what writing studies experts know about their subject to improve conversations with students and other nonexperts, the application of the ideas in the present study can lead to better discussions about information literacy with those who in the past may not have fully understood its value.

Defining Research

Before getting to the heart of this paper’s argument, it may be helpful to first establish more clearly what, exactly, is meant by “research.”

In their “Policy for Protection of Human Research Subjects,” the Office for Human Research Protections defines research as a systematic investigation intended to contribute to generalizable knowledge. 4 Institutional Review Boards commonly use this definition to guide researchers applying for approval to pursue research involving human subjects.

The Standards also portrays research as an investigation, one that likely involves the use of library resources. The prescribed steps for the research process include the identification of a gap in knowledge, the identification and evaluation of relevant sources, and the ethical use of those sources. 5

In the Framework , research is alluded to as a “reflective discovery of information” in the expanded definition of information literacy. 6 This journey of reflective discovery is intended to lead to the creation of new knowledge.

Information-seeking is a concept related closely to research that takes into consideration contexts beyond the scientific and academic ones that are the primary concern of the above definitions. Wilson describes information-seeking as a behavior that “arises as a consequence of a need perceived by an information user who…makes demands upon formal or informal information sources or services, which result in success or failure to find relevant information.” 7

It is necessary to define research broadly in a discussion of research as both an activity and a subject of study, because the study of research can take many forms and context is always a consideration. For this reason, the understanding of research in this paper will encompass the following:

• Research is any formal or informal process that is undertaken to fill a gap in knowledge, build on existing knowledge, or create new knowledge.
• Goals of research include but are not limited to answering a research question, testing a hypothesis, or satisfying curiosity.
• Research involves investigation of some kind. This investigation may be formal, such as an exhaustive literature review or the careful implementation of the scientific method, or it may be informal, such as a brief Google search. More formal research investigations may be qualitative or quantitative in nature.
• The research process is often iterative rather than linear.
• The results of research may be captured in a research product or a set of research products. The products of research can take many forms, including but not limited to: formally published research studies, dissertations, conference proceedings, creative works, presentations, speeches, news and magazine articles, and blog posts.
• Research products often include evidence of research in some way, whether it is a list of citations, a detailed description of methodology, a quote from an interview subject, a list of acknowledgements, a verbal allusion to a source of information (as in a speech), or contextual links (as in an online blog post).

Research envisioned through an information literacy lens is often academic in nature. This type of research will be referred to as “academic research” throughout this paper. Table 1 outlines additional terms that will be used to refer to different types of research where necessary. This is not intended as a definitive list of research genres but rather a guide that will serve to clarify certain points. Note that some types of research may overlap with others.

Research Is a Subject of Study

A study of research is one in which the products or processes of research are analyzed to better understand some aspect of research itself. This is most directly seen in studies that observe actual research behaviors or evaluate specific research products. The study of research also has an influence on other areas of inquiry. Context is often key to studies of research.

The study of research is most prevalent in literature found in the library and information science (LIS) field. However, it also has relevant applications in other fields. This section will first summarize areas of inquiry directly and indirectly related to the study of research that can be found in LIS literature. A few relevant examples from the related field of writing studies will also be mentioned. Brief consideration will then be given to a relevant example from the field of psychology.

The Study of Research in Library and Information Science

Researchers in library and information science study the processes and products of research to improve systems and services, to understand how those systems and services are used, to analyze collections, to measure the impact of research-related instruction, to trace the development of a research topic over time, and more. These areas of inquiry are studied in a variety of contexts using a range of methods and populations. The study of research is relevant to virtually every specialization in library and information science. It is not an exaggeration to say that if you open any of the core journals in this field, such as those identified in a 2014 study by Nixon, 8 you are likely to find at least one article that is concerned directly or indirectly with the study of research in some way, shape, or form.

The study of research is a theme that has long been present in LIS literature but can be difficult to locate because until now it has not generally been named as such. The metaconcept introduced here gives us a novel lens through which to view our work and begin to articulate what we know about research as both an activity and a subject of study in a new way. When this lens is applied to content analyses and literature reviews, which are fairly common in LIS literature 9 and are themselves an example of the study of research, these works can serve as a valuable proxy for identifying topics related to the study of research in our field. An analysis by Tuomaala, Jarvelin, & Vakkari from 2014 may be most useful in this respect for the present discussion. 10 The breakdown of topics and subtopics the authors created for their study is specific enough to begin to see shades of the research-as-subject metaconcept. In their analysis, the authors found that information seeking, which includes subtopics such as information use and information management, accounted for 12.3 percent of the LIS literature in 2005, the most recent year considered for the study. The study of research also has applications related to studies of information storage and retrieval, a separate topic that includes subtopics such as cataloging and the testing of retrieval systems. More than 30 percent of the articles published that year related to this topic. Other potentially relevant areas from Tuomaala, Jarvelin, and Vakkari’s study include research on user education (1.7%), citation patterns (6.5%), and webometrics (2.9%).

What does the study of research in LIS look like? For one, it is often concerned with context. Researchers seek to gain important insights into how different populations seek or use information in different contexts. Some of the populations studied in recent issues of core LIS journals include disadvantaged adolescents, Catholic clergy, linguists, and poultry farmers, to name just a few. 11 Contexts of interest found in recent literature include not just academic or scholarly ones 12 but also personal, as in studies of everyday life information seeking, 13 and professional, as in studies of how information is accessed and used in various workplace environments. 14 Those who study the products of research may be interested in understanding how researchers cite data, what common themes can be found in the research on a particular subject, or how the content of one type of research product might distinguish it from another type of research product. 15 In all of these cases, context matters to the researcher.

Context also matters to those whose work may be informed by the study of research though research itself is not the direct object of study. For example, the work of collection management researchers must be informed at least in part by how a particular population uses the collection in question. 16 Usability studies may be primarily concerned with issues of design, but the researcher must also take into account the context in which the resource being tested will actually be used. 17 A study of a library’s physical space must include some consideration for the research and information-seeking activities that users conduct in that space, which will be different depending on details such as the type and size of the library as well as the population it serves. 18 Researchers who create algorithms or implement other methods to improve the effectiveness of information retrieval systems must have some understanding of the needs and behaviors of the system’s front-end users. 19 Though the examples cited are all from recent literature, they represent areas of inquiry that have developed over a long period of time.

In the past, the study of academic research as conducted by students has been of particular concern to those who teach information literacy. Leckie, for example, comments on how typical research assignments reflect an expert approach to research that may be inaccessible to novice student researchers. 20 Information literacy instruction is also often informed by studies that establish an understanding of students’ research behavior, including their method of strategic satisficing, 21 why they prefer certain resources and tools over others, 22 and why their choices do not always match expert expectations of quality and reliability. 23 Understanding gaps between the research skills librarians teach and the ones that are actually used in the workplace, as in Head, Van Hoeck, Eschler, and Fullerton, is another area of inquiry that has gained importance over time. 24

Among these studies of the products and processes of academic research are arguments for teaching students about the contextual nature of research. Fister advocates for creating a better awareness of the rhetorical aspects of research, 25 an idea that was later put into action by Davidson and Crateau. 26 Simmons proposes applying genre theory and critical information literacy to research instruction so that librarians can position themselves as discourse mediators, studying and teaching the conventions of research in different disciplines as anthropologists study and teach the practices of different cultures. 27 Harris makes a similar argument: “Before we make assumptions about how to assist communities of learning, we may also need to define and navigate the social, political, and cultural characteristics of that community.” 28

The study of research touches nearly every aspect of the library and information science field, in one form or another. But, as Faix points out, experts in other fields also take part in scholarly conversations about research. 29 This includes related fields such as writing studies, where authors like Brent and North approach the study of research from a composition perspective. 30 However, the study of research is also relevant to researchers in more scientific fields, which are often considered outside the scope of information literacy instruction. Though this paper focuses primarily on information literacy instruction, the overall argument is that such instruction would be more effective if it involved the study of research to help students appreciate the contextual nature of the research process. This means expanding our thinking about research beyond the library-based academic notions we have favored so far. For this reason, a relevant example of the study of research in psychology is provided in the next section.

The Study of Replicability and Reproducibility in Psychology

The methods, goals, and motivations of scientific research are considered to be distinct from the ones described by documents such as the Standards and the Framework . That this is the case serves as further evidence in support of the importance of context to the research process. However, scientific researchers have also been known to turn inward and examine the processes and products of research as it is represented in their fields.

In the field of psychology, the work done as part of the Reproducibility Project is particularly relevant to the present discussion. As part of this project, a team of researchers attempted to replicate the results of 100 psychological studies. 31 Their findings led them to create a set of recommendations for how to improve the research and publication process in their field to better promote replicability. One of these recommendations was to teach students to study research publications in their fields to evaluate the evidence used and learn to see potential methodological flaws.

The findings of this project inspired a number of responses. Some researchers studied the methods undertaken by those who worked on the project and used these analyses to question or criticize the results. 32 Others turned to conversations about whether replicability and reproducibility should be goals of psychological research in the first place. 33 There are also studies, 34 published since then, that seek to establish whether there are methods that can be used to improve the replicability of a study and others 35 that recommend new approaches to evaluating replicability itself. A similar study to investigate the reproducibility of cancer biology research is also being undertaken. 36

From these discussions, it becomes clear that research is not just an activity but also a subject of study for researchers in LIS and other fields. This metaconcept has important connections to the contextual nature of research. Both ideas are essential to learning about research in a meaningful way. Despite this, information literacy instruction tends to be generally skills-based with little or no discussion of these ideas. The reason for this may be that, for many, models of information literacy instruction have been built around the Standards , a document that places priority on teaching research skills over research-related concepts.

The Importance of Context: Limitations of the Standards and New Opportunities

As stated earlier, the Standards is a skills-based document. When considering the historical context of this document, its focus on the activity of research makes sense. Information literacy had developed over time from a job skill to one that was more closely related to research. Meanwhile, bibliographic instruction had also shifted from the original concept-based approaches to ones that focused more on teaching students basic access skills. 37 The Standards simply reflected these ways of thinking.

The Standards was also developed at a time when academic librarians were seeking to stake a place for themselves in the missions of their institutions, which had become more closely tied to the employability of their graduates. 38 For such institutions, learning outcomes became the favored way of gauging the success of a particular program. One of the Standards ’ stated goals is to provide measurable learning outcomes for information literacy. 39 To be measurable, learning outcomes must be based on what can be observed. It is much easier to measure the development of skills than it is to measure changes in a student’s worldview.

The limitations of the Standards have been well documented over time. 40 One of the main shortcomings of the Standards has always been in its failure to acknowledge the importance of context to the research process. More accurately, the Standards assume a single research context: that of library-based academic research. The closest the document comes to referencing the contextual nature of research is the occasional gesture toward discipline-specific research, which is still a highly academic notion (see table 2). Despite the aspiration of the Standards toward transferability, 41 research studies that have tested this idea tend to have mixed results. 42 In other words, despite its stated intentions, what the document is really doing is, as Mark points out, reflecting a tendency in the academy to measure expertise by one’s ability to adopt the conventions of academia. 43

Because the Standards does not adequately take into account the contextual nature of research, neither does Standards -based information literacy instruction. Instead, such instruction focuses primarily if not exclusively on teaching students the basic skills associated with library-based academic research. We know this because influential tools created to standardize the assessment of information literacy learning, such as the Information Literacy VALUE rubrics and the learning goals suggested by the Middle States Commission of Higher Education, reflect it. 44 We also know this because studies of syllabi for credit-bearing information literacy courses show that the most common topics taught as part of these courses are skills-based. 45

The influence of the Standards has had a noticeable effect on the way librarians think about teaching information literacy. When asked by Hofer, Townsend, and Brunetti about the most common “stuck places” students encountered when learning about research, the answers given by the librarians who participated in the study were concerned almost exclusively with academic research skills. 46 One place where a more contextual view of research shows through is in the respondents’ stated desire to help students better understand how the process of information creation might differ from one discipline to another.

The Standards has also had an effect on how information literacy is perceived by those outside the library field. When Gullikson asked nonlibrary faculty at what academic level they would expect students to have achieved individual learning outcomes from the Standards , the majority of those who responded indicated that they would expect students to have mastered these skills in the early part of their careers in higher education, if not before. 47 Standards- based information literacy, in the eyes of nonlibrarians, is at best seen as what Norgaard calls “a mere look up skill.” 48

The Standards provides no path to introducing students to the contextual nature of research. Because of this, the idea that research is both an activity and a subject of study became lost in our information literacy instruction and our thinking about information literacy instruction despite the fact that it remained a prevalent theme in our professional literature. In insisting on the importance of context to the research process, 49 the Framework gives us a way to change our thinking and our instruction.

Each of the Framework ’s six frames is infused with implicit and explicit references to the contextual nature of research (see table 3). In fact, the only frame in which the word “context” does not appear in one form or another is “Research as Inquiry,” which still manages to highlight the importance of distinguishing between processes of inquiry intended to meet different needs.

Of course, the Framework, like the Standards , is also a product of ACRL and so, as Foasberg points out, its contexts of interest are still primarily academic in nature. 50 No doubt research is currently underway to test the transferability of the Framework . In the meantime, it is not difficult to imagine how the six frames could apply to nonacademic forms of research. For example, negotiating a meaning from varying perspectives, as described in the “Scholarship as Conversation” frame, is as of much concern to those conducting personal, professional, or creative research as it is to those conducting academic research. Those who follow the investigative steps of the scientific method can likely find relevance in the idea of “Research as Inquiry.”

It may be true that not every threshold concept will apply to every research context. For some, that might be seen as a shortcoming of the present argument. However, it is worth remembering that the Framework is intended to be a flexible document, making it clear that there is room for more threshold concepts than those identified in the original version. 51 Further, in establishing a set of threshold concepts related to writing studies, Adler-Kassner and Wardle and their collaborators identified 37 threshold concepts, some of which may be more applicable to the study and activity of certain genres of writing than others. Granted, this work is not intended for broad implementation the way the Framework is, but both documents are of a similar spirit. 52

As stated earlier, students often enter the information literacy classroom unable to recognize that, while the skills and knowledge they have developed are valuable in some research contexts, they may be less so in others. For information literacy instructors, this has been a significant barrier, one that the Standards provided no meaningful way to overcome. The metaconcept that has been established here gives us a lens through which to understand research as not just an activity but also a subject of study. The Framework provides a path to pass on this knowledge to students by introducing them to the importance of context to the research process. The next section describes how a common model for composition instruction could be adapted for this purpose.

A Suggested Model for Practical Application

In Standards -based information literacy instruction, students are introduced to the conventions of academic research at the same time that they are expected to apply those conventions. They are expected to do this correctly without ever having seen or studied an example of such research, except perhaps one provided by their instructor for informational purposes. Badke criticizes this approach, colorfully stating, “teaching application without teaching method and philosophy is akin to showing someone how to steer and use the brakes on a car without teaching overall driving technique and the rules of the road.” 53

In writing studies, there is a similar expectation that, as Sommers and Saltz put it, students will “become master builders while they are still apprentices.” 54 However, composition instruction does not generally begin and end with application the way information literacy instruction does. Instead, students first study a selected example of a genre of writing to learn about the conventions of that genre and then attempt to apply those conventions in their own work. Information literacy instruction could benefit from emulating this structure.

Rather than organizing an information literacy course around units based on skills, sources, or tools, the course could be organized instead around different research contexts. More work may need to be done to determine what exactly those contexts can or should be or whether the conventions, goals, and motivations of those contexts can be said to represent “genres” as the term is understood by researchers of genre theory. 55 However, a general information literacy course could conceivably be organized around units on academic research, personal research, professional research, creative research, scientific research, and more.

In this approach, research skills like those described by the Standards would still be valuable but would only be taught after students first had the opportunity to study an example piece of research. Similar to the work of some professionals who study research, students could closely examine the types of sources used and think about the roles those sources play in the author’s research. They might also study the way the author gives credit to those sources, perhaps noticing that, in some research contexts, credit is given through formal citation while in others it is done through contextual links, quotes from interview subjects, or some other way. By doing this, students would learn how the conventions of research change from context to context. They may begin to develop a more realistic view of how much more there is to learn beyond the skills they already have and why it is worth learning.

As an illustration of how a unit in a course designed like this would work, consider that in a composition course students might first be given Letter from a Birmingham Jail by Martin Luther King Jr. as an example of persuasive writing. They would study this piece before trying to emulate King’s rhetorical moves in their own work.

In a unit on academic research in an information literacy course, students might first be given an example research essay or scholarly article. Rather than studying the writing, they would look at the evidence of research in the source. They might be asked to notice how the author uses citations or footnotes and includes a list of sources at the end. Attention might be drawn to the nature of the sources the author used, and critical thought might be given to why he or she made those choices. A student could also be asked to comment on how each source was used in the example piece: to add new information, to present and answer a contradicting view, to pull a quote, and so on.

The same could be done with units on other types of research. In a different unit, a personal blog post could be used as an example of personal research in which the evidence of research might appear as contextual links rather than formal citations. Or a news article could be studied as an example of journalistic or professional research in which quotes from sources with firsthand knowledge of an event are privileged over other types of sources. Even King’s Letter could be used as an example of research. In this piece, King borrows ideas from and makes reference to Socrates and the Bible to support his ideas. He also relies on the authority granted to him by his own personal experience with the issues he is discussing. 56

After studying the conventions of a genre of research through an example piece, students could then be taught the skills needed to complete the type of research each product represents. As a culminating project, students could be required to create a research product of their own that follows the conventions they learned about and then reflect on the ways that they used or challenged those conventions in their own work.

What is described above would be most appropriate for a general information literacy course taught at the undergraduate level. Instructors who teach more advanced or discipline-based information literacy could adapt this approach to suit their students’ needs and interests. For example, such instruction could focus more closely on the evaluation of research as it is most often represented in a field of study or profession. Students could be taught to see flaws in an author’s methodology, reasoning, or use of sources. They might also benefit from reviewing studies of information behavior of relevant populations to gain an understanding of how these populations interact with and create information in various settings. Instructors could invite students to think critically about the research practices in their fields and reflect on areas of potential improvement.

Caveats and Potential Concerns

It is necessary at this point to acknowledge that the common model for teaching composition described earlier is not without its critics in that field. Connors, for example, argues that using genres and modes to teach writing is more of a convenience to the instructor than a reflection of how writing actually works. 57 Hillocks makes the case that using genre and form to teach composition neglects the importance of inquiry and teaching students how to work with content. 58

In implementing a similar model for information literacy instruction, information literacy instructors may also have concerns. Foremost among these may be a reluctance to teach research outside the discipline-agnostic academic context of past Standards -based instruction. To do so, it has been argued in the past, would be to tread on the toes of disciplinary faculty who are the rightfully recognized experts on research in their fields of study and also perhaps to stray outside our professional strengths. 59 In response to this, it must be acknowledged that disciplinary faculty have been valuable partners in teaching information literacy in the past and could continue to be so in this new approach. As far as professional strengths, the Standards may have been limited to library-based academic research but the study of research in the LIS field is not, showing that contexts outside academia are, in fact, within our professional domain. Even if they were not, librarians tend to portray themselves as research experts as a way of communicating their value to their institutions. Taking advantage of the ways in which researchers in our own field have cultivated an understanding of how research works in a variety of contexts can only enhance our ability to label ourselves this way.

Another possible area of concern might be one anticipated by Townsend, Brunetti, and Hofer who acknowledge that threshold concepts like the ones found in the Framework tend to privilege certain ways of thinking. 60 Information literacy instructors may feel that the study of research is for professionals only and that teaching it to students would set up an expectation that, to be successful researchers, they need to become junior librarians or junior professors. However, it is worth noting that the goal of composition instruction, which involves both the study and practice of writing, is to teach students to be competent writers with an appreciation for rhetorical context. They are introduced to expert ways of thinking as a way of expanding their worldview but are not expected to become published (or even publishable) authors as a result of what they learn.

Finally, there may be some question of whether teaching students the conventions associated with different research contexts and then expecting them to follow those conventions stifles creativity by inviting conformity to existing systems. In answer to this, it could be argued that using the conventions of research as a teaching tool opens the door to conversations about why those conventions exist in the first place and in what ways they uphold what Beilin refers to as the “knowledge regime.” 61 Teaching students to think critically about the research that goes into creating a particular research product would enable them to more clearly see how the recontextualization process that is part of all research is subject to the inherent biases and worldviews of the author. 62 Even more important, as observed by Simmons, when students learn about generic conventions, they may learn to see themselves as having “the potential to effect changes in the conventions instead of simply learning to conform to the established patterns.” 63 In other words, learning “the rules” is also the first step in learning how to break those rules and challenge the systems that created them in meaningful and interesting ways.

Current models of information literacy instruction that treat research as nothing more than a basic skill do not serve students well. They also do not serve information literacy well. Research is not a basic skill that can be mastered for a lifetime in the space of a single instruction session. It is an activity that relies heavily on rhetorical context. It is also a subject of study with areas of inquiry in which context is often a large consideration. To paraphrase Wardle and Adler-Kassner, 64 a successful researcher is someone who cultivates an understanding of the expectations associated with research in a given context and then meaningfully engages with those expectations. Such a researcher is both a consumer and a creator of information.

The metaconcept introduced in this article, that research is both an activity and a subject of study, is an attempt to name something that has been present in LIS literature all along but for which there has been no room in information literacy instruction in the past. Future work to identify the ways in which this metaconcept has manifested itself in the literature in our field will be valuable in helping us to articulate the value of our work in a new way. In the meantime, it could serve as a useful frame for transforming information literacy instruction and enhancing the reputation of information literacy as something more than a basic skill.

1. Valeria E. Molteni and Emily K. Chan, “Student Confidence/Overconfidence in the Research Process,” Journal of Academic Librarianship 41, no. 1 (2015): 2–8.

2. Nancy Sommers and Laura Saltz, “The Novice as Expert: Writing the Freshman Year,” College Composition and Communication 56, no. 1 (2004): 124–49.

3. Elizabeth Wardle and Linda Adler-Kassner, “Metaconcept: Writing Is an Activity and a Subject of Study,” in Naming What We Know: Threshold Concepts of Writing Studies , eds. Linda Adler-Kassner and Elizabeth Wardle (Boulder: University Press of Colorado, 2015), 15–16.

4. Office for Human Research Protection, “Basic HHS Policy for Protection of Human Research Subjects” (2009), available online at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html [accessed 23 January 2018].

5. ACRL Information Literacy Competency Standards for Higher Education , “Information Literacy Defined” (2000), available online at www.ala.org/acrl/standards/informationliteracycompetency [accessed 23 January 2018].

6. ACRL Framework for Information Literacy for Higher Education , “Introduction” (2015), available online at www.ala.org/acrl/standards/ilframework [accessed 23 January 2018].

7. T.D. Wilson, “Models in Information Behaviour Research,” Journal of Documentation 55, no. 3 (1999): 251.

8. Judith M. Nixon, “Core Journals in Library and Information Science: Developing a Methodology for Ranking LIS Journals,” College & Research Libraries 75, no. 1 (2014): 66–90.

9. Examples include: Stephen E. Atkins, “Subject Trends in Library and Information Science Research, 1975–1984,” Library Trends 36, no. 4 (Spring 1988): 633–58; Lois Buttlar, “Analyzing the Library Periodical Literature: Content and Authorship,” College & Research Libraries 52, no. 1 (Jan. 1991): 38–53; Gloria S. Cline, ” College & Research Libraries : Its First Forty Years,” College & Research Libraries 43, no. 3 (1982): 208–32; Gregory A. Crawford, ”The Research Literature of Academic Librarianship: A Comparison of College & Research Libraries and Journal of Academic Librarianship ,” College & Research Libraries 60, no. 3 (1999): 224–30; Amy VanScoy and Cady Fontana, “How Reference and Information Services is Studied: Research Approaches and Methods,” Library & Information Science Research 38, no. 2 (2016): 94–100.

10. Otto Tuomaala, Kalervo Jarvelin, and Pertti Vakkari, “Evolution of Library and Information Science, 1965–2005: Content Analysis of Journal Articles,” Journal of the Association for Information Science & Technology 65, no. 7 (2014): 1446–62.

11. Steven Buchanan and Lauren Tuckerman, “The Information Behaviours of Disadvantaged and Disengaged Adolescents,” Journal of Documentation 72, no. 3 (2016): 527–48; Jacob Dankasa, “Mapping the Everyday Life Information Needs of Catholic Clergy: Savolainen’s ELIS Model Revisited,” Journal of Documentation 72, no. 3 (2016): 549–68; Maja Krtalic, Sanjica Faletar Tanackovic, and Damir Hasenay, “Linguists as Newspaper Users: Perceptions and Experiences,” Library and Information Science Research 38, no. 2 (2016): 108–16; Grace Msoffe and Patrick Ngulube, “Farmers’ Access to Poultry Management Information in Selected Areas of Tanzania,” Library and Information Science Research 38, no. 3 (2016): 82–90.

12. Examples include: Nancy Falciani-White, “Understanding the ‘Complexity of Experience’: Modeling Faculty Research Practices,” Journal of Academic Librarianship 42, no. 2 (2016): 118–26; Christopher V. Hollister, “An Exploratory Study on Post-tenure Research Productivity Among Academic Librarians,” Journal of Academic Librarianship 42, no. 4 (2016): 368–81; Sloan Komissarov and James Murray, “Factors That Influence Undergraduate Information-seeking Behavior and Opportunities for Student Success,” Journal of Academic Librarianship 42, no. 4 (2016): 423–49; Carol Sabbar and Iris Xie, “Language in the Information-Seeking Context: A Study of U.S. Scholars Using Non-English Sources,” Journal of Documentation 72, no. 1 (2016): 103–26.

13. Examples include: Lisa M. Given et al., “Watching Young Children ‘Play’ with Information Technology: Everyday Life Information Seeking in the Home,” Library and Information Science Research 38, no. 4 (2016): 344–52; Helena Känsäkoski and Maija-Leena Huotari, “Applying the Theory of Information Worlds Within a Health Care Practise in Finland,” Journal of Documentation 72, no. 2 (2016): 321–41; Reijo Savolainen, “Approaches to Socio-Cultural Barriers to Information Seeking,” Library and Information Science Research 38, no. 1 (2016): 52–59.

14. Examples include: Elham Sayyad Abdi, Helen Partridge, and Christine Bruce, “Web Designers and Developers’ Experience of Information Literacy: A Phenomenographic Study,” Library and Information Science Research 38, no. 4 (2016): 353–59; Rebecca Lea French and Kirsty Williamson, “The Information Practices of Welfare Workers: Conceptualizing and Modelling Information Bricolage,” Journal of Documentation 72, no. 4 (2016): 737–54; Ayse Göker et al., “Expeditions Through Image Jungles: The Commercial Use of Image Libraries in an Online Environment,” Journal of Documentation 72, no. 1 (2016): 5–23.

15. Examples related to each theme mentioned include: Nicolas Robinson-Garcia, Evaristo Jimenez-Contreras, and Daniel Torres-Salinas, “Analyzing Data Practices Using the Data Citation Index,” Journal of the Association for Information Science & Technology 67, no. 12 (2016): 2964–75; Angela Dresselhaus, “Literature of Acquisitions in Review, 2012–2013,” Library Resources & Technical Services 60, no. 3 (2016): 169–81; and Dian Walster, Deborah H. Charbonneau, and Kafi Kumasi, “Finding and Reading Reports of Research: How Academic Librarians Can Help Students Be More Successful,” Journal of Academic Librarianship 42, no. 6 (2016): 732–38.

16. Examples include: Cheryl D. Bain et al., “Using WorldShare Collection Evaluation to Analyze Physical Science and Engineering Monograph Holdings by Discipline,” Collection Management 41, no. 3 (2016): 133–51; Michael Hughes, “A Long-Term Study of Collection Use Based on Detailed Library of Congress Classification, a Statistical Tool for Collection Management Decisions,” Collection Management 41, no. 3 (2016): 152–67; Blanca Rodriguez-Bravo and Francisco Rodriguez-Sedano, “Trends in Library Collection Circulation in Spanish Universities,” Library Resources & Technical Services 60, no. 4 (2016): 248–58.

17. Examples include: Kelsey Renee Brett, Ashley Lierman, and Cherie Turner, “Lessons Learned: A Primo Usability Study,” Information Technology and Libraries 35, no. 1 (2016): 7–25; Reese Hoi Yin Fung, Dickson K.W. Chiu, Eddie H.T. Ko, Kevin K.W. Ho, and Patrick Lo, “Heuristic Usability Evaluation of University of Hong Kong Libraries’ Mobile Website,” Journal of Academic Librarianship 42, no. 5 (2016): 581–94; Joanne Oud, “Accessibility of Vendor-Created Database Tutorials for People with Disabilities,” Information Technology and Libraries 35, no. 4 (2016): 7–18; Kyunghye Yoon et al., “An Exploratory Study of Library Website Accessibility for Visually Impaired Users,” Library & Information Science Research 38, no. 3 (2016): 250–58.

18. Examples include: Çağrı Imamoğlu and Meltem Ö. Gürel, “‘Good Fences Make Good Neighbors’: Territorial Dividers Increase User Satisfaction and Efficiency in Library Study Spaces,” Journal of Academic Librarianship 42, no. 1 (2016): 65–73; Vera Lux, Robert J. Snyder, and Colleen Boff, “Why Users Come to the Library: A Case Study of Library and Non-Library Units,” Journal of Academic Librarianship 42, no. 2 (2016): 109–17; Silas M. Oliveira, “Space Preferences at James White Library: What Students Really Want,” Journal of Academic Librarianship 42, no. 4 (2016): 355–67.

19. Examples include: Edward Kai Fung Dang, Robert W.P. Luk, and James Allan, “A Context-Dependent Relevance Model,” Journal of the Association for Information Science & Technology 67, no. 3 (2016): 582–93; Bo Xu, Hongfei Lin, and Yuan Lin, “Assessment of Learning to Rank Methods for Query Expansion,” Journal of the Association for Information Science & Technology 67, no. 6 (2016): 1345–57.

20. Gloria J. Leckie, (1996). “Desperately Seeking Citations: Uncovering Faculty Assumptions About the Undergraduate Research Process,” Journal of Academic Librarianship 22, no. 3 (1996): 201–08.

21. Claire Warwick et al., “Cognitive Economy and Satisficing in Information Seeking: A Longitudinal Study of Undergraduate Information Behavior,” Journal of the American Society for Information Science & Technology 60, no. 12 (2009): 2402–15.

22. James P. Purdy, “Why First-Year College Students Select Online Research Resources as Their Favorite,” First Monday 17, no. 9 (2012).

23. Kyung-Sun Kim and Sei-Ching Joanna Sin, “Selecting Quality Sources: Bridging the Gap Between the Perception and Use of Information Sources,” Journal of Information Science 37, no. 2 (2011): 178–88.

24. Allison J. Head, Michele Van Hoeck, Jordan Eschler, and Sean Fullerton, “What Information Competencies Matter in Today’s Workplace?” Library and Information Research 37, no. 114 (2013): 75–104.

25. Barbara Fister, “Teaching the Rhetorical Dimensions of Research,” Research Strategies 11, no. 4 (1993): 211–19.

26. Jeanne R. Davidson and Carole Anne Crateau. “Intersections: Teaching Research Through a Rhetorical Lens,” Research Strategies 16, no. 4 (1998): 245–57.

27. Michelle Holschuh Simmons, “Librarians as Disciplinary Discourse Mediators: Using Genre Theory to Move toward Critical Information Literacy,” portal: Libraries and the Academy 5, no. 3 (2005): 297–311.

28. Benjamin R. Harris, “Communities as Necessity in Information Literacy Development: Challenging the Standards,” Journal of Academic Librarianship 34, no. 3 (2008): 250.

29. Allison Faix, “Assisting Students to Identify Sources: An Investigation,” Library Review 53, no. 8/9 (2014): 624–36.

30. Doug Brent, “Crossing Boundaries: Co-Op Students Relearning to Write,” College Composition and Communication 63, no. 4 (2012): 558–92; Sarah North, “Different Values, Different Skills? A Comparison of Essay Writing by Students from Arts and Science Backgrounds,” Studies in Higher Education 30, no. 5 (2005): 517–33.

31. Jens B. Asendorpf et al., “Recommendations for Increasing Replicability in Psychology,” European Journal of Personality 27, no. 2 (2013): 108–19.

32. Examples include: Shane W. Bench et al., “Does Expertise Matter in Replication? An Examination of the Reproducibility Project: Psychology,” Journal of Experimental Social Psychology 68 (2017): 181–84; and Alexander Etz and Joachim Vandekerckhove, “A Bayesian Perspective on the Reproducibility Project: Psychology,” Plos One 11, no. 2 (2016): 1–12.

33. Wolfgang Stroebe, “Are Most Published Social Psychological Findings False?” Journal of Experimental Social Psychology 66 (2016): 134–44.

34. Examples include: Mark J. Brandt et al., “The Replication Recipe: What Makes for a Convincing Replication?” Journal of Experimental Social Psychology 50 (2014): 217–24; and Sean Grant, Lukasz Cybulski, and Evan Mayo-Wilson, “Improving Transparency and Reproducibility through Registration: The Status of Intervention Trials Published in Clinical Psychology Journals,” Journal of Consulting and Clinical Psychology 84, no. 9 (2016): 753–67.

35. Uri Simonsohn, “Small Telescopes: Detectability and the Evaluation of Replication Results,” Psychological Science 26, no. 5 (2015): 559–69.

36. Timothy M. Errington et al., “Science Forum: An Open Investigation of the Reproducibility of Cancer Biology Research,” eLife 3 (2014).

37. Shirley J. Behrens, “A Conceptual Analysis and Historical Overview of Information Literacy,” College & Research Libraries 55, no. 4 (1994): 309–22; Frances L. Hopkins, “A Century of Bibliographyic Instruction: The Historical Claim to Professional and Academic Legitimacy,” College & Research Libraries 43, no. 3 (1982): 192–98; Mary F. Salony, “The History of Bibliographic Instruction: Changing Trends From Books to the Electronic World,” Reference Librarian 24, no. 51 (1995): 31–51.

38. Emily Drabinski, “Toward a Kairos of Library Instruction,” Journal of Academic Librarianship 40, no. 5 (2014): 480–85; Heidi L.M. Jacobs, “Information Literacy and Reflective Pedagogical Praxis,” Journal of Academic Librarianship 34, no. 3 (2008): 256–62.

39. ACRL Standards , “Information Literacy and Assessment.”

40. Notable examples of such thinking include: James Elmborg, “Critical Information Literacy: Implications for Instructional Practice,” Journal of Academic Librarianship 32, no. 2 (2006): 192–99; Edward K. Owusu-Ansah, “Information Literacy and the Academic Library: A Critical Look at a Concept and the Controversies Surrounding It,” Journal of Academic Librarianship 29, no. 4 (2003): 219–30; Troy A. Swanson, “Applying a Critical Pedagogical Perspective to Information Literacy Standards,” Community & Junior College Libraries 12, no. 4 (2004): 65–78: Eamon Tewell, “A Decade of Critical Information Literacy: A Review of the Literature,” Communications in Information Literacy 9, no. 1 (2015): 24–43.

41. ACRL Standards , “Information Literacy Defined”; ACRL Standards , “Information Literacy and Higher Education.”

42. Examples include: Brent, “Crossing Boundaries”; Jason Eyre, “Context and Learning: The Value and Limits of Library-Based Information Literacy Teaching,” Health Information and Libraries Journal 29, no. 4 (2012): 344–48; and Kaye Towlson and Nathan Rush, “Carving the Information Literacy Niche Within Graduate Employability ,” New Review of Academic Librarianship 19, no. 3 (2013): 300–15.

43. Amy E. Mark, “Privileging Peer Review: Implications for Undergraduates ,” Communications in Information Literacy 5, no. 1 (2011): 4–8.

44. Association of American Colleges & Universities, “Information Literacy VALUE Rubric” (2010), available online at https://www.aacu.org/value/rubrics/information-literacy [accessed 23 January 2018]; Middle States Association of Colleges and Schools Commission on Higher Education, Developing Research & Communication Skills: Guidelines for Information Literacy Instruction (Philadelphia: Middle States Commission on Higher Education, 2003).

45. Paul L. Hrycaj, “An Analysis of Online Syllabi for Credit-Bearing Library Skills Courses,” College & Research Libraries 67, no. 6 (2006): 525–35; Rachael E. Elrod, Elise D. Wallace, and Cecilia B. Sirigos, “Teaching Information Literacy: A Review of 100 Syllabi,” Southeastern Librarian 60, no. 3 (2012): 8–15.

46. Amy R. Hofer, Lori Townsend, and Korey Brunetti, “Troublesome Concepts and Information Literacy: Investigating Threshold Concepts for IL Instruction,” portal: Libraries and the Academy 12, no. 4 (2012): 387–405.

47. Shelley Gullikson, “Faculty Perceptions of ACRL’s Information Literacy Competency Standards for Higher Education,” Journal of Academic Librarianship 32, no. 6 (2006): 583–92.

48. Rolf Norgaard, “Writing Information Literacy: Contributions to a Concept,” Reference & User Services Quarterly 43, no. 2 (2003): 126.

49. ACRL Framework , “Introduction.”

50. Nancy M. Foasberg, “From Standards to Frameworks for IL: How the ACRL Framework Addresses Critiques of the Standards ,” portal: Libraries and the Academy 15, no. 4 (2015): 708.

51. ACRL Framework , “Introduction.”

52. Elizabeth Wardle and Linda Adler-Kassner, “Naming What We Know: The Project of This Book,” in Naming What We Know: Threshold Concepts of Writing Studies, eds. Linda Adler-Kassner and Elizabeth Wardle (Boulder: University Press of Colorado, 2015), 8.

53. William Badke, “A Rationale for Information Literacy as a Credit-Bearing Discipline ,” Journal of Information Literacy 2, no. 1 (2008).

54. Sommers and Saltz, “The Novice as Expert,” 132.

55. Amy J. Devitt, Writing Genres (Carbondale: Southern Illinois University Press, 2004).

56. Martin Luther King, Jr., Letter from a Birmingham Jail , available online at https://kinginstitute.stanford.edu/king-papers/documents/letter-birmingham-jail [accessed 23 January 2018].

57. Robert J. Connors, “The Rise and Fall of the Modes of Discourse,” College Composition and Communication 32, no. 4 (1981): 444–55.

58. George Hillocks, Jr., “The Focus on Form vs. Content in Teaching Writing,” Research in the Teaching of English 40, no. 2 (2005): 238–48.

59. Richard Feinberg and Christine King, “Short-Term Library Skill Competencies: Arguing for the Achievable,” College & Research Libraries 49, no. 1 (1988): 24–28.

60. Lori Townsend, Korey Brunetti, and Amy R. Hofer, “Threshold Concepts and Information Literacy,” portal: Libraries and the Academy 11, no. 3 (2011): 853–69.

61. Ian Beilin, “Beyond the Threshold: Conformity, Resistance, and the ACRL Information Literacy Framework for Higher Education,” In the Library with the Lead Pipe (Feb. 25, 2015), available online at www.inthelibrarywiththeleadpipe.org/2015/beyond-the-threshold-conformity-resistance-and-the-aclr-information-literacy-framework-for-higher-education/ [accessed 26 October 2018].

62. Christine Pawley, “Information Literacy: A Contradictory Coupling,” Library Quarterly 73, no. 4 (2003): 422–52.

63. Simmons, “Librarians as Disciplinary Discourse Mediators,” 302.

64. Wardle and Adler-Kassner, “Metaconcept,” 16.

* Allison Hosier is Information Literacy Librarian in the University Libraries at the University at Albany, State University of New York; email: [email protected] . ©2019 Allison Hosier, Attribution-NonCommercial ( http://creativecommons.org/licenses/by-nc/4.0/ ) CC BY-NC.

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Home » Scope of the Research – Writing Guide and Examples

Scope of the Research – Writing Guide and Examples

Table of Contents

Scope of the Research

Scope of research refers to the range of topics, areas, and subjects that a research project intends to cover. It is the extent and limitations of the study, defining what is included and excluded in the research.

The scope of a research project depends on various factors, such as the research questions , objectives , methodology, and available resources. It is essential to define the scope of the research project clearly to avoid confusion and ensure that the study addresses the intended research questions.

How to Write Scope of the Research

Writing the scope of the research involves identifying the specific boundaries and limitations of the study. Here are some steps you can follow to write a clear and concise scope of the research:

• Identify the research question: Start by identifying the specific question that you want to answer through your research . This will help you focus your research and define the scope more clearly.
• Define the objectives: Once you have identified the research question, define the objectives of your study. What specific goals do you want to achieve through your research?
• Determine the population and sample: Identify the population or group of people that you will be studying, as well as the sample size and selection criteria. This will help you narrow down the scope of your research and ensure that your findings are applicable to the intended audience.
• Identify the variables: Determine the variables that will be measured or analyzed in your research. This could include demographic variables, independent variables , dependent variables , or any other relevant factors.
• Define the timeframe: Determine the timeframe for your study, including the start and end date, as well as any specific time intervals that will be measured.
• Determine the geographical scope: If your research is location-specific, define the geographical scope of your study. This could include specific regions, cities, or neighborhoods that you will be focusing on.
• Outline the limitations: Finally, outline any limitations or constraints of your research, such as time, resources, or access to data. This will help readers understand the scope and applicability of your research findings.

Examples of the Scope of the Research

Some Examples of the Scope of the Research are as follows:

Title : “Investigating the impact of artificial intelligence on job automation in the IT industry”

Scope of Research:

This study aims to explore the impact of artificial intelligence on job automation in the IT industry. The research will involve a qualitative analysis of job postings, identifying tasks that can be automated using AI. The study will also assess the potential implications of job automation on the workforce, including job displacement, job creation, and changes in job requirements.

Title : “Developing a machine learning model for predicting cyberattacks on corporate networks”

This study will develop a machine learning model for predicting cyberattacks on corporate networks. The research will involve collecting and analyzing network traffic data, identifying patterns and trends that are indicative of cyberattacks. The study aims to build an accurate and reliable predictive model that can help organizations identify and prevent cyberattacks before they occur.

Title: “Assessing the usability of a mobile app for managing personal finances”

This study will assess the usability of a mobile app for managing personal finances. The research will involve conducting a usability test with a group of participants, evaluating the app’s ease of use, efficiency, and user satisfaction. The study aims to identify areas of the app that need improvement, and to provide recommendations for enhancing its usability and user experience.

Title : “Exploring the effects of mindfulness meditation on stress reduction among college students”

This study aims to investigate the impact of mindfulness meditation on reducing stress levels among college students. The research will involve a randomized controlled trial with two groups: a treatment group that receives mindfulness meditation training and a control group that receives no intervention. The study will examine changes in stress levels, as measured by self-report questionnaires, before and after the intervention.

Title: “Investigating the impact of social media on body image dissatisfaction among young adults”

This study will explore the relationship between social media use and body image dissatisfaction among young adults. The research will involve a cross-sectional survey of participants aged 18-25, assessing their social media use, body image perceptions, and self-esteem. The study aims to identify any correlations between social media use and body image dissatisfaction, and to determine if certain social media platforms or types of content are particularly harmful.

When to Write Scope of the Research

Here is a guide on When to Write the Scope of the Research:

• Before starting your research project, it’s important to clearly define the scope of your study. This will help you stay focused on your research question and avoid getting sidetracked by irrelevant information.
• The scope of the research should be determined by the research question or problem statement. It should outline what you intend to investigate and what you will not be investigating.
• The scope should also take into consideration any limitations of the study, such as time, resources, or access to data. This will help you realistically plan and execute your research.
• Writing the scope of the research early in the research process can also help you refine your research question and identify any gaps in the existing literature that your study can address.
• It’s important to revisit the scope of the research throughout the research process to ensure that you stay on track and make any necessary adjustments.
• The scope of the research should be clearly communicated in the research proposal or study protocol to ensure that all stakeholders are aware of the research objectives and limitations.
• The scope of the research should also be reflected in the research design, methods, and analysis plan. This will ensure that the research is conducted in a systematic and rigorous manner that is aligned with the research objectives.
• The scope of the research should be written in a clear and concise manner, using language that is accessible to all stakeholders, including those who may not be familiar with the research topic or methodology.
• When writing the scope of the research, it’s important to be transparent about any assumptions or biases that may influence the research findings. This will help ensure that the research is conducted in an ethical and responsible manner.
• The scope of the research should be reviewed and approved by the research supervisor, committee members, or other relevant stakeholders. This will ensure that the research is feasible, relevant, and contributes to the field of study.
• Finally, the scope of the research should be clearly stated in the research report or dissertation to provide context for the research findings and conclusions. This will help readers understand the significance of the research and its contribution to the field of study.

Purpose of Scope of the Research

Purposes of Scope of the Research are as follows:

• Defines the boundaries and extent of the study.
• Determines the specific objectives and research questions to be addressed.
• Provides direction and focus for the research.
• Helps to identify the relevant theories, concepts, and variables to be studied.
• Enables the researcher to select the appropriate research methodology and techniques.
• Allows for the allocation of resources (time, money, personnel) to the research.
• Establishes the criteria for the selection of the sample and data collection methods.
• Facilitates the interpretation and generalization of the results.
• Ensures the ethical considerations and constraints are addressed.
• Provides a framework for the presentation and dissemination of the research findings.

Advantages of Scope of the Research

Here are some advantages of having a well-defined scope of research:

• Provides clarity and focus: Defining the scope of research helps to provide clarity and focus to the study. This ensures that the research stays on track and does not deviate from its intended purpose.
• Helps to manage resources: Knowing the scope of research allows researchers to allocate resources effectively. This includes managing time, budget, and personnel required to conduct the study.
• Improves the quality of research: A well-defined scope of research helps to ensure that the study is designed to achieve specific objectives. This helps to improve the quality of the research by reducing the likelihood of errors or bias.
• Facilitates communication: A clear scope of research enables researchers to communicate the goals and objectives of the study to stakeholders, such as funding agencies or participants. This facilitates understanding and enhances cooperation.
• Enables replication : A well-defined scope of research makes it easier to replicate the study in the future. This allows other researchers to validate the findings and build upon them, leading to the advancement of knowledge in the field.
• Increases the relevance of research: Defining the scope of research helps to ensure that the study is relevant to the problem or issue being investigated. This increases the likelihood that the findings will be useful and applicable to real-world situations.
• Reduces the risk of scope creep : Scope creep occurs when the research expands beyond the original scope, leading to an increase in the time, cost, and resources required to complete the study. A clear definition of the scope of research helps to reduce the risk of scope creep by establishing boundaries and limitations.
• Enhances the credibility of research: A well-defined scope of research helps to enhance the credibility of the study by ensuring that it is designed to achieve specific objectives and answer specific research questions. This makes it easier for others to assess the validity and reliability of the study.
• Provides a framework for decision-making : A clear scope of research provides a framework for decision-making throughout the research process. This includes decisions related to data collection, analysis, and interpretation.

Scope of the Research Vs Scope of the Project

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• What Is a Research Design | Types, Guide & Examples

What Is a Research Design | Types, Guide & Examples

Published on June 7, 2021 by Shona McCombes . Revised on November 20, 2023 by Pritha Bhandari.

A research design is a strategy for answering your   research question  using empirical data. Creating a research design means making decisions about:

• Your overall research objectives and approach
• Whether you’ll rely on primary research or secondary research
• Your sampling methods or criteria for selecting subjects
• Your data collection methods
• The procedures you’ll follow to collect data
• Your data analysis methods

A well-planned research design helps ensure that your methods match your research objectives and that you use the right kind of analysis for your data.

Table of contents

Step 1: consider your aims and approach, step 2: choose a type of research design, step 3: identify your population and sampling method, step 4: choose your data collection methods, step 5: plan your data collection procedures, step 6: decide on your data analysis strategies, other interesting articles, frequently asked questions about research design.

• Introduction

Before you can start designing your research, you should already have a clear idea of the research question you want to investigate.

There are many different ways you could go about answering this question. Your research design choices should be driven by your aims and priorities—start by thinking carefully about what you want to achieve.

The first choice you need to make is whether you’ll take a qualitative or quantitative approach.

Qualitative research designs tend to be more flexible and inductive , allowing you to adjust your approach based on what you find throughout the research process.

Quantitative research designs tend to be more fixed and deductive , with variables and hypotheses clearly defined in advance of data collection.

It’s also possible to use a mixed-methods design that integrates aspects of both approaches. By combining qualitative and quantitative insights, you can gain a more complete picture of the problem you’re studying and strengthen the credibility of your conclusions.

Practical and ethical considerations when designing research

As well as scientific considerations, you need to think practically when designing your research. If your research involves people or animals, you also need to consider research ethics .

• How much time do you have to collect data and write up the research?
• Will you be able to gain access to the data you need (e.g., by travelling to a specific location or contacting specific people)?
• Do you have the necessary research skills (e.g., statistical analysis or interview techniques)?
• Will you need ethical approval ?

At each stage of the research design process, make sure that your choices are practically feasible.

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Within both qualitative and quantitative approaches, there are several types of research design to choose from. Each type provides a framework for the overall shape of your research.

Types of quantitative research designs

Quantitative designs can be split into four main types.

• Experimental and   quasi-experimental designs allow you to test cause-and-effect relationships
• Descriptive and correlational designs allow you to measure variables and describe relationships between them.

With descriptive and correlational designs, you can get a clear picture of characteristics, trends and relationships as they exist in the real world. However, you can’t draw conclusions about cause and effect (because correlation doesn’t imply causation ).

Experiments are the strongest way to test cause-and-effect relationships without the risk of other variables influencing the results. However, their controlled conditions may not always reflect how things work in the real world. They’re often also more difficult and expensive to implement.

Types of qualitative research designs

Qualitative designs are less strictly defined. This approach is about gaining a rich, detailed understanding of a specific context or phenomenon, and you can often be more creative and flexible in designing your research.

The table below shows some common types of qualitative design. They often have similar approaches in terms of data collection, but focus on different aspects when analyzing the data.

Your research design should clearly define who or what your research will focus on, and how you’ll go about choosing your participants or subjects.

In research, a population is the entire group that you want to draw conclusions about, while a sample is the smaller group of individuals you’ll actually collect data from.

Defining the population

A population can be made up of anything you want to study—plants, animals, organizations, texts, countries, etc. In the social sciences, it most often refers to a group of people.

For example, will you focus on people from a specific demographic, region or background? Are you interested in people with a certain job or medical condition, or users of a particular product?

The more precisely you define your population, the easier it will be to gather a representative sample.

• Sampling methods

Even with a narrowly defined population, it’s rarely possible to collect data from every individual. Instead, you’ll collect data from a sample.

To select a sample, there are two main approaches: probability sampling and non-probability sampling . The sampling method you use affects how confidently you can generalize your results to the population as a whole.

Probability sampling is the most statistically valid option, but it’s often difficult to achieve unless you’re dealing with a very small and accessible population.

For practical reasons, many studies use non-probability sampling, but it’s important to be aware of the limitations and carefully consider potential biases. You should always make an effort to gather a sample that’s as representative as possible of the population.

Case selection in qualitative research

In some types of qualitative designs, sampling may not be relevant.

For example, in an ethnography or a case study , your aim is to deeply understand a specific context, not to generalize to a population. Instead of sampling, you may simply aim to collect as much data as possible about the context you are studying.

In these types of design, you still have to carefully consider your choice of case or community. You should have a clear rationale for why this particular case is suitable for answering your research question .

For example, you might choose a case study that reveals an unusual or neglected aspect of your research problem, or you might choose several very similar or very different cases in order to compare them.

Data collection methods are ways of directly measuring variables and gathering information. They allow you to gain first-hand knowledge and original insights into your research problem.

You can choose just one data collection method, or use several methods in the same study.

Survey methods

Surveys allow you to collect data about opinions, behaviors, experiences, and characteristics by asking people directly. There are two main survey methods to choose from: questionnaires and interviews .

Observation methods

Observational studies allow you to collect data unobtrusively, observing characteristics, behaviors or social interactions without relying on self-reporting.

Observations may be conducted in real time, taking notes as you observe, or you might make audiovisual recordings for later analysis. They can be qualitative or quantitative.

Other methods of data collection

There are many other ways you might collect data depending on your field and topic.

If you’re not sure which methods will work best for your research design, try reading some papers in your field to see what kinds of data collection methods they used.

Secondary data

If you don’t have the time or resources to collect data from the population you’re interested in, you can also choose to use secondary data that other researchers already collected—for example, datasets from government surveys or previous studies on your topic.

With this raw data, you can do your own analysis to answer new research questions that weren’t addressed by the original study.

Using secondary data can expand the scope of your research, as you may be able to access much larger and more varied samples than you could collect yourself.

However, it also means you don’t have any control over which variables to measure or how to measure them, so the conclusions you can draw may be limited.

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As well as deciding on your methods, you need to plan exactly how you’ll use these methods to collect data that’s consistent, accurate, and unbiased.

Planning systematic procedures is especially important in quantitative research, where you need to precisely define your variables and ensure your measurements are high in reliability and validity.

Operationalization

Some variables, like height or age, are easily measured. But often you’ll be dealing with more abstract concepts, like satisfaction, anxiety, or competence. Operationalization means turning these fuzzy ideas into measurable indicators.

If you’re using observations , which events or actions will you count?

If you’re using surveys , which questions will you ask and what range of responses will be offered?

You may also choose to use or adapt existing materials designed to measure the concept you’re interested in—for example, questionnaires or inventories whose reliability and validity has already been established.

Reliability and validity

Reliability means your results can be consistently reproduced, while validity means that you’re actually measuring the concept you’re interested in.

For valid and reliable results, your measurement materials should be thoroughly researched and carefully designed. Plan your procedures to make sure you carry out the same steps in the same way for each participant.

If you’re developing a new questionnaire or other instrument to measure a specific concept, running a pilot study allows you to check its validity and reliability in advance.

Sampling procedures

As well as choosing an appropriate sampling method , you need a concrete plan for how you’ll actually contact and recruit your selected sample.

That means making decisions about things like:

• How many participants do you need for an adequate sample size?
• What inclusion and exclusion criteria will you use to identify eligible participants?
• How will you contact your sample—by mail, online, by phone, or in person?

If you’re using a probability sampling method , it’s important that everyone who is randomly selected actually participates in the study. How will you ensure a high response rate?

If you’re using a non-probability method , how will you avoid research bias and ensure a representative sample?

Data management

It’s also important to create a data management plan for organizing and storing your data.

Will you need to transcribe interviews or perform data entry for observations? You should anonymize and safeguard any sensitive data, and make sure it’s backed up regularly.

Keeping your data well-organized will save time when it comes to analyzing it. It can also help other researchers validate and add to your findings (high replicability ).

On its own, raw data can’t answer your research question. The last step of designing your research is planning how you’ll analyze the data.

Quantitative data analysis

In quantitative research, you’ll most likely use some form of statistical analysis . With statistics, you can summarize your sample data, make estimates, and test hypotheses.

Using descriptive statistics , you can summarize your sample data in terms of:

• The distribution of the data (e.g., the frequency of each score on a test)
• The central tendency of the data (e.g., the mean to describe the average score)
• The variability of the data (e.g., the standard deviation to describe how spread out the scores are)

The specific calculations you can do depend on the level of measurement of your variables.

Using inferential statistics , you can:

• Make estimates about the population based on your sample data.
• Test hypotheses about a relationship between variables.

Regression and correlation tests look for associations between two or more variables, while comparison tests (such as t tests and ANOVAs ) look for differences in the outcomes of different groups.

Your choice of statistical test depends on various aspects of your research design, including the types of variables you’re dealing with and the distribution of your data.

Qualitative data analysis

In qualitative research, your data will usually be very dense with information and ideas. Instead of summing it up in numbers, you’ll need to comb through the data in detail, interpret its meanings, identify patterns, and extract the parts that are most relevant to your research question.

Two of the most common approaches to doing this are thematic analysis and discourse analysis .

There are many other ways of analyzing qualitative data depending on the aims of your research. To get a sense of potential approaches, try reading some qualitative research papers in your field.

If you want to know more about the research process , methodology , research bias , or statistics , make sure to check out some of our other articles with explanations and examples.

• Simple random sampling
• Stratified sampling
• Cluster sampling
• Likert scales
• Reproducibility

 Statistics

• Null hypothesis
• Statistical power
• Probability distribution
• Effect size
• Poisson distribution

Research bias

• Optimism bias
• Cognitive bias
• Implicit bias
• Hawthorne effect
• Anchoring bias
• Explicit bias

A research design is a strategy for answering your   research question . It defines your overall approach and determines how you will collect and analyze data.

A well-planned research design helps ensure that your methods match your research aims, that you collect high-quality data, and that you use the right kind of analysis to answer your questions, utilizing credible sources . This allows you to draw valid , trustworthy conclusions.

Quantitative research designs can be divided into two main categories:

• Correlational and descriptive designs are used to investigate characteristics, averages, trends, and associations between variables.
• Experimental and quasi-experimental designs are used to test causal relationships .

Qualitative research designs tend to be more flexible. Common types of qualitative design include case study , ethnography , and grounded theory designs.

The priorities of a research design can vary depending on the field, but you usually have to specify:

• Your research questions and/or hypotheses
• Your overall approach (e.g., qualitative or quantitative )
• The type of design you’re using (e.g., a survey , experiment , or case study )
• Your data collection methods (e.g., questionnaires , observations)
• Your data collection procedures (e.g., operationalization , timing and data management)
• Your data analysis methods (e.g., statistical tests  or thematic analysis )

A sample is a subset of individuals from a larger population . Sampling means selecting the group that you will actually collect data from in your research. For example, if you are researching the opinions of students in your university, you could survey a sample of 100 students.

In statistics, sampling allows you to test a hypothesis about the characteristics of a population.

Operationalization means turning abstract conceptual ideas into measurable observations.

For example, the concept of social anxiety isn’t directly observable, but it can be operationally defined in terms of self-rating scores, behavioral avoidance of crowded places, or physical anxiety symptoms in social situations.

Before collecting data , it’s important to consider how you will operationalize the variables that you want to measure.

A research project is an academic, scientific, or professional undertaking to answer a research question . Research projects can take many forms, such as qualitative or quantitative , descriptive , longitudinal , experimental , or correlational . What kind of research approach you choose will depend on your topic.

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Home Market Research

What is Research: Definition, Methods, Types & Examples

The search for knowledge is closely linked to the object of study; that is, to the reconstruction of the facts that will provide an explanation to an observed event and that at first sight can be considered as a problem. It is very human to seek answers and satisfy our curiosity. Let’s talk about research.

Content Index

What is Research?

What are the characteristics of research.

• Comparative analysis chart

Qualitative methods

Quantitative methods, 8 tips for conducting accurate research.

Research is the careful consideration of study regarding a particular concern or research problem using scientific methods. According to the American sociologist Earl Robert Babbie, “research is a systematic inquiry to describe, explain, predict, and control the observed phenomenon. It involves inductive and deductive methods.”

Inductive methods analyze an observed event, while deductive methods verify the observed event. Inductive approaches are associated with qualitative research , and deductive methods are more commonly associated with quantitative analysis .

Research is conducted with a purpose to:

• Identify potential and new customers
• Understand existing customers
• Set pragmatic goals
• Develop productive market strategies
• Address business challenges
• Put together a business expansion plan
• Identify new business opportunities
• Good research follows a systematic approach to capture accurate data. Researchers need to practice ethics and a code of conduct while making observations or drawing conclusions.
• The analysis is based on logical reasoning and involves both inductive and deductive methods.
• Real-time data and knowledge is derived from actual observations in natural settings.
• There is an in-depth analysis of all data collected so that there are no anomalies associated with it.
• It creates a path for generating new questions. Existing data helps create more research opportunities.
• It is analytical and uses all the available data so that there is no ambiguity in inference.
• Accuracy is one of the most critical aspects of research. The information must be accurate and correct. For example, laboratories provide a controlled environment to collect data. Accuracy is measured in the instruments used, the calibrations of instruments or tools, and the experiment’s final result.

What is the purpose of research?

There are three main purposes:

• Exploratory: As the name suggests, researchers conduct exploratory studies to explore a group of questions. The answers and analytics may not offer a conclusion to the perceived problem. It is undertaken to handle new problem areas that haven’t been explored before. This exploratory data analysis process lays the foundation for more conclusive data collection and analysis.

LEARN ABOUT: Descriptive Analysis

• Descriptive: It focuses on expanding knowledge on current issues through a process of data collection. Descriptive research describe the behavior of a sample population. Only one variable is required to conduct the study. The three primary purposes of descriptive studies are describing, explaining, and validating the findings. For example, a study conducted to know if top-level management leaders in the 21st century possess the moral right to receive a considerable sum of money from the company profit.

LEARN ABOUT: Best Data Collection Tools

• Explanatory: Causal research or explanatory research is conducted to understand the impact of specific changes in existing standard procedures. Running experiments is the most popular form. For example, a study that is conducted to understand the effect of rebranding on customer loyalty.

Here is a comparative analysis chart for a better understanding:

It begins by asking the right questions and choosing an appropriate method to investigate the problem. After collecting answers to your questions, you can analyze the findings or observations to draw reasonable conclusions.

When it comes to customers and market studies, the more thorough your questions, the better the analysis. You get essential insights into brand perception and product needs by thoroughly collecting customer data through surveys and questionnaires . You can use this data to make smart decisions about your marketing strategies to position your business effectively.

To make sense of your study and get insights faster, it helps to use a research repository as a single source of truth in your organization and manage your research data in one centralized data repository .

Types of research methods and Examples

Research methods are broadly classified as Qualitative and Quantitative .

Both methods have distinctive properties and data collection methods .

Qualitative research is a method that collects data using conversational methods, usually open-ended questions . The responses collected are essentially non-numerical. This method helps a researcher understand what participants think and why they think in a particular way.

Types of qualitative methods include:

• One-to-one Interview
• Focus Groups
• Ethnographic studies
• Text Analysis

Quantitative methods deal with numbers and measurable forms . It uses a systematic way of investigating events or data. It answers questions to justify relationships with measurable variables to either explain, predict, or control a phenomenon.

Types of quantitative methods include:

• Survey research
• Descriptive research
• Correlational research

LEARN MORE: Descriptive Research vs Correlational Research

Remember, it is only valuable and useful when it is valid, accurate, and reliable. Incorrect results can lead to customer churn and a decrease in sales.

It is essential to ensure that your data is:

• Valid – founded, logical, rigorous, and impartial.
• Accurate – free of errors and including required details.
• Reliable – other people who investigate in the same way can produce similar results.
• Timely – current and collected within an appropriate time frame.
• Complete – includes all the data you need to support your business decisions.

Gather insights

• Identify the main trends and issues, opportunities, and problems you observe. Write a sentence describing each one.
• Keep track of the frequency with which each of the main findings appears.
• Make a list of your findings from the most common to the least common.
• Evaluate a list of the strengths, weaknesses, opportunities, and threats identified in a SWOT analysis .
• Prepare conclusions and recommendations about your study.
• Act on your strategies
• Look for gaps in the information, and consider doing additional inquiry if necessary
• Plan to review the results and consider efficient methods to analyze and interpret results.

Review your goals before making any conclusions about your study. Remember how the process you have completed and the data you have gathered help answer your questions. Ask yourself if what your analysis revealed facilitates the identification of your conclusions and recommendations.

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Research methods--quantitative, qualitative, and more: overview.

• Quantitative Research
• Qualitative Research
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About Research Methods

This guide provides an overview of research methods, how to choose and use them, and supports and resources at UC Berkeley. 

As Patten and Newhart note in the book Understanding Research Methods , "Research methods are the building blocks of the scientific enterprise. They are the "how" for building systematic knowledge. The accumulation of knowledge through research is by its nature a collective endeavor. Each well-designed study provides evidence that may support, amend, refute, or deepen the understanding of existing knowledge...Decisions are important throughout the practice of research and are designed to help researchers collect evidence that includes the full spectrum of the phenomenon under study, to maintain logical rules, and to mitigate or account for possible sources of bias. In many ways, learning research methods is learning how to see and make these decisions."

The choice of methods varies by discipline, by the kind of phenomenon being studied and the data being used to study it, by the technology available, and more.  This guide is an introduction, but if you don't see what you need here, always contact your subject librarian, and/or take a look to see if there's a library research guide that will answer your question. 

Suggestions for changes and additions to this guide are welcome! 

START HERE: SAGE Research Methods

Without question, the most comprehensive resource available from the library is SAGE Research Methods.  HERE IS THE ONLINE GUIDE  to this one-stop shopping collection, and some helpful links are below:

• SAGE Research Methods
• Little Green Books  (Quantitative Methods)
• Little Blue Books  (Qualitative Methods)
• Dictionaries and Encyclopedias  
• Case studies of real research projects
• Sample datasets for hands-on practice
• Streaming video--see methods come to life
• Methodspace- -a community for researchers
• SAGE Research Methods Course Mapping

Library Data Services at UC Berkeley

Library Data Services Program and Digital Scholarship Services

The LDSP offers a variety of services and tools !  From this link, check out pages for each of the following topics:  discovering data, managing data, collecting data, GIS data, text data mining, publishing data, digital scholarship, open science, and the Research Data Management Program.

Be sure also to check out the visual guide to where to seek assistance on campus with any research question you may have!

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Other Data Services at Berkeley

D-Lab Supports Berkeley faculty, staff, and graduate students with research in data intensive social science, including a wide range of training and workshop offerings Dryad Dryad is a simple self-service tool for researchers to use in publishing their datasets. It provides tools for the effective publication of and access to research data. Geospatial Innovation Facility (GIF) Provides leadership and training across a broad array of integrated mapping technologies on campu Research Data Management A UC Berkeley guide and consulting service for research data management issues

General Research Methods Resources

Here are some general resources for assistance:

• Assistance from ICPSR (must create an account to access): Getting Help with Data , and Resources for Students
• Wiley Stats Ref for background information on statistics topics
• Survey Documentation and Analysis (SDA) .  Program for easy web-based analysis of survey data.

Consultants

• D-Lab/Data Science Discovery Consultants Request help with your research project from peer consultants.
• Research data (RDM) consulting Meet with RDM consultants before designing the data security, storage, and sharing aspects of your qualitative project.
• Statistics Department Consulting Services A service in which advanced graduate students, under faculty supervision, are available to consult during specified hours in the Fall and Spring semesters.

Related Resourcex

• IRB / CPHS Qualitative research projects with human subjects often require that you go through an ethics review.
• OURS (Office of Undergraduate Research and Scholarships) OURS supports undergraduates who want to embark on research projects and assistantships. In particular, check out their "Getting Started in Research" workshops
• Sponsored Projects Sponsored projects works with researchers applying for major external grants.
• Next: Quantitative Research >>
• Last Updated: Apr 25, 2024 11:09 AM
• URL: https://guides.lib.berkeley.edu/researchmethods

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How to appropriately choose research subjects

Affiliation.

• 1 Consulting Center of Biomedical Statistics, Academy of Military Medical Sciences, Beijing 100850, China. [email protected]
• PMID: 21419075
• DOI: 10.3736/jcim20110303

The research subject is the first key element of the three key elements in the research design. An appropriate selection of research subjects is crucial to the success of the research. This article summarizes the general principles for the selection of research subjects, the types and numbers of research subjects and the common mistakes that researchers tend to make in the selection of the research subjects. This article also provides the methodology suggestions for the selection of research subjects.

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What is the difference between "subject" and "object" of study/research?

Let's say that I collected data on a person: his favourites, character, attributes, behaviour, etc. Was he the subject or object of my study/research?

Next, I collect data on an ethnic community: their culture. Is this ethnic community the subject or the object of my study/research?

Finally, I will collect data on a mountain (non-living): it's height, it's history, etc. Will this mountain be the subject or the object of my study/research?

I looked up the two words in an Oxford dictionary and I found similar meanings:

• Subject : a person or thing that is being discussed, described, or dealt with. "I've said all there is to be said on the subject"
• Object : a person or thing to which a specified action or feeling is directed. "disease became the object of investigation"

• They are more or less interchangable, but subject is more common in my experience. –  Justin Nov 10, 2020 at 12:48

I had the same question. It's a strange shift of meanings, and it doesn't end with scientific research. "Subject" also means "a person ruled over by another, especially a monarch or state authority" ( Wiktionary ), but since it is ruled over we can say it's actually an object.

I couldn't find any research on this point. But I figured out some arguments myself:

Use "subject" when you passively observe it. Use "object" when you actively affect it and change its behavior.

Yes, an object is "a person or thing to which a specified action is directed". But just an observation is hardly counts as an action. If a person continues to act by his own will and you just register its behavior then he is still a subject. He continues to do it regardless of your presence and observation.

The same argument applies to communities. And it can be extended to a mountain too. Until you perform some actions to change the natural order of things (e.g. you detonate explosions in order to observe an avalanche), it's still a subject.

Sure, ideal passive observation is impossible (see e.g. observer effect ), But you should at least clarify your intentions.

Use "subject" for persons and high-developed animals. Or define "object" more precisely.

"Object" has a negative connotation since you objectivize it. Yes, as a researcher you strive towards objectivity. But "object" sounds unethical. So, I'd use "subject" for persons and animals regardless of the distinction made in #1.

On the other hand, generally you don't research a subject as the whole. In your example, you actually study a person's favorites, character, attributes and behavior. So you can say that favorites, character etc. are objects of your research. And then you don't need to talk about the subject at all.

This answer also proposes to use "agent" for a person taking an active role in an experiment.

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10.1 Overview of Single-Subject Research

Learning objectives.

• Explain what single-subject research is, including how it differs from other types of psychological research.
• Explain what case studies are, including some of their strengths and weaknesses.
• Explain who uses single-subject research and why.

What Is Single-Subject Research?

Single-subject research is a type of quantitative research that involves studying in detail the behavior of each of a small number of participants. Note that the term single-subject does not mean that only one participant is studied; it is more typical for there to be somewhere between two and 10 participants. (This is why single-subject research designs are sometimes called small- n designs, where n is the statistical symbol for the sample size.) Single-subject research can be contrasted with group research , which typically involves studying large numbers of participants and examining their behavior primarily in terms of group means, standard deviations, and so on. The majority of this book is devoted to understanding group research, which is the most common approach in psychology. But single-subject research is an important alternative, and it is the primary approach in some areas of psychology.

Before continuing, it is important to distinguish single-subject research from two other approaches, both of which involve studying in detail a small number of participants. One is qualitative research, which focuses on understanding people’s subjective experience by collecting relatively unstructured data (e.g., detailed interviews) and analyzing those data using narrative rather than quantitative techniques. Single-subject research, in contrast, focuses on understanding objective behavior through experimental manipulation and control, collecting highly structured data, and analyzing those data quantitatively.

It is also important to distinguish single-subject research from case studies. A case study is a detailed description of an individual, which can include both qualitative and quantitative analyses. (Case studies that include only qualitative analyses can be considered a type of qualitative research.) The history of psychology is filled with influential cases studies, such as Sigmund Freud’s description of “Anna O.” (see Note 10.5 “The Case of “Anna O.”” ) and John Watson and Rosalie Rayner’s description of Little Albert (Watson & Rayner, 1920), who learned to fear a white rat—along with other furry objects—when the researchers made a loud noise while he was playing with the rat. Case studies can be useful for suggesting new research questions and for illustrating general principles. They can also help researchers understand rare phenomena, such as the effects of damage to a specific part of the human brain. As a general rule, however, case studies cannot substitute for carefully designed group or single-subject research studies. One reason is that case studies usually do not allow researchers to determine whether specific events are causally related, or even related at all. For example, if a patient is described in a case study as having been sexually abused as a child and then as having developed an eating disorder as a teenager, there is no way to determine whether these two events had anything to do with each other. A second reason is that an individual case can always be unusual in some way and therefore be unrepresentative of people more generally. Thus case studies have serious problems with both internal and external validity.

The Case of “Anna O.”

Sigmund Freud used the case of a young woman he called “Anna O.” to illustrate many principles of his theory of psychoanalysis (Freud, 1961). (Her real name was Bertha Pappenheim, and she was an early feminist who went on to make important contributions to the field of social work.) Anna had come to Freud’s colleague Josef Breuer around 1880 with a variety of odd physical and psychological symptoms. One of them was that for several weeks she was unable to drink any fluids. According to Freud,

She would take up the glass of water that she longed for, but as soon as it touched her lips she would push it away like someone suffering from hydrophobia.…She lived only on fruit, such as melons, etc., so as to lessen her tormenting thirst (p. 9).

But according to Freud, a breakthrough came one day while Anna was under hypnosis.

[S]he grumbled about her English “lady-companion,” whom she did not care for, and went on to describe, with every sign of disgust, how she had once gone into this lady’s room and how her little dog—horrid creature!—had drunk out of a glass there. The patient had said nothing, as she had wanted to be polite. After giving further energetic expression to the anger she had held back, she asked for something to drink, drank a large quantity of water without any difficulty, and awoke from her hypnosis with the glass at her lips; and thereupon the disturbance vanished, never to return.

Freud’s interpretation was that Anna had repressed the memory of this incident along with the emotion that it triggered and that this was what had caused her inability to drink. Furthermore, her recollection of the incident, along with her expression of the emotion she had repressed, caused the symptom to go away.

As an illustration of Freud’s theory, the case study of Anna O. is quite effective. As evidence for the theory, however, it is essentially worthless. The description provides no way of knowing whether Anna had really repressed the memory of the dog drinking from the glass, whether this repression had caused her inability to drink, or whether recalling this “trauma” relieved the symptom. It is also unclear from this case study how typical or atypical Anna’s experience was.

Figure 10.2

“Anna O.” was the subject of a famous case study used by Freud to illustrate the principles of psychoanalysis.

Wikimedia Commons – public domain.

Assumptions of Single-Subject Research

Again, single-subject research involves studying a small number of participants and focusing intensively on the behavior of each one. But why take this approach instead of the group approach? There are several important assumptions underlying single-subject research, and it will help to consider them now.

First and foremost is the assumption that it is important to focus intensively on the behavior of individual participants. One reason for this is that group research can hide individual differences and generate results that do not represent the behavior of any individual. For example, a treatment that has a positive effect for half the people exposed to it but a negative effect for the other half would, on average, appear to have no effect at all. Single-subject research, however, would likely reveal these individual differences. A second reason to focus intensively on individuals is that sometimes it is the behavior of a particular individual that is primarily of interest. A school psychologist, for example, might be interested in changing the behavior of a particular disruptive student. Although previous published research (both single-subject and group research) is likely to provide some guidance on how to do this, conducting a study on this student would be more direct and probably more effective.

A second assumption of single-subject research is that it is important to discover causal relationships through the manipulation of an independent variable, the careful measurement of a dependent variable, and the control of extraneous variables. For this reason, single-subject research is often considered a type of experimental research with good internal validity. Recall, for example, that Hall and his colleagues measured their dependent variable (studying) many times—first under a no-treatment control condition, then under a treatment condition (positive teacher attention), and then again under the control condition. Because there was a clear increase in studying when the treatment was introduced, a decrease when it was removed, and an increase when it was reintroduced, there is little doubt that the treatment was the cause of the improvement.

A third assumption of single-subject research is that it is important to study strong and consistent effects that have biological or social importance. Applied researchers, in particular, are interested in treatments that have substantial effects on important behaviors and that can be implemented reliably in the real-world contexts in which they occur. This is sometimes referred to as social validity (Wolf, 1976). The study by Hall and his colleagues, for example, had good social validity because it showed strong and consistent effects of positive teacher attention on a behavior that is of obvious importance to teachers, parents, and students. Furthermore, the teachers found the treatment easy to implement, even in their often chaotic elementary school classrooms.

Who Uses Single-Subject Research?

Single-subject research has been around as long as the field of psychology itself. In the late 1800s, one of psychology’s founders, Wilhelm Wundt, studied sensation and consciousness by focusing intensively on each of a small number of research participants. Herman Ebbinghaus’s research on memory and Ivan Pavlov’s research on classical conditioning are other early examples, both of which are still described in almost every introductory psychology textbook.

In the middle of the 20th century, B. F. Skinner clarified many of the assumptions underlying single-subject research and refined many of its techniques (Skinner, 1938). He and other researchers then used it to describe how rewards, punishments, and other external factors affect behavior over time. This work was carried out primarily using nonhuman subjects—mostly rats and pigeons. This approach, which Skinner called the experimental analysis of behavior —remains an important subfield of psychology and continues to rely almost exclusively on single-subject research. For excellent examples of this work, look at any issue of the Journal of the Experimental Analysis of Behavior . By the 1960s, many researchers were interested in using this approach to conduct applied research primarily with humans—a subfield now called applied behavior analysis (Baer, Wolf, & Risley, 1968). Applied behavior analysis plays an especially important role in contemporary research on developmental disabilities, education, organizational behavior, and health, among many other areas. Excellent examples of this work (including the study by Hall and his colleagues) can be found in the Journal of Applied Behavior Analysis .

Although most contemporary single-subject research is conducted from the behavioral perspective, it can in principle be used to address questions framed in terms of any theoretical perspective. For example, a studying technique based on cognitive principles of learning and memory could be evaluated by testing it on individual high school students using the single-subject approach. The single-subject approach can also be used by clinicians who take any theoretical perspective—behavioral, cognitive, psychodynamic, or humanistic—to study processes of therapeutic change with individual clients and to document their clients’ improvement (Kazdin, 1982).

Key Takeaways

• Single-subject research—which involves testing a small number of participants and focusing intensively on the behavior of each individual—is an important alternative to group research in psychology.
• Single-subject studies must be distinguished from case studies, in which an individual case is described in detail. Case studies can be useful for generating new research questions, for studying rare phenomena, and for illustrating general principles. However, they cannot substitute for carefully controlled experimental or correlational studies because they are low in internal and external validity.
• Single-subject research has been around since the beginning of the field of psychology. Today it is most strongly associated with the behavioral theoretical perspective, but it can in principle be used to study behavior from any perspective.
• Practice: Find and read a published article in psychology that reports new single-subject research. (A good source of articles published in the Journal of Applied Behavior Analysis can be found at http://seab.envmed.rochester.edu/jaba/jabaMostPop-2011.html .) Write a short summary of the study.

Practice: Find and read a published case study in psychology. (Use case study as a key term in a PsycINFO search.) Then do the following:

• Describe one problem related to internal validity.
• Describe one problem related to external validity.
• Generate one hypothesis suggested by the case study that might be interesting to test in a systematic single-subject or group study.

Baer, D. M., Wolf, M. M., & Risley, T. R. (1968). Some current dimensions of applied behavior analysis. Journal of Applied Behavior Analysis , 1 , 91–97.

Freud, S. (1961). Five lectures on psycho-analysis . New York, NY: Norton.

Kazdin, A. E. (1982). Single-case research designs: Methods for clinical and applied settings . New York, NY: Oxford University Press.

Skinner, B. F. (1938). The behavior of organisms: An experimental analysis . New York, NY: Appleton-Century-Crofts.

Watson, J. B., & Rayner, R. (1920). Conditioned emotional reactions. Journal of Experimental Psychology , 3 , 1–14.

Wolf, M. (1976). Social validity: The case for subjective measurement or how applied behavior analysis is finding its heart. Journal of Applied Behavior Analysis, 11 , 203–214.

Research Methods in Psychology Copyright © 2016 by University of Minnesota is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License , except where otherwise noted.

What is Research? – Definition, Objectives & Types of Research

Introduction: Research is a systematic and structured investigation that seeks to expand knowledge, uncover new insights, and provide evidence-based understanding in various fields. It is vital in advancing human understanding, addressing complex problems, and driving innovation. Research encompasses a wide range of methodologies, including empirical studies, experiments, surveys, and theoretical analyses, conducted by researchers across academic, scientific, and professional domains. New discoveries are made through research, theories are developed and tested, and practical solutions are generated. The impact of research is far-reaching, influencing advancements in technology, healthcare, social sciences, environmental conservation, and more. It drives progress, informs policy decisions, and shapes the future by providing a solid foundation of reliable and verified knowledge. The importance of research cannot be overstated, as it drives human knowledge forward and fosters societal development and improvement. Types of Research

What is Research?

The primary objective of the research is to contribute to the existing body of knowledge by uncovering new insights, validating existing theories, or challenging prevailing assumptions. It is driven by the pursuit of truth, accuracy, and evidence-based understanding.

Research can take various forms, depending on the discipline and the nature of the inquiry. It can be empirical, involving the collection and analysis of data through experiments, surveys, observations, or interviews. It can also be theoretical, involving the critical analysis of existing literature and concepts to develop new frameworks or models.

The research process is characterized by systematic and organized steps. It begins with identifying a research problem or topic of interest, followed by an extensive literature review to understand the existing knowledge and identify gaps. Research questions or hypotheses are formulated, and a research design is developed to guide data collection and analysis.

Data collection methods can vary widely, ranging from quantitative approaches such as surveys or experiments to qualitative approaches such as interviews or case studies. Researchers analyze the collected data using appropriate statistical or qualitative analysis techniques to draw meaningful conclusions.

One of the key aspects of research is its emphasis on objectivity and rigor. Researchers strive to minimize bias, ensure the reliability and validity of findings, and maintain ethical standards in their research practices.

The impact of research extends far beyond the academic realm. Research findings inform decision-making processes in various sectors, including healthcare, policy development, business strategies, environmental conservation, and social sciences. It drives technological advancements, fosters innovation, and provides the foundation for evidence-based practices.

Furthermore, research is an iterative process, with new studies building upon and refining existing knowledge. It is a collaborative endeavor, often involving interdisciplinary collaborations and the exchange of ideas among researchers worldwide.

Definitions of Research:

Research is a systematic and organized investigation conducted to expand knowledge, gain a deeper understanding, and generate new insights in a specific field. It involves rigorous and organized data collection, analysis, and interpretation to address research questions or hypotheses. The pursuit of new information drives research, the validation of existing theories, or the exploration of new perspectives. It employs various methodologies to gather and analyze data, including empirical studies, experiments, surveys, interviews, or theoretical analyses. The ultimate goal of the research is to contribute to the existing body of knowledge, advance understanding, and inform decision-making processes across academic, scientific, and professional domains.

Kasi (2009) 1 defines “Research is, therefore, a method for investigating and collecting information aimed at the discovery of new facts or interpretation of existing information, to discover or revise facts, theories, and applications.”

Research is stated by Gina Wisker 1 as “Research is about asking and beginning to answer questions, seeking knowledge and understanding of the world and its processes, and testing assumptions and beliefs.”

Redman and Mory define research as a “systematized effort to gain new knowledge.” 2

Burns (1997) defines research as “a systematic investigation to find answers to a problem.” 2

“The word research is composed of two syllables, re and search. The dictionary defines the former as a prefix meaning again, anew, or over again and the latter as a verb meaning to examine closely and carefully, to test and try, or to probe. Together, they form a noun describing a careful, systematic, patient study and investigation in some field of knowledge undertaken to establish facts or principles.” (Grinnell 1993) 2

Objectives of Research:

The research objectives can vary depending on the specific field of study, the nature of the research, and the researcher’s goals. However, some common purposes of the research include:

• Answer questions: Research aims to provide answers to specific questions or hypotheses. It seeks to investigate and uncover information, data, or insights about a particular topic or issue.
• Solve problems: Research is often conducted to address real-world issues or challenges. It aims to identify innovative solutions, strategies, or approaches that can help overcome obstacles and improve existing systems or practices.
• Generate new knowledge: Research endeavors to contribute to the existing body of knowledge by uncovering new information, theories, or perspectives. It involves exploring uncharted territory or expanding upon existing knowledge in various fields of study.
• Improve understanding: Research aims to deepen our understanding of complex phenomena, processes, or concepts. It seeks to clarify misconceptions, explore underlying mechanisms, or uncover relationships between variables, leading to a more comprehensive and accurate understanding of the subject.
• Add value: Research brings value by providing practical or theoretical benefits. It can lead to technological advancements, policies or practices, enhanced decision-making processes, or the development of new products, services, or theories.

Types of Research:

C.R. Kothari, a renowned Indian researcher and author, has proposed several types of research in his book Research Methodology: Methods and Techniques . According to Kothari, research can be categorized into the following types:

• Descriptive Research: Descriptive research is a method of investigation that provides an accurate and comprehensive description of a specific phenomenon, situation, or population. It involves collecting data through various methods, such as surveys, interviews, or observations, and analyzing the data to identify patterns, characteristics, or trends. Descriptive research does not aim to establish causal relationships or manipulate variables but instead aims to answer questions about what is happening or the current state of the research subject. This type of research is valuable in generating a foundational understanding of a topic, informing decision-making processes, and providing a basis for further research in various fields of study.
• Analytical Research: Analytical research focuses on critically examining and interpreting existing data, information, or theories to gain deeper insights and understanding. It involves analyzing and evaluating data or literature to identify patterns, relationships, or underlying causes. Analytical research aims to go beyond descriptive findings and delves into the reasons and explanations behind observed phenomena. This type of research often involves rigorous statistical analysis, comparative studies, or theoretical frameworks to draw conclusions and make inferences. Analytical research is crucial in advancing knowledge, refining theories, and providing evidence-based insights that can inform decision-making and policy development in various fields of study.
• Applied Research: Applied research is a type of research that is conducted to address practical problems or improve existing practices. It focuses on directly applying knowledge and theories to real-world situations and aims to provide actionable solutions. Applied research often involves collaborating with stakeholders, such as industry professionals or policymakers, to ensure the research outcomes have practical relevance. This type of research emphasizes implementing and evaluating interventions, strategies, or technologies to solve specific issues. The results of applied research can potentially impact society, leading to advancements in technology, policy improvements, or enhanced practices in various domains, including healthcare, education, business, and engineering.
• Fundamental Research: Fundamental research, also known as basic research or pure research, is a type of inquiry that aims to expand knowledge and understanding in a particular field. It explores theoretical concepts, principles, and fundamental laws without immediate practical application. Fundamental research is driven by curiosity and the desire to explore new frontiers of knowledge. It often involves the formulation of hypotheses, experimentation, and rigorous data analysis. The fundamental research findings may not have immediate or direct practical implications. Still, they lay the groundwork for applied research and can lead to significant breakthroughs, innovations, and advancements in various scientific disciplines. Fundamental research is essential for pushing the boundaries of knowledge and fostering a deeper understanding of the world around us.
• Qualitative Research: Qualitative research is an exploratory approach to understanding individuals’ or groups’ meaning, context, and subjective experiences. It involves collecting and analyzing non-numerical data, such as interviews, observations, or textual analysis, to gain deep insights into complex social phenomena. Qualitative research focuses on uncovering underlying motivations, beliefs, attitudes, and cultural influences that shape human behavior. It emphasizes the richness, depth, and complexity of human experiences and seeks to provide a detailed and holistic understanding of a research topic. Qualitative research methods allow for flexibility and adaptability, enabling researchers to capture nuances and explore emerging themes. This type of research is valuable in fields such as anthropology, sociology, psychology, and education, where a deep understanding of human behavior and social processes is sought.
• Quantitative Research: Quantitative research systematically gathers and analyzes numerical data to uncover patterns, trends, and relationships. It involves collecting structured data through surveys, experiments, or observations and applying statistical techniques for data analysis. Quantitative research aims to quantify variables, measure phenomena, and draw objective conclusions based on statistical evidence. This type of research focuses on obtaining precise and measurable results, often using large sample sizes to increase the generalizability of findings. Quantitative research is prevalent in social sciences, economics, psychology, and market research, where numerical data and statistical analysis provide a rigorous and quantifiable approach to understanding and explaining phenomena.

Significance of Research:

The significance of research cannot be overstated, as it serves as the cornerstone of progress and development in various fields. Whether in science, technology, social sciences, or humanities, research is vital in advancing knowledge, addressing problems, and shaping society.

One of the primary significances of research is its ability to expand our understanding and knowledge base. Through rigorous investigation, research uncovers new information, theories, and insights that contribute to the existing body of knowledge. It allows us to delve deeper into complex phenomena, explore uncharted territories, and uncover hidden connections. This expansion of knowledge forms the basis for innovation, development, and the evolution of society.

Research also serves as a powerful tool for problem-solving. It enables us to identify and address pressing issues, whether they are in healthcare, education, economics, or any other field. By systematically examining problems, collecting and analyzing relevant data, and developing evidence-based solutions, research provides the means to overcome challenges and improve existing practices. It empowers us to make informed decisions, develop effective strategies, and allocate resources wisely.

Furthermore, research plays a critical role in informing decision-making processes. Policymakers, business leaders, and organizations rely on research findings to guide their choices, shape policies, and plan for the future. Research provides reliable and credible information, allowing decision-makers to navigate complex issues more confidently and accurately. It serves as a bridge between theory and practice, translating abstract concepts into tangible outcomes that benefit society.

Innovation and improvement are other significant outcomes of research. Research drives innovation by exploring new ideas, pushing boundaries, and challenging established norms. It leads to the developing of new technologies, products, and services that improve our quality of life. Research also fosters improvements in existing practices and processes by identifying inefficiencies, gaps, and areas for enhancement. Through research, we continuously strive to find better, more efficient ways of doing things.

Research has a profound impact on society as a whole. It addresses social issues, informs public policies, and promotes positive social change. Research provides evidence-based solutions that address societal challenges, from healthcare interventions to educational reforms. It influences public opinion, shapes cultural norms, and contributes to communities’ well-being and progress.

Moreover, research plays a crucial role in validating and challenging existing knowledge. It provides empirical evidence that supports or challenges established theories and concepts. Through rigorous scrutiny and critical analysis, research ensures that knowledge constantly evolves, grows, and adapts to new information. It encourages intellectual discourse, promotes healthy skepticism, and encourages a culture of lifelong learning.

References: 

• Kasi, P. (2009). Research: What, Why and How? AuthorHouse.
• Kothari, C. R. (2004). Research Methodology: Methods and Techniques . New Age International.

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1000+ FREE Research Topics & Title Ideas

If you’re at the start of your research journey and are trying to figure out which research topic you want to focus on, you’ve come to the right place. Select your area of interest below to view a comprehensive collection of potential research ideas.

Research Topic FAQs

What (exactly) is a research topic.

A research topic is the subject of a research project or study – for example, a dissertation or thesis. A research topic typically takes the form of a problem to be solved, or a question to be answered.

A good research topic should be specific enough to allow for focused research and analysis. For example, if you are interested in studying the effects of climate change on agriculture, your research topic could focus on how rising temperatures have impacted crop yields in certain regions over time.

To learn more about the basics of developing a research topic, consider our free research topic ideation webinar.

What constitutes a good research topic?

A strong research topic comprises three important qualities : originality, value and feasibility.

• Originality – a good topic explores an original area or takes a novel angle on an existing area of study.
• Value – a strong research topic provides value and makes a contribution, either academically or practically.
• Feasibility – a good research topic needs to be practical and manageable, given the resource constraints you face.

To learn more about what makes for a high-quality research topic, check out this post .

What's the difference between a research topic and research problem?

A research topic and a research problem are two distinct concepts that are often confused. A research topic is a broader label that indicates the focus of the study , while a research problem is an issue or gap in knowledge within the broader field that needs to be addressed.

To illustrate this distinction, consider a student who has chosen “teenage pregnancy in the United Kingdom” as their research topic. This research topic could encompass any number of issues related to teenage pregnancy such as causes, prevention strategies, health outcomes for mothers and babies, etc.

Within this broad category (the research topic) lies potential areas of inquiry that can be explored further – these become the research problems . For example:

• What factors contribute to higher rates of teenage pregnancy in certain communities?
• How do different types of parenting styles affect teen pregnancy rates?
• What interventions have been successful in reducing teenage pregnancies?

Simply put, a key difference between a research topic and a research problem is scope ; the research topic provides an umbrella under which multiple questions can be asked, while the research problem focuses on one specific question or set of questions within that larger context.

How can I find potential research topics for my project?

There are many steps involved in the process of finding and choosing a high-quality research topic for a dissertation or thesis. We cover these steps in detail in this video (also accessible below).

How can I find quality sources for my research topic?

Finding quality sources is an essential step in the topic ideation process. To do this, you should start by researching scholarly journals, books, and other academic publications related to your topic. These sources can provide reliable information on a wide range of topics. Additionally, they may contain data or statistics that can help support your argument or conclusions.

Identifying Relevant Sources

When searching for relevant sources, it’s important to look beyond just published material; try using online databases such as Google Scholar or JSTOR to find articles from reputable journals that have been peer-reviewed by experts in the field.

You can also use search engines like Google or Bing to locate websites with useful information about your topic. However, be sure to evaluate any website before citing it as a source—look for evidence of authorship (such as an “About Us” page) and make sure the content is up-to-date and accurate before relying on it.

Evaluating Sources

Once you’ve identified potential sources for your research project, take some time to evaluate them thoroughly before deciding which ones will best serve your purpose. Consider factors such as author credibility (are they an expert in their field?), publication date (is the source current?), objectivity (does the author present both sides of an issue?) and relevance (how closely does this source relate to my specific topic?).

By researching the current literature on your topic, you can identify potential sources that will help to provide quality information. Once you’ve identified these sources, it’s time to look for a gap in the research and determine what new knowledge could be gained from further study.

How can I find a good research gap?

Finding a strong gap in the literature is an essential step when looking for potential research topics. We explain what research gaps are and how to find them in this post.

How should I evaluate potential research topics/ideas?

When evaluating potential research topics, it is important to consider the factors that make for a strong topic (we discussed these earlier). Specifically:

• Originality
• Feasibility

So, when you have a list of potential topics or ideas, assess each of them in terms of these three criteria. A good topic should take a unique angle, provide value (either to academia or practitioners), and be practical enough for you to pull off, given your limited resources.

Finally, you should also assess whether this project could lead to potential career opportunities such as internships or job offers down the line. Make sure that you are researching something that is relevant enough so that it can benefit your professional development in some way. Additionally, consider how each research topic aligns with your career goals and interests; researching something that you are passionate about can help keep motivation high throughout the process.

How can I assess the feasibility of a research topic?

When evaluating the feasibility and practicality of a research topic, it is important to consider several factors.

First, you should assess whether or not the research topic is within your area of competence. Of course, when you start out, you are not expected to be the world’s leading expert, but do should at least have some foundational knowledge.

Time commitment

When considering a research topic, you should think about how much time will be required for completion. Depending on your field of study, some topics may require more time than others due to their complexity or scope.

Additionally, if you plan on collaborating with other researchers or institutions in order to complete your project, additional considerations must be taken into account such as coordinating schedules and ensuring that all parties involved have adequate resources available.

Resources needed

It’s also critically important to consider what type of resources are necessary in order to conduct the research successfully. This includes physical materials such as lab equipment and chemicals but can also include intangible items like access to certain databases or software programs which may be necessary depending on the nature of your work. Additionally, if there are costs associated with obtaining these materials then this must also be factored into your evaluation process.

Potential risks

It’s important to consider the inherent potential risks for each potential research topic. These can include ethical risks (challenges getting ethical approval), data risks (not being able to access the data you’ll need), technical risks relating to the equipment you’ll use and funding risks (not securing the necessary financial back to undertake the research).

If you’re looking for more information about how to find, evaluate and select research topics for your dissertation or thesis, check out our free webinar here . Alternatively, if you’d like 1:1 help with the topic ideation process, consider our private coaching services .

Psst... there’s more!

This post was based on one of our popular Research Bootcamps . If you're working on a research project, you'll definitely want to check this out ...

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"Field of study" vs. "subject of study"

What is the difference between field and subject and what is the discipline here?

• differences

• " field of study " refers a broad area of academic interest containing many topics, for example, " human cell growth is my field of study. "
• " subject of study " refers to a specific entity of interest within a given context, for example, " The HeLa cell line has emerged as an important subject of study. "

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2 What Is Human Subjects Research?

Kirstin Borgerson, Associate Professor, Department of Philosophy, Dalhousie University, Halifax, Nova Scotia, Canada

• Published: 15 December 2020
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This chapter provides an overview of the nature, scope, and practice of human subjects research. It begins by tackling the general question, “What is research?” Attempts to answer this question typically define research by its methods and/or goals, and the chapter surveys the limits of these definitions through discussion of tough boundary cases. Along the way, the chapter describes various methods (quantitative, qualitative) and types of human subjects research (clinical, social scientific, etc.). The second section of the chapter investigates who is referred to by the language of “human subjects”: which humans tend to be selected as research participants, where human subjects are located globally, and how these locations are changing. The chapter also raises questions about which subjects are considered human in this context, for instance, whether definitions include embryos, cadavers, or stem cells. Throughout, the chapter highlights the ethical issues raised by the various types of activities and subjects described.

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Information for Research Subjects

Learn about becoming a research participant at the University of Rochester

True to the University of Rochester’s Mission Statement, ‘Learn, Discover, Heal, Create—and Make the World Ever Better’, research has been a long-standing tradition at the University of Rochester . Our researchers are among the nation’s leaders across a wide range of fields, including medicine, human behavior, education, politics, optics and economics.

Find an open research study

Faqs: participating in research.

Participating in research can be a fun and exciting way to give back to your community, but it doesn’t necessarily come without risk. Becoming a research participant is an important decision that should be taken seriously.

Background and overview

Research studies are done to discover new information or to answer a question about how we learn, behave, and function. Some studies might involve simple tasks like completing a survey, being observed among a group of people, or participating in a group discussion. Other studies, sometimes called clinical trials, involve more risky procedures like testing a new drug or medical device.

Each research study has its own set of criteria to determine who can participate. This depends on the research question being asked and may include restrictions based on age, behaviors, health status, or other traits.

Deciding to participate

Research is designed to benefit society. This might include learning how to live healthier lives, how to better treat conditions or diseases, why we do the things we do, or how we learn and develop. And while there are several reasons why people choose to participate in research, most people participate based on the possibility of helping themselves or others.

It’s important to understand that you may not directly benefit from participating in research. In fact, with a lot of research, you will not receive any benefit. For some types of research however, there may be a possibility that you could receive benefit, but there is no guarantee.

Most studies involve some risk, though the risks can range from very small to very serious. Some examples of risks include:

• side effects or reactions to experimental drugs, treatments, or procedures
• feeling anxious or uncomfortable
• breach in confidentiality or invasion of privacy.

Side effects or other risks you might experience may be temporary or go away with treatment, but in rare cases they may be permanent, cause disability, or be life threatening. There may also be risks in participating that we don’t know about.

To start, you will be given information about the study so that you can make an informed decision about whether or not to participate. You will also be given an opportunity to ask questions about the study. This process is called informed consent . Before you can start the study, you need to agree to participate (i.e., consent). Participation is always voluntary.

Once you provide consent, the specific procedures or activities you’ll be asked to complete can vary widely and depend on what is being studied. Regardless, all the activities you will be asked to complete will be described during the consent process.

Before you agree to be in the study, make sure you have a solid understanding of the following:

• the voluntary nature of the study
• why the study is being done
• who is doing the study
• the procedures, activities, tests, or treatments involved (including how long they will take, how often they have to be completed, and whether there are any other treatment options available rather than being in the study)
• potential risks, discomforts, or side effects
• potential benefits to participating, if any
• how your privacy will be protected
• how long your participation will last
• what will happen if you are injured while participating
• the costs to you, if any
• what to do if you change your mind about participating
• whom to contact with questions, concerns, or problems

Each study is different, so time requirements will vary. Some may require very little of your time, perhaps only 5–10 minutes, while others may require multiple visits over an extended period of time, sometimes up to several years. Your time commitment for a particular study will be described during the consent process.

informed consent

Informed consent is the process of telling interested individuals what is involved in taking part in a specific research study. Typically, this includes:

• reviewing written information
• giving the potential volunteer time to review this information while considering participation (taking it home to review with friends or family, if desired)
• discussing the information verbally
• answering any questions

Once all of the information is provided to you and your questions are answered, you will then be asked to decide whether or not to take part in the study.

All decisions are voluntary, and you must provide your agreement (i.e., consent) before any study activities can begin. Usually, this involves signing a consent form. Although, for some studies, verbally agreeing to participate may be sufficient.

Once you provide consent to be in the study, you will continue to receive important information about your participation throughout the study.

It’s important to understand what is involved in taking part in a research study and to carefully consider what that means for you. Research can pose risks to your health, safety, and welfare, so it’s important to understand exactly what those risks are.

It’s also important to understand that taking part in research is voluntary. You make the decision about whether or not to participate, and if you agree to take part, you can always change your mind later.

State law determines who can provide consent. In New York State, only individuals 18 years of age and older can provide consent. Minors, based on their age and ability, are usually asked for their agreement to participate in research, but their parent or legal guardian must also provide their permission to participate. Other special considerations are also made when a minor is a ward of the state or adults are unable to make decisions for themselves.

If you have questions about who can or cannot provide consent, be sure to ask the study team.

The following key points are most important about informed consent:

• Being in a study is voluntary—it is your choice.
• If you join a study, you can change your mind and stop at any time.
• If you have questions about anything that is not clear to you, you can ask them at any point of time before, during, or after the study.
• If you feel you need more time or information to make an informed decision about whether or not to take part in the study, do not hesitate to ask for it.

Subject Protections

Research studies involving humans must be approved and monitored by an Institutional Review Board (IRB). An IRB is a committee of individuals responsible for reviewing research to ensure adequate protections are in place to protect the people who take part.

For each study reviewed, the IRB checks to see that:

• there is a good reason to conduct the study
• the risks related to participating are the least possible
• the risks related to participating are reasonable given the knowledge that will be gained from conducting the study
• the plan for selecting subjects to participate is fair
• subjects will be provided enough information about the study

Protecting the information you provide to researchers is a high priority, particularly if you provide health-related or sensitive information.

As part of the IRB approval process described above, all researchers must provide a plan to adequately protect the information they plan to collect in order for the study to be approved. This might include assigning a code to the information collected instead of using your name or other identifiable information and storing the information in a secure manner.

You are free to withdraw from a research study at any time, for any reason. Your relationship with the hospital, clinic, academic institution, or employer will not be affected and you will not lose any benefits to which you are entitled.

Note that in some cases, a researcher may decide to end your participation in the study early. This may happen if the study is no longer in your best interest, if you can no longer complete study activities, or if the study ends early for some other reason.

Additional participant resources

Downloadable information.

• Participating in Research Overview
• Informed Consent

External resources

• About Research Participation (Department of Health & Human Service)
• Children & Clinical Studies (National Heart, Lung & Blood Institute)
• Clinical Research Trials and You (National Institutes of Health)

University research studies

• Search UR Health Research
• Join the UR Health Research Volunteer Registry to be contacted for future studies
• Follow UR Health Research on Facebook
• CenterWatch Clinical Trials Search
• ClinicalTrials.gov
• National Institutes of Health List of Registries
• ResearchMatch

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WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects

Adopted by the 18 th WMA General Assembly, Helsinki, Finland, June 1964 and amended by the: 29 th WMA General Assembly, Tokyo, Japan, October 1975 35 th WMA General Assembly, Venice, Italy, October 1983 41 st WMA General Assembly, Hong Kong, September 1989 48 th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 52 nd WMA General Assembly, Edinburgh, Scotland, October 2000 53 rd WMA General Assembly, Washington DC, USA, October 2002 (Note of Clarification added) 55 th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added) 59 th WMA General Assembly, Seoul, Republic of Korea, October 2008 64 th WMA General Assembly, Fortaleza, Brazil, October 2013

1.         The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

The Declaration is intended to be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.

2.         Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians. The WMA encourages others who are involved in medical research involving human subjects to adopt these principles.

General Principles

3.         The Declaration of Geneva of the WMA binds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient’s best interest when providing medical care.”

4.         It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty.

5.         Medical progress is based on research that ultimately must include studies involving human subjects.

6.         The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.

7.         Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights.

8.         While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.

9.         It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.

10.       Physicians must consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.

11.       Medical research should be conducted in a manner that minimises possible harm to the environment.

12.       Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional.

13.       Groups that are underrepresented in medical research should be provided appropriate access to participation in research.

14.       Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.

15.       Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.

Risks, Burdens and Benefits

16.       In medical practice and in medical research, most interventions involve risks and burdens.

Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.

17.       All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation.

Measures to minimise the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher.

18.       Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed.

When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study.

Vulnerable Groups and Individuals

19.       Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm.

All vulnerable groups and individuals should receive specifically considered protection.

20.       Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.

Scientific Requirements and Research Protocols

21.       Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected.

22.       The design and performance of each research study involving human subjects must be clearly described and justified in a research protocol.

The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding funding, sponsors, institutional affiliations, potential conflicts of interest, incentives for subjects and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study.

In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions.

Research Ethics Committees

23.       The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins. This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration.

The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. After the end of the study, the researchers must submit a final report to the committee containing a summary of the study’s findings and conclusions.

Privacy and C onfidentiality

24.       Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.

Informed Consent

25.       Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.

26.       In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information.

After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.

All medical research subjects should be given the option of being informed about the general outcome and results of the study.

27.       When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship.

28.       For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.

29.       When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorised representative. The potential subject’s dissent should be respected.

30.       Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research  group. In such circumstances the physician must seek informed consent from the legally authorised representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research must be obtained as soon as possible from the subject or a legally authorised representative.

31.       The physician must fully inform the patient which aspects of their care are related to the research. The refusal of a patient to participate in a study or the patient’s decision to withdraw from the study must never adversely affect the patient-physician relationship.

32.       For medical research using identifiable human material or data, such as research on material or data contained in biobanks or similar repositories, physicians must seek informed consent for its collection, storage and/or reuse. There may be exceptional situations where consent would be impossible or impracticable to obtain for such research. In such situations the research may be done only after consideration and approval of a research ethics committee.

Use of Placebo

33.       The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:

Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or

Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention

and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.

Extreme care must be taken to avoid abuse of this option.

Post-Trial Provisions

34.       In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.

Research Registration and Publication and Dissemination of Results

35.       Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.

36.       Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.

Unproven Interventions in Clinical Practice

37.       In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorised representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.

Policy Types

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Related WMA Policies

Wma declaration of venice on end of life medical care, wma international code of medical ethics.

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FDA's Role: ClinicalTrials.gov Information

Federal law requires responsible parties to register with and submit results information to the ClinicalTrials.gov data bank for certain applicable clinical trials . 

Transparency of clinical trial information is important to scientific advancement. Registering certain trials and posting summary results information permits the scientific community to build on the information made available. The public’s participation in clinical trials makes it possible to further advance scientific progress. Posting clinical trial information on ClinicalTrials.gov honors volunteers who participate in research to advance medical science and enhances public trust by creating a transparent and robust public record of clinical trials and information about their results.

Federal law requires:

• A certification of compliance with ClinicalTrials.gov requirements to accompany certain human drug, biological product and device applications and submissions to FDA.
• The inclusion of a particular statement (see below) in the informed consent documents for applicable clinical trials, which are trials that will be entered into the ClinicalTrials.gov databank. 
• FDA to oversee compliance and take appropriate enforcement action related to failure to submit required clinical trial information to ClinicalTrials.gov.

Requirements for Certification of Compliance with Certain Product Applications

FDA developed Form FDA 3674 which may be used to provide certification. The certification must accompany certain human drug, biological product and device applications and submissions. In general, FDA recommends that Form FDA 3674 accompany the following applications and submissions to FDA:

• Investigational New Drug Application (IND)
• New Clinical Protocol Submitted to an IND
• New Drug Application (NDA)
• Efficacy Supplement to an Approved NDA
• Biologics License Application (BLA)
• Efficacy Supplement to an Approved BLA
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• PMA Panel Track Supplement
• Humanitarian Device Exemption (HDE)
• 510(k) submissions that refer to, relate to or include information on a clinical trial

Federal law does not require the submission of a Form FDA 3674 with an Investigational Device Exemption (IDE) application.

More information is available in FDA Guidance on Form FDA 3674 .  

Informed Consent Requirements

Federal law requires the following exact statement to be included in the informed consent documents of applicable clinical trials :

“A description of this clinical trial will be available on http://www.ClinicalTrials.gov , as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”

See FDA’s guidance on Informed Consent Elements, 21 CFR 50.25(c) for more information. 

ClinicalTrials.gov Compliance and Enforcement Activities

The FDA’s compliance activities related to the ClinicalTrials.gov requirements provide the opportunity for responsible parties to take voluntary corrective actions before the agency proceeds with enforcement action. The agency uses a risk-based approach to compliance and enforcement to prioritize the greatest risks to public health. 

The final guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank outlines FDA’s approach to its compliance and enforcement activities related to ClinicalTrials.gov, including potential civil money penalties for violations.

See pre-notices of noncompliance and notices of noncompliance for more information. 

Questions Related to ClinicalTrials.gov

See Submit Studies to ClinicalTrials.gov PRS for information about registering clinical trials on ClinicalTrials.gov. Contact [email protected] with questions related to:

• Regulations at 42 CFR Part 11
• How to register studies and how to submit clinical trial results information
• Technical issues related to submission of information to the ClinicalTrials.gov databank

Contact [email protected] with questions about compliance and enforcement of ClinicalTrials.gov requirements. 

Complaints to FDA should be reported to the office handling the type of study involved. See FDA contact information for complaints .

Additional resources

• ClinicalTrials.gov – a Three-Part Series
• Final Rule on Clinical Trials Registration and Results Information Submission  
• ClinicalTrials.gov - Pre-Notices for Potential Noncompliance  
• ClinicalTrials.gov - Notices of Noncompliance and Civil Money Penalty Actions
• ClinicalTrials.gov regulations (42 CFR Part 11)
• Details of the statutory language of Title VIII of FDAAA
• NIH Checklist for evaluating whether a clinical trial is an applicable clinical trial  
• Form FDA 3674 (including instructions)
• FDA Guidance on Form FDA 3674
• FDA Guidance on Informed Consent Elements at 21 CFR 50.25(c)
• FDA guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank

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What is Scientific Research and How Can it be Done?

Scientific researches are studies that should be systematically planned before performing them. In this review, classification and description of scientific studies, planning stage randomisation and bias are explained.

Research conducted for the purpose of contributing towards science by the systematic collection, interpretation and evaluation of data and that, too, in a planned manner is called scientific research: a researcher is the one who conducts this research. The results obtained from a small group through scientific studies are socialised, and new information is revealed with respect to diagnosis, treatment and reliability of applications. The purpose of this review is to provide information about the definition, classification and methodology of scientific research.

Before beginning the scientific research, the researcher should determine the subject, do planning and specify the methodology. In the Declaration of Helsinki, it is stated that ‘the primary purpose of medical researches on volunteers is to understand the reasons, development and effects of diseases and develop protective, diagnostic and therapeutic interventions (method, operation and therapies). Even the best proven interventions should be evaluated continuously by investigations with regard to reliability, effectiveness, efficiency, accessibility and quality’ ( 1 ).

The questions, methods of response to questions and difficulties in scientific research may vary, but the design and structure are generally the same ( 2 ).

Classification of Scientific Research

Scientific research can be classified in several ways. Classification can be made according to the data collection techniques based on causality, relationship with time and the medium through which they are applied.

• Observational
• Experimental
• Descriptive
• Retrospective
• Prospective
• Cross-sectional
• Social descriptive research ( 3 )

Another method is to classify the research according to its descriptive or analytical features. This review is written according to this classification method.

I. Descriptive research

• Case series
• Surveillance studies

II. Analytical research

• Observational studies: cohort, case control and cross- sectional research
• Interventional research: quasi-experimental and clinical research
• Case Report: it is the most common type of descriptive study. It is the examination of a single case having a different quality in the society, e.g. conducting general anaesthesia in a pregnant patient with mucopolysaccharidosis.
• Case Series: it is the description of repetitive cases having common features. For instance; case series involving interscapular pain related to neuraxial labour analgesia. Interestingly, malignant hyperthermia cases are not accepted as case series since they are rarely seen during historical development.
• Surveillance Studies: these are the results obtained from the databases that follow and record a health problem for a certain time, e.g. the surveillance of cross-infections during anaesthesia in the intensive care unit.

Moreover, some studies may be experimental. After the researcher intervenes, the researcher waits for the result, observes and obtains data. Experimental studies are, more often, in the form of clinical trials or laboratory animal trials ( 2 ).

Analytical observational research can be classified as cohort, case-control and cross-sectional studies.

Firstly, the participants are controlled with regard to the disease under investigation. Patients are excluded from the study. Healthy participants are evaluated with regard to the exposure to the effect. Then, the group (cohort) is followed-up for a sufficient period of time with respect to the occurrence of disease, and the progress of disease is studied. The risk of the healthy participants getting sick is considered an incident. In cohort studies, the risk of disease between the groups exposed and not exposed to the effect is calculated and rated. This rate is called relative risk. Relative risk indicates the strength of exposure to the effect on the disease.

Cohort research may be observational and experimental. The follow-up of patients prospectively is called a prospective cohort study . The results are obtained after the research starts. The researcher’s following-up of cohort subjects from a certain point towards the past is called a retrospective cohort study . Prospective cohort studies are more valuable than retrospective cohort studies: this is because in the former, the researcher observes and records the data. The researcher plans the study before the research and determines what data will be used. On the other hand, in retrospective studies, the research is made on recorded data: no new data can be added.

In fact, retrospective and prospective studies are not observational. They determine the relationship between the date on which the researcher has begun the study and the disease development period. The most critical disadvantage of this type of research is that if the follow-up period is long, participants may leave the study at their own behest or due to physical conditions. Cohort studies that begin after exposure and before disease development are called ambidirectional studies . Public healthcare studies generally fall within this group, e.g. lung cancer development in smokers.

• Case-Control Studies: these studies are retrospective cohort studies. They examine the cause and effect relationship from the effect to the cause. The detection or determination of data depends on the information recorded in the past. The researcher has no control over the data ( 2 ).

Cross-sectional studies are advantageous since they can be concluded relatively quickly. It may be difficult to obtain a reliable result from such studies for rare diseases ( 2 ).

Cross-sectional studies are characterised by timing. In such studies, the exposure and result are simultaneously evaluated. While cross-sectional studies are restrictedly used in studies involving anaesthesia (since the process of exposure is limited), they can be used in studies conducted in intensive care units.

• Quasi-Experimental Research: they are conducted in cases in which a quick result is requested and the participants or research areas cannot be randomised, e.g. giving hand-wash training and comparing the frequency of nosocomial infections before and after hand wash.
• Clinical Research: they are prospective studies carried out with a control group for the purpose of comparing the effect and value of an intervention in a clinical case. Clinical study and research have the same meaning. Drugs, invasive interventions, medical devices and operations, diets, physical therapy and diagnostic tools are relevant in this context ( 6 ).

Clinical studies are conducted by a responsible researcher, generally a physician. In the research team, there may be other healthcare staff besides physicians. Clinical studies may be financed by healthcare institutes, drug companies, academic medical centres, volunteer groups, physicians, healthcare service providers and other individuals. They may be conducted in several places including hospitals, universities, physicians’ offices and community clinics based on the researcher’s requirements. The participants are made aware of the duration of the study before their inclusion. Clinical studies should include the evaluation of recommendations (drug, device and surgical) for the treatment of a disease, syndrome or a comparison of one or more applications; finding different ways for recognition of a disease or case and prevention of their recurrence ( 7 ).

Clinical Research

In this review, clinical research is explained in more detail since it is the most valuable study in scientific research.

Clinical research starts with forming a hypothesis. A hypothesis can be defined as a claim put forward about the value of a population parameter based on sampling. There are two types of hypotheses in statistics.

• H 0 hypothesis is called a control or null hypothesis. It is the hypothesis put forward in research, which implies that there is no difference between the groups under consideration. If this hypothesis is rejected at the end of the study, it indicates that a difference exists between the two treatments under consideration.
• H 1 hypothesis is called an alternative hypothesis. It is hypothesised against a null hypothesis, which implies that a difference exists between the groups under consideration. For example, consider the following hypothesis: drug A has an analgesic effect. Control or null hypothesis (H 0 ): there is no difference between drug A and placebo with regard to the analgesic effect. The alternative hypothesis (H 1 ) is applicable if a difference exists between drug A and placebo with regard to the analgesic effect.

The planning phase comes after the determination of a hypothesis. A clinical research plan is called a protocol . In a protocol, the reasons for research, number and qualities of participants, tests to be applied, study duration and what information to be gathered from the participants should be found and conformity criteria should be developed.

The selection of participant groups to be included in the study is important. Inclusion and exclusion criteria of the study for the participants should be determined. Inclusion criteria should be defined in the form of demographic characteristics (age, gender, etc.) of the participant group and the exclusion criteria as the diseases that may influence the study, age ranges, cases involving pregnancy and lactation, continuously used drugs and participants’ cooperation.

The next stage is methodology. Methodology can be grouped under subheadings, namely, the calculation of number of subjects, blinding (masking), randomisation, selection of operation to be applied, use of placebo and criteria for stopping and changing the treatment.

I. Calculation of the Number of Subjects

The entire source from which the data are obtained is called a universe or population . A small group selected from a certain universe based on certain rules and which is accepted to highly represent the universe from which it is selected is called a sample and the characteristics of the population from which the data are collected are called variables. If data is collected from the entire population, such an instance is called a parameter . Conducting a study on the sample rather than the entire population is easier and less costly. Many factors influence the determination of the sample size. Firstly, the type of variable should be determined. Variables are classified as categorical (qualitative, non-numerical) or numerical (quantitative). Individuals in categorical variables are classified according to their characteristics. Categorical variables are indicated as nominal and ordinal (ordered). In nominal variables, the application of a category depends on the researcher’s preference. For instance, a female participant can be considered first and then the male participant, or vice versa. An ordinal (ordered) variable is ordered from small to large or vice versa (e.g. ordering obese patients based on their weights-from the lightest to the heaviest or vice versa). A categorical variable may have more than one characteristic: such variables are called binary or dichotomous (e.g. a participant may be both female and obese).

If the variable has numerical (quantitative) characteristics and these characteristics cannot be categorised, then it is called a numerical variable. Numerical variables are either discrete or continuous. For example, the number of operations with spinal anaesthesia represents a discrete variable. The haemoglobin value or height represents a continuous variable.

Statistical analyses that need to be employed depend on the type of variable. The determination of variables is necessary for selecting the statistical method as well as software in SPSS. While categorical variables are presented as numbers and percentages, numerical variables are represented using measures such as mean and standard deviation. It may be necessary to use mean in categorising some cases such as the following: even though the variable is categorical (qualitative, non-numerical) when Visual Analogue Scale (VAS) is used (since a numerical value is obtained), it is classified as a numerical variable: such variables are averaged.

Clinical research is carried out on the sample and generalised to the population. Accordingly, the number of samples should be correctly determined. Different sample size formulas are used on the basis of the statistical method to be used. When the sample size increases, error probability decreases. The sample size is calculated based on the primary hypothesis. The determination of a sample size before beginning the research specifies the power of the study. Power analysis enables the acquisition of realistic results in the research, and it is used for comparing two or more clinical research methods.

Because of the difference in the formulas used in calculating power analysis and number of samples for clinical research, it facilitates the use of computer programs for making calculations.

It is necessary to know certain parameters in order to calculate the number of samples by power analysis.

• Type-I (α) and type-II (β) error levels
• Difference between groups (d-difference) and effect size (ES)
• Distribution ratio of groups
• Direction of research hypothesis (H1)

a. Type-I (α) and Type-II (β) Error (β) Levels

Two types of errors can be made while accepting or rejecting H 0 hypothesis in a hypothesis test. Type-I error (α) level is the probability of finding a difference at the end of the research when there is no difference between the two applications. In other words, it is the rejection of the hypothesis when H 0 is actually correct and it is known as α error or p value. For instance, when the size is determined, type-I error level is accepted as 0.05 or 0.01.

Another error that can be made during a hypothesis test is a type-II error. It is the acceptance of a wrongly hypothesised H 0 hypothesis. In fact, it is the probability of failing to find a difference when there is a difference between the two applications. The power of a test is the ability of that test to find a difference that actually exists. Therefore, it is related to the type-II error level.

Since the type-II error risk is expressed as β, the power of the test is defined as 1–β. When a type-II error is 0.20, the power of the test is 0.80. Type-I (α) and type-II (β) errors can be intentional. The reason to intentionally make such an error is the necessity to look at the events from the opposite perspective.

b. Difference between Groups and ES

ES is defined as the state in which statistical difference also has clinically significance: ES≥0.5 is desirable. The difference between groups is the absolute difference between the groups compared in clinical research.

c. Allocation Ratio of Groups

The allocation ratio of groups is effective in determining the number of samples. If the number of samples is desired to be determined at the lowest level, the rate should be kept as 1/1.

d. Direction of Hypothesis (H1)

The direction of hypothesis in clinical research may be one-sided or two-sided. While one-sided hypotheses hypothesis test differences in the direction of size, two-sided hypotheses hypothesis test differences without direction. The power of the test in two-sided hypotheses is lower than one-sided hypotheses.

After these four variables are determined, they are entered in the appropriate computer program and the number of samples is calculated. Statistical packaged software programs such as Statistica, NCSS and G-Power may be used for power analysis and calculating the number of samples. When the samples size is calculated, if there is a decrease in α, difference between groups, ES and number of samples, then the standard deviation increases and power decreases. The power in two-sided hypothesis is lower. It is ethically appropriate to consider the determination of sample size, particularly in animal experiments, at the beginning of the study. The phase of the study is also important in the determination of number of subjects to be included in drug studies. Usually, phase-I studies are used to determine the safety profile of a drug or product, and they are generally conducted on a few healthy volunteers. If no unacceptable toxicity is detected during phase-I studies, phase-II studies may be carried out. Phase-II studies are proof-of-concept studies conducted on a larger number (100–500) of volunteer patients. When the effectiveness of the drug or product is evident in phase-II studies, phase-III studies can be initiated. These are randomised, double-blinded, placebo or standard treatment-controlled studies. Volunteer patients are periodically followed-up with respect to the effectiveness and side effects of the drug. It can generally last 1–4 years and is valuable during licensing and releasing the drug to the general market. Then, phase-IV studies begin in which long-term safety is investigated (indication, dose, mode of application, safety, effectiveness, etc.) on thousands of volunteer patients.

II. Blinding (Masking) and Randomisation Methods

When the methodology of clinical research is prepared, precautions should be taken to prevent taking sides. For this reason, techniques such as randomisation and blinding (masking) are used. Comparative studies are the most ideal ones in clinical research.

Blinding Method

A case in which the treatments applied to participants of clinical research should be kept unknown is called the blinding method . If the participant does not know what it receives, it is called a single-blind study; if even the researcher does not know, it is called a double-blind study. When there is a probability of knowing which drug is given in the order of application, when uninformed staff administers the drug, it is called in-house blinding. In case the study drug is known in its pharmaceutical form, a double-dummy blinding test is conducted. Intravenous drug is given to one group and a placebo tablet is given to the comparison group; then, the placebo tablet is given to the group that received the intravenous drug and intravenous drug in addition to placebo tablet is given to the comparison group. In this manner, each group receives both the intravenous and tablet forms of the drug. In case a third party interested in the study is involved and it also does not know about the drug (along with the statistician), it is called third-party blinding.

Randomisation Method

The selection of patients for the study groups should be random. Randomisation methods are used for such selection, which prevent conscious or unconscious manipulations in the selection of patients ( 8 ).

No factor pertaining to the patient should provide preference of one treatment to the other during randomisation. This characteristic is the most important difference separating randomised clinical studies from prospective and synchronous studies with experimental groups. Randomisation strengthens the study design and enables the determination of reliable scientific knowledge ( 2 ).

The easiest method is simple randomisation, e.g. determination of the type of anaesthesia to be administered to a patient by tossing a coin. In this method, when the number of samples is kept high, a balanced distribution is created. When the number of samples is low, there will be an imbalance between the groups. In this case, stratification and blocking have to be added to randomisation. Stratification is the classification of patients one or more times according to prognostic features determined by the researcher and blocking is the selection of a certain number of patients for each stratification process. The number of stratification processes should be determined at the beginning of the study.

As the number of stratification processes increases, performing the study and balancing the groups become difficult. For this reason, stratification characteristics and limitations should be effectively determined at the beginning of the study. It is not mandatory for the stratifications to have equal intervals. Despite all the precautions, an imbalance might occur between the groups before beginning the research. In such circumstances, post-stratification or restandardisation may be conducted according to the prognostic factors.

The main characteristic of applying blinding (masking) and randomisation is the prevention of bias. Therefore, it is worthwhile to comprehensively examine bias at this stage.

Bias and Chicanery

While conducting clinical research, errors can be introduced voluntarily or involuntarily at a number of stages, such as design, population selection, calculating the number of samples, non-compliance with study protocol, data entry and selection of statistical method. Bias is taking sides of individuals in line with their own decisions, views and ideological preferences ( 9 ). In order for an error to lead to bias, it has to be a systematic error. Systematic errors in controlled studies generally cause the results of one group to move in a different direction as compared to the other. It has to be understood that scientific research is generally prone to errors. However, random errors (or, in other words, ‘the luck factor’-in which bias is unintended-do not lead to bias ( 10 ).

Another issue, which is different from bias, is chicanery. It is defined as voluntarily changing the interventions, results and data of patients in an unethical manner or copying data from other studies. Comparatively, bias may not be done consciously.

In case unexpected results or outliers are found while the study is analysed, if possible, such data should be re-included into the study since the complete exclusion of data from a study endangers its reliability. In such a case, evaluation needs to be made with and without outliers. It is insignificant if no difference is found. However, if there is a difference, the results with outliers are re-evaluated. If there is no error, then the outlier is included in the study (as the outlier may be a result). It should be noted that re-evaluation of data in anaesthesiology is not possible.

Statistical evaluation methods should be determined at the design stage so as not to encounter unexpected results in clinical research. The data should be evaluated before the end of the study and without entering into details in research that are time-consuming and involve several samples. This is called an interim analysis . The date of interim analysis should be determined at the beginning of the study. The purpose of making interim analysis is to prevent unnecessary cost and effort since it may be necessary to conclude the research after the interim analysis, e.g. studies in which there is no possibility to validate the hypothesis at the end or the occurrence of different side effects of the drug to be used. The accuracy of the hypothesis and number of samples are compared. Statistical significance levels in interim analysis are very important. If the data level is significant, the hypothesis is validated even if the result turns out to be insignificant after the date of the analysis.

Another important point to be considered is the necessity to conclude the participants’ treatment within the period specified in the study protocol. When the result of the study is achieved earlier and unexpected situations develop, the treatment is concluded earlier. Moreover, the participant may quit the study at its own behest, may die or unpredictable situations (e.g. pregnancy) may develop. The participant can also quit the study whenever it wants, even if the study has not ended ( 7 ).

In case the results of a study are contrary to already known or expected results, the expected quality level of the study suggesting the contradiction may be higher than the studies supporting what is known in that subject. This type of bias is called confirmation bias. The presence of well-known mechanisms and logical inference from them may create problems in the evaluation of data. This is called plausibility bias.

Another type of bias is expectation bias. If a result different from the known results has been achieved and it is against the editor’s will, it can be challenged. Bias may be introduced during the publication of studies, such as publishing only positive results, selection of study results in a way to support a view or prevention of their publication. Some editors may only publish research that extols only the positive results or results that they desire.

Bias may be introduced for advertisement or economic reasons. Economic pressure may be applied on the editor, particularly in the cases of studies involving drugs and new medical devices. This is called commercial bias.

In recent years, before beginning a study, it has been recommended to record it on the Web site www.clinicaltrials.gov for the purpose of facilitating systematic interpretation and analysis in scientific research, informing other researchers, preventing bias, provision of writing in a standard format, enhancing contribution of research results to the general literature and enabling early intervention of an institution for support. This Web site is a service of the US National Institutes of Health.

The last stage in the methodology of clinical studies is the selection of intervention to be conducted. Placebo use assumes an important place in interventions. In Latin, placebo means ‘I will be fine’. In medical literature, it refers to substances that are not curative, do not have active ingredients and have various pharmaceutical forms. Although placebos do not have active drug characteristic, they have shown effective analgesic characteristics, particularly in algology applications; further, its use prevents bias in comparative studies. If a placebo has a positive impact on a participant, it is called the placebo effect ; on the contrary, if it has a negative impact, it is called the nocebo effect . Another type of therapy that can be used in clinical research is sham application. Although a researcher does not cure the patient, the researcher may compare those who receive therapy and undergo sham. It has been seen that sham therapies also exhibit a placebo effect. In particular, sham therapies are used in acupuncture applications ( 11 ). While placebo is a substance, sham is a type of clinical application.

Ethically, the patient has to receive appropriate therapy. For this reason, if its use prevents effective treatment, it causes great problem with regard to patient health and legalities.

Before medical research is conducted with human subjects, predictable risks, drawbacks and benefits must be evaluated for individuals or groups participating in the study. Precautions must be taken for reducing the risk to a minimum level. The risks during the study should be followed, evaluated and recorded by the researcher ( 1 ).

After the methodology for a clinical study is determined, dealing with the ‘Ethics Committee’ forms the next stage. The purpose of the ethics committee is to protect the rights, safety and well-being of volunteers taking part in the clinical research, considering the scientific method and concerns of society. The ethics committee examines the studies presented in time, comprehensively and independently, with regard to ethics and science; in line with the Declaration of Helsinki and following national and international standards concerning ‘Good Clinical Practice’. The method to be followed in the formation of the ethics committee should be developed without any kind of prejudice and to examine the applications with regard to ethics and science within the framework of the ethics committee, Regulation on Clinical Trials and Good Clinical Practice ( www.iku.com ). The necessary documents to be presented to the ethics committee are research protocol, volunteer consent form, budget contract, Declaration of Helsinki, curriculum vitae of researchers, similar or explanatory literature samples, supporting institution approval certificate and patient follow-up form.

Only one sister/brother, mother, father, son/daughter and wife/husband can take charge in the same ethics committee. A rector, vice rector, dean, deputy dean, provincial healthcare director and chief physician cannot be members of the ethics committee.

Members of the ethics committee can work as researchers or coordinators in clinical research. However, during research meetings in which members of the ethics committee are researchers or coordinators, they must leave the session and they cannot sign-off on decisions. If the number of members in the ethics committee for a particular research is so high that it is impossible to take a decision, the clinical research is presented to another ethics committee in the same province. If there is no ethics committee in the same province, an ethics committee in the closest settlement is found.

Thereafter, researchers need to inform the participants using an informed consent form. This form should explain the content of clinical study, potential benefits of the study, alternatives and risks (if any). It should be easy, comprehensible, conforming to spelling rules and written in plain language understandable by the participant.

This form assists the participants in taking a decision regarding participation in the study. It should aim to protect the participants. The participant should be included in the study only after it signs the informed consent form; the participant can quit the study whenever required, even when the study has not ended ( 7 ).

Peer-review: Externally peer-reviewed.

Author Contributions: Concept - C.Ö.Ç., A.D.; Design - C.Ö.Ç.; Supervision - A.D.; Resource - C.Ö.Ç., A.D.; Materials - C.Ö.Ç., A.D.; Analysis and/or Interpretation - C.Ö.Ç., A.D.; Literature Search - C.Ö.Ç.; Writing Manuscript - C.Ö.Ç.; Critical Review - A.D.; Other - C.Ö.Ç., A.D.

Conflict of Interest: No conflict of interest was declared by the authors.

Financial Disclosure: The authors declared that this study has received no financial support.

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Systematic and rigorous inquiry allows us to discover the fundamental mechanisms and causes of disease and disparities. At our Office of Research ( research@BSPH), we translate that knowledge to develop, evaluate, and disseminate treatment and prevention strategies and inform public health practice. Research along this entire spectrum represents a fundamental mission of the Johns Hopkins Bloomberg School of Public Health.

From laboratories at Baltimore’s Wolfe Street building, to Bangladesh maternity wards in densely   packed neighborhoods, to field studies in rural Botswana, Bloomberg School faculty lead research that directly addresses the most critical public health issues worldwide. Research spans from molecules to societies and relies on methodologies as diverse as bench science and epidemiology. That research is translated into impact, from discovering ways to eliminate malaria, increase healthy behavior, reduce the toll of chronic disease, improve the health of mothers and infants, or change the biology of aging.

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In order to provide  extensive guidance, infrastructure, and support in pursuit of its research mission,   research@BSPH  employs three core areas: strategy and development, implementation and impact, and integrity and oversight. Our exceptional research teams comprised of faculty, postdoctoral fellows, students, and committed staff are united in our collaborative, collegial, and entrepreneurial approach to problem solving. T he Bloomberg School ensures that our research is accomplished according to the highest ethical standards and complies with all regulatory requirements. In addition to our institutional review board (IRB) which provides oversight for human subjects research, basic science studies employee techniques to ensure the reproducibility of research. 

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Probiotics: What You Need To Know

.header_greentext{color:green!important;font-size:24px!important;font-weight:500!important;}.header_bluetext{color:blue!important;font-size:18px!important;font-weight:500!important;}.header_redtext{color:red!important;font-size:28px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;font-size:28px!important;font-weight:500!important;}.header_purpletext{color:purple!important;font-size:31px!important;font-weight:500!important;}.header_yellowtext{color:yellow!important;font-size:20px!important;font-weight:500!important;}.header_blacktext{color:black!important;font-size:22px!important;font-weight:500!important;}.header_whitetext{color:white!important;font-size:22px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;}.Green_Header{color:green!important;font-size:24px!important;font-weight:500!important;}.Blue_Header{color:blue!important;font-size:18px!important;font-weight:500!important;}.Red_Header{color:red!important;font-size:28px!important;font-weight:500!important;}.Purple_Header{color:purple!important;font-size:31px!important;font-weight:500!important;}.Yellow_Header{color:yellow!important;font-size:20px!important;font-weight:500!important;}.Black_Header{color:black!important;font-size:22px!important;font-weight:500!important;}.White_Header{color:white!important;font-size:22px!important;font-weight:500!important;} What are probiotics?

Probiotics are live microorganisms that are intended to have health benefits when consumed or applied to the body. They can be found in yogurt and other fermented foods, dietary supplements , and beauty products. Cases of severe or fatal infections have been reported in premature infants who were given probiotics, and the U.S. Food and Drug Administration (FDA) has warned health care providers about this risk.

Although people often think of bacteria and other microorganisms as harmful “germs,” many are actually helpful. Some bacteria help digest food, destroy disease-causing cells, or produce vitamins. Many of the microorganisms in probiotic products are the same as or similar to microorganisms that naturally live in our bodies.

What types of bacteria are in probiotics?

Probiotics may contain a variety of microorganisms. The most common are bacteria that belong to groups called Lactobacillus and Bifidobacterium . Other bacteria may also be used as probiotics, and so may yeasts such as Saccharomyces boulardii .

Different types of probiotics may have different effects. For example, if a specific kind of Lactobacillus helps prevent an illness, that doesn’t necessarily mean that another kind of Lactobacillus or any of the Bifidobacterium probiotics would do the same thing.

Are prebiotics the same as probiotics?

No, prebiotics aren’t the same as probiotics. Prebiotics are nondigestible food components that selectively stimulate the growth or activity of desirable microorganisms.

What are synbiotics?

Synbiotics are products that combine probiotics and prebiotics.

How popular are probiotics?

The 2012 National Health Interview Survey (NHIS) showed that about 4 million (1.6 percent) U.S. adults had used probiotics or prebiotics in the past 30 days. Among adults, probiotics or prebiotics were the third most commonly used dietary supplement other than vitamins and minerals. The use of probiotics by adults quadrupled between 2007 and 2012. The 2012 NHIS also showed that 300,000 children age 4 to 17 (0.5 percent) had used probiotics or prebiotics in the 30 days before the survey.

How might probiotics work?

Probiotics may have a variety of effects in the body, and different probiotics may act in different ways.

Probiotics might:

• Help your body maintain a healthy community of microorganisms or help your body’s community of microorganisms return to a healthy condition after being disturbed
• Produce substances that have desirable effects
• Influence your body’s immune response.

How are probiotics regulated in the United States?

Government regulation of probiotics in the United States is complex. Depending on a probiotic product’s intended use, the FDA might regulate it as a dietary supplement, a food ingredient, or a drug.

Many probiotics are sold as dietary supplements, which don’t require FDA approval before they are marketed. Dietary supplement labels may make claims about how the product affects the structure or function of the body without FDA approval, but they aren’t allowed to make health claims, such as saying the supplement lowers your risk of getting a disease, without the FDA’s consent.

If a probiotic is going to be marketed as a drug for treatment of a disease or disorder, it has to meet stricter requirements. It must be proven safe and effective for its intended use through clinical trials and be approved by the FDA before it can be sold.

.header_greentext{color:green!important;font-size:24px!important;font-weight:500!important;}.header_bluetext{color:blue!important;font-size:18px!important;font-weight:500!important;}.header_redtext{color:red!important;font-size:28px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;font-size:28px!important;font-weight:500!important;}.header_purpletext{color:purple!important;font-size:31px!important;font-weight:500!important;}.header_yellowtext{color:yellow!important;font-size:20px!important;font-weight:500!important;}.header_blacktext{color:black!important;font-size:22px!important;font-weight:500!important;}.header_whitetext{color:white!important;font-size:22px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;}.Green_Header{color:green!important;font-size:24px!important;font-weight:500!important;}.Blue_Header{color:blue!important;font-size:18px!important;font-weight:500!important;}.Red_Header{color:red!important;font-size:28px!important;font-weight:500!important;}.Purple_Header{color:purple!important;font-size:31px!important;font-weight:500!important;}.Yellow_Header{color:yellow!important;font-size:20px!important;font-weight:500!important;}.Black_Header{color:black!important;font-size:22px!important;font-weight:500!important;}.White_Header{color:white!important;font-size:22px!important;font-weight:500!important;} Learning About the Microbiome

The community of microorganisms that lives on us and in us is called the “microbiome,” and it’s a hot topic for research. The Human Microbiome Project, supported by the National Institutes of Health (NIH) from 2007 to 2016, played a key role in this research by mapping the normal bacteria that live in and on the healthy human body. With this understanding of a normal microbiome as the basis, researchers around the world, including many supported by NIH, are now exploring the links between changes in the microbiome and various diseases. They’re also developing new therapeutic approaches designed to modify the microbiome to treat disease and support health.

The National Center for Complementary and Integrative Health (NCCIH) is among the many agencies funding research on the microbiome. Researchers supported by NCCIH are studying the interactions between components of food and microorganisms in the digestive tract. The focus is on the ways in which diet-microbiome interactions may lead to the production of substances with beneficial health effects.

.header_greentext{color:green!important;font-size:24px!important;font-weight:500!important;}.header_bluetext{color:blue!important;font-size:18px!important;font-weight:500!important;}.header_redtext{color:red!important;font-size:28px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;font-size:28px!important;font-weight:500!important;}.header_purpletext{color:purple!important;font-size:31px!important;font-weight:500!important;}.header_yellowtext{color:yellow!important;font-size:20px!important;font-weight:500!important;}.header_blacktext{color:black!important;font-size:22px!important;font-weight:500!important;}.header_whitetext{color:white!important;font-size:22px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;}.Green_Header{color:green!important;font-size:24px!important;font-weight:500!important;}.Blue_Header{color:blue!important;font-size:18px!important;font-weight:500!important;}.Red_Header{color:red!important;font-size:28px!important;font-weight:500!important;}.Purple_Header{color:purple!important;font-size:31px!important;font-weight:500!important;}.Yellow_Header{color:yellow!important;font-size:20px!important;font-weight:500!important;}.Black_Header{color:black!important;font-size:22px!important;font-weight:500!important;}.White_Header{color:white!important;font-size:22px!important;font-weight:500!important;} What has science shown about the effectiveness of probiotics for health conditions?

A great deal of research has been done on probiotics, but much remains to be learned about whether they’re helpful and safe for various health conditions.

Probiotics have shown promise for a variety of health purposes, including prevention of antibiotic-associated diarrhea (including diarrhea caused by Clostridium difficile ), prevention of necrotizing enterocolitis and sepsis in premature infants, treatment of infant colic , treatment of periodontal disease , and induction or maintenance of remission in ulcerative colitis .

However, in most instances, we still don’t know which probiotics are helpful and which are not. We also don’t know how much of the probiotic people would have to take or who would be most likely to benefit. Even for the conditions that have been studied the most, researchers are still working toward finding the answers to these questions.

The following sections summarize the research on probiotics for some of the conditions for which they’ve been studied.

Gastrointestinal Conditions

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• Probiotics have been studied for antibiotic-associated diarrhea in general, as well as for antibiotic-associated diarrhea caused by one specific bacterium, Clostridium difficile . This section discusses the research on antibiotic-associated diarrhea in general. C. difficile is discussed in a separate section below.
• A 2017 review of 17 studies (3,631 total participants) in people who were not hospitalized indicated that giving probiotics to patients along with antibiotics was associated with a decrease of about half in the likelihood of antibiotic-associated diarrhea. However, this conclusion was considered tentative because the quality of the studies was only moderate. Patients who were given probiotics had no more side effects than patients who didn’t receive them.
• Probiotics may be helpful for antibiotic-associated diarrhea in young and middle-aged people, but a benefit has not been demonstrated in elderly people, according to a 2016 review of 30 studies (7,260 participants), 5 of which focused on people age 65 or older. It’s uncertain whether probiotics actually don’t work in elderly people or whether no effect was seen because there were only a few studies of people in this age group.
• A review of 23 studies (with 3,938 participants) of probiotics to prevent antibiotic-associated diarrhea in children provided moderate quality evidence that probiotics had a protective effect. No serious side effects were observed in children who were otherwise healthy, except for the infection for which they were being treated.

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• The bacterium Clostridium difficile can infect the colon (large intestine) of patients who have received antibiotics, causing diarrhea that can range from mild to severe. C. difficile infection is difficult to treat and sometimes comes back after treatment. It’s more common in people who take antibiotics long-term and in elderly people, and it can spread in hospitals and nursing homes. C. difficile infection affects about half a million people a year in the United States and causes about 15,000 deaths.
• A 2017 analysis of 31 studies (8,672 total patients) concluded that it is moderately certain that probiotics can reduce the risk of C. difficile diarrhea in adults and children who are receiving antibiotics. Most of these studies involved hospital patients. The analysis also concluded that the use of probiotics along with antibiotics appears to be safe, except for patients who are very weak or have poorly functioning immune systems.
• The types of probiotics that would be most useful in reducing the risk of C. difficile diarrhea, the length of time for which they should be taken, and the most appropriate doses are uncertain.

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• A 2014 review of 14 studies (1,182 participants) of probiotics for constipation in adults showed some evidence of benefit, especially for Bifidobacterium lactis .
• A 2017 evaluation of 9 studies (778 participants) of probiotics for constipation in elderly people indicated that probiotics produced a small but meaningful benefit. The type of bacteria most often tested was Bifidobacterium longum . The researchers who performed the evaluation suggested that probiotics might be helpful for chronic constipation in older people as an addition to the usual forms of treatment.
• A 2017 review looked at 7 studies of probiotics for constipation in children (515 participants). The studies were hard to compare because of differences in the groups of children studied, the types of probiotics used, and other factors. The reviewers did not find evidence that any of the probiotics tested in the children were helpful. A second 2017 review, which included 4 of the same studies and 2 others (498 total participants in the 6 studies examined), took a more optimistic view of the evidence, noting that overall, probiotics did increase stool frequency, and that the effect was more noticeable in Asian than European children.

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• Diarrhea is a common side effect of chemotherapy or radiotherapy for cancer. It’s been suggested that probiotics might help prevent or treat this type of diarrhea. However, a 2018 review of 12 studies (1,554 participants) found that the evidence for a beneficial effect of probiotics was inconclusive.

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• In diverticulosis, small pouches develop at weak spots in the wall of the colon (large intestine). In most cases, this does not cause any symptoms. If symptoms (such as bloating, constipation, diarrhea, or cramping) do occur, the condition is called diverticular disease. If any of the pouches become inflamed, the condition is called diverticulitis. Patients with diverticulitis can have severe abdominal pain and may develop serious complications.
• A 2016 review of 11 studies (764 participants) of probiotics for diverticular disease was unable to reach conclusions on whether the probiotics were helpful because of the poor quality of the studies.

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• Inflammatory bowel disease is a term for a group of conditions that cause a portion of the digestive system to become inflamed; the most common types are ulcerative colitis and Crohn’s disease. Symptoms may include abdominal pain, diarrhea (which may be bloody), loss of appetite, weight loss, and fever. The symptoms can range from mild to severe, and they may come and go. Treatment includes medicines and in some cases, surgery.
• A 2014 review of 21 studies in patients with ulcerative colitis (1,700 participants) indicated that adding probiotics, prebiotics, or synbiotics to conventional treatment could be helpful in inducing or maintaining remission of the disease. The same review also looked at 14 studies (746 participants) of probiotics, prebiotics, or synbiotics for Crohn’s disease and did not find evidence that they were beneficial.

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• A 2018 review of 53 studies (5,545 total participants) of probiotics for irritable bowel syndrome (IBS) concluded that probiotics may have beneficial effects on global IBS symptoms and abdominal pain, but it was not possible to draw definite conclusions about their effectiveness or to identify which species, strains, or combinations of probiotics are most likely to be helpful.

For more information, see the NCCIH fact sheet on irritable bowel syndrome .

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• A 2018 review evaluated 11 studies (5,143 participants) of probiotics or prebiotics for prevention of traveler’s diarrhea and found evidence that they may be helpful. However, the review didn’t assess the quality of the studies and didn’t include data on side effects.
• A 2017 clinical practice guideline by the International Society of Travel Medicine stated that there’s insufficient evidence to recommend probiotics or prebiotics to prevent or treat traveler’s diarrhea. The guidelines acknowledged that there’s evidence suggesting a small benefit but pointed out that studies vary greatly in terms of factors such as the probiotic strains used, the causes of the diarrhea, and geographic locations. Also, some studies had weaknesses in their design.

.header_greentext{color:green!important;font-size:24px!important;font-weight:500!important;}.header_bluetext{color:blue!important;font-size:18px!important;font-weight:500!important;}.header_redtext{color:red!important;font-size:28px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;font-size:28px!important;font-weight:500!important;}.header_purpletext{color:purple!important;font-size:31px!important;font-weight:500!important;}.header_yellowtext{color:yellow!important;font-size:20px!important;font-weight:500!important;}.header_blacktext{color:black!important;font-size:22px!important;font-weight:500!important;}.header_whitetext{color:white!important;font-size:22px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;}.Green_Header{color:green!important;font-size:24px!important;font-weight:500!important;}.Blue_Header{color:blue!important;font-size:18px!important;font-weight:500!important;}.Red_Header{color:red!important;font-size:28px!important;font-weight:500!important;}.Purple_Header{color:purple!important;font-size:31px!important;font-weight:500!important;}.Yellow_Header{color:yellow!important;font-size:20px!important;font-weight:500!important;}.Black_Header{color:black!important;font-size:22px!important;font-weight:500!important;}.White_Header{color:white!important;font-size:22px!important;font-weight:500!important;} Conditions in Infants

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• Colic is excessive, unexplained crying in young infants. Babies with colic may cry for 3 hours a day or more, but they eat well and grow normally. The cause of colic is not well understood, but studies have shown differences in the microbial community in the digestive tract between infants who have colic and those who don’t, which suggests that microorganisms may be involved.
• A 2018 review of 7 studies (471 participants) of probiotics for colic, 5 of which involved the probiotic Lactobacillus reuteri DSM 17938, found that this probiotic was associated with successful treatment (defined as a reduction of more than half in daily crying time). However, the effect was mainly seen in exclusively breastfed infants.
• No harmful effects were seen in a review of 4 studies (345 participants) of L. reuteri DSM 17938 for colic or in a small NCCIH-funded study that included repeated physical examinations and blood tests in infants with colic who were given this probiotic, as well as parents’ reports of symptoms.

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• Necrotizing enterocolitis is a serious, sometimes fatal disease that occurs in premature infants. It involves injury or damage to the intestinal tract, causing death of intestinal tissue. Its exact cause is unknown, but an abnormal reaction to food components and the microorganisms that live in a premature baby’s digestive tract may play a role.
• A 2017 review of 23 studies (7,325 infants) showed that probiotics helped to prevent necrotizing enterocolitis in very-low-birth-weight infants. However, the results of individual studies varied; not all showed a benefit. Probiotics that included both Lactobacillus and Bifidobacterium seemed to produce the best results, but it was not possible to identify the most beneficial strains within these large groups of bacteria.
• None of the infants in the studies described above developed harmful short-term side effects from the probiotics. However, the long-term effects of receiving probiotics at such a young age are uncertain. Outside of these studies, there have been instances when probiotics did have harmful effects in newborns. In 2023, the FDA warned health care providers that premature infants who are given probiotics are at risk of severe, potentially fatal infections caused by the microorganisms in the products.

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• Sepsis is a serious illness in which the body has a harmful, overwhelming response to an infection. It can cause major organs and body systems to stop working properly and can be life threatening. The risk of sepsis is highest in infants, children, the elderly, and people with serious medical problems. One group particularly at risk for sepsis is premature infants.
• A review of 37 studies (9,416 participants) found that probiotics were helpful in reducing the risk of sepsis in premature infants.

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.header_greentext{color:greenimportant;font-size:24pximportant;font-weight:500important;}.header_bluetext{color:blueimportant;font-size:18pximportant;font-weight:500important;}.header_redtext{color:redimportant;font-size:28pximportant;font-weight:500important;}.header_darkred{color:#803d2fimportant;font-size:28pximportant;font-weight:500important;}.header_purpletext{color:purpleimportant;font-size:31pximportant;font-weight:500important;}.header_yellowtext{color:yellowimportant;font-size:20pximportant;font-weight:500important;}.header_blacktext{color:blackimportant;font-size:22pximportant;font-weight:500important;}.header_whitetext{color:whiteimportant;font-size:22pximportant;font-weight:500important;}.header_darkred{color:#803d2fimportant;}.green_header{color:greenimportant;font-size:24pximportant;font-weight:500important;}.blue_header{color:blueimportant;font-size:18pximportant;font-weight:500important;}.red_header{color:redimportant;font-size:28pximportant;font-weight:500important;}.purple_header{color:purpleimportant;font-size:31pximportant;font-weight:500important;}.yellow_header{color:yellowimportant;font-size:20pximportant;font-weight:500important;}.black_header{color:blackimportant;font-size:22pximportant;font-weight:500important;}.white_header{color:whiteimportant;font-size:22pximportant;font-weight:500important;} dental caries (tooth decay).

• A small amount of research, all in infants and young children, has examined the possibility that probiotics might be helpful in preventing dental caries (also called cavities or tooth decay). A review of 7 studies (1,715 total participants) found that the use of probiotics was associated with fewer cavities in 4 of the 7 studies, but the quality of the evidence was low, and no definite conclusions about the effectiveness of probiotics could be reached.

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• Periodontal diseases result from infections and inflammation of the gums and bone that surround and support the teeth. If the disease is severe, the gums can pull away from the teeth, bone can be lost, and teeth may loosen or fall out.
• A 2016 review of 12 studies (452 participants) that evaluated probiotics for periodontal disease found evidence that they could be a helpful addition to treatment by reducing disease-causing bacteria and improving clinical signs of the disease. However, effects may differ for different probiotics.

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.header_greentext{color:greenimportant;font-size:24pximportant;font-weight:500important;}.header_bluetext{color:blueimportant;font-size:18pximportant;font-weight:500important;}.header_redtext{color:redimportant;font-size:28pximportant;font-weight:500important;}.header_darkred{color:#803d2fimportant;font-size:28pximportant;font-weight:500important;}.header_purpletext{color:purpleimportant;font-size:31pximportant;font-weight:500important;}.header_yellowtext{color:yellowimportant;font-size:20pximportant;font-weight:500important;}.header_blacktext{color:blackimportant;font-size:22pximportant;font-weight:500important;}.header_whitetext{color:whiteimportant;font-size:22pximportant;font-weight:500important;}.header_darkred{color:#803d2fimportant;}.green_header{color:greenimportant;font-size:24pximportant;font-weight:500important;}.blue_header{color:blueimportant;font-size:18pximportant;font-weight:500important;}.red_header{color:redimportant;font-size:28pximportant;font-weight:500important;}.purple_header{color:purpleimportant;font-size:31pximportant;font-weight:500important;}.yellow_header{color:yellowimportant;font-size:20pximportant;font-weight:500important;}.black_header{color:blackimportant;font-size:22pximportant;font-weight:500important;}.white_header{color:whiteimportant;font-size:22pximportant;font-weight:500important;} allergic rhinitis (hay fever).

• A review of 23 studies (1,919 participants) in which probiotics were tested for treating allergic rhinitis found some evidence that they may be helpful for improving symptoms and quality of life. However, because the studies tested different probiotics and measured different effects, no recommendations about the use of probiotics could be made. Few side effects of probiotics were reported in these studies.

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• A review of 11 studies (910 participants) of probiotics for asthma in children had inconclusive results.

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• Atopic dermatitis is an itchy chronic skin disorder that’s associated with allergies but not caused by them. It’s most common in infants and may start as early as age 2 to 6 months. Many people outgrow it by early adulthood. Atopic dermatitis is one of several types of eczema.
• A 2017 review of 13 studies (1,271 participants) of probiotics for the treatment of atopic dermatitis in infants and children did not find consistent evidence of a beneficial effect. A review of 9 studies (269 participants) in adults provided preliminary evidence that some strains of probiotics might be beneficial for symptoms of atopic dermatitis.

.header_greentext{color:green!important;font-size:24px!important;font-weight:500!important;}.header_bluetext{color:blue!important;font-size:18px!important;font-weight:500!important;}.header_redtext{color:red!important;font-size:28px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;font-size:28px!important;font-weight:500!important;}.header_purpletext{color:purple!important;font-size:31px!important;font-weight:500!important;}.header_yellowtext{color:yellow!important;font-size:20px!important;font-weight:500!important;}.header_blacktext{color:black!important;font-size:22px!important;font-weight:500!important;}.header_whitetext{color:white!important;font-size:22px!important;font-weight:500!important;}.header_darkred{color:#803d2f!important;}.Green_Header{color:green!important;font-size:24px!important;font-weight:500!important;}.Blue_Header{color:blue!important;font-size:18px!important;font-weight:500!important;}.Red_Header{color:red!important;font-size:28px!important;font-weight:500!important;}.Purple_Header{color:purple!important;font-size:31px!important;font-weight:500!important;}.Yellow_Header{color:yellow!important;font-size:20px!important;font-weight:500!important;}.Black_Header{color:black!important;font-size:22px!important;font-weight:500!important;}.White_Header{color:white!important;font-size:22px!important;font-weight:500!important;} Prevention of Allergies

• It’s been suggested that changes in people’s lifestyles and environment may have led to reduced contact with microorganisms early in life, and that this decrease may have contributed to an increase in allergies. This is sometimes called the “hygiene hypothesis,” although factors unrelated to hygiene, such as smaller family size and the use of antibiotics, may also play a role. Studies have been done in which probiotics were given to pregnant women and/or young infants in the hope of preventing the development of allergies.
• A 2015 review of 17 studies (4,755 participants) that evaluated the use of probiotics during pregnancy or early infancy found that infants exposed to probiotics had a lower risk of developing atopic dermatitis, especially if they were exposed to a mixture of probiotics. However, probiotics did not have an effect on the risks of asthma, wheezing, or hay fever (allergic rhinitis).

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.header_greentext{color:greenimportant;font-size:24pximportant;font-weight:500important;}.header_bluetext{color:blueimportant;font-size:18pximportant;font-weight:500important;}.header_redtext{color:redimportant;font-size:28pximportant;font-weight:500important;}.header_darkred{color:#803d2fimportant;font-size:28pximportant;font-weight:500important;}.header_purpletext{color:purpleimportant;font-size:31pximportant;font-weight:500important;}.header_yellowtext{color:yellowimportant;font-size:20pximportant;font-weight:500important;}.header_blacktext{color:blackimportant;font-size:22pximportant;font-weight:500important;}.header_whitetext{color:whiteimportant;font-size:22pximportant;font-weight:500important;}.header_darkred{color:#803d2fimportant;}.green_header{color:greenimportant;font-size:24pximportant;font-weight:500important;}.blue_header{color:blueimportant;font-size:18pximportant;font-weight:500important;}.red_header{color:redimportant;font-size:28pximportant;font-weight:500important;}.purple_header{color:purpleimportant;font-size:31pximportant;font-weight:500important;}.yellow_header{color:yellowimportant;font-size:20pximportant;font-weight:500important;}.black_header{color:blackimportant;font-size:22pximportant;font-weight:500important;}.white_header{color:whiteimportant;font-size:22pximportant;font-weight:500important;} acne.

• Research has identified mechanisms by which probiotics, either taken orally or used topically (applied to the skin), might influence acne. However, there has been very little research in people on probiotics for acne, and the American Academy of Dermatology’s 2016 guidelines for managing acne state that the existing evidence isn’t strong enough to justify any recommendations about the use of probiotics.

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• When the liver is damaged and unable to remove toxic substances from the blood, the toxins can build up in the bloodstream and affect the nervous system. This may lead to impairments of brain function called hepatic encephalopathy.
• A 2017 review looked at 21 studies (1,420 participants) of probiotics for hepatic encephalopathy and concluded that they were generally of low quality. There was evidence that compared with a placebo (an inactive substance) or no treatment, probiotics probably had beneficial effects on hepatic encephalopathy, but it was uncertain whether probiotics were better than lactulose, a conventional treatment for liver disease.

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• Probiotics have been tested for their effects against upper respiratory infections (a group that includes the common cold, middle ear infections, sinusitis, and various throat infections). A 2015 evaluation of 12 studies with 3,720 total participants indicated that people taking probiotics may have fewer and shorter upper respiratory infections. However, the quality of the evidence was low because some of the studies were poorly conducted.

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• A 2015 review of 9 studies (735 participants) of probiotics for the prevention of urinary tract infection did not find evidence of a beneficial effect.

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• Probiotics have an extensive history of apparently safe use, particularly in healthy people. However, few studies have looked at the safety of probiotics in detail, so there’s a lack of solid information on the frequency and severity of side effects.
• The risk of harmful effects from probiotics is greater in people with severe illnesses or compromised immune systems. When probiotics are being considered for high-risk individuals, such as premature infants or seriously ill hospital patients, the potential risks of probiotics should be carefully weighed against their benefits. Cases of severe or fatal infections have been reported in premature infants who were given probiotics, and the U.S. Food and Drug Administration (FDA) has warned health care providers about this risk.
• Possible harmful effects of probiotics include infections, production of harmful substances by the probiotic microorganisms, and transfer of antibiotic resistance genes from probiotic microorganisms to other microorganisms in the digestive tract.
• Some probiotic products have been reported to contain microorganisms other than those listed on the label. In some instances, these contaminants may pose serious health risks.

NCCIH-Funded Research

NCCIH sponsors a variety of research projects related to probiotics or the microbiome. In addition to the previously mentioned studies on diet-microbiome interactions in the digestive tract, recent topics include:

• The mechanisms by which probiotics may help to reduce postmenopausal bone loss
• Engineering probiotics to synthesize natural substances for microbiome-brain research
• The mechanisms by which certain probiotics may relieve chronic pelvic pain
• The effects of a specific Bifidobacterium strain on changes in short-chain fatty acid production in the gut that may play a role in antibiotic-associated diarrhea.

More To Consider

• Don’t use probiotics as a reason to postpone seeing your health care provider about any health problem.
• If you’re considering a probiotic dietary supplement, consult your health care provider first. This is especially important if you have health problems. Anyone with a serious underlying health condition should be monitored closely while taking probiotics.
• Take charge of your health—talk with your health care providers about any complementary health approaches you use. Together, you can make shared, well-informed decisions.

For More Information

Nccih clearinghouse.

The NCCIH Clearinghouse provides information on NCCIH and complementary and integrative health approaches, including publications and searches of Federal databases of scientific and medical literature. The Clearinghouse does not provide medical advice, treatment recommendations, or referrals to practitioners.

Toll-free in the U.S.: 1-888-644-6226

Telecommunications relay service (TRS): 7-1-1

Website: https://www.nccih.nih.gov

Email: [email protected] (link sends email)

Know the Science

NCCIH and the National Institutes of Health (NIH) provide tools to help you understand the basics and terminology of scientific research so you can make well-informed decisions about your health. Know the Science features a variety of materials, including interactive modules, quizzes, and videos, as well as links to informative content from Federal resources designed to help consumers make sense of health information.

Explaining How Research Works (NIH)

Know the Science: How To Make Sense of a Scientific Journal Article

Understanding Clinical Studies (NIH)

A service of the National Library of Medicine, PubMed® contains publication information and (in most cases) brief summaries of articles from scientific and medical journals. For guidance from NCCIH on using PubMed, see How To Find Information About Complementary Health Approaches on PubMed .

Website: https://pubmed.ncbi.nlm.nih.gov/

MedlinePlus

To provide resources that help answer health questions, MedlinePlus (a service of the National Library of Medicine) brings together authoritative information from the National Institutes of Health as well as other Government agencies and health-related organizations.

Website: https://www.medlineplus.gov

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• Bafeta A, Koh M, Riveros C, et al. Harms reporting in randomized controlled trials of interventions aimed at modifying microbiota: a systematic review. Annals of Internal Medicine . 2018;169(4):240-247.
• Blaabjerg S, Artzi DM, Aabenhus R. Probiotics for the prevention of antibiotic-associated diarrhea in outpatients—a systematic review and meta-analysis. Antibiotics . 2017;6(4).pii:E21.
• Butel M-J. Probiotics, gut microbiota and health. Médecine et Maladies Infectieuses . 2014;44(1):1-8.
• Cohen PA. Probiotic safety—no guarantees. JAMA Internal Medicine . 2018;178(12):1577-1578.
• Degnan FH. The US Food and Drug Administration and probiotics: regulatory categorization. Clinical Infectious Diseases. 2008;46(Suppl 2):S133–S136.
• Didari T, Solki S, Mozaffari S, et al. A systematic review of the safety of probiotics. Expert Opinion on Drug Safety . 2014;13(2):227–239.
• Dryl R, Szajewska H. Probiotics for management of infantile colic: a systematic review of randomized controlled trials. Archives of Medical Science. 2018;14(5):1137-1143.
• Fijan S. Microorganisms with claimed probiotic properties: an overview of recent literature. International Journal of Environmental Research and Public Health. 2014;11(5):4745-4767.
• Ford AC, Harris LA, Lacy BE, et al. Systematic review with meta-analysis: the efficacy of prebiotics, probiotics, synbiotics and antibiotics in irritable bowel syndrome. Alimentary Pharmacology & Therapeutics . 2018;48(10):1044-1060.
• Goldenberg JZ, Yap C, Lytvyn L, et al. Probiotics for the prevention of Clostridium difficile -associated diarrhea in adults and children. Cochrane Database of Systematic Reviews. 2017;(12):CD006095. Accessed at www.cochranelibrary.com on January 23, 2018.
• Guarner F, Khan AG, Garisch J, et al. World Gastroenterology Organisation Global Guidelines. Probiotics and Prebiotics. October 2011. Journal of Clinical Gastroenterology . 2012;46(6):468–481.
• Hempel S, Newberry SJ, Maher AR, et al. Probiotics for the prevention and treatment of antibiotic-associated diarrhea: a systematic review and meta-analysis. JAMA . 2012;307(18):1959–1969.
• Hempel S, Newberry S, Ruelaz A, et al. Safety of Probiotics to Reduce Risk and Prevent or Treat Disease. Evidence Report/Technology Assessment no. 200. Rockville, MD: Agency for Healthcare Research and Quality; 2011. AHRQ publication no. 11-E007.
• Rao SC, Athalye-Jape GK, Deshpande GC, et al. Probiotic supplementation and late-onset sepsis in preterm infants: a meta-analysis. Pediatrics. 2016;137(3):e20153684.
• Sanders ME, Akkermans LM, Haller D, et al. Safety assessment of probiotics for human use. Gut Microbes . 2010;1(3):164-185.
• Thomas JP, Raine T, Reddy S, et al. Probiotics for the prevention of necrotizing enterocolitis in very low-birth-weight infants: a meta-analysis and systematic review. Acta Paediatrica . 2017;106(11):1729-1741.
• U.S. Food and Drug Administration. Warning Regarding Use of Probiotics in Preterm Infants. Issued September 29, 2023. Accessed at  https://www.fda.gov/media/172606 on October 2, 2023.
• Zuccotti G, Meneghin F, Aceti A, et al. Probiotics for prevention of atopic diseases in infants: systematic review and meta-analysis. Allergy. 2015;70(11):1356-13

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• Bae J-M. Prophylactic efficacy of probiotics on travelers’ diarrhea: an adaptive meta-analysis of randomized controlled trials. Epidemiology and Health . 2018;40:e2018043.
• Black LI, Clarke TC, Barnes PM, Stussman BJ, Nahin RL. Use of complementary health approaches among children aged 4-17 years in the United States: National Health Interview Survey, 2007-2012. National health statistics reports; no 78. Hyattsville, MD: National Center for Health Statistics. 2015.
• Cao L, Wang L, Yang L, et al. Long-term effect of early-life supplementation with probiotics on preventing atopic dermatitis: a meta-analysis. Journal of Dermatological Treatment . 2015;26(6):537-540.
• Clarke TC, Black LI, Stussman BJ, Barnes PM, Nahin RL. Trends in the use of complementary health approaches among adults: United States, 2002–2012. National health statistics reports; no 79. Hyattsville, MD: National Center for Health Statistics. 2015.
• Dalal R, McGee RG, Riordan SM, et al. Probiotics for people with hepatic encephalopathy. Cochrane Database of Systematic Reviews . 2017;(2):CD008716. Accessed at www.cochranelibrary.com on November 15, 2018.
• Dimidi E, Christodoulides S, Fragkos KC, et al. The effect of probiotics on functional constipation in adults: a systematic review and meta-analysis of randomized controlled trials. American Journal of Clinical Nutrition . 2014;100(4):1075-1084.
• Doron S, Snydman DR. Risk and safety of probiotics. Clinical Infectious Diseases . 2015;60(Suppl 2):S129-S134.
• Fatheree NY, Liu Y, Taylor CM, et al. Lactobacillus reuteri for infants with colic: a double-blind, placebo-controlled, randomized clinical trial. Journal of Pediatrics . 2017;191:170-178.
• Ghouri YA, Richards DM, Rahimi EF, et al. Systematic review of randomized controlled trials of probiotics, prebiotics, and synbiotics in inflammatory bowel disease. Clinical and Experimental Gastroenterology . 2014;7:473-487.
• Gibson GR, Hutkins R, Sanders ME, et al. Expert consensus document: The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of prebiotics. Nature Reviews. Gastroenterology & Hepatology . 2017;14(8):491-502.
• Goldenberg JZ, Lytvyn L, Steurich J, et al. Probiotics for the prevention of pediatric antibiotic-associated diarrhea. Cochrane Database of Systematic Reviews . 2015;(12):CD004827. Accessed at www.cochranelibrary.com on November 2, 2018.
• Hao Q, Dong BR, Wu T. Probiotics for preventing acute upper respiratory tract infections. Cochrane Database of Systematic Reviews . 2015;(2):CD006895. Accessed at www.cochranelibrary.com on March 6, 2018.
• Hoffmann DE, Fraser CM, Palumbo FB, et al. Probiotics: finding the right regulatory balance. Science . 2013;342(6156):314-315.
• Huang R, Hu J. Positive effect of probiotics on constipation in children: a systematic review and meta-analysis of six randomized controlled trials. Frontiers in Cellular and Infection Microbiology. 2017;7:153.
• Huang R, Ning H, Shen M, et al. Probiotics for the treatment of atopic dermatitis in children: a systematic review and meta-analysis of randomized controlled trials. Frontiers in Cellular and Infection Microbiology. 2017;7:392.
• Jafarnejad S, Shab-Bidar S, Speakman JR, et al. Probiotics reduce the risk of antibiotic-associated diarrhea in adults (18-64 years) but not the elderly (>65 years): a meta-analysis. Nutrition in Clinical Practice . 2016;31(4):502-513.
• Jørgensen MR, Castiblanco G, Twetman S, et al. Prevention of caries with probiotic bacteria during early childhood. Promising but inconsistent findings. American Journal of Dentistry . 2016;29(3):127-131.
• Kechagia M, Basoulis D, Konstantopoulou S, et al. Health benefits of probiotics: a review. ISRN Nutrition . 2013;2013:48165.
• Kelesidis T, Pothoulakis C. Efficacy and safety of the probiotic Saccharomyces boulardii for the prevention and therapy of gastrointestinal disorders. Therapeutic Advances in Gastroenterology . 2012;5(2):111-125.
• Kober M-M, Bowe WP. The effect of probiotics on immune regulation, acne, and photoaging. International Journal of Women’s Dermatology . 2015;1(2):85-89.
• Lahner E, Bellisario C, Hassan C, et al. Probiotics in the treatment of diverticular disease. A systematic review. Journal of Gastrointestinal and Liver Diseases . 2016;25(1):79-86.
• Lin J, Zhang Y, He C, et al. Probiotics supplementation in children with asthma: a systematic review and meta-analysis. Journal of Paediatrics and Child Health. 2018;54(9):953-961.
• Marcason W. Probiotics: where do we stand? Journal of the Academy of Nutrition and Dietetics. 2013;113(10):1424.
• Martínez-Martínez MI, Calabuig-Tolsá R, Cauli O. The effect of probiotics as a treatment for constipation in elderly people: a systematic review. Archives of Gerontology and Geriatrics. 2017;71:142-149.
• Matsubara VH, Bandara HM, Ishikawa KH, et al. The role of probiotic bacteria in managing periodontal disease: a systematic review. Expert Review of Anti-infective Therapy . 2016;14(7):643-655.
• Notay M, Foolad N, Vaughn AR, et al. Probiotics, prebiotics, and synbiotics for the treatment and prevention of adult dermatological diseases. American Journal of Clinical Dermatology . 2017;18(6):721-732.
• Oelschlaeger TA. Mechanisms of probiotic actions – A review. International Journal of Medical Microbiology . 2010;300(1):57-62.
• Osborn DA, Sinn JKH. Prebiotics in infants for prevention of allergy. Cochrane Database of Systematic Reviews . 2013(3):CD006474. Accessed at www.cochranelibrary.com on March 6, 2018.
• Petschow B, Doré J, Hibberd P, et al. Probiotics, prebiotics, and the host microbiome: the science of translation. Annals of the New York Academy of Sciences . 2013;1306:1–17.
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Acknowledgments

NCCIH thanks Yisong Wang, Ph.D., and David Shurtleff, Ph.D., for their review of the 2019 update of this publication.

This publication is not copyrighted and is in the public domain. Duplication is encouraged.

NCCIH has provided this material for your information. It is not intended to substitute for the medical expertise and advice of your health care provider(s). We encourage you to discuss any decisions about treatment or care with your health care provider. The mention of any product, service, or therapy is not an endorsement by NCCIH.

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Probiotics - Systematic Reviews/Reviews/Meta-analyses (PubMed®)

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Stanford University School of Medicine blog

‘Cyclic sighing’ can help breathe away anxiety

Feeling anxious? You're far from alone. During the pandemic, rates of anxiety and depression soared around the globe, resulting in a shortage of mental health care providers and long wait times for therapy.

But, according to a new study from Stanford Medicine , there's an easy, at-home way to help lower your stress level: It's called cyclic sighing, a controlled breathing exercise that emphasizes long exhalations. What's more, it can take as little as five minutes to experience less anxiety, a better mood and even decreased rates of breathing at rest, a sign of overall body calmness.

"What's interesting about the breath is that it's right on the edge of conscious control," said David Spiegel , MD, the Jack, Lulu, and Sam Willson Professor in Medicine and associate chair of psychiatry and behavioral sciences, who co-led the study with Stanford Medicine neurobiologist Andrew Huberman , PhD, and Melis Yilmaz Balban, PhD, former Stanford Medicine senior research scientist. "Most of the time breathing is automatic, like digestion, heartbeat and other bodily functions, but you can very easily take over and control your breath, which then affects your overall physiology and stress response."

Breaking the anxiety spiral

Imagine you've just experienced something stressful -- maybe a critical email from your boss or a phone call from your child's school principal. As soon as you start to worry, your heart rate speeds, and you breathe a little more quickly. Your muscles tighten, your armpits get sweaty and you suddenly feel restless and fidgety.

For many people, especially those with anxiety disorders, these physical changes trigger a chain reaction of thoughts and fears, said Spiegel, who is the director of the Center on Stress and Health at Stanford Medicine. "As soon as you notice what's going on in your body, your brain thinks, 'Oh no, this must be really bad,' and you get more anxious. It's like a snowball rolling downhill."

But taking charge of your breathing can break the cycle, Spiegel said. "When we teach people to control the physical effects of a stressor on their body, it puts them in a better position to deal with the stressor itself."

The instructions are simple: Breathe in through your nose. When you've comfortably filled your lungs, take a second, deeper sip of air to expand your lungs as much as possible. Then, very slowly, exhale through your mouth until all the air is gone.

After one or two of these deep sighs, you may already feel calmer, but to get the full effect, Spiegel recommends repeating these deep sighs for about five minutes. Exhalation activates the parasympathetic nervous system, he said, which slows down heart rate and has an overall soothing effect on the body.

Putting cyclic sighing to the test

There's a long history of using controlled breathing in traditional practices like yoga, tai chi and meditation, but scientists are just beginning to study how these breathing exercises work and which ones are most beneficial.

Huberman and Spiegel recently led a randomized, controlled trial of cyclic sighing compared to two other types of breathing exercises, one emphasizing inhalation and another asking participants to breathe in and out for equal amounts of time. Each of the 111 healthy volunteers were asked to perform their assigned exercise for five minutes a day over the course of one month. (People with moderate to severe psychiatric conditions were not a part of this preliminary study.)

Before and after completing their daily breathing exercises, participants answered two online questionnaires: the State Anxiety Inventory, a standardized measurement of current anxiety levels, and the Positive and Negative Affect Schedule, a common research tool used to assess good and bad feelings on a scale from 1 to 5.

The trial also included a control group of participants who passively observed their breath during five minutes of mindfulness meditation.

"In mindfulness meditation, we instruct people to be aware of their breath but not try to control it," Spiegel said. "For the other groups, we asked participants to directly control an activity that normally goes on more or less automatically."

Hundreds of studies have demonstrated the benefits of mindfulness meditation for reducing stress and anxiety, and as expected, the mindfulness group reported lower anxiety and improved mood. But in this study , published Jan. 17 in Cell Reports Medicine , the controlled breathing groups reported even more improvements, with significantly greater increases in positive affect -- good feelings such as energy, joy and peacefulness.

On average, participants in the controlled breathing groups experienced a daily increase in positive affect of 1.91 points on the Positive and Negative Affect Schedule scale, compared to 1.22 points for the mindfulness meditation group, an improvement that's greater by about one-third.

"Controlled breathing exercises may have a more rapid, more direct effect on physiology than mindfulness," Spiegel said, noting that people typically meditate for 20 to 30 minutes at a time. "We wanted to see whether a quicker intervention, repeated for just five minutes over the course of 30 days, could still have lasting effects." 

The researchers also hypothesized that cyclic sighing, with its focus on slow exhalation, might be more effective than the other two types of controlled breathing.

Indeed, while all three controlled breathing interventions decreased anxiety and negative mood, participants in the cyclic sighing group had the greatest daily improvement in positive feelings on the Positive and Negative Affect Schedule questionnaire. The effect increased as the study went on, suggesting that the more consecutive days they practiced cyclic sighing, the more it helped their mood.

Slower breathing rate, calmer body

In addition to tracking anxiety and mood, participants wore sensors to monitor their resting breathing rate and heart rate. Although no changes to heart rate were observed in any of the groups, participants in the cyclic sighing group significantly lowered their resting breathing rate, more than the mindfulness or other controlled breathing groups.

"They were breathing more slowly not just during the exercise, but throughout the day, indicating a lasting effect on physiology," Spiegel said.

Respiratory rate was also inversely correlated with a change in positive affect, suggesting that the participants whose breathing slowed down the most were also the ones who experienced the greatest improvement in mood. 

"We know that people who are breathing very rapidly feel more anxious, such as during a panic attack," Spiegel said. "Controlled breathwork seems to be a straightforward way to do the opposite: lower physiologic arousal and regulate your mood."

Simple, quick and free

One of the best parts of cyclic sighing is that it can be done anytime, anywhere -- with zero cost and zero side effects. In fact, due to the pandemic, the team conducted the entire trial remotely.

"Now we know we can reach a much bigger and more diverse population than if we'd done everything in the lab," said Spiegel.

In the future, Spiegel and Huberman plan to use functional MRI to measure brain activity during the controlled breathing exercises, and they hope to conduct treatment studies in specific populations with anxiety or mood disorders.

"There's a growing interest in nonpharmacological ways of helping people regulate their mood," Spiegel said. "We may be able to identify certain kinds of anxiety that respond substantially to this simple treatment."

In the meantime, Spiegel says there's no harm in trying cyclic sighing for yourself.

Photo by Fokussiert

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