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Literature reviews, what is a literature review, learning more about how to do a literature review.

• Planning the Review
• The Research Question
• Choosing Where to Search
• Organizing the Review
• Writing the Review

A literature review is a review and synthesis of existing research on a topic or research question. A literature review is meant to analyze the scholarly literature, make connections across writings and identify strengths, weaknesses, trends, and missing conversations. A literature review should address different aspects of a topic as it relates to your research question. A literature review goes beyond a description or summary of the literature you have read. 

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• Literature Review: The What, Why and How-to Guide
• Introduction

Literature Review: The What, Why and How-to Guide — Introduction

• Getting Started
• How to Pick a Topic
• Strategies to Find Sources
• Evaluating Sources & Lit. Reviews
• Tips for Writing Literature Reviews
• Writing Literature Review: Useful Sites
• Citation Resources
• Other Academic Writings

What are Literature Reviews?

So, what is a literature review? "A literature review is an account of what has been published on a topic by accredited scholars and researchers. In writing the literature review, your purpose is to convey to your reader what knowledge and ideas have been established on a topic, and what their strengths and weaknesses are. As a piece of writing, the literature review must be defined by a guiding concept (e.g., your research objective, the problem or issue you are discussing, or your argumentative thesis). It is not just a descriptive list of the material available, or a set of summaries." Taylor, D.  The literature review: A few tips on conducting it . University of Toronto Health Sciences Writing Centre.

Goals of Literature Reviews

What are the goals of creating a Literature Review?  A literature could be written to accomplish different aims:

• To develop a theory or evaluate an existing theory
• To summarize the historical or existing state of a research topic
• Identify a problem in a field of research 

Baumeister, R. F., & Leary, M. R. (1997). Writing narrative literature reviews .  Review of General Psychology , 1 (3), 311-320.

What kinds of sources require a Literature Review?

• A research paper assigned in a course
• A thesis or dissertation
• A grant proposal
• An article intended for publication in a journal

All these instances require you to collect what has been written about your research topic so that you can demonstrate how your own research sheds new light on the topic.

Types of Literature Reviews

What kinds of literature reviews are written?

Narrative review: The purpose of this type of review is to describe the current state of the research on a specific topic/research and to offer a critical analysis of the literature reviewed. Studies are grouped by research/theoretical categories, and themes and trends, strengths and weakness, and gaps are identified. The review ends with a conclusion section which summarizes the findings regarding the state of the research of the specific study, the gaps identify and if applicable, explains how the author's research will address gaps identify in the review and expand the knowledge on the topic reviewed.

• Example : Predictors and Outcomes of U.S. Quality Maternity Leave: A Review and Conceptual Framework:  10.1177/08948453211037398  

Systematic review : "The authors of a systematic review use a specific procedure to search the research literature, select the studies to include in their review, and critically evaluate the studies they find." (p. 139). Nelson, L. K. (2013). Research in Communication Sciences and Disorders . Plural Publishing.

• Example : The effect of leave policies on increasing fertility: a systematic review:  10.1057/s41599-022-01270-w

Meta-analysis : "Meta-analysis is a method of reviewing research findings in a quantitative fashion by transforming the data from individual studies into what is called an effect size and then pooling and analyzing this information. The basic goal in meta-analysis is to explain why different outcomes have occurred in different studies." (p. 197). Roberts, M. C., & Ilardi, S. S. (2003). Handbook of Research Methods in Clinical Psychology . Blackwell Publishing.

• Example : Employment Instability and Fertility in Europe: A Meta-Analysis:  10.1215/00703370-9164737

Meta-synthesis : "Qualitative meta-synthesis is a type of qualitative study that uses as data the findings from other qualitative studies linked by the same or related topic." (p.312). Zimmer, L. (2006). Qualitative meta-synthesis: A question of dialoguing with texts .  Journal of Advanced Nursing , 53 (3), 311-318.

• Example : Women’s perspectives on career successes and barriers: A qualitative meta-synthesis:  10.1177/05390184221113735

Literature Reviews in the Health Sciences

• UConn Health subject guide on systematic reviews Explanation of the different review types used in health sciences literature as well as tools to help you find the right review type
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Literature Reviews

• What is a literature review?
• Steps in the Literature Review Process
• Define your research question
• Determine inclusion and exclusion criteria
• Choose databases and search
• Review Results
• Synthesize Results
• Analyze Results
• Librarian Support

What is a Literature Review?

A literature or narrative review is a comprehensive review and analysis of the published literature on a specific topic or research question. The literature that is reviewed contains: books, articles, academic articles, conference proceedings, association papers, and dissertations. It contains the most pertinent studies and points to important past and current research and practices. It provides background and context, and shows how your research will contribute to the field. 

A literature review should: 

• Provide a comprehensive and updated review of the literature;
• Explain why this review has taken place;
• Articulate a position or hypothesis;
• Acknowledge and account for conflicting and corroborating points of view

From  S age Research Methods

Purpose of a Literature Review

A literature review can be written as an introduction to a study to:

• Demonstrate how a study fills a gap in research
• Compare a study with other research that's been done

Or it can be a separate work (a research article on its own) which:

• Organizes or describes a topic
• Describes variables within a particular issue/problem

Limitations of a Literature Review

Some of the limitations of a literature review are:

• It's a snapshot in time. Unlike other reviews, this one has beginning, a middle and an end. There may be future developments that could make your work less relevant.
• It may be too focused. Some niche studies may miss the bigger picture.
• It can be difficult to be comprehensive. There is no way to make sure all the literature on a topic was considered.
• It is easy to be biased if you stick to top tier journals. There may be other places where people are publishing exemplary research. Look to open access publications and conferences to reflect a more inclusive collection. Also, make sure to include opposing views (and not just supporting evidence).

Source: Grant, Maria J., and Andrew Booth. “A Typology of Reviews: An Analysis of 14 Review Types and Associated Methodologies.” Health Information & Libraries Journal, vol. 26, no. 2, June 2009, pp. 91–108. Wiley Online Library, doi:10.1111/j.1471-1842.2009.00848.x.

Meryl Brodsky : Communication and Information Studies

Hannah Chapman Tripp : Biology, Neuroscience

Carolyn Cunningham : Human Development & Family Sciences, Psychology, Sociology

Larayne Dallas : Engineering

Janelle Hedstrom : Special Education, Curriculum & Instruction, Ed Leadership & Policy ​

Susan Macicak : Linguistics

Imelda Vetter : Dell Medical School

For help in other subject areas, please see the guide to library specialists by subject .

Periodically, UT Libraries runs a workshop covering the basics and library support for literature reviews. While we try to offer these once per academic year, we find providing the recording to be helpful to community members who have missed the session. Following is the most recent recording of the workshop, Conducting a Literature Review. To view the recording, a UT login is required.

• October 26, 2022 recording
• Last Updated: Oct 26, 2022 2:49 PM
• URL: https://guides.lib.utexas.edu/literaturereviews

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What is a Literature Review? How to Write It (with Examples)

A literature review is a critical analysis and synthesis of existing research on a particular topic. It provides an overview of the current state of knowledge, identifies gaps, and highlights key findings in the literature. 1 The purpose of a literature review is to situate your own research within the context of existing scholarship, demonstrating your understanding of the topic and showing how your work contributes to the ongoing conversation in the field. Learning how to write a literature review is a critical tool for successful research. Your ability to summarize and synthesize prior research pertaining to a certain topic demonstrates your grasp on the topic of study, and assists in the learning process. 

Table of Contents

• What is the purpose of literature review? 
• a. Habitat Loss and Species Extinction: 
• b. Range Shifts and Phenological Changes: 
• c. Ocean Acidification and Coral Reefs: 
• d. Adaptive Strategies and Conservation Efforts: 
• How to write a good literature review 
• Choose a Topic and Define the Research Question: 
• Decide on the Scope of Your Review: 
• Select Databases for Searches: 
• Conduct Searches and Keep Track: 
• Review the Literature: 
• Organize and Write Your Literature Review: 
• Frequently asked questions 

What is a literature review?

A well-conducted literature review demonstrates the researcher’s familiarity with the existing literature, establishes the context for their own research, and contributes to scholarly conversations on the topic. One of the purposes of a literature review is also to help researchers avoid duplicating previous work and ensure that their research is informed by and builds upon the existing body of knowledge.

What is the purpose of literature review?

A literature review serves several important purposes within academic and research contexts. Here are some key objectives and functions of a literature review: 2  

• Contextualizing the Research Problem: The literature review provides a background and context for the research problem under investigation. It helps to situate the study within the existing body of knowledge. 
• Identifying Gaps in Knowledge: By identifying gaps, contradictions, or areas requiring further research, the researcher can shape the research question and justify the significance of the study. This is crucial for ensuring that the new research contributes something novel to the field. 
• Understanding Theoretical and Conceptual Frameworks: Literature reviews help researchers gain an understanding of the theoretical and conceptual frameworks used in previous studies. This aids in the development of a theoretical framework for the current research. 
• Providing Methodological Insights: Another purpose of literature reviews is that it allows researchers to learn about the methodologies employed in previous studies. This can help in choosing appropriate research methods for the current study and avoiding pitfalls that others may have encountered. 
• Establishing Credibility: A well-conducted literature review demonstrates the researcher’s familiarity with existing scholarship, establishing their credibility and expertise in the field. It also helps in building a solid foundation for the new research. 
• Informing Hypotheses or Research Questions: The literature review guides the formulation of hypotheses or research questions by highlighting relevant findings and areas of uncertainty in existing literature. 

Literature review example

Let’s delve deeper with a literature review example: Let’s say your literature review is about the impact of climate change on biodiversity. You might format your literature review into sections such as the effects of climate change on habitat loss and species extinction, phenological changes, and marine biodiversity. Each section would then summarize and analyze relevant studies in those areas, highlighting key findings and identifying gaps in the research. The review would conclude by emphasizing the need for further research on specific aspects of the relationship between climate change and biodiversity. The following literature review template provides a glimpse into the recommended literature review structure and content, demonstrating how research findings are organized around specific themes within a broader topic. 

Literature Review on Climate Change Impacts on Biodiversity:

Climate change is a global phenomenon with far-reaching consequences, including significant impacts on biodiversity. This literature review synthesizes key findings from various studies: 

a. Habitat Loss and Species Extinction:

Climate change-induced alterations in temperature and precipitation patterns contribute to habitat loss, affecting numerous species (Thomas et al., 2004). The review discusses how these changes increase the risk of extinction, particularly for species with specific habitat requirements. 

b. Range Shifts and Phenological Changes:

Observations of range shifts and changes in the timing of biological events (phenology) are documented in response to changing climatic conditions (Parmesan & Yohe, 2003). These shifts affect ecosystems and may lead to mismatches between species and their resources. 

c. Ocean Acidification and Coral Reefs:

The review explores the impact of climate change on marine biodiversity, emphasizing ocean acidification’s threat to coral reefs (Hoegh-Guldberg et al., 2007). Changes in pH levels negatively affect coral calcification, disrupting the delicate balance of marine ecosystems. 

d. Adaptive Strategies and Conservation Efforts:

Recognizing the urgency of the situation, the literature review discusses various adaptive strategies adopted by species and conservation efforts aimed at mitigating the impacts of climate change on biodiversity (Hannah et al., 2007). It emphasizes the importance of interdisciplinary approaches for effective conservation planning. 

How to write a good literature review

Writing a literature review involves summarizing and synthesizing existing research on a particular topic. A good literature review format should include the following elements. 

Introduction: The introduction sets the stage for your literature review, providing context and introducing the main focus of your review. 

• Opening Statement: Begin with a general statement about the broader topic and its significance in the field. 
• Scope and Purpose: Clearly define the scope of your literature review. Explain the specific research question or objective you aim to address. 
• Organizational Framework: Briefly outline the structure of your literature review, indicating how you will categorize and discuss the existing research. 
• Significance of the Study: Highlight why your literature review is important and how it contributes to the understanding of the chosen topic. 
• Thesis Statement: Conclude the introduction with a concise thesis statement that outlines the main argument or perspective you will develop in the body of the literature review. 

Body: The body of the literature review is where you provide a comprehensive analysis of existing literature, grouping studies based on themes, methodologies, or other relevant criteria. 

• Organize by Theme or Concept: Group studies that share common themes, concepts, or methodologies. Discuss each theme or concept in detail, summarizing key findings and identifying gaps or areas of disagreement. 
• Critical Analysis: Evaluate the strengths and weaknesses of each study. Discuss the methodologies used, the quality of evidence, and the overall contribution of each work to the understanding of the topic. 
• Synthesis of Findings: Synthesize the information from different studies to highlight trends, patterns, or areas of consensus in the literature. 
• Identification of Gaps: Discuss any gaps or limitations in the existing research and explain how your review contributes to filling these gaps. 
• Transition between Sections: Provide smooth transitions between different themes or concepts to maintain the flow of your literature review. 

Conclusion: The conclusion of your literature review should summarize the main findings, highlight the contributions of the review, and suggest avenues for future research. 

• Summary of Key Findings: Recap the main findings from the literature and restate how they contribute to your research question or objective. 
• Contributions to the Field: Discuss the overall contribution of your literature review to the existing knowledge in the field. 
• Implications and Applications: Explore the practical implications of the findings and suggest how they might impact future research or practice. 
• Recommendations for Future Research: Identify areas that require further investigation and propose potential directions for future research in the field. 
• Final Thoughts: Conclude with a final reflection on the importance of your literature review and its relevance to the broader academic community. 

Conducting a literature review

Conducting a literature review is an essential step in research that involves reviewing and analyzing existing literature on a specific topic. It’s important to know how to do a literature review effectively, so here are the steps to follow: 1  

Choose a Topic and Define the Research Question:

• Select a topic that is relevant to your field of study. 
• Clearly define your research question or objective. Determine what specific aspect of the topic do you want to explore? 

Decide on the Scope of Your Review:

• Determine the timeframe for your literature review. Are you focusing on recent developments, or do you want a historical overview? 
• Consider the geographical scope. Is your review global, or are you focusing on a specific region? 
• Define the inclusion and exclusion criteria. What types of sources will you include? Are there specific types of studies or publications you will exclude? 

Select Databases for Searches:

• Identify relevant databases for your field. Examples include PubMed, IEEE Xplore, Scopus, Web of Science, and Google Scholar. 
• Consider searching in library catalogs, institutional repositories, and specialized databases related to your topic. 

Conduct Searches and Keep Track:

• Develop a systematic search strategy using keywords, Boolean operators (AND, OR, NOT), and other search techniques. 
• Record and document your search strategy for transparency and replicability. 
• Keep track of the articles, including publication details, abstracts, and links. Use citation management tools like EndNote, Zotero, or Mendeley to organize your references. 

Review the Literature:

• Evaluate the relevance and quality of each source. Consider the methodology, sample size, and results of studies. 
• Organize the literature by themes or key concepts. Identify patterns, trends, and gaps in the existing research. 
• Summarize key findings and arguments from each source. Compare and contrast different perspectives. 
• Identify areas where there is a consensus in the literature and where there are conflicting opinions. 
• Provide critical analysis and synthesis of the literature. What are the strengths and weaknesses of existing research? 

Organize and Write Your Literature Review:

• Literature review outline should be based on themes, chronological order, or methodological approaches. 
• Write a clear and coherent narrative that synthesizes the information gathered. 
• Use proper citations for each source and ensure consistency in your citation style (APA, MLA, Chicago, etc.). 
• Conclude your literature review by summarizing key findings, identifying gaps, and suggesting areas for future research. 

The literature review sample and detailed advice on writing and conducting a review will help you produce a well-structured report. But remember that a literature review is an ongoing process, and it may be necessary to revisit and update it as your research progresses. 

Frequently asked questions

A literature review is a critical and comprehensive analysis of existing literature (published and unpublished works) on a specific topic or research question and provides a synthesis of the current state of knowledge in a particular field. A well-conducted literature review is crucial for researchers to build upon existing knowledge, avoid duplication of efforts, and contribute to the advancement of their field. It also helps researchers situate their work within a broader context and facilitates the development of a sound theoretical and conceptual framework for their studies.

Literature review is a crucial component of research writing, providing a solid background for a research paper’s investigation. The aim is to keep professionals up to date by providing an understanding of ongoing developments within a specific field, including research methods, and experimental techniques used in that field, and present that knowledge in the form of a written report. Also, the depth and breadth of the literature review emphasizes the credibility of the scholar in his or her field.  

Before writing a literature review, it’s essential to undertake several preparatory steps to ensure that your review is well-researched, organized, and focused. This includes choosing a topic of general interest to you and doing exploratory research on that topic, writing an annotated bibliography, and noting major points, especially those that relate to the position you have taken on the topic. 

Literature reviews and academic research papers are essential components of scholarly work but serve different purposes within the academic realm. 3 A literature review aims to provide a foundation for understanding the current state of research on a particular topic, identify gaps or controversies, and lay the groundwork for future research. Therefore, it draws heavily from existing academic sources, including books, journal articles, and other scholarly publications. In contrast, an academic research paper aims to present new knowledge, contribute to the academic discourse, and advance the understanding of a specific research question. Therefore, it involves a mix of existing literature (in the introduction and literature review sections) and original data or findings obtained through research methods. 

Literature reviews are essential components of academic and research papers, and various strategies can be employed to conduct them effectively. If you want to know how to write a literature review for a research paper, here are four common approaches that are often used by researchers.  Chronological Review: This strategy involves organizing the literature based on the chronological order of publication. It helps to trace the development of a topic over time, showing how ideas, theories, and research have evolved.  Thematic Review: Thematic reviews focus on identifying and analyzing themes or topics that cut across different studies. Instead of organizing the literature chronologically, it is grouped by key themes or concepts, allowing for a comprehensive exploration of various aspects of the topic.  Methodological Review: This strategy involves organizing the literature based on the research methods employed in different studies. It helps to highlight the strengths and weaknesses of various methodologies and allows the reader to evaluate the reliability and validity of the research findings.  Theoretical Review: A theoretical review examines the literature based on the theoretical frameworks used in different studies. This approach helps to identify the key theories that have been applied to the topic and assess their contributions to the understanding of the subject.  It’s important to note that these strategies are not mutually exclusive, and a literature review may combine elements of more than one approach. The choice of strategy depends on the research question, the nature of the literature available, and the goals of the review. Additionally, other strategies, such as integrative reviews or systematic reviews, may be employed depending on the specific requirements of the research.

The literature review format can vary depending on the specific publication guidelines. However, there are some common elements and structures that are often followed. Here is a general guideline for the format of a literature review:  Introduction:   Provide an overview of the topic.  Define the scope and purpose of the literature review.  State the research question or objective.  Body:   Organize the literature by themes, concepts, or chronology.  Critically analyze and evaluate each source.  Discuss the strengths and weaknesses of the studies.  Highlight any methodological limitations or biases.  Identify patterns, connections, or contradictions in the existing research.  Conclusion:   Summarize the key points discussed in the literature review.  Highlight the research gap.  Address the research question or objective stated in the introduction.  Highlight the contributions of the review and suggest directions for future research.

Both annotated bibliographies and literature reviews involve the examination of scholarly sources. While annotated bibliographies focus on individual sources with brief annotations, literature reviews provide a more in-depth, integrated, and comprehensive analysis of existing literature on a specific topic. The key differences are as follows: 

References 

• Denney, A. S., & Tewksbury, R. (2013). How to write a literature review.  Journal of criminal justice education ,  24 (2), 218-234. 
• Pan, M. L. (2016).  Preparing literature reviews: Qualitative and quantitative approaches . Taylor & Francis. 
• Cantero, C. (2019). How to write a literature review.  San José State University Writing Center . 

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How to Do a Systematic Review: A Best Practice Guide for Conducting and Reporting Narrative Reviews, Meta-Analyses, and Meta-Syntheses

Affiliations.

• 1 Behavioural Science Centre, Stirling Management School, University of Stirling, Stirling FK9 4LA, United Kingdom; email: [email protected].
• 2 Department of Psychological and Behavioural Science, London School of Economics and Political Science, London WC2A 2AE, United Kingdom.
• 3 Department of Statistics, Northwestern University, Evanston, Illinois 60208, USA; email: [email protected].
• PMID: 30089228
• DOI: 10.1146/annurev-psych-010418-102803

Systematic reviews are characterized by a methodical and replicable methodology and presentation. They involve a comprehensive search to locate all relevant published and unpublished work on a subject; a systematic integration of search results; and a critique of the extent, nature, and quality of evidence in relation to a particular research question. The best reviews synthesize studies to draw broad theoretical conclusions about what a literature means, linking theory to evidence and evidence to theory. This guide describes how to plan, conduct, organize, and present a systematic review of quantitative (meta-analysis) or qualitative (narrative review, meta-synthesis) information. We outline core standards and principles and describe commonly encountered problems. Although this guide targets psychological scientists, its high level of abstraction makes it potentially relevant to any subject area or discipline. We argue that systematic reviews are a key methodology for clarifying whether and how research findings replicate and for explaining possible inconsistencies, and we call for researchers to conduct systematic reviews to help elucidate whether there is a replication crisis.

Keywords: evidence; guide; meta-analysis; meta-synthesis; narrative; systematic review; theory.

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Home » Literature Review – Types Writing Guide and Examples

Literature Review – Types Writing Guide and Examples

Table of Contents

Literature Review

Definition:

A literature review is a comprehensive and critical analysis of the existing literature on a particular topic or research question. It involves identifying, evaluating, and synthesizing relevant literature, including scholarly articles, books, and other sources, to provide a summary and critical assessment of what is known about the topic.

Types of Literature Review

Types of Literature Review are as follows:

• Narrative literature review : This type of review involves a comprehensive summary and critical analysis of the available literature on a particular topic or research question. It is often used as an introductory section of a research paper.
• Systematic literature review: This is a rigorous and structured review that follows a pre-defined protocol to identify, evaluate, and synthesize all relevant studies on a specific research question. It is often used in evidence-based practice and systematic reviews.
• Meta-analysis: This is a quantitative review that uses statistical methods to combine data from multiple studies to derive a summary effect size. It provides a more precise estimate of the overall effect than any individual study.
• Scoping review: This is a preliminary review that aims to map the existing literature on a broad topic area to identify research gaps and areas for further investigation.
• Critical literature review : This type of review evaluates the strengths and weaknesses of the existing literature on a particular topic or research question. It aims to provide a critical analysis of the literature and identify areas where further research is needed.
• Conceptual literature review: This review synthesizes and integrates theories and concepts from multiple sources to provide a new perspective on a particular topic. It aims to provide a theoretical framework for understanding a particular research question.
• Rapid literature review: This is a quick review that provides a snapshot of the current state of knowledge on a specific research question or topic. It is often used when time and resources are limited.
• Thematic literature review : This review identifies and analyzes common themes and patterns across a body of literature on a particular topic. It aims to provide a comprehensive overview of the literature and identify key themes and concepts.
• Realist literature review: This review is often used in social science research and aims to identify how and why certain interventions work in certain contexts. It takes into account the context and complexities of real-world situations.
• State-of-the-art literature review : This type of review provides an overview of the current state of knowledge in a particular field, highlighting the most recent and relevant research. It is often used in fields where knowledge is rapidly evolving, such as technology or medicine.
• Integrative literature review: This type of review synthesizes and integrates findings from multiple studies on a particular topic to identify patterns, themes, and gaps in the literature. It aims to provide a comprehensive understanding of the current state of knowledge on a particular topic.
• Umbrella literature review : This review is used to provide a broad overview of a large and diverse body of literature on a particular topic. It aims to identify common themes and patterns across different areas of research.
• Historical literature review: This type of review examines the historical development of research on a particular topic or research question. It aims to provide a historical context for understanding the current state of knowledge on a particular topic.
• Problem-oriented literature review : This review focuses on a specific problem or issue and examines the literature to identify potential solutions or interventions. It aims to provide practical recommendations for addressing a particular problem or issue.
• Mixed-methods literature review : This type of review combines quantitative and qualitative methods to synthesize and analyze the available literature on a particular topic. It aims to provide a more comprehensive understanding of the research question by combining different types of evidence.

Parts of Literature Review

Parts of a literature review are as follows:

Introduction

The introduction of a literature review typically provides background information on the research topic and why it is important. It outlines the objectives of the review, the research question or hypothesis, and the scope of the review.

Literature Search

This section outlines the search strategy and databases used to identify relevant literature. The search terms used, inclusion and exclusion criteria, and any limitations of the search are described.

Literature Analysis

The literature analysis is the main body of the literature review. This section summarizes and synthesizes the literature that is relevant to the research question or hypothesis. The review should be organized thematically, chronologically, or by methodology, depending on the research objectives.

Critical Evaluation

Critical evaluation involves assessing the quality and validity of the literature. This includes evaluating the reliability and validity of the studies reviewed, the methodology used, and the strength of the evidence.

The conclusion of the literature review should summarize the main findings, identify any gaps in the literature, and suggest areas for future research. It should also reiterate the importance of the research question or hypothesis and the contribution of the literature review to the overall research project.

The references list includes all the sources cited in the literature review, and follows a specific referencing style (e.g., APA, MLA, Harvard).

How to write Literature Review

Here are some steps to follow when writing a literature review:

• Define your research question or topic : Before starting your literature review, it is essential to define your research question or topic. This will help you identify relevant literature and determine the scope of your review.
• Conduct a comprehensive search: Use databases and search engines to find relevant literature. Look for peer-reviewed articles, books, and other academic sources that are relevant to your research question or topic.
• Evaluate the sources: Once you have found potential sources, evaluate them critically to determine their relevance, credibility, and quality. Look for recent publications, reputable authors, and reliable sources of data and evidence.
• Organize your sources: Group the sources by theme, method, or research question. This will help you identify similarities and differences among the literature, and provide a structure for your literature review.
• Analyze and synthesize the literature : Analyze each source in depth, identifying the key findings, methodologies, and conclusions. Then, synthesize the information from the sources, identifying patterns and themes in the literature.
• Write the literature review : Start with an introduction that provides an overview of the topic and the purpose of the literature review. Then, organize the literature according to your chosen structure, and analyze and synthesize the sources. Finally, provide a conclusion that summarizes the key findings of the literature review, identifies gaps in knowledge, and suggests areas for future research.
• Edit and proofread: Once you have written your literature review, edit and proofread it carefully to ensure that it is well-organized, clear, and concise.

Examples of Literature Review

Here’s an example of how a literature review can be conducted for a thesis on the topic of “ The Impact of Social Media on Teenagers’ Mental Health”:

• Start by identifying the key terms related to your research topic. In this case, the key terms are “social media,” “teenagers,” and “mental health.”
• Use academic databases like Google Scholar, JSTOR, or PubMed to search for relevant articles, books, and other publications. Use these keywords in your search to narrow down your results.
• Evaluate the sources you find to determine if they are relevant to your research question. You may want to consider the publication date, author’s credentials, and the journal or book publisher.
• Begin reading and taking notes on each source, paying attention to key findings, methodologies used, and any gaps in the research.
• Organize your findings into themes or categories. For example, you might categorize your sources into those that examine the impact of social media on self-esteem, those that explore the effects of cyberbullying, and those that investigate the relationship between social media use and depression.
• Synthesize your findings by summarizing the key themes and highlighting any gaps or inconsistencies in the research. Identify areas where further research is needed.
• Use your literature review to inform your research questions and hypotheses for your thesis.

For example, after conducting a literature review on the impact of social media on teenagers’ mental health, a thesis might look like this:

“Using a mixed-methods approach, this study aims to investigate the relationship between social media use and mental health outcomes in teenagers. Specifically, the study will examine the effects of cyberbullying, social comparison, and excessive social media use on self-esteem, anxiety, and depression. Through an analysis of survey data and qualitative interviews with teenagers, the study will provide insight into the complex relationship between social media use and mental health outcomes, and identify strategies for promoting positive mental health outcomes in young people.”

Reference: Smith, J., Jones, M., & Lee, S. (2019). The effects of social media use on adolescent mental health: A systematic review. Journal of Adolescent Health, 65(2), 154-165. doi:10.1016/j.jadohealth.2019.03.024

Reference Example: Author, A. A., Author, B. B., & Author, C. C. (Year). Title of article. Title of Journal, volume number(issue number), page range. doi:0000000/000000000000 or URL

Applications of Literature Review

some applications of literature review in different fields:

• Social Sciences: In social sciences, literature reviews are used to identify gaps in existing research, to develop research questions, and to provide a theoretical framework for research. Literature reviews are commonly used in fields such as sociology, psychology, anthropology, and political science.
• Natural Sciences: In natural sciences, literature reviews are used to summarize and evaluate the current state of knowledge in a particular field or subfield. Literature reviews can help researchers identify areas where more research is needed and provide insights into the latest developments in a particular field. Fields such as biology, chemistry, and physics commonly use literature reviews.
• Health Sciences: In health sciences, literature reviews are used to evaluate the effectiveness of treatments, identify best practices, and determine areas where more research is needed. Literature reviews are commonly used in fields such as medicine, nursing, and public health.
• Humanities: In humanities, literature reviews are used to identify gaps in existing knowledge, develop new interpretations of texts or cultural artifacts, and provide a theoretical framework for research. Literature reviews are commonly used in fields such as history, literary studies, and philosophy.

Role of Literature Review in Research

Here are some applications of literature review in research:

• Identifying Research Gaps : Literature review helps researchers identify gaps in existing research and literature related to their research question. This allows them to develop new research questions and hypotheses to fill those gaps.
• Developing Theoretical Framework: Literature review helps researchers develop a theoretical framework for their research. By analyzing and synthesizing existing literature, researchers can identify the key concepts, theories, and models that are relevant to their research.
• Selecting Research Methods : Literature review helps researchers select appropriate research methods and techniques based on previous research. It also helps researchers to identify potential biases or limitations of certain methods and techniques.
• Data Collection and Analysis: Literature review helps researchers in data collection and analysis by providing a foundation for the development of data collection instruments and methods. It also helps researchers to identify relevant data sources and identify potential data analysis techniques.
• Communicating Results: Literature review helps researchers to communicate their results effectively by providing a context for their research. It also helps to justify the significance of their findings in relation to existing research and literature.

Purpose of Literature Review

Some of the specific purposes of a literature review are as follows:

• To provide context: A literature review helps to provide context for your research by situating it within the broader body of literature on the topic.
• To identify gaps and inconsistencies: A literature review helps to identify areas where further research is needed or where there are inconsistencies in the existing literature.
• To synthesize information: A literature review helps to synthesize the information from multiple sources and present a coherent and comprehensive picture of the current state of knowledge on the topic.
• To identify key concepts and theories : A literature review helps to identify key concepts and theories that are relevant to your research question and provide a theoretical framework for your study.
• To inform research design: A literature review can inform the design of your research study by identifying appropriate research methods, data sources, and research questions.

Characteristics of Literature Review

Some Characteristics of Literature Review are as follows:

• Identifying gaps in knowledge: A literature review helps to identify gaps in the existing knowledge and research on a specific topic or research question. By analyzing and synthesizing the literature, you can identify areas where further research is needed and where new insights can be gained.
• Establishing the significance of your research: A literature review helps to establish the significance of your own research by placing it in the context of existing research. By demonstrating the relevance of your research to the existing literature, you can establish its importance and value.
• Informing research design and methodology : A literature review helps to inform research design and methodology by identifying the most appropriate research methods, techniques, and instruments. By reviewing the literature, you can identify the strengths and limitations of different research methods and techniques, and select the most appropriate ones for your own research.
• Supporting arguments and claims: A literature review provides evidence to support arguments and claims made in academic writing. By citing and analyzing the literature, you can provide a solid foundation for your own arguments and claims.
• I dentifying potential collaborators and mentors: A literature review can help identify potential collaborators and mentors by identifying researchers and practitioners who are working on related topics or using similar methods. By building relationships with these individuals, you can gain valuable insights and support for your own research and practice.
• Keeping up-to-date with the latest research : A literature review helps to keep you up-to-date with the latest research on a specific topic or research question. By regularly reviewing the literature, you can stay informed about the latest findings and developments in your field.

Advantages of Literature Review

There are several advantages to conducting a literature review as part of a research project, including:

• Establishing the significance of the research : A literature review helps to establish the significance of the research by demonstrating the gap or problem in the existing literature that the study aims to address.
• Identifying key concepts and theories: A literature review can help to identify key concepts and theories that are relevant to the research question, and provide a theoretical framework for the study.
• Supporting the research methodology : A literature review can inform the research methodology by identifying appropriate research methods, data sources, and research questions.
• Providing a comprehensive overview of the literature : A literature review provides a comprehensive overview of the current state of knowledge on a topic, allowing the researcher to identify key themes, debates, and areas of agreement or disagreement.
• Identifying potential research questions: A literature review can help to identify potential research questions and areas for further investigation.
• Avoiding duplication of research: A literature review can help to avoid duplication of research by identifying what has already been done on a topic, and what remains to be done.
• Enhancing the credibility of the research : A literature review helps to enhance the credibility of the research by demonstrating the researcher’s knowledge of the existing literature and their ability to situate their research within a broader context.

Limitations of Literature Review

Limitations of Literature Review are as follows:

• Limited scope : Literature reviews can only cover the existing literature on a particular topic, which may be limited in scope or depth.
• Publication bias : Literature reviews may be influenced by publication bias, which occurs when researchers are more likely to publish positive results than negative ones. This can lead to an incomplete or biased picture of the literature.
• Quality of sources : The quality of the literature reviewed can vary widely, and not all sources may be reliable or valid.
• Time-limited: Literature reviews can become quickly outdated as new research is published, making it difficult to keep up with the latest developments in a field.
• Subjective interpretation : Literature reviews can be subjective, and the interpretation of the findings can vary depending on the researcher’s perspective or bias.
• Lack of original data : Literature reviews do not generate new data, but rather rely on the analysis of existing studies.
• Risk of plagiarism: It is important to ensure that literature reviews do not inadvertently contain plagiarism, which can occur when researchers use the work of others without proper attribution.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

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Research Methods

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Literature Review

• What is a Literature Review?
• What is NOT a Literature Review?
• Purposes of a Literature Review
• Types of Literature Reviews
• Literature Reviews vs. Systematic Reviews
• Systematic vs. Meta-Analysis

Literature Review  is a comprehensive survey of the works published in a particular field of study or line of research, usually over a specific period of time, in the form of an in-depth, critical bibliographic essay or annotated list in which attention is drawn to the most significant works.

Also, we can define a literature review as the collected body of scholarly works related to a topic:

• Summarizes and analyzes previous research relevant to a topic
• Includes scholarly books and articles published in academic journals
• Can be an specific scholarly paper or a section in a research paper

The objective of a Literature Review is to find previous published scholarly works relevant to an specific topic

• Help gather ideas or information
• Keep up to date in current trends and findings
• Help develop new questions

A literature review is important because it:

• Explains the background of research on a topic.
• Demonstrates why a topic is significant to a subject area.
• Helps focus your own research questions or problems
• Discovers relationships between research studies/ideas.
• Suggests unexplored ideas or populations
• Identifies major themes, concepts, and researchers on a topic.
• Tests assumptions; may help counter preconceived ideas and remove unconscious bias.
• Identifies critical gaps, points of disagreement, or potentially flawed methodology or theoretical approaches.
• Indicates potential directions for future research.

All content in this section is from Literature Review Research from Old Dominion University 

Keep in mind the following, a literature review is NOT:

Not an essay 

Not an annotated bibliography  in which you summarize each article that you have reviewed.  A literature review goes beyond basic summarizing to focus on the critical analysis of the reviewed works and their relationship to your research question.

Not a research paper   where you select resources to support one side of an issue versus another.  A lit review should explain and consider all sides of an argument in order to avoid bias, and areas of agreement and disagreement should be highlighted.

A literature review serves several purposes. For example, it

• provides thorough knowledge of previous studies; introduces seminal works.
• helps focus one’s own research topic.
• identifies a conceptual framework for one’s own research questions or problems; indicates potential directions for future research.
• suggests previously unused or underused methodologies, designs, quantitative and qualitative strategies.
• identifies gaps in previous studies; identifies flawed methodologies and/or theoretical approaches; avoids replication of mistakes.
• helps the researcher avoid repetition of earlier research.
• suggests unexplored populations.
• determines whether past studies agree or disagree; identifies controversy in the literature.
• tests assumptions; may help counter preconceived ideas and remove unconscious bias.

As Kennedy (2007) notes*, it is important to think of knowledge in a given field as consisting of three layers. First, there are the primary studies that researchers conduct and publish. Second are the reviews of those studies that summarize and offer new interpretations built from and often extending beyond the original studies. Third, there are the perceptions, conclusions, opinion, and interpretations that are shared informally that become part of the lore of field. In composing a literature review, it is important to note that it is often this third layer of knowledge that is cited as "true" even though it often has only a loose relationship to the primary studies and secondary literature reviews.

Given this, while literature reviews are designed to provide an overview and synthesis of pertinent sources you have explored, there are several approaches to how they can be done, depending upon the type of analysis underpinning your study. Listed below are definitions of types of literature reviews:

Argumentative Review      This form examines literature selectively in order to support or refute an argument, deeply imbedded assumption, or philosophical problem already established in the literature. The purpose is to develop a body of literature that establishes a contrarian viewpoint. Given the value-laden nature of some social science research [e.g., educational reform; immigration control], argumentative approaches to analyzing the literature can be a legitimate and important form of discourse. However, note that they can also introduce problems of bias when they are used to to make summary claims of the sort found in systematic reviews.

Integrative Review      Considered a form of research that reviews, critiques, and synthesizes representative literature on a topic in an integrated way such that new frameworks and perspectives on the topic are generated. The body of literature includes all studies that address related or identical hypotheses. A well-done integrative review meets the same standards as primary research in regard to clarity, rigor, and replication.

Historical Review      Few things rest in isolation from historical precedent. Historical reviews are focused on examining research throughout a period of time, often starting with the first time an issue, concept, theory, phenomena emerged in the literature, then tracing its evolution within the scholarship of a discipline. The purpose is to place research in a historical context to show familiarity with state-of-the-art developments and to identify the likely directions for future research.

Methodological Review      A review does not always focus on what someone said [content], but how they said it [method of analysis]. This approach provides a framework of understanding at different levels (i.e. those of theory, substantive fields, research approaches and data collection and analysis techniques), enables researchers to draw on a wide variety of knowledge ranging from the conceptual level to practical documents for use in fieldwork in the areas of ontological and epistemological consideration, quantitative and qualitative integration, sampling, interviewing, data collection and data analysis, and helps highlight many ethical issues which we should be aware of and consider as we go through our study.

Systematic Review      This form consists of an overview of existing evidence pertinent to a clearly formulated research question, which uses pre-specified and standardized methods to identify and critically appraise relevant research, and to collect, report, and analyse data from the studies that are included in the review. Typically it focuses on a very specific empirical question, often posed in a cause-and-effect form, such as "To what extent does A contribute to B?"

Theoretical Review      The purpose of this form is to concretely examine the corpus of theory that has accumulated in regard to an issue, concept, theory, phenomena. The theoretical literature review help establish what theories already exist, the relationships between them, to what degree the existing theories have been investigated, and to develop new hypotheses to be tested. Often this form is used to help establish a lack of appropriate theories or reveal that current theories are inadequate for explaining new or emerging research problems. The unit of analysis can focus on a theoretical concept or a whole theory or framework.

* Kennedy, Mary M. "Defining a Literature."  Educational Researcher  36 (April 2007): 139-147.

All content in this section is from The Literature Review created by Dr. Robert Larabee USC

Robinson, P. and Lowe, J. (2015),  Literature reviews vs systematic reviews.  Australian and New Zealand Journal of Public Health, 39: 103-103. doi: 10.1111/1753-6405.12393

What's in the name? The difference between a Systematic Review and a Literature Review, and why it matters . By Lynn Kysh from University of Southern California

Systematic review or meta-analysis?

A  systematic review  answers a defined research question by collecting and summarizing all empirical evidence that fits pre-specified eligibility criteria.

A  meta-analysis  is the use of statistical methods to summarize the results of these studies.

Systematic reviews, just like other research articles, can be of varying quality. They are a significant piece of work (the Centre for Reviews and Dissemination at York estimates that a team will take 9-24 months), and to be useful to other researchers and practitioners they should have:

• clearly stated objectives with pre-defined eligibility criteria for studies
• explicit, reproducible methodology
• a systematic search that attempts to identify all studies
• assessment of the validity of the findings of the included studies (e.g. risk of bias)
• systematic presentation, and synthesis, of the characteristics and findings of the included studies

Not all systematic reviews contain meta-analysis. 

Meta-analysis is the use of statistical methods to summarize the results of independent studies. By combining information from all relevant studies, meta-analysis can provide more precise estimates of the effects of health care than those derived from the individual studies included within a review.  More information on meta-analyses can be found in  Cochrane Handbook, Chapter 9 .

A meta-analysis goes beyond critique and integration and conducts secondary statistical analysis on the outcomes of similar studies.  It is a systematic review that uses quantitative methods to synthesize and summarize the results.

An advantage of a meta-analysis is the ability to be completely objective in evaluating research findings.  Not all topics, however, have sufficient research evidence to allow a meta-analysis to be conducted.  In that case, an integrative review is an appropriate strategy. 

Some of the content in this section is from Systematic reviews and meta-analyses: step by step guide created by Kate McAllister.

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Review vs. Research Articles

How can you tell if you are looking at a research paper, review paper or a systematic review  examples and article characteristics are provided below to help you figure it out., research papers.

A research article describes a study that was performed by the article’s author(s). It explains the methodology of the study, such as how data was collected and analyzed, and clarifies what the results mean. Each step of the study is reported in detail so that other researchers can repeat the experiment.

To determine if a paper is a research article, examine its wording. Research articles describe actions taken by the researcher(s) during the experimental process. Look for statements like “we tested,” “I measured,” or “we investigated.” Research articles also describe the outcomes of studies. Check for phrases like “the study found” or “the results indicate.” Next, look closely at the formatting of the article. Research papers are divided into sections that occur in a particular order: abstract, introduction, methods, results, discussion, and references.

Let's take a closer look at this research paper by Bacon et al. published in the International Journal of Hypertension :

Review Papers

Review articles do not describe original research conducted by the author(s). Instead, they give an overview of a specific subject by examining previously published studies on the topic. The author searches for and selects studies on the subject and then tries to make sense of their findings. In particular, review articles look at whether the outcomes of the chosen studies are similar, and if they are not, attempt to explain the conflicting results. By interpreting the findings of previous studies, review articles are able to present the current knowledge and understanding of a specific topic.

Since review articles summarize the research on a particular topic, students should read them for background information before consulting detailed, technical research articles. Furthermore, review articles are a useful starting point for a research project because their reference lists can be used to find additional articles on the subject.

Let's take a closer look at this review paper by Bacon et al. published in Sports Medicine :

Systematic Review Papers

A systematic review is a type of review article that tries to limit the occurrence of bias. Traditional, non-systematic reviews can be biased because they do not include all of the available papers on the review’s topic; only certain studies are discussed by the author. No formal process is used to decide which articles to include in the review. Consequently, unpublished articles, older papers, works in foreign languages, manuscripts published in small journals, and studies that conflict with the author’s beliefs can be overlooked or excluded. Since traditional reviews do not have to explain the techniques used to select the studies, it can be difficult to determine if the author’s bias affected the review’s findings.

Systematic reviews were developed to address the problem of bias. Unlike traditional reviews, which cover a broad topic, systematic reviews focus on a single question, such as if a particular intervention successfully treats a medical condition. Systematic reviews then track down all of the available studies that address the question, choose some to include in the review, and critique them using predetermined criteria. The studies are found, selected, and evaluated using a formal, scientific methodology in order to minimize the effect of the author’s bias. The methodology is clearly explained in the systematic review so that readers can form opinions about the quality of the review.

Let's take a closer look this systematic review paper by Vigano et al. published in Lancet Oncology :

Finding Review and Research Papers in PubMed

Many databases have special features that allow the searcher to restrict results to articles that match specific criteria. In other words, only articles of a certain type will be displayed in the search results. These “limiters” can be useful when searching for research or review articles. PubMed has a limiter for article type, which is located on the left sidebar of the search results page. This limiter can filter the search results to show only review articles.

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Review Typologies

There are many types of evidence synthesis projects, including systematic reviews as well as others. The selection of review type is wholly dependent on the research question. Not all research questions are well-suited for systematic reviews.

• Review Typologies (from LITR-EX) This site explores different review methodologies such as, systematic, scoping, realist, narrative, state of the art, meta-ethnography, critical, and integrative reviews. The LITR-EX site has a health professions education focus, but the advice and information is widely applicable.

Review the table to peruse review types and associated methodologies. Librarians can also help your team determine which review type might be appropriate for your project. 

Reproduced from Grant, M. J. and Booth, A. (2009), A typology of reviews: an analysis of 14 review types and associated methodologies. Health Information & Libraries Journal, 26: 91-108.  doi:10.1111/j.1471-1842.2009.00848.x

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Exploring the Difference Between Exempt Human Subjects Research and Expedited IRB Review

We’ve heard that there is some confusion about exempt human subjects research and expedited IRB review. Expedited review is not the same as exempt research. Here are a few points to provide clarity.

For human subjects research, certain types may qualify for an exemption from the regulatory requirements in the Common Rule (45 CFR 46). This is commonly referred to as exempt research. Exempt research generally does not need to be reviewed by an Institutional Review Board (IRB). You can review details about the exemption types on our Definition of Human Subjects Research website or the Office for Human Research Protection’s Exemptions website . There are eight categories of exemptions.

Separately, research that is non-exempt human subjects research (i.e., research subject to the HHS regulations at 45 CFR 46 ) and meets certain conditions may be reviewed by an IRB through an expedited review procedure. Therse conditions are listed in the OHRP guidance: Expedited Review Categories (1998) .  There are nine categories of research for expedited review.  

You can learn more about the NIH requirements for human subjects research on the NIH Human Subjects Research website . Remember, most human subjects research (everything that meets the definition of clinical research ) also requires inclusion monitoring. You can find out more on the inclusion policy webpages .

Have questions? Reach out to your program officer. You can also send human subjects research questions to [email protected] and inclusion-related questions to [email protected] .

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Procedural Changes for Expedited Review of Human Subjects Research

The Charles River Campus Institutional Review Board (CRC IRB) is discontinuing annual progress reports for expedited research and moving instead to a triennial review cycle. For research teams, this will go into effect at the next expedited annual progress report review and will apply to all newly approved expedited research going forward.

Annual continuing review will remain for research reviewed by the full board, per regulatory requirements.

Who does this affect:

Investigators with research that has been approved by expedited review.

The CRC IRB is moving from an annual progress report to a triennial progress report (every three years) for research approved by expedited review.

At the next annual progress report review an IRB analyst will assess the protocol to confirm that it still meets expedited review criteria, and that it is appropriate to move to a triennial review. If appropriate, investigators will receive an approval notice with their next triennial progress report review date – and, if applicable, a stamped consent form with the approval date only. This will also apply to newly approved expedited research.

With regulatory changes that went into effect several years ago, the requirement for annual continuing review was discontinued. The CRC IRB maintained an annual progress report at that time to assess compliance and has been satisfied with the results to date. Research that is reviewed by expedited procedures are minimal risk. By switching to a triennial review, investigators and the IRB office can better focus on other compliance and quality assurance matters. Additionally, the switch to triennial review is consistent with other compliance committee review schedules at BU and peer institutions for research that is minimal risk.

• Investigators must continue to submit amendments for changes to their research and receive approval prior to implementation of those changes.
• Investigators must continue to submit incidents (non-compliance, deviations, unanticipated problems, etc.) within five days of learning of the event.
• The only change is from an annual progress report for research approved by expedited review to a triennial review.
• Annual review is still required for research that is reviewed by the full board.

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Study designs: Part 7 – Systematic reviews

Priya ranganathan.

Department of Anaesthesiology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India

Rakesh Aggarwal

1 Director, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India

In this series on research study designs, we have so far looked at different types of primary research designs which attempt to answer a specific question. In this segment, we discuss systematic review, which is a study design used to summarize the results of several primary research studies. Systematic reviews often also use meta-analysis, which is a statistical tool to mathematically collate the results of various research studies to obtain a pooled estimate of treatment effect; this will be discussed in the next article.

In the previous six articles in this series on study designs, we have looked at different types of primary research study designs which are used to answer research questions. In this article, we describe the systematic review, a type of secondary research design that is used to summarize the results of prior primary research studies. Systematic reviews are considered the highest level of evidence for a particular research question.[ 1 ]

SYSTEMATIC REVIEWS

As defined in the Cochrane Handbook for Systematic Reviews of Interventions , “Systematic reviews seek to collate evidence that fits pre-specified eligibility criteria in order to answer a specific research question. They aim to minimize bias by using explicit, systematic methods documented in advance with a protocol.”[ 2 ]

NARRATIVE VERSUS SYSTEMATIC REVIEWS

Review of available data has been done since times immemorial. However, the traditional narrative reviews (“expert reviews”) do not involve a systematic search of the literature. Instead, the author of the review, usually an expert on the subject, used informal methods to identify (what he or she thinks are) the key studies on the topic. The final review thus is a summary of these “selected” studies. Since studies are chosen at will (haphazardly!) and without clearly defined criteria, such reviews preferentially include those studies that favor the author's views, leading to a potential for subjectivity or selection bias.

In contrast, systematic reviews involve a formal prespecified protocol with explicit, transparent criteria for the inclusion and exclusion of studies, thereby ensuring completeness of coverage of the available evidence, and providing a more objective, replicable, and comprehensive overview it.

META-ANALYSIS

Many systematic reviews use an additional tool, known as meta-analysis, which is a statistical technique for combining the results of multiple studies in a systematic review in a mathematically appropriate way, to create a single (pooled) and more precise estimate of treatment effect. The feasibility of performing a meta-analysis in a systematic review depends on the number of studies included in the final review and the degree of heterogeneity in the inclusion criteria as well as the results between the included studies. Meta-analysis will be discussed in detail in the next article in this series.

THE PROCESS OF A SYSTEMATIC REVIEW

The conduct of a systematic review involves several sequential key steps.[ 3 , 4 ] As in other research study designs, a clearly stated research question and a well-written research protocol are essential before commencing a systematic review.

Step 1: Stating the review question

Systematic reviews can be carried out in any field of medical research, e.g. efficacy or safety of interventions, diagnostics, screening or health economics. In this article, we focus on systematic reviews of studies looking at the efficacy of interventions. As for the other study designs, for a systematic review too, the question is best framed using the Population, Intervention, Comparator, and Outcome (PICO) format.

For example, Safi et al . carried out a systematic review on the effect of beta-blockers on the outcomes of patients with myocardial infarction.[ 5 ] In this review, the Population was patients with suspected or confirmed myocardial infarction, the Intervention was beta-blocker therapy, the Comparator was either placebo or no intervention, and the Outcomes were all-cause mortality and major adverse cardiovascular events. The review question was “ In patients with suspected or confirmed myocardial infarction, does the use of beta-blockers affect mortality or major adverse cardiovascular outcomes? ”

Step 2: Listing the eligibility criteria for studies to be included

It is essential to explicitly define a priori the criteria for selection of studies which will be included in the review. Besides the PICO components, some additional criteria used frequently for this purpose include language of publication (English versus non-English), publication status (published as full paper versus unpublished), study design (randomized versus quasi-experimental), age group (adults versus children), and publication year (e.g. in the last 5 years, or since a particular date). The PICO criteria used may not be very specific, e.g. it is possible to include studies that use one or the other drug belonging to the same group. For instance, the systematic review by Safi et al . included all randomized clinical trials, irrespective of setting, blinding, publication status, publication year, or language, and reported outcomes, that had used any beta-blocker and in a broad range of doses.[ 5 ]

Step 3: Comprehensive search for studies that meet the eligibility criteria

A thorough literature search is essential to identify all articles related to the research question and to ensure that no relevant article is left out. The search may include one or more electronic databases and trial registries; in addition, it is common to hand-search the cross-references in the articles identified through such searches. One could also plan to reach out to experts in the field to identify unpublished data, and to search the grey literature non-peer-reviewednon-peer-reviewed. This last option is particularly helpful non-pharmacologic (theses, conference abstracts, and non-peer-reviewed journals). These sources are particularly helpful when the intervention is relatively new, since data on these may not yet have been published as full papers and hence are unlikely to be found in literature databases. In the review by Safi et al ., the search strategy included not only several electronic databases (Cochrane, MEDLINE, EMBASE, LILACS, etc.) but also other resources (e.g. Google Scholar, WHO International Clinical Trial Registry Platform, and reference lists of identified studies).[ 5 ] It is not essential to include all the above databases in one's search. However, it is mandatory to define in advance which of these will be searched.

Step 4: Identifying and selecting relevant studies

Once the search strategy defined in the previous step has been run to identify potentially relevant studies, a two-step process is followed. First, the titles and abstracts of the identified studies are processed to exclude any duplicates and to discard obviously irrelevant studies. In the next step, full-text papers of the remaining articles are retrieved and closely reviewed to identify studies that meet the eligibility criteria. To minimize bias, these selection steps are usually performed independently by at least two reviewers, who also assign a reason for non-selection to each discarded study. Any discrepancies are then resolved either by an independent reviewer or by mutual consensus of the original reviewers. In the Cochrane review on beta-blockers referred to above, two review authors independently screened the titles for inclusion, and then, four review authors independently reviewed the screen-positive studies to identify the trials to be included in the final review.[ 5 ] Disagreements were resolved by discussion or by taking the opinion of a separate reviewer. A summary of this selection process, showing the degree of agreement between reviewers, and a flow diagram that depicts the numbers of screened, included and excluded (with reason for exclusion) studies are often included in the final review.

Step 5: Data extraction

In this step, from each selected study, relevant data are extracted. This should be done by at least two reviewers independently, and the data then compared to identify any errors in extraction. Standard data extraction forms help in objective data extraction. The data extracted usually contain the name of the author, the year of publication, details of intervention and control treatments, and the number of participants and outcome data in each group. In the review by Safi et al ., four review authors independently extracted data and resolved any differences by discussion.[ 5 ]

Handling missing data

Some of the studies included in the review may not report outcomes in accordance with the review methodology. Such missing data can be handled in two ways – by contacting authors of the original study to obtain the necessary data and by using data imputation techniques. Safi et al . used both these approaches – they tried to get data from the trial authors; however, where that failed, they analyzed the primary outcome (mortality) using the best case (i.e. presuming that all the participants in the experimental arm with missing data had survived and those in the control arm with missing mortality data had died – representing the maximum beneficial effect of the intervention) and the worst case (all the participants with missing data in the experimental arm assumed to have died and those in the control arm to have survived – representing the least beneficial effect of the intervention) scenarios.

Evaluating the quality (or risk of bias) in the included studies

The overall quality of a systematic review depends on the quality of each of the included studies. Quality of a study is inversely proportional to the potential for bias in its design. In our previous articles on interventional study design in this series, we discussed various methods to reduce bias – such as randomization, allocation concealment, participant and assessor blinding, using objective endpoints, minimizing missing data, the use of intention-to-treat analysis, and complete reporting of all outcomes.[ 6 , 7 ] These features form the basis of the Cochrane Risk of Bias Tool (RoB 2), which is a commonly used instrument to assess the risk of bias in the studies included in a systematic review.[ 8 ] Based on this tool, one can classify each study in a review as having low risk of bias, having some concerns regarding bias, or at high risk of bias. Safi et al . used this tool to classify the included studies as having low or high risk of bias and presented these data in both tabular and graphical formats.[ 5 ]

In some reviews, the authors decide to summarize only studies with a low risk of bias and to exclude those with a high risk of bias. Alternatively, some authors undertake a separate analysis of studies with low risk of bias, besides an analysis of all the studies taken together. The conclusions from such analyses of only high-quality studies may be more robust.

Step 6: Synthesis of results

The data extracted from various studies are pooled quantitatively (known as a meta-analysis) or qualitatively (if pooling of results is not considered feasible). For qualitative reviews, data are usually presented in the tabular format, showing the characteristics of each included study, to allow for easier interpretation.

Sensitivity analyses

Sensitivity analyses are used to test the robustness of the results of a systematic review by examining the impact of excluding or including studies with certain characteristics. As referred to above, this can be based on the risk of bias (methodological quality), studies with a specific study design, studies with a certain dosage or schedule, or sample size. If results of these different analyses are more-or-less the same, one can be more certain of the validity of the findings of the review. Furthermore, such analyses can help identify whether the effect of the intervention could vary across different levels of another factor. In the beta-blocker review, sensitivity analysis was performed depending on the risk of bias of included studies.[ 5 ]

IMPORTANT RESOURCES FOR CARRYING OUT SYSTEMATIC REVIEWS AND META-ANALYSES

Cochrane is an organization that works to produce good-quality, updated systematic reviews related to human healthcare and policy, which are accessible to people across the world.[ 9 ] There are more than 7000 Cochrane reviews on various topics. One of its main resources is the Cochrane Library (available at https://www.cochranelibrary.com/ ), which incorporates several databases with different types of high-quality evidence to inform healthcare decisions, including the Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials (CENTRAL), and Cochrane Clinical Answers.

The Cochrane Handbook for Systematic Reviews of Interventions

The Cochrane handbook is an official guide, prepared by the Cochrane Collaboration, to the process of preparing and maintaining Cochrane systematic reviews.[ 10 ]

Review Manager software

Review Manager (RevMan) is a software developed by Cochrane to support the preparation and maintenance of systematic reviews, including tools for performing meta-analysis.[ 11 ] It is freely available in both online (RevMan Web) and offline (RevMan 5.3) versions.

Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement

The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement is an evidence-based minimum set of items for reporting of systematic reviews and meta-analyses of randomized trials.[ 12 ] It can be used both by authors of such studies to improve the completeness of reporting and by reviewers and readers to critically appraise a systematic review. There are several extensions to the PRISMA statement for specific types of reviews. An update is currently underway.

Meta-analysis of Observational Studies in Epidemiology statement

The Meta-analysis of Observational Studies in Epidemiology statement summarizes the recommendations for reporting of meta-analyses in epidemiology.[ 13 ]

PROSPERO is an international database for prospective registration of protocols for systematic reviews in healthcare.[ 14 ] It aims to avoid duplication of and to improve transparency in reporting of results of such reviews.

Financial support and sponsorship

Conflicts of interest.

There are no conflicts of interest.

Part 1. Overview Information

National Institutes of Health ( NIH )

National Eye Institute ( NEI )

National Heart, Lung, and Blood Institute ( NHLBI )

National Human Genome Research Institute ( NHGRI )

National Institute on Aging ( NIA )

National Institute on Alcohol Abuse and Alcoholism ( NIAAA )

National Institute of Allergy and Infectious Diseases ( NIAID )

National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS )

National Institute of Biomedical Imaging and Bioengineering ( NIBIB )

Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD )

National Institute on Deafness and Other Communication Disorders ( NIDCD )

National Institute of Dental and Craniofacial Research ( NIDCR )

National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK )

National Institute on Drug Abuse ( NIDA )

National Institute of Environmental Health Sciences ( NIEHS )

National Institute of General Medical Sciences ( NIGMS )

National Institute of Mental Health ( NIMH )

National Institute of Neurological Disorders and Stroke ( NINDS )

National Institute on Minority Health and Health Disparities ( NIMHD )

National Library of Medicine ( NLM )

National Center for Complementary and Integrative Health ( NCCIH )

National Cancer Institute ( NCI )

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Research on Women's Health ( ORWH )

Office of Data Science Strategy ( ODSS )

Special Note: Not all NIH Institutes and Centers participate in Parent Announcements. Candidates should carefully note which ICs participate in this announcement and view their respective areas of research interest and requirements at the Table of IC-Specific Information, Requirements and Staff Contacts website. ICs that do not participate in this announcement will not consider applications for funding. Consultation with NIH staff before submitting an application is strongly encouraged.

• August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice  NOT-OD-22-198 .
• August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice  NOT-OD-22-189 .

See Section III. 3. Additional Information on Eligibility .

The primary purpose of the NIH Mentored Clinical Scientist Research Career Development Awards (K08) program is to prepare qualified individuals for careers that have a significant impact on the health-related research needs of the Nation. This program represents the continuation of a long-standing NIH program that provides support and "protected time" to individuals with a clinical doctoral degree for an intensive, supervised research career development experience in the fields of biomedical and behavioral research, including translational research.

This Notice of Funding Opportunity (NOFO) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial . Under this NOFO applicants are permitted to propose a research experience in a clinical trial led by a mentor or co-mentor. Those proposing a clinical trial or an ancillary clinical trial as lead investigator, should apply to the companion NOFO ( PA-24-181 ).

Not Applicable

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Career Development (K) Instructions in the  How to Apply - Application Guide  except where instructed to do otherwise (in this NOFO or in a Notice from the  NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in  Section IV . When the program-specific instructions deviate from those in the How to Apply - Application Guide , follow the program-specific instructions.  Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

• Use the NIH ASSIST system to prepare, submit and track your application online.
• Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
• Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 2. Full Text of Announcement

Section i. funding opportunity description.

The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the  NIH Research Training and Career Development  website.

The objective of the NIH Mentored Clinical Scientist Research Career Development Award (K08) is to provide salary and research support for a sustained period of “protected time” (3-5 years) to support didactic study and/or mentored research for individuals with clinical doctoral degrees (e.g., MD, DDS, DMD, DO, DC, OD, ND, DVM, PharmD, or PhD in clinical disciplines). The K08 provides support for an intensive, mentored research career development experience in biomedical or behavioral research, including translational research. For the purpose of this award, translational research is defined as the application of basic research discoveries toward the diagnosis, management, and prevention of human disease. Individuals with a clinical doctoral degree interested in pursuing a career in patient-oriented research should refer to the NIH Mentored Patient Oriented Research Career Development Award (K23).

The K08 award may be used by candidates with different levels of prior research training and at different stages in their mentored career development. For example, a candidate with limited experience in a given field of research may use an award to support a career development experience that includes a designated period of didactic training followed by a period of closely supervised research experience. A candidate with previous research experience and training may not require extensive additional didactic preparation, and may use an award to support a career development experience that focuses on an intensive, supervised research experience.

Note: This Notice of Funding Opportunity (NOFO) is designed specifically for proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Under this NOFO are permitted to propose a research experience in a clinical trial led by a mentor or co-mentor. Those proposing a clinical trial or an ancillary clinical trial as lead investigator, should apply to the companion NOFO ( PA-24-181 ).

Special Note:  Because of the differences in individual Institute and Center (IC) program requirements for this NOFO, prospective applicants are strongly encouraged to consult the  Table of IC-Specific Information, Requirements and Staff Contacts , to make sure that their application is appropriate for the requirements of one of the participating NIH ICs.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

The  OER Glossary  and the How to Apply - Application Guide  provides details on these application types.

Not Allowed: Only accepting applications that do not propose clinical trials.

Note: Applicants may propose to gain experience in a clinical trial led by a mentor/co-mentor as part of their research career development.

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Other Award Budget Information

The participating NIH Institutes and Centers will provide salary and fringe benefits for the award recipient (see Table of IC-Specific Information, Requirements and Staff Contacts ). Further guidance on budgeting for career development salaries is provided in the  How to Apply - Application Guide . 

In addition, the candidate may derive additional compensation for effort associated with other Federal sources or awards provided the total salary derived from all Federal sources does not exceed the maximum legislated salary rate (see http://grants.nih.gov/grants/policy/salcap_summary.html ) and the total percent effort does not exceed 100%. See also NOT-OD-17-094 .

These funds may be used for the following expenses: (a) tuition and fees related to career development; (b) research-related expenses, such as supplies, equipment and technical personnel; c) travel to research meetings or training; and (d) statistical services including personnel and computer time.

Salary for mentors, secretarial and administrative assistants, etc. is not allowed.

NIH grants policies as described in the  NIH Grants Policy Statement  will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• U.S. Territory or Possession
• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations)  are not  eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations  are not  eligible to apply.

Foreign components, as  defined in the NIH Grants Policy Statement ,  are allowed. 

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement 2.3.9.2 Electronically Submitted Applications for additional information.

• NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal  Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

All PD(s)/PI(s) must be registered with ORCID . The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help .

Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with their mentor and organization to develop an application for support. Individuals from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities , NOT-OD-22-019 . Multiple PDs/PIs are not allowed.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

Current and former PDs/PIs on NIH research project (R01), program project (P01), center grants (P50), or Project Leads of program project (P01), or center grants (P50), other major individual career development awards (e.g., DP5, K01, K07, K08, K22, K23, K25, K76, K99/R00), or Project Leads of program project (P01) or center grants (P50) or the equivalent are not eligible. Current and former PDs/PIs of an NIH Small Grant (R03), Exploratory/Developmental Grants (R21/R33), Planning Grant (R34/U34), Dissertation Award (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible, as do PD/PIs of Transition Scholar (K38) awards and individuals appointed to institutional K programs (K12, KL2). Candidates for the K08  award must have a clinical doctoral degree. Such degrees include, but are not limited to, the MD, DO, DDS, DMD, OD, DC, PharmD, ND (Doctor of Naturopathy), and DVM.  Individuals with the PhD or other doctoral degree in clinical disciplines such as clinical psychology, nursing, clinical genetics, speech-language pathology, audiology or rehabilitation are also eligible. Individuals holding the PhD in a non-clinical discipline who are certified to perform clinical duties should contact the appropriate Institute concerning their eligibility for a K08 award.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definitions of Terms . 

3. Additional Information on Eligibility

Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.

NIH will not accept duplicate or highly overlapping applications under review at the same time per  NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application . An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review. (See  NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications ).

Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not have substantial scientific and/or budgetary overlap with the career award application. K award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PD/PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-18-157. 

At the time of award, the candidate must have a “full-time” appointment at the academic institution. Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their program of career development. Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program. 

Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility.

After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances.  See NOT-OD-18-156   and NIH Grants Policy Statement , Section 12.3.6.4 Temporary Adjustments to the Percent Effort Requirement for more details.

Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support and facilities. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidate’s research. The candidate must work with the mentor(s) in preparing the application. The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate’s career stage. The recruitment of women, individuals from underrepresented  racial and ethnic groups, and individuals with disabilities as potential mentors is encouraged.

The mentor(s) or mentoring team must demonstrate appropriate expertise, experience, and ability to guide the candidate in the organization, management and implementation of the proposed research and/or clinical trial.

The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research.

Section IV. Application and Submission Information

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Career Development (K) Instructions in the  How to Apply - Application Guide  except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications .

Page Limitations

All page limitations described in the How to Apply - Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply - Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

Other Project Information

SF424(R&R) Senior/Key Person Profile Expanded

R&R Budget

PHS 398 Cover Page Supplement

PHS 398 Career Development Award Supplemental Form

The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:

Candidate Research Plan Other Candidate Information Mentor, Co-Mentor, Consultant, Collaborators Environment & Institutional Commitment to the Candidate Other Research Plan Sections Appendix

Candidate Section

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

Candidate Information and Goals for Career Development

Candidate’s Background

• Describe the candidate's commitment to a health-related research career. Describe all the candidate's professional responsibilities in the recipient institution and elsewhere and describe their relationship to the proposed activities on the career award.
• Describe prior training and how it relates to the objectives and long-term career plans of the candidate.
• Describe the candidate's research efforts to this point in their research career, including any publications, prior research interests and experience.
• Provide evidence of the candidate's potential to develop into an independent investigator.

Career Goals and Objectives​

• Describe a systematic plan: (1) that shows a logical progression from prior research and training experiences to the research and career development experiences that will occur during the career award period and then to independent investigator status; and (2) that justifies the need for further career development to become an independent investigator. 

Candidate’s Plan for Career Development/Training Activities During Award Period

• The candidate and the mentor(s) are jointly responsible for the preparation of the career development plan.  A career development timeline is often helpful.  
• The didactic (if any) and the research aspects of the plan must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the candidate's career goals. 
• Describe the professional responsibilities/activities including other research projects beyond the minimum required 9 person months (75% full-time professional effort) commitment to the career award.  Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator.

Research Plan Section

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Research Strategy

• A sound research project that is consistent with the candidate’s level of research development and objectives of their career development plan must be provided. The research description should demonstrate the quality of the candidate’s research thus far and also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the research.
• The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan.
• If the applicant is proposing to gain experience in a clinical trial, ancillary clinical trial or a clinical trial feasibility study as part of his or her research career development, describe the relationship of the proposed research project to the clinical trial.

Training in the Responsible Conduct of Research

• All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). See How to Apply - Application Guide for instructions.

Mentor, Co-Mentor, Consultant, Collaborators Section

Plans and Statements of Mentor and Co-mentor(s)

• The candidate must name a primary mentor who, together with the candidate, is responsible for the planning, directing, monitoring, and executing the proposed program.  The candidate may also nominate co-mentors as appropriate to the goals of the program.   
• The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award. 
• Include a statement that the candidate will commit at least 9 person months (75% of full-time professional effort) to the career development program and related career development activities. 
• The application must include a statement from the mentor providing: 1) information on his/her research qualifications and previous experience as a research supervisor; 2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period; 3) a plan for career progression for the candidate to move from the mentored stage of his/her career to independent research investigator status during the project period of the award; and 4) a plan for monitoring the candidate’s research, publications, and progression towards independence. 
• Similar information must be provided by any co-mentor.  If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described.  Co-mentors should clearly describe how they will coordinate the mentoring of the candidate. If any co-mentor is not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of face-to-face meetings. 
• The mentor must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report.
• If the candidate is proposing to gain experience in a clinical trial as part of his or her research career development, the mentor or co-mentor of the mentoring team must include a statement to document leadership of the clinical trial, and appropriate expertise to guide the applicant in any proposed clinical trials research experience.

Letters of Support from Collaborators, Contributors and Consultants

• Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Unless also listed as senior/key personnel, collaborators and consultants do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. 
• Advisory committee members (if applicable): Signed statements must be provided by each member of the proposed advisory committee.  These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute.  Unless also listed as senior/key personnel, these individuals do not need to provide their biographical sketches. 

Environmental and Institutional Commitment to the Candidate

Description of Institutional Environment

• The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate. 
• Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.
• Describe the resources and facilities that will be available to the candidate. 

Institutional Commitment to the Candidate’s Research Career Development

• The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award. 
• Provide assurances that the candidate will be able to devote the required effort to activities under this award. The remaining effort should be devoted to activities related to the development of the candidate’s career as an independent scientist. 
• Provide assurances that the candidate will have access to appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations, as applicable) to carry out the proposed research plan. 
• Provide assurance that appropriate time and support will be available for any proposed mentor(s) and/or other staff consistent with the career development plan.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Limited items are allowed in the Appendix.  Follow all instructions for the Appendix as described in the How to Apply - Application Guide ; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide , with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

• For NOFOs that do not allow independent clinical trials, do not complete Section 4 – Protocol Synopsis information or Section 5 - Other Clinical Trial-related Attachments.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

Reference Letters

Candidates must carefully follow the How to Apply - Application Guide , including the time period for when reference letters will be accepted . Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov. 

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I.  contains information about Key Dates and Times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications .

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply - Application Guide .

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement .

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide . Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit  How to Apply - Application Guide . If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form . Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide .

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy .

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following : Reviewers should evaluate the candidate’s potential for developing an independent research program that will make important contributions to the field, taking into consideration the years of research experience and the likely value of the proposed research career development as a vehicle for developing a successful, independent research program.

Overall Impact

Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate’s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

  Candidate

• Does the candidate have the potential to develop as an independent and productive researcher? 
• Are the candidate's prior training and research experience appropriate for this award? 
• Is the candidate’s academic, clinical (if relevant), and research record of high quality? 
• Is there evidence of the candidate’s commitment to meeting the program objectives to become an independent investigator in research? 
• Do the reference letters address the above review criteria, and do they provide evidence that the candidate has a high potential for becoming an independent investigator?

Career Development Plan/Career Goals and Objectives

• What is the likelihood that the plan will contribute substantially to the scientific development of the candidate and lead to scientific independence? 
• Are the candidate's prior training and research experience appropriate for this award?
• Are the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence? 
• Are there adequate plans for monitoring and evaluating the candidate’s research and career development progress?
• If proposed, will the clinical trial experience contribute to the applicant's research career development?

Research Plan

• Are the proposed research questions, design, and methodology of significant scientific and technical merit?
• Is the prior research that serves as the key support for the proposed project rigorous?
• Has the candidate included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project?
• Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
• Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
• Is the research plan relevant to the candidate's research career objectives?
• Is the research plan appropriate to the candidate's stage of research development and as a vehicle for developing the research skills described in the career development plan?  
• If proposed, will the clinical trial experience contribute to the research project?

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

• Are the qualifications of the mentor(s) in the area of the proposed research appropriate? 
• Does the mentor(s) adequately address the candidate’s potential and their strengths and areas needing improvement? 
• Is there adequate description of the quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate? 
• Is the mentor’s description of the elements of the research career development activities, including formal course work adequate? 
• Is there evidence of the mentor’s, consultant’s, and/or collaborator’s previous experience in fostering the development of independent investigators? 
• Is there evidence of the mentor's current research productivity and peer-reviewed support? 
• Is active/pending support for the proposed research project appropriate and adequate? 
• Are there adequate plans for monitoring and evaluating the career development recipient’s progress toward independence?
• Are the mentor’s research qualifications, scientific stature, experience, and mentoring track record appropriate for the candidate's research career development needs?
• Are the nature and extent of the proposed mentorship adequate and appropriate, and is the commitment of the mentor(s) to the candidate's advanced research career development appropriate?
• Does the mentor(s) have a history of research productivity and support?
• If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, is there evidence of the appropriate expertise, experience, and ability on the part of the mentor(s) to guide the applicant during participation in the clinical trial?

Environment & Institutional Commitment to the Candidate

• Is there clear commitment of the sponsoring institution to ensure that the required minimum of the candidate’s effort will be devoted directly to the research described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities? 
• Is the institutional commitment to the career development of the candidate appropriately strong? 
• Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate adequate and appropriate? 
• Is the environment for the candidate’s scientific and professional development of high quality? 
• Is there assurance that the institution intends the candidate to be an integral part of its research program as an independent investigator?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects .

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research .

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms ) or the rationale for not sharing the resources, is reasonable.

All applications for support under this NOFO must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the candidate, including any prior instruction or participation in RCR as appropriate for the candidate’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction – instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE , and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019 .

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Authentication of Key Biological and/or Chemical Resources

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policies and practices , using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board.

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons . Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the  NIH Grants Policy Statement Section 2.4.4 Disposition of Applications .

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the  NIH Grants Policy Statement . This request is not a Notice of Award nor should it be construed to be an indicator of possible funding. 

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient’s business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions . Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the  NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities , including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions. 

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance ( HHS-690 ). To learn more, see Laws and Regulations Enforced by the HHS Office for Civil Rights website . 

HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement . Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement . The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. For mentored awards, the Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement . NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement. 

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (Responsibility/Qualification in SAM.gov, formerly FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

5. Evaluation

In carrying out its stewardship of human resource-related programs, NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Because of the difference in individual Institute and Center (IC) program requirements for this NOFO, prospective applications  MUST  consult the  Table of IC-Specific Information, Requirements, and Staff Contacts , to make sure that their application is responsive to the requirements of one of the participating NIH ICs. Prior consultation with NIH staff is strongly encouraged.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

Finding Help Online:  https://www.era.nih.gov/need-help (preferred method of contact) Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources) Email:  [email protected]  (preferred method of contact) Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace) Contact Center Telephone: 800-518-4726 Email:  [email protected]

See Table of IC-Specific Information, Requirements and Staff Contacts .

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts . All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Please note that the NIH Loan Repayment Programs (LRPs) are a set of programs to attract and retain promising early-stage investigators in research careers by helping them to repay their student loans. Recipients of career development awards are encouraged to consider applying for an extramural LRP award.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 75.

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files .

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Research: Why People Really Buy Upcycled Products

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Creativity is more of a selling point than sustainability.

Researchers who analyzed consumer feedback from Etsy discovered that what consumers value most about upcycled products is not their sustainability but their creativity. Their findings offer some guidelines for companies who hope to design and successfully market upcycled products: 1) Designers should consider using components from other industries to enhance the appeal of their products and encourage cross-industry collaboration; 2) Product designers and managers should identify new uses for product components; 3) Marketers should emphasize creativity, as well as sustainability, in their messaging about upcycled products; and 4) Companies can boost the appeal of new products by emphasizing design elements that remind consumers of upcycled products.

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• SC Sara Caprioli is a postdoctoral researcher at the TUM School of Management in Germany. Her work focuses on the effects of creativity and artificial intelligence on human behavior.
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Playing it Safe: Explore the FTC's Top Video Game Cases

Learn about the FTC's notable video game cases and what our agency is doing to keep the public safe.

Latest Data Visualization

FTC Refunds to Consumers

Explore refund statistics including where refunds were sent and the dollar amounts refunded with this visualization.

About the FTC

Our mission is protecting the public from deceptive or unfair business practices and from unfair methods of competition through law enforcement, advocacy, research, and education.

Learn more about the FTC

Meet the Chair

Lina M. Khan was sworn in as Chair of the Federal Trade Commission on June 15, 2021.

Chair Lina M. Khan

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Fact Sheet on FTC’s Proposed Final Noncompete Rule

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• Office of Policy Planning
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The following outline provides a high-level overview of the FTC’s proposed final rule :

• Specifically, the final rule provides that it is an unfair method of competition—and therefore a violation of Section 5 of the FTC Act—for employers to enter into noncompetes with workers after the effective date.
• Fewer than 1% of workers are estimated to be senior executives under the final rule.
• Specifically, the final rule defines the term “senior executive” to refer to workers earning more than $151,164 annually who are in a “policy-making position.”
• Reduced health care costs: $74-$194 billion in reduced spending on physician services over the next decade.
• New business formation: 2.7% increase in the rate of new firm formation, resulting in over 8,500 additional new businesses created each year.
• This reflects an estimated increase of about 3,000 to 5,000 new patents in the first year noncompetes are banned, rising to about 30,000-53,000 in the tenth year.
• This represents an estimated increase of 11-19% annually over a ten-year period.
• The average worker’s earnings will rise an estimated extra $524 per year. 

The Federal Trade Commission develops policy initiatives on issues that affect competition, consumers, and the U.S. economy. The FTC will never demand money, make threats, tell you to transfer money, or promise you a prize. Follow the  FTC on social media , read  consumer alerts  and the  business blog , and  sign up to get the latest FTC news and alerts .

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Victoria Graham Office of Public Affairs 415-848-5121