NLM Grants for Scholarly Works in Biomedicine and Health (G13 Clinical Trial Not Allowed)

NLM Grants for Scholarly Works in Biomedicine and Health (G13 Clinical Trial Not Allowed) is sponsored by National Library of Medicine (NLM). NLM Grants for Scholarly Works in Biomedicine and Health is a grant from the National Library of Medicine (NLM) that funds the creation, translation, and dissemination of scholarly works that synthesize and communicate biomedical knowledge to health professionals and researchers.

Expired PAR-23-183: NLM Grants for Scholarly Works in Biomedicine and Health (G13 Clinical Trial Not Allowed) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Library of Medicine ( NLM ) Office of Research on Women's Health ( ORWH ) August 13, 2024 Participation Added ( NOT-OD-24-164 ) Funding Opportunity Title NLM Grants for Scholarly Works in Biomedicine and Health (G13 Clinical G13 Health Sciences Publication Support Awards (NLM) September 22, 2025 - Notice of Pre-Application Technical Assistance Webinar for NLM Grants for Scholarly Works in Biomedicine and Health (G13 Clinical Trial Not Allowed).

See Notice NOT-LM-25-005 March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025.

See Notice NOT-OD-24-084 August 13, 2024 - Notice of Participation of the Office of Research on Women's Health (ORWH) in PAR-23-183, " NLM Grants for Scholarly Works in Biomedicine and Health (G13 Clinical Trial Not Allowed)." See Notice NOT-OD-24-164 July 3, 2024 - Notice of Correction to PAR-23-183: Clarification on the Types of Activities Supported.

See Notice NOT-LM-24-002 NOT-OD-22-195 New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023 NOT-OD-22-189 Implementation Details for the NIH Data Management and Sharing Policy NOT-OD-22-198 Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023 NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available Notice of Funding Opportunity (NOFO) Number Companion Funding Opportunity See Section III.

3. Additional Information on Eligibility. Assistance Listing Number(s) Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) solicits grant applications for the preparation of book-length manuscripts and other works of academic and/or public health policy value to U.S. health professionals, public health officials, biomedical researchers and historians of the health sciences.

This Notice of Funding Opportunity (NOFO) solicits grant applications for the preparation of book-length manuscripts and other works of academic and/or public health policy value to U.S. health professionals, public health officials, biomedical researchers and historians of the health sciences.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) January 26, 2024, January 26, 2025, January 26, 2026 Renewal / Resubmission / Revision (as allowed) 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.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description The National Library of Medicine (NLM) awards Grants for Scholarly Works in Biomedicine and Health for the preparation of book-length manuscripts and other works of academic and/or public health value to U.S. health professionals, public health officials, biomedical researchers, historians of the health sciences, and scholars of all disciplines working at the intersection of the digital humanities/data science and the history of the health sciences.

Grants are awarded for major critical reviews, state-of-the-art summaries, historical studies, and other useful organizations of knowledge in clinical medicine, public health, biomedical research, and informatics/information sciences. Regardless of topic, there should be clear evidence that the scholarly work proposed fills a void and has considerable usefulness to the intended audience.

This Notice of Funding Opportunity (NOFO) is being released to assist scholars in biomedical fields since they often face competing demands for their time, including requirements for clinical care services, teaching, research and administrative duties.

Therefore, it is the intent of this NOFO to provide for a grant award that will provide significant protected time to support the writing of a scholarly work that reflects thoughtful analysis and synthesis. Given that this award will only cover two years of support, it is expected that applicants have their ideas well solidified, and all materials needed to write the scholarly work collected before applying to this NOFO.

NLM Grants for Scholarly Works can be used to support several types of projects of academic and/or public health policy value, including but not limited to: Works focusing on the history or philosophy of medicine, public health and the life sciences, the development of medical research and health services, bioethics, and studies on the interrelationship of medicine and society.

Works focusing on the history or philosophy of biomedical informatics, computational biology, health information sciences, health communications, or health sciences librarianship. Analytical and comprehensive critical reviews which identify the present status of research and practice in various health-related fields, addressing advances which have been made, problems requiring examination, and emerging trends.

NLM Grants for Scholarly Works is designed to support works of academic and/or public health value that will ultimately be published by a commercial or academic press or similar print or electronic dissemination service that assures quality and availability of the product. Self-publishing by the author is not considered an appropriate dissemination vehicle.

NLM Grants for Scholarly Works in Biomedicine and Health does not support the following types of projects or activities: Archival research or data collection Production of textbooks, curriculum materials, or online learning modules Preparation of a scientific manuscript for a peer-reviewed journal Production of works intended for lay audiences Initial reporting of original scientific research findings, including the initial publication of dissertation research Development of coding systems, ontologies, or vocabularies for computational use Publication of proceedings of meetings, conferences, or workshops Production of journals, reprints, other serials, or other costs of publishing such as author page charges Production of manuals, bibliographies, or catalogs Development, maintenance, or operation of databases Mass digitization of existing archives or print materials Work judged to have significant commercial viability Projects of local interest only, or works for which access is restricted to a select group Revisions or upgrades of existing works of academic and/or public health value Although it is not expected that the final scholarly work be published by award end, all grantees are required to provide NLM with two copies of the final scholarly work when officially released.

NLM recommends that all hard copy text sponsored by this program be published on acid-free permanent paper as set forth by the American National Standards Institute - Permanence of Paper for Publications and Documents in Libraries and Archives (ANSI/NISO Z39. 48-1992). See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Applicants may request up to $75,000 direct costs per year to support salary and fringe benefits for project personnel.

Salaries requested must not exceed the levels commensurate with the institution’s policy for similar positions and may not exceed the legislatively mandated salary cap. See: https://grants. nih.

gov/grants/policy/salcap_summary. htm Applicants may also request up to $5,000 direct costs per year for other costs needed to develop the final products (such as supplies, design/editing services, travel, etc.). These costs must be justified as specifically required to complete the scholarly work.

F&A costs will be provided using the organization’s negotiated “Other Sponsored Activities” rate, or other applicable non-research rate. The scope of the proposed project should determine the project period. The maximum project period is 2 years.

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 Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education 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) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government 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 Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 not allowed. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

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 registrations; 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.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement. 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2. 3.

7. 4 Submission of Resubmission Application . This means that the 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 2. 3.

9. 4 Similar, Essentially Identical, or Identical Applications ). Section IV.

Application and Submission Information 1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution.

Links to apply using ASSIST or Grants. gov Workspace 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 Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es) and telephone number(s) of the PD/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO. All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Applicants should address the following aspects of the proposed scholarly work in their proposals: Significance: (What do you intend to do?)

State concisely the importance and health relevance of the proposed work. Provide evidence of the significance of, need for, and usefulness of the proposed work. If there are similar works, describe how the proposed work differs, extends, or enhances them.

Describe how the proposed work is of academic and/or public health importance to U.S. health professionals, public health officials, biomedical researchers, and/or historians of the health sciences. Describe the intended audience of the scholarly work. Include up to two letters of support from the target audience attesting to the need of the scholarly work.

Innovation: (What is novel about this project?) If appropriate, explain how the application challenges and seeks to shift current research or clinical practice paradigms. Describe any novel theoretical concepts or point-of-view that the scholarly work will present.

Describe any unique materials upon which the proposed work is based. Approach: (How are you going to do the work?) Describe the approach that will be used to ensure timely completion of the scholarly work.

Include how information that will be the focus of scholarly work has been collected and how it will be analyzed and synthesized to produce the scholarly work. Describe the current status of your writing or development of the scholarly work. Describe how the proposed work will be organized.

Provide a brief topic or chapter outline. Include a timeline in the approach section that contains important milestones to measure progress towards a final draft of the scholarly work. If applicable, include evidence that the proposed work will or has been considered for publication by a university press, professional society, or other publisher.

Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide. A Resource Sharing Plan is not applicable for this NOFO. 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 instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: A Data Management and Sharing Plan is not applicable for this NOFO. Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

No publications or other material may be included in the Appendix. Applicants can include one sample chapter and either a detailed topic/chapter list or storyboard of the book or work to be produced.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) 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 All instructions in the SF424 (R&R) Application Guide must be followed.

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

3. Unique Entity Identifier and System for Award Management (SAM) See Part 1. 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.

Overview Information 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). 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 Policy on Late Application Submission.

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 SF424 (R&R) Application Guide. 5.

Intergovernmental Review (E. O. 12372) This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . 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 SF424 (R&R) 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. 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 SF424 (R&R) 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 and responsiveness by NLM/NIH. Applications that are incomplete, non-compliant and/or nonresponsive 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 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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?

How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Are there already similar, well-regarded works in the area? If so, will the proposed work be significantly different?

Will it extend or enhance a specific discipline or set of disciplines? Is the proposed work of academic and/or public health policy value to U.S. health professionals, public health officials, biomedical researchers, and/or historians of the health sciences? Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project?

If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project? RFA/PAR only: Additional Questions may be added and should be explained to the applicant in Section IV. 2.

Does the PD(s)/PI(s)'s previous scholarly record contribute to the probability of success? Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?

Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? RFA/PAR only: Additional Questions may be added and should be explained to the applicant in Section IV. 2.

Does the project propose a novel point-of-view, or is the work based upon unique sources not previously known and/or studied? Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project?

Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) as required by statute, inclusion (or exclusion) of individuals on the basis of sex, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Will the scholarly work be published or distributed in a way that assures the quality and public availability of the product? Has the information that will be the focus of the scholarly work been collected and is it sufficient to produce the scholarly work? How will the information be analyzed and synthesized to produce the scholarly work?

Does the sample chapter and detailed topic list or storyboard support the quality of the proposed scholarly work? Does the timeline presented seem reasonable for completing the scholarly work with clearly established milestones.

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) as required by statute, inclusion (or exclusion) of individuals on the basis of sex, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

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, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults), as required by statute, 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