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Clinical Research: NIH

This guide is designed to be a resource for those conducting clinical research at UF. It includes tabs for resources, training, IRB, Safety and Ethics, NIH, Standards and Templates, and Professional Associations.

NIH Links

NIH Collaboratory Online Book on Pragmatic Trials

Additional Requirements for NIH-funded studies and awardees

Recent Announcements (in reverse chronological order)

Related to AI use in NIH grant applications

Supporting Fairness and Originality in NIH Research Applications

Effective for applications submitted for the September 25, 2025 receipt date and beyond

- NIH will not consider applications that are substantially developed by AI, or contain sections substantially developed by AI, to be original ideas of applicants

- NIH will only accept six applications per PI per calendar year

 

Related to Publication Costs

Request for Information on Maximizing Research Funds by Limiting Allowable Publishing Costs

NIH is seeking feedback on policy options limiting allowable publication costs in an effort to maximize the use of funds on research activities

Responses will be accepted through September 15, 2025 

NIH to crack down on excessive publisher fees for publicly funded research

On July 8, 2025 NIH announced they will institute a new policy capping the amount publishers can charge NIH-funded researchers to make their publications freely available to the public

Policy to start in FY 2026

Amount of cap is not yet known

 

Related to NIH Public Access Policy

Revised 2024 NIH Public Access Policy: new effective date

The policy effective date has been updated to July 1, 2025

- applies to peer-reviewed articles arising from NIH funded research accepted for publication in a journal on or after July 1, 2025

- all other aspects of the 2024 policy (linked below) will remain the same

2024 NIH Public Access Policy (original)

Originally released December 17, 2024 with an effective date of December 31, 2025, this new NIH Public Access Policy updates the 2008 policy

- the main difference is that the article must be made available in PubMed Central immediately upon acceptance for publication; no embargo period is allowed under this 2024 policy (2008 policy allowed for an embargo period of up to 12 months)

Consistent with OSTP Memorandum below

Office of Science and Technology Policy (OSTP) update has already led to to change in the NIH Public Access Policy, other federal funders will be affected by the end of 2025 

Effective no later than December 31, 2025, publications and research funded by taxpayers must be made freely accessible to the public, without an embargo

Related information and resources

Resource addressing current policy and how to comply: https://guides.uflib.ufl.edu/nih/compliance 

 

Related to Data Management and Sharing Plans

Changes to Data Management and Sharing (DMS) Plan Progress Reporting

Effective October 1, 2024, RPPRs will have new questions related to DMS plan activities

NIH Policy for Data Management and Sharing

Effective January 25, 2023, new Data Management and Sharing (DMS) policy replaces 2003 NIH Data Sharing Policy

Forms-H application packages must be used for applications with due dates of January 25, 2023 or later

Forms-H changes

Related information and resources

DMSP format from NIH  (Word doc template for DMSP with instructions)

Per NIH, the Fall 2022 FORMS-H version of the NIH Application Guide will include instructions for developing a data management and sharing plan (DMSP) https://grants.nih.gov/grants/forms/all-forms-and-formats.htm?category=format-pages&id=2099

Link to policy details: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html

NIH Webinar Series discussing the policy

Understanding the New NIH Data Management and Sharing (DMS) Policy (August 11, 2022)

Diving Deeper into the New NIH Data Management and Sharing (DMS) Policy (September 22, 2022)

Link to supplemental information re: the elements of a DMSP: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-014.html

NIH instructions on writing a DMSP: includes some sample plans

    Many NIH institutes and centers have more specific requirements, in addition to the general DMS Policy

NIH institute and center data sharing policies

    DMS Policy and Privacy

Protecting privacy when sharing human research

  - Best practices and principles

Word document with sample Informed Consent language for data to be shared in the National Institute of Mental Health Data Archive (NDA)

  - while this document is specific to NDA, this informed consent language is likely useful researchers planning to share data in other repositories

Additional DMSP writing resources

DMPTool, an online tool for creating DMPs for various funders that comply with their requirements

          Provides templates including a Word and PDF version of NIH-GEN DMSP (Forthcoming 2023)

  - Note their disclaimer: "... researchers should always consult the program officers and policy documents directly for authoritative guidance."

Video from HHS Office of Research Integrity on FAIR Principles and Data Management and Sharing Plans (Sep 2024)

Video tutorial from NNLM on Creating Data Management Plans with DMPTool (Dec 13, 2022)

UF Research Education and Training Programs guide to NIH Data Management Sharing Plans and Repositories

Repositories list from NIH

 

Long-standing requirements

1.  ORCID iDs

Fiscal Year 2020, ORCID iDs to be required for individuals supported by NIH research training, research education, career development, and fellowship awards

Effective October 2019, ORCID iDs will be required at the time of appointment for those appointed to institutional awards including:

T03, T15, T32, T34, T35, T37, T42, T90/R90, TL1, TL4, TU2, K12/KL2, R25, R38, RL5, RL9

Effective January 25, 2020, ORCID iDs will be required at the time of application for those applying for individual awards including:

F05, F30, F31, F32, F33, F37, F38, F99/K00, FI2, K01, K02, K05, K07, K08, K18, K22, K23, K24, K25, K26, K38, K43, K76, K99/R00

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-109.html#.XSc3Q6u_VWA.email

Related information

Link to register for your ORCID iD: https://orcid.org/register. ORCID states that registration takes 30 seconds.

2.  Clinical Trials Registration

Effective January 18, 2017, all NIH-funded clinical trials must register their studies and report their results on ClinicalTrials.gov (NOTE: no longer just "applicable clinical trials")

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-149.html

https://clinicaltrials.gov/

For PIs entering data in the system for the first time, you can send an email to register@clinicaltrials.gov and they will answer any questions you might have. They state that they will even teleconference and walk you through the process if necessary.

Related information

International Committee of Medical Journal Editors (ICMJE) likewise requires clinical trial registration as a condition of publication; while they recognize additional registries, ClinicalTrials.gov satisfies the ICMJE requirement as well 

http://icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html

Link to complete Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals document: http://icmje.org/recommendations/

List of journal titles that adopted the ICMJE requirement: http://icmje.org/journals-following-the-icmje-recommendations/

A data sharing plan will also be a requirement of clinicaltrials.gov and ICMJE publication in the near future: http://www.nejm.org/doi/full/10.1056/NEJMe1705439#t=article

3.  NIH Public Access Policy

Publications resulting from NIH-funded research must be made publicly available in PubMed Central (PMC)

Original policy dated back to 2008

Policy was updated in 2024 and went into effect July 1, 2025 (see 2024 policy information in Recent Announcements above)

Related information

Resource addressing current policy and how to comply: https://guides.uflib.ufl.edu/nih/compliance 

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