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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

2024 NIH Public Access Policy

Released December 17, 2024 with an Effective Date of December 31, 2025, this new NIH Public Access Policy updates the 2008 policy

- applies to peer-reviewed articles arising from NIH funded research accepted for publication in a journal on or after December 31, 2025

Consistent with OSTP Memorandum below

Office of Science and Technology Policy (OSTP) update will lead to change in the NIH Public Access Policy

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

- peer-reviewed articles arising from NIH funded projects will be required to be made freely available in PubMed Central immediately upon publication; current NIH policy allows for a 12-month embargo period (see Item 3. NIH Public Access Policy below for more information on the current policy)

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

Supplemental information from September 21, 2022: Protecting privacy when sharing human research participant data

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 available in PubMed Central (PMC) no later than 12 months after publication

Link to policy details: https://publicaccess.nih.gov/policy.htm

Note: While a 12 month embargo period is currently acceptable to NIH, articles accepted for publication after Dec 31, 2025 will not be allowed an embargo period per updated NIH policy and consistent with Office of Science and Technology Policy (OSTP): https://www.whitehouse.gov/ostp/news-updates/2022/08/25/ostp-issues-guidance-to-make-federally-funded-research-freely-available-without-delay/

Related information

When and How to Comply with this NIH Public Access Policy: https://publicaccess.nih.gov/

Some publishers handle this themselves, other times the author has to get directly involved

Journals that make the final published version of all NIH-funded articles available in PMC without author involvement are known as Method A journals.

To find Method A journals: https://publicaccess.nih.gov/submit_process_journals.htm

Journals that make the final published version of NIH-funded articles available in PMC at the author's request (and often requires that you have paid for the open access option) are known as Method B journals.

Journals that do NOT make the manuscript available in PMC, requiring the author to handle the submission, are known as Method C journals.

 Link to NIHMS to enter manuscript: https://www.nihms.nih.gov/db/sub.cgi

Journals that make the final accepted version of NIH-funded articles available in PMC but require the author to complete the submission are known as Method D journals.

Link to instructions for navigating the NIH Manuscript Submission (NIHMS) process: https://www.ncbi.nlm.nih.gov/books/NBK3846/

Video for navigating the NIHMS system: https://www.youtube.com/watch?v=UwIrhRTj8-M

Covers depositing files and providing initial approval

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