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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 News

Additional Requirements for NIH-funded studies and awardees

Upcoming

1. 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

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

Current

1.  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.

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

2.  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

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 published version of NIH-funded articles available in PMC but require the author to complete the submission are known as Method D journals.

Ultimately, the Principal Investigator (PI) is responsible for ensuring compliance of publications arising from his/her grant

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

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=IIEBtfnSqMA&feature=youtu.be

Part 1 covers initial submission

Part 2 covers post-submission review and final approval (starts at about 6:40 mark)

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