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Training & Resources - NIH Clinical Trial Policies

Learn about training opportunities and use the resources below to help spread the word about NIH's clinical trial policies. We will continue to post additional resources, so check back frequently!

Slide Decks

Feel free to use these slides for your own outreach. Use just a slide or two or the whole deck.

Presentation on rationale: NIH Clinical Trials and Transparency Reforms. Why the Changes? 16 slides PowerPoint (6 MB) Posted
 Brief overview presentation: Doing Human Subject Research? Changing NIH Policies May Impact You. 
13 slides
PowerPoint (1.7 MB)
Full length presentation: Doing Human Subjects Research? Changing NIH Policies May Impact You. 31 slides PowerPoint (1.3 MB)

Human Subjects & Clinical Trial Questionnaires

Use these questionnaires to help your team answer the questions, "Am I doing human subjects research?" & "Does your human subjects research study meet the NIH definition of a clinical trial?"

                              Your human subjects study may meet the NIH definition of a clinical trial.

                              Your human subjects study may meet the NIH definition of a clinical trial.



Human Subjects, Clinical Trials and Inclusion Resources One-Pager Find useful links to tools, workflows, websites and other important resources for human subjects, clinical trials and inclusion. PDF


Funding Opportunity Types by Clinical Trial Allowability
Refer to this table for help determining which Notices of Funding Opportunities (NOFO) to use.


Sometimes a simple explanation with a video is all you need.

A Walk Through the PHS Human Subjects and Clinical Trials Information Form      Duration:
 6 min 
Decorative image link to the video: How to choose th right FOA
How to Choose the Right FOA
/grants/how-to-apply-application-guide/video/choose-FOA/story_html5.html  Duration:
 12 min 

Human Subjects System (HSS)

HSS - An Overview

eRA website with information on the Human Subjects System

HSS - Training Resources Includes training resources for the Human Subjects System including video tutorials
HSS - FAQs Frequently Asked Questions on using the Human Subjects System


Basic Experimental Studies Involving Humans (BESH) (MP3 & Transcript) July 29, 2021

Valid/Stratified Analyses (MP3 & Transcript)

August 6, 2018

NIH's Inclusion Across the Lifespan Policy (MP3 & Transcript)

August 6, 2018

Changes to the NIH Appendix Policy for 2018 (MP3 & Transcript)

December 29, 2017

Why it's so important to Submit Applications Early (MP3 & Transcript) December 29, 2017
History of the NIH Definition of a Clinical Trial(MP3 & Transcript) October 17, 2017
Understanding the Definition of a Clinical Trial and What that Means for You (MP3 & Transcript) October 17, 2017

Recorded Training

An Overview of NIH Policies on Clinical Trials

Description: Video presentation by the Director of the OER Division of Human Subjects Research for the December 2022 NIH Grants Conference PreCon event, Human Subjects Research: Policies, Clinical Trials, & Inclusion. The presentation explains the NIH Clinical Trial policies and when/how the policies should be applied to research that may be funded.


Power Point

   Duration: 79:52 min Posted: December 7, 2022

Open Mike Blogs from Dr. Mike Lauer, NIH Deputy Director for Extramural Research

NIH Clinical Trials Reporting Compliance: A Shared Commitment March 24, 2023
Designing Analyses by Sex or Gender, Race, and Ethnicity in NIH-defined Phase 3 Clinical Trials March 10, 2022
Enhanced Checks for Compliance with Clinical Trial Registration and Reporting in RPPR November 9, 2021
If One Aim or a Small Part of My Proposed Project in an NIH Grant Application Meets the NIH Definition of a Clinical Trial, Is My Entire Application Considered a Clinical Trial? September 28, 2021
New and Updated Resources Available to Help Design Rigorous Clinical Trials  June 9, 2021
Where to Post Informed Consent Forms for NIH-Funded Clinical Trials June 4, 2019
Is My Ancillary Study Considered a Clinical Trial?  January 8, 2019
How Do You Define a “Study” for the Purposes of Providing Information on the PHS Human Subject and Clinical Trial Form? July 25, 2018
Continuing to Work with the Community on Registration and Results Reporting for Basic Experimental Studies involving Humans July 24, 2019
New Funding Opportunities for Basic Experimental Studies Involving Humans November 28, 2018
Understanding Age in the NIH Portfolio: Implementation of the NIH Inclusion Across the Lifespan Policy November 13, 2018
NCATS Trial Innovation Network July 3, 2018
NIH Announces Inclusion Across the Lifespan Policy January 24, 2018
Continuing to Strengthen Inclusion Reporting on NIH-funded Phase III Trials January 8, 2018
Further Refining Case Studies and FAQs about the NIH Definition of a Clinical Trial in Response to Your Questions January 4, 2018
Be Careful to Pick the Right Funding Opportunity Announcement (FOA) December 7, 2017
Implementing a New Human Subject and Clinical Trial Information Form October 11, 2017
Continuing to Clarify the NIH Definition of a Clinical Trial September 8, 2017
4 Questions For Researchers and Institutions Involved In Human Subjects Research August 11, 2017
Direct email to NIH PIs, recent applicants, and research administrators August 11, 2017