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 9/7/2017
Brief overview presentation:  Doing Human Subject Research? Changing NIH Policies May Impact You.	13 slides	PowerPoint (1.7 MB)	Updated 9/25/2017
Full length presentation: Doing Human Subjects Research? Changing NIH Policies May Impact You.	31 slides	PowerPoint (1.3 MB)	Updated   12/11/2018

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?"

	https://grants.nih.gov/policy/humansubjects/hs-decision.htm
	https://grants.nih.gov/ct-decision/index.htm

One-Pagers

Funding Opportunity Types by Clinical Trial Allowability

Refer to this table for help determining which Funding Opportunity Announcement (FOA) to use.

PDF

Posted 2/7/2019

Trainings

Single IRB & Exceptions Process Webinar

October 18, 2017

Videos

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

A Walk Through the PHS Human Subjects and Clinical Trials Information Form	https://www.youtube.com/watch?v=FNgOHqmk0rY&list=PLOEUwSnjvqBJeHcb4yai7_fDnFZFPEmQK&index=2&t=0s	Duration:  6 min
How to Choose the Right FOA	https://grants.nih.gov/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

Podcasts

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
Understanding the Definition of a Clinical Trial and What that Means for You (MP3 & Transcript)	October 17, 2017

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

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