This page provides background on how NIH’s clinical trials dissemination policy relates to the federal regulation (FDAAA Section 801 as implemented by 42 CFR Part 11).
Both the NIH policy and the federal regulation aim to increase the availability of information to the public about clinical trials – information that is not systematically available from other public sources. The regulation and NIH policy do not affect the design or conduct of clinical trials or define what type of data should be collected during a clinical trial. Rather, they aim to help ensure that information about clinical trials and their results are made publicly available, in a timely manner, via ClinicalTrials.gov, a publicly accessible database operated by the NIH’s National Library of Medicine (NLM).
FDAAA, Section 801, and the Final Rule (42 CFR Part 11)
Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) refers to a federal statute established in 2007 requiring the registration and reporting of information on "applicable clinical trials" on Clinicaltrials.gov.
In 2016, the Department of Health and Human Services (HHS) issued a regulation to further increase the availability of information about clinical trials, and clarify FDAAA 801. This regulation, 42 CFR Part 11 , is called the Final Rule for Clinical Trials Registration and Results Information Submission, or "Final Rule". The Final Rule describes requirements for registering and submitting summary results information for certain clinical trials to ClinicalTrials.gov. The changes made to FDAAA 801 by the Final Rule are available as a summary and table (PDF) .
NIH's Clinical Trials Dissemination Policy
A complementary NIH policy applies to all clinical trials funded by NIH, regardless of whether they are subject to the Final Rule. The NIH Policy on Dissemination of NIH-Funded Clinical Trial Information, effective for competing applications and contract proposals submitted on or after January 18, 2017, states that all NIH-funded awardees and investigators conducting clinical trials will register and report the results of their trial in ClinicalTrials.gov.
NIH is delaying enforcement of this policy until September 24, 2023 for basic experimental studies with humans (see NOT-OD-18-212, NOT-OD-19-126, and NOT-OD-21-088). NIH will continue to expect registration and reporting for these types of studies but will allow flexibility to report in other existing basic science portals.
- Table comparing the FDAAA 801 "Final Rule" with the NIH clinical trials dissemination policy
- FDAAA 801 Requirements
- FAQs on the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11)
- Checklist for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (ACT)
- Blog posts on clinical trials reporting on Open Mike, the blog of Dr. Michael Lauer, NIH deputy director for extramural research
- NIH News Release: HHS takes steps to provide more information about clinical trials to the public (September 16, 2016)
- "Toward a New Era of Trust and Transparency in Clinical Trials" (Journal of the American Medical Association, 2016)
- "The Final Rule of U.S Clinical Trials Registration and Results Information Submission" (New England Journal of Medicine, 2016)
- Background on the development of the NIH policy ("Sharing Clinical Trial Information" section, NIH Office of Science Policy website)