Notice Number: NOT-OD-17-038

Key Dates
Release Date: January 19, 2017

Issued by
National Institutes of Health (NIH)

Purpose

Today, the U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies published the final rule to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects (Common Rule). The final rule is intended to enhance protections for human research participants, facilitate valuable research, and reduce burdens for investigators, research institutions, and Institutional Review Boards (IRBs). See: https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-protection-of-human-subjects

The general effective/compliance date of the final rule is January 20, 2018. Studies that have not yet undergone initial IRB review will be subject to the new requirements on that date. Research ongoing on that date will continue to be subject to the current Common Rule requirements unless an institution chooses to comply with the final rule requirements for ongoing studies as well (these transition provisions are explained in the final rule preamble and appear in Section 101(l) of the regulatory text). The single IRB requirement for multi-site studies takes effect three years later (January 20, 2020). The NIH policy on the use of single IRBs in multi-site studies takes effect in September of this year.

HHS intends to issue further guidance on specific provisions of the rule.

NIH will be working with the Office for Human Research Protections in the coming months to develop additional guidance for the research community and, as necessary and appropriate, NIH will update relevant policies.

HHS released a Press Release about the final rule on January 18, 2017, that can be accessed at: https://www.hhs.gov/about/news/2017/01/18/final-rule-enhances-protections-research-participants-modernizes-oversight-system.html

Inquiries

Inquiries about the final rule should be directed to:

Office for Human Research Protections
[email protected]
Please direct inquiries about this Notice to:

National Institutes of Health
Office of Science Policy
[email protected]