NIH has released NOT-OD-19-050, which announces the publication of the Final Rule amending the Federal Policy for the Protection of Human Subjects (Common Rule). HSS and other Common Rule departments published the Final Rule in the Federal Register on January 19, 2017, and subsequently amended the Final Rule to delay the general compliance date until January 21, 2019.
Several provisions in the Revised Common Rule may result in changes to NIH policies and procedures, including: 1) removal of the requirement for Institutional Review Boards (IRBs) to review grant applications and contract proposals related to research; 2) a new requirement for clinical trial informed consent documents to be posted on a public federal government website; 3) changes to categories of research that qualify for an exemption, and 4) removal of the requirement for annual IRB reviews for certain categories of research.
As of January 21, 2019, studies initiated on or after that date, ongoing studies that voluntarily transitioned to the Revised Common Rule, and studies that voluntarily implemented the three burden-reducing provisions during the delay period (July 19, 2018 through January 20, 2019), are expected to comply with all Revised Common Rule requirements for the remainder of the study.
The complete notice, including a brief description of several NIH provisions that apply to these studies, is available at NOT-OD-19-050.
Additional details, including deadlines, requirements and processes for adopting the new provisions, can be found in the Final Rule.
