It has been four years since the 2011 Advance Notice of Proposed Rule Making (ANPRM) for the Common Rule and the U.S. Department of Health and Human Services (HHS) has now released their much-awaited Notice of Proposed Rulemaking (NPRM).
The NPRM is open for comment until 5 p.m. on 6 January 2015.
Note: Since the NPRM was published on September 8, 2015 (80 FR 53933) with a public comment end date of December 7, 2015, participating federal departments and agencies have received requests to extend the comment period to allow sufficient time for a full review of the NPRM. The new comment period deadline is January 6, 2015.
Who does this affect?
Because the NPRM proposed changes affect many areas of research, individuals involved with human subjects research (from researchers to IRB members to administrators) need to be aware and learn about the proposed changes.
Why is the NPRM important?
The Federal Policy for the Protection of Human Subjects (known as the “Common Rule”) was published in 1991. Research settings, research types, and research administration are greatly different today than in 1991. Technical revisions were made in 2005, but the NPRM (which was proposed by sixteen federal departments and agencies) is the first set of substantial changes proposed to the Common Rule in 25 years.
What are the proposed changes?
The following list from OHRP encompasses the most significant changes to the Common Rule proposed in the NPRM.
Once the comment period closes on 6 January 2015 at 5 p.m., HHS will review all comments and then issue a Final Rule. The NPRM proposes allowing a year for the research community to implement most of the changes, and three years for two of the proposed changes.
U.S. Department of Health and Human Services (HHS). 2015. “Regulations.” May 4. Accessed October 12. http://www.hhs.gov/ohrp/humansubjects/index.html
- OHRP Webinar Series on the Common Rule NPRM
- PRIM&R NPRM Resources
- Federal Register with the NPRM
- Overview of the NPRM. (Video: Jerry Menikoff, 2015).