On April 19, HHS and 16 other federal agencies released a new Notice of Proposed Rulemaking (NPRM) that would delay the general compliance date for the revised Common Rule an addition six months, to January 21, 2019. The NPRM also proposes to allow institutions to implement three “burden-reducing provisions” during the delay period. Comments on the NPRM are due May 21, and as you consider developing and submitting your comments, I wanted to share the letter PRIM&R has submitted. Read more
On April 19, HHS and 16 other federal agencies released a new Notice of Proposed Rulemaking (NPRM) proposing to delay the general compliance date for the revised Federal Policy for the Protection of Human Subjects, or “Common Rule,” six more months to January 21, 2019. On June 18, HHS released a final rule confirming this delay, while allowing three "burden-reducing provisions" during the delay period. Read more
Ending five and a half years of rulemaking and speculation, the US Department of Health and Human Services (HHS) and 15 other Federal Agencies released a final revision of the Federal Policy for the Protection of Human Subjects, or “Common Rule,” on January 19, 2017. These are the first revisions to the Common Rule since it was promulgated in 1991. Read more
Update: The Office of the Federal Register pre-published the revisions to the Common Rule on January 18.
There has been a lot of anticipation and uncertainty in the research oversight community during the 16 months since the release of the Notice of Proposed Rulemaking to revise the Common Rule. We learned last week that the process is, in the final days of the Obama Administration, officially moving forward.
On January 4, a revised Common Rule Read more
Since the release of the Notice of Proposed Rulemaking to revise the Common Rule a year ago, I have been thinking about biospecimens research, specifically about the role of public trust in the success of such research, and about some of the tensions that arise between respecting people’s autonomy, and advancing potentially important and beneficial science. This is a complicated cluster of issues that, while particularly salient to biospecimen research, is generalizable to the research enterprise as a whole. Read more
