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
TAG ARCHIVES FOR NPRM
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.
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
In Case You Missed It (ICYMI): From time-to-time, Ampersand will feature particularly well-received posts from the recent past. These posts remain timely as topics of discussion in the fields of research ethics, human subjects protections, or animal care and use. Highlighting them now enables readers who may have missed them a chance to read and comment. In this ICYMI, part of a series of posts working through the Notice of Proposed Rulemaking for revisions to the Federal Policy for the Protection of Human Subjects, PRIM&R Executive Director Elisa Hurley explains the impetus for [...] Read more
In this week’s Research Ethics Roundup, a collection of articles explore debates on regulations and regulators: NPR covers a critique of revisions to the Common Rule, a Nature editorial responds to legislation that would loosen FDA regulations, and former FDA commissioners ask Congress to make the agency more independent. Read more