For those of us in human research protections, the Common Rule changes were the most hotly anticipated item of 2016. The unveiling of the final changes on January 19, 2017 has been, for so many of us, a source of confusion, consternation, stress, and in some cases, relief.
As technology and science have advanced at a dizzying pace, the rules had stood still, unable to adequately address ever-growing biorepositories, genomic analysis implications, and the advent of social media and electronic health tools. Now that the changes are here and we have a mandate to implement them, we are clamoring to understand the revisions and how to update our processes without disrupting and confusing the investigators and administrators we spent so [...] Read more
As the biomedical research enterprise increasingly moves to a more participatory model of research, where research participants are treated more as partners than passive subjects, we can expect greater emphasis on returning individual-level results of research to participants. A prominent example is the All of Us Research Program. Read more
This week’s Research Ethics Roundup examines why legal experts are advising against voluntary compliance of Common Rule changes, President Trump’s plan for the National Institutes of Health (NIH)’s budget, the debate over whether technology can replace animal models in research, and the reaction to President Trump’s pick for Food and Drug Administration (FDA) Commissioner. Read more
On January 28, 2017, PRIM&R hosted PRIM&R’s Primer on the Revised Common Rule, a webinar to introduce the human subjects research community to the changes present in the revised Federal Policy for the Protection of Human Subjects. Published on January 19, the revised policy, or “Common Rule,” represents the first significant regulatory changes in human research oversight since 1991. Presented by P. Pearl O’Rourke, MD, and Heather Pierce, JD, MPH, this webinar provided an overview of the noteworthy changes from the current rule, as well as a discussion of various possible fates of the revised Common Rule under the new presidential administration. 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