On September 8, the Department of Health and Human Services (DHHS) issued a Notice of Proposed Rulemaking (NPRM) for revisions to the Federal Policy for the Protection of Human Subjects , or "Common Rule." If adopted, the proposals in the NPRM will result in the most substantive revisions to the core regulation governing federally funded human subjects research in the United States since 1981.
TAG ARCHIVES FOR informed consent
The much-anticipated Notice of Proposed Rulemaking—offering the first changes to the Common Rule since its publication in 1991—has now been released. in the interest of providing PRIM&R’s community with as much exposure to the issues raised within it, and the writing and scholarship around the proposed rules changes, PRIM&R and other organizations are cross-posting their thoughts. This post, from Dr. Celia B. Fisher at Fordham University, focuses on the proposed changes to minimal risk. It originally appeared on Ethics & Society, the Fordham University Center for Ethics Education blog.
In the wake of the controversy over the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT), a team of bioethicists set out to answer two main questions raised by the controversy: (1) “what do people think about the risks and benefits of research on medical practices?,” and (2) “what do people think about different approaches to informing patients that this type of research is being conducted?” Their research, the Research on Medical Practices Ethics Study, examined the views of the general population regarding research on medical practices through a series [...] Read more
I recently had occasion to think fondly of a member of our PRIM&R community whom we lost in April: Alan Wertheimer, PhD. Alan was a senior research scholar in the Department of Bioethics at the National Institutes of Health, professor emeritus of political science at the University of Vermont, and a long-time PRIM&R faculty and conference planning committee member. He was also a cherished friend and mentor to me. He passed away April 10.
Ever the scholar and truth-seeker, Alan never hesitated to let me know—collegially, of course—if he disagreed with something I said. For instance, he wrote me a note about my Read more
To fulfill ethical requirements, each year, millions of people (Krall, 2009) engage in an informed consent discussion before joining clinical trials, weighing both possible risks and benefits of the trial participation when making their choice to take part in the proposed study Read more