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
by Jim Gearhart, BA, Member of the Board of Directors for Quorum Review IRB
PRIM&R is pleased to share a post from Jim Gearhart, a member of the PRIM&R Blog Squad for the 2014 Advancing Ethical Research (AER) Conference. The PRIM&R Blog Squad is composed of PRIM&R members who will blog here, on Ampersand, about the conference to give our readers an inside peek of what happened December 4-7 in Baltimore, MD.
PRIM&R’s 2014 AER Conference got off to an inspiring start on Friday with perceptive discussions [...] Read more
We all know that designing a mechanism for obtaining valid informed consent is a perennial challenge, but it seems to be receiving special and renewed interest lately.
The United States Food and Drug Administration (FDA) recently released a draft guidance, Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors, for public comment. The draft is intended to replace the FDA’s previous, and much briefer, guidance on informed consent, which dates from 1998. Throughout the new draft guidance, the FDA emphasizes that informed consent involves more than a form, and encourages investigators, IRBs, [...] Read more
by Meryn Robinson, education and membership services intern
Since its founding in 1974, PRIM&R’s highest priority has been to provide those charged with ensuring research protections, as well as those involved in the design and implementation of research protocols, with the education, practical tools, and cutting-edge strategies needed for their work protecting subjects. As we celebrate our 40th anniversary, we are reflecting upon four decades of connecting and protecting, and recounting some of the events that have shaped the field’s rich history in our 40 Years of Research Ethics series.
In 1951, Read more
by Andrea Johnson, JD, CIP, regulatory specialist in the Research Integrity Office at Oregon Health and Science University
Respect for persons is one of the three tenets of human research subject protections advanced by The Belmont Report. It includes two moral requirements:
- Autonomy of individuals must be acknowledged; and
- Persons with diminished autonomy [...] Read more