Traditional research methodologies are being used to address a number of longstanding challenges, including how to make health care more efficient and effective, and how to fight poverty. This week’s Research Ethics Roundup sheds light on the role of research in answering those questions, as well as other stories related to research ethics and oversight.
Don’t Weaken the FDA’s Drug Approval Process: The 21st Century Cures Act proposes significant changes to the approval process for many medical products. In this opinion piece for The New York Times, Gregg Gonsalves, Mark Harington, and David A. Kessler warn that “Congress should [...] Read more
This week’s Research Ethics Roundup highlights ethical issues related to clinical trials studying the psychedelics, as well as moves toward making research more efficient, innovative, and transparent.
The Trip Treatment: Author and journalist Michael Pollan reports on the reemergence of research on psychedelics. In this article from The New Yorker, Pollan shares stories of participants and their experiences in clinical trials studying the psychedelic psilocybin.
Clinical-Trial Specialist Could Be Next FDA Chief: In this article from Nature, journalist Heidi Ledford provides background on Robert Califf, who was recently [...] Read more
By Jim Gearhart, BA, Member of the Board of Directors for Quorum Review IRB
If one quote sums up the usefulness of PRIM&R’s annual Advancing Ethical Research (AER) Conference, I think it’s one I heard over the lunch table: "This is why you come to PRIM&R: to hear what’s coming up for the next year."
And I know I already used that line, in my last Blog Squad post from the 2014 AER Conference, but it came back to me again this week. Not even two months [...] Read more
by Krystal Bradford, CIP, Research Compliance Specialist at Cincinnati Children’s Hospital Medical Center
PRIM&R is pleased to introduce Krystal Bradford, CIP, 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 [...] Read more
by Avery Avrakotos, Education and Policy Manager
PRIM&R has long been committed to the protection of the rights and welfare of human subjects, and strongly believes that informed consent is an essential mechanism for providing potential subjects with the information they need to make considered, autonomous decisions about research participation.
In July, the US Food and Drug Administration (FDA) announced it [...] Read more