TAG ARCHIVES FOR FDA

27
Feb2015

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

6
Feb2015

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

16
Sep2014

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

9
Sep2014

 

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The United States Food and Drug Administration (FDA) recently released a draft guidance, Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors, for public comment.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 Throughout the new draft guidance, the FDA emphasizes that informed consent involves more than a form, and encourages investigators, IRBs, [...]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

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