In November 2015, the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) jointly released draft guidance for institutional review boards (IRBs) who oversee human subjects research under the FDA and/or DHHS regulations. This is the first time the agencies have jointly issued specific guidance on IRB meeting minutes. Read more
TAG ARCHIVES FOR IRB administration
The research world, and inevitably PRIM&R’s 2015 Advancing Ethical Research Conference (AER15), is abuzz with the proposed changes to the common rule. As most people are wondering what exactly these potential changes could mean for their research organizations, the question becomes "Are we ready?"
There is much to be said about single IRB review, but as P. Pearl O'Rourke, MD, pointed out during the pre-conference presentation "Single IRBs Are Here: Are You Ready?", up to this point it has been voluntary to participate in a reliance agreement with another institution or organization. What the new rule will force is a relationship that many institutions lack the infrastructure [...] Read more
by Maeve Luthin, Professional Development Manager
by Michael (Mike) Kraten, PhD, CPA, IRB Chair at Providence College
PRIM&R is pleased to share a post from Mike Kraten, 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 [...] Read more