IRBs consistently struggle with identifying and retaining skilled, motivated members. How do you navigate the challenges of maintaining a knowledgeable and committed IRB? Read more
TAG ARCHIVES FOR IRB administration
PRIM&R submitted comments to the Department of Health and Human Services’ (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) in response to their jointly released draft guidance on meeting minutes for institutional review boards (IRBs) who oversee human subjects research under the FDA and/or DHHS regulations. Read more
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(DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) jointly released draft guidance for institutional review boards (IRBs) who oversee human subjects research under the FDA and/or DHHS regulations.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
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