TAG ARCHIVES FOR single IRB

2
Dec2015

On September 8, the Department of Health and Human Services (DHHS) issued a Notice of Proposed Rulemaking (NPRM) for revisions to the Federal Policy for the Protection of Human Subjects, or "Common Rule." If adopted, the proposals in the NPRM will result in the most substantive revisions to the core regulation governing federally funded human subjects research in the United States since 1981.

In earlier posts, we explored a new category of activities that would be excluded from oversight under the Common Rule and proposed changes to the category of Read more

14
Nov2015

I attended Thursday’s Single IRB AER15 Pre-Conference program and found it educational, thought-provoking, and beneficial. While my institution (Cincinnati Children’s Hospital) has been steadily expanding into the realm of single IRBs, in my role as an educator, I’ve only recently become involved.  That’s why I chose this topic.

Let’s jump in with some terminology….

So what is a single IRB as compared to a central IRB? I’ve been calling all studies involving reliance on multiple IRBs central IRBs, so learning that I had it wrong was my first surprise. Proper terminology is key. The difference is that networks and/or consortia [...] Read more