TAG ARCHIVES FOR single IRB

15
Feb2017

On January 28, 2017, PRIM&R hosted PRIM&R’s Primer on the Revised Common Rule, a webinar to introduce the human subjects research community to the changes present in the revised Federal Policy for the Protection of Human Subjects. Published on January 19, the revised policy, or “Common Rule,” represents the first significant regulatory changes in human research oversight since 1991. Presented by P. Pearl O’Rourke, MD, and Heather Pierce, JD, MPH, this webinar provided an overview of the noteworthy changes from the current rule, as well as a discussion of various possible fates of the revised Common Rule under the new presidential administration. Read more

25
Jan2017

I’m intrigued, on multiple levels, by the ethical, regulatory, and operational challenges of The Precision Medicine Initiative® (PMI) Cohort Program, now called the All of UsSM Research Program. This program—should it move forward—will be the largest health and medical research program on precision medicine in US history, and proposes to enroll one million or more volunteers in the next few years.

The PMI was introduced to the American public by former President Obama in his 2015 State of the Union address. It was summarized on the White House PMI website1 at the time as “a bold [...] Read more

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