I could never have guessed just how large and life changing a venture creating a two-way, system-wide IRB infrastructure would be when I received exactly that project in late 2010. Now, as we approach the single IRB mandate, I wanted to share a little bit about the efforts that I was fortunate to lead and participate in for the benefit of all the organizations not only contemplating this step, but being required to implement it at this juncture. I can only hope this brief effort to capitulate our successes and failures will lead you and your organization to even grander aspirations and achievements than my own. Read more
TAG ARCHIVES FOR single IRB
For those of us in human research protections, the Common Rule changes were the most hotly anticipated item of 2016. The unveiling of the final changes on January 19, 2017 has been, for so many of us, a source of confusion, consternation, stress, and in some cases, relief. Read more
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
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
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.