How does your organization view noncompliance investigations? Are they seen as an opportunity for learning and growth? If we are honest, many of us would not volunteer to learn or grow our HRPPs through a noncompliance investigation. We want to get through it and hope it does not occur again. That is wishful thinking and is not the wisest approach to addressing and mitigating noncompliance. The AER19 session, “How to Investigate, Mitigate, Report and Learn from Noncompliance—Avoiding Pitfalls and Seizing Opportunities for Improvement” inspired me to believe that there can be a bright side through the process of noncompliance investigations. Read more
Pediatric subjects participating in HHS-funded or FDA-regulated studies are afforded additional protections not codified in subpart A of the Federal Policy for the Protection of Human Subjects (the Common Rule). On September 18, 2019, PRIM&R hosted a webinar, Pediatric Risk Determination: IRB Considerations and Cases. Presented by Rich Gormon, MD, and Donna L. Snyder, MD, this webinar helped attendees understand pediatric subpart D regulations, identify criteria for pediatric approvable research, and evaluate if the interventions or procedures in a protocol hold the prospect of direct benefit.
After the webinar, the speakers responded to attendee questions time didn’t permit us to address live. We’re pleased to share those responses with the readers of Ampersand. Read more
COVID-19 presents enormous challenges to research ethics oversight. Here, we’ve begun a collection of oversight-related resources in order to best prepare our community for the operational and review concerns brought on by the viral outbreak. Read more
I was eager to attend the session "Reviewing Exercise Science Research at Primarily SBER Institutions" (speakers: Summer B. Cook, PhD; Michael Leary, PhD CIP; Meghan Felicia Pronovost, MS) during the 2019 Social, Behavioral, and Educational Research Conference (SBER19) specifically because of some of the research occurring at my institution. I was curious how our process stacked up with other institutions, and I had hopes of providing tips to improve research methods for our investigators/student researchers as well as the review and critical thinking practices of the IRB committee. I noticed a plethora of similarities and opportunities for advancement, as expected. As the session continued, I began to wonder how we as administrators balance the specificity of our application and approval process with the variation of protocols we review in our limited capacities. I thought to myself: what would it take to integrate a change in practice based on new education from SBER19? What is the added value of the change? How does it compare with the amount of work it would take to devise and implement the change? Read more
PRIM&R endorses the OSTP efforts to improve the consistency of guidelines for best practices in long-term storage of data from federally funded research. We especially appreciate the current step of developing a proposed, common set of desirable characteristics of data repositories, because this kind of forward thinking has the potential to improves standards for both government and non-governmental data repositories alike. Read more
More than 100 research trials are reported to be underway on coronavirus already. It remains essential to lean on prior conversations and learning to put us in a position to conduct the best, most ethical research we can in a time of crisis. Read more