6
Apr2020

Webinar Follow-Up: COVID-19—How HRPPs are Preparing and Responding

Tags:
6 Apr
Comments: 1

The COVID-19 pandemic is impacting human subjects research in unprecedented ways. On March 23, PRIM&R hosted a forum to provide an opportunity to hear from HRPP leaders representing universities, academic health care systems, and an independent IRB on the key issues and strategies HRPPs should be considering and implementing in the face of the COVID-19 pandemic. 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

30
Mar2020

PRIM&R Responds to NIH Strategic Plan Framework

Tags:
30 Mar
No comments

PRIM&R is generally very pleased with the breadth and aims of the framework. The framework’s third objective, which emphasizes integrity, accountability, and social responsibility in the conduct of science, demonstrates NIH’s clear commitment to the idea that good science is responsible science. Read more

23
Mar2020

AER19 Blog Squad: Is There a Bright Side to Noncompliance Investigations?

Tags:
23 Mar
No comments

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

16
Mar2020

Webinar Follow-Up: Pediatric Risk Determination – IRB Considerations and Cases

Tags:
16 Mar
No comments

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

9
Mar2020

AER19 Blog Squad: IRB and Exercise Science at Primarily SBER Institutions – The Value of Change

Tags:
9 Mar
No comments

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