TAG ARCHIVES FOR Single IRBs

30
Oct2018

I am thrilled to attend my second PRIM&R Advancing Ethical Research Conference (AER18) and to share my experiences as a Blog Squad member! With so many recent and forthcoming regulatory changes—the revised Common Rule, NIH single IRB of record mandate, and the EU General Data Protection Regulation (GDPR), just to name a few—this is an exciting time for the human research projections community, and I am delighted to explore these topics with you! Read more

17
Apr2018

This post draws on information I learned from two presentations. The first, “SBER in the Era of the Revised Common Rule: An Overview of the Most Relevant Regulatory Changes” by Yvonne Lau, MBBS, MBHL, PhD (Director, Division of Education and Development, Office for Human Research Protections), was given at PRIM&R’s 2017 AER conference. The second, “Clinical Trials in the SBER Context” by Melissa W. Riddle, PhD (Chief, Behavioral and Social Sciences Research Branch, National Institute of Dental and Craniofacial Research) and Cindy S. Shindledecker, CIP (Director, Health Sciences and Behavioral Sciences Institutional Review Board, University of Michigan), was given at PRIM&R’s 2017 SBER conference. (Dr. Riddle was absent, but her colleague Wendy Webber, ND, PhD, MPH (Acting Deputy Director, National Center for Complementary and Integrative Health) was able to do an impromptu presentation on behalf of NIH.) Read more

11
Aug2017

PRIM&R invites members of our conference Blog Squads to reflect on the conference they attended in an additional post six months after the event. In this post, AER16 Blog Squad member Seth Hall reflects on how he's applied what he learned at AER16 to his day-to-day work. Read more

22
Jun2017

In January 2018, the new single IRB (sIRB) requirement for National Institutes of Health (NIH)-funded multi-site studies will go into effect. NIH’s goal for this mandate is to reduce administrative burden that does not actively contribute to protection of human subjects. The NIH posits that this policy will also result in opportunities for enhanced oversight by the reviewing IRB. Read more

2
May2017

Because of the intensity of my institution’s human research program, I always have to strike a balance, upon returning from a PRIM&R Advancing Ethical Research conference, between wanting to immediately focus on incorporating what I’ve learned—policy revisions, procedural changes, and staff/member training ideas—and having to jump instead into the usual fray of trying to keep up with “normal” responsibilities. As with so many things in life, compromise and balance come into play. Read more