Columbus was a wonderful locale for PRIM&R’s 2018 IACUC Conference and certainly demonstrated what the first few days of spring can look like in the Midwest! The PRIM&R Board, Planning Committee, and staff consistently manage to organize an outstanding array of keynote speakers along with amazing breakout sessions and workshops. Read more
On April 19, HHS and 16 other federal agencies released a new Notice of Proposed Rulemaking (NPRM) proposing to delay the general compliance date for the revised Federal Policy for the Protection of Human Subjects, or “Common Rule,” six more months to January 21, 2019. On June 18, HHS released a final rule confirming this delay, while allowing three "burden-reducing provisions" during the delay period. Read more
As a relative newcomer to the IRB administrator profession, one of my goals for the 2017 Advancing Ethical Resesarch Conference was to meet and develop a network of other professionals at institutions similar to my own. At my institution, I am the only full-time IRB administrator, and at times, it can feel like I am alone in the wilderness of IRB administration. While there are countless useful resources available online, there is often much more nuance and perspective to be gained by being able to bounce ideas and discuss pitfalls with a more experienced individuals Read more
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
You are the chairperson of a central IRB overseeing a large phase 3 study. Based on an anonymous call, you determine that one of the investigators is not accepting homeless people who want to enroll in the study. Read more
One of the most illuminating sessions from PRIM&R’s 2017 SBER Conference was “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). 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. She offered guidance on how to interpret the NIH definition of clinical trials by breaking down its various components. Read more
