At the 2017 AER conference, I caught the plenary session, “New Frontiers: The Changing Landscape of Research Regulations.” One of the presenters, John R. Baumann, PhD, the Associate Vice President for Research Compliance at Indiana University, shared with us how his institution was approaching the upcoming changes to the Common Rule, including the elimination of continuing review. Read more
“Well, it depends” is something I think we’ve all said to a student or faculty researcher when they ask when a project requires IRB review. These gray areas get especially complicated when it comes to program improvement projects and ethnographic research. Furthermore, I think a lot of researchers submit to the IRB as insurance or just out of habit. It is important to remember, however, that not all activities that researchers may be involved in–even if they are employing research skills–are research. Read more
Like many others, I attended the 2017 Advancing Ethical Research Conference eager to hear presentations from the experts, but also looking forward to hearing from other attendees about their interpretations of the revisions to the Common Rule. I went in with a list of questions a mile long. 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
