TAG ARCHIVES FOR Blog Squad

5
Apr2018

At PRIM&R’s 2017 SBER conference, I had the opportunity to sit in on the excellent didactic session, “Certificates of Confidentiality (CoCs) and National Institute of Justice (NIJ) Privacy Certificates,” given by Petrice Brown-Longenecker, PhD, CIP (Extramural Human Research Protection Officer, NIH); Elonna Ekweani, JD (Public Health Analyst, NIH); Mary Ramirez, MA, CIP (Assistant Director, Health Sciences and Behavioral Sciences IRB, University of Michigan); and Leslie E. Wolf, JD, MPH (Professor; Director, Center for Law, Health, and Society, Georgia State University College of Law). Read more

13
Feb2018

One of my favorite parts of attending PRIM&R's annual Advancing Ethical Research Conference is that it refocuses my efforts on what really matters. In the year since the last conference, I've processed countless exempt 2 determinations, requests for waivers of signed consent, and study team member modifications. I have been doing this while also contributing to new institutional policies and procedures, software requirements, and workflows in order to comply with the revised Common Rule. Some days, we all feel drowned in an ocean of regulations and rules—some days, we all get the Regulatory Robot Blues. However, the first keynote speaker at the 2017 Social, Behavioral, and Educational Research Conference reminded me of why human subjects research protection is my passion. Read more

30
Jan2018

Just before I left for San Antonio, I held an educational session with my IRB members, focusing on the revisions to the Common Rule that were likely to have the greatest impact on our processes. As an institution focused primarily on social, behavioral, and educational research (SBER), it seems likely that a large number of our currently expedited review projects will become exempt projects, especially under .104(d)(2) and .104(d)(3). Read more

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