TAG ARCHIVES FOR AER17

10
Apr2018

The NIH Definition of Clinical Trial and its Implications: Part One of Two

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10 Apr
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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

6
Apr2018

The Importance of Listening

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6 Apr
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One of primary tasks of the IRB is the evaluation of the informed consent process to make sure it facilitates participant understanding of the research project. The revised Common Rule emphasizes this responsibility and includes several new provisions focused on highlighting key information meant to improve participant understanding. It is clear that there are areas for improvement in conveying information about research involvement and explaining the choice participants need to make. But, how do we know whether these efforts are truly improving understanding and how do we assess participants’ views on their experiences in research? Read more

5
Apr2018

Adapting Certificates of Confidentiality Policy Under the 21st Century Cures Act: Benefits and Challenges

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5 Apr
Comments: 1

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

The Gravity of Becoming a Regulatory Robot

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13 Feb
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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