TAG ARCHIVES FOR Blog Squad

6
Jan2017

Much of my AER16 schedule focused on risks in vulnerable populations. For me, an important backdrop for these topics was presented in the Plenary Session A New Framework for Human Subjects Research? An Update from NAS, moderated by Alexander Capron. The presenters, Barbara Bierer, MD, Steven Joffe, MD, MPH, and Heather Pierce, JD, MPH, did not discuss research risks or vulnerable populations, but they discussed how the current regulatory and policy framework fits with current research practices. Read more

4
Jan2017

As an IRB chair, one specific goal I had for the 2016 AER Conference was to figure out the best way to help educate my board and faculty about what is, and what is not, research. While I heard the concept of “IRB creep” regularly at the conference, our IRB is too new, and its members too inexperienced, to currently have this problem. Instead, I wanted to focus on figuring out best practices for how to inform my community on what it is we do, how we do it, and how we can help create more research opportunities at Nashua Community College (NCC). Read more

3
Jan2017

As part of my AER16 conference participation, I attended Panel III: Research With Children and Adolescents: Who and How is the Decisions Made to Participate? moderated by Susan Z. Kornetsky. The presentation examined the tension among the heightened protections of children, specifically adolescent participants, under Subpart D of 45 CFR 46, the need for research with these populations, and the desire for participant autonomy. Read more

13
Dec2016

In the AER16 session B20: Research with Children: Regulations and Beyond with presenters Francis J. DiMario, MD, MA, CIP, Jaime O. Hernandez, JD, M.Be., and Robert M. Nelson, MD, PhD, I came to understand—for possibly the first time in my career—the federal regulations as accommodating. Don’t get me wrong, Subpart B, C, and D of 45 CFR 46 scrupulously outline the additional protections IRBs must consider when conducting research with vulnerable populations. However, I now realize that the regulations were written with intentional flexibility. Read more

5
Dec2016

Educate Those Who Donate

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On the first day of AER16 in sunny, warm Anaheim, I attended the Biobanking in an Era of Research towards Precision Medicine pre-conference program. The course examined the contemporary challenges of biobanking— among them, obtaining meaningful consent, ownership of shared biospecimens and return of research results—and focused on practical strategies for addressing them. Read more

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