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


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


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


I actually struggled quite a bit with which pre-conference session to attend— as a new chair, and new to the IRB process, I have a lot to learn. My mentor suggested the IRB Chairs Boot Camp: Tools for Successful IRB Leadership. I’m still processing most of the things I learned (the agenda outlines the topics covered), but throughout the day, I was repeatedly reminded of the importance of educating all those involved in the research review process. Read more


Approaching the world of social, behavioral and educational research (SBER) can be particularly challenging for those whose domestic regulatory framework does not provide a context for this type of research. Having the opportunity to participate in the AER16 Pre-Conference Program, Critical Topics in Social, Behavioral, and Educational Research, was a great help in meeting these challenges. Read more