TAG ARCHIVES FOR vulnerable populations

1
Mar2017

It’s hard to grasp how little you know. Having worked as an IRB administrator at a research hospital for a little over a year, I think I’ve come far in understanding ethical review of medical research. The learning curve is steep, but my study of the regulations and supporting materials, as well as help from the professionals I work with, provided me with a base of knowledge about ethical research. I applied what I learned in my day-to-day work, and when unique events arose, I went back to source material or relied on my colleagues to find to a solution. Read more

18
Jan2017

Just before entering the Arena to participate in Panel VI: Re-Framing Informed Consent: Respecting Participants When Barriers to Regulatory Consent Exist moderated by Christine Grady, RN, PhD, and panelists Michelle H. Biros, MD; Neal Dickert Jr., MD, PhD; and Robert Silbergleit, MD, I recalled the three questions that I formulated upon registering for the AER16 conference. Read more

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

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

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