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
TAG ARCHIVES FOR vulnerable populations
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
On July 10, 2015, the US House of Representatives passed H.R. 6, the 21st Century Cures Act, with a vote of 344-77. The passage of the bill, which many have hailed as a noteworthy example of bipartisan collaboration, is the result of more than a year of congressional hearings, roundtable discussions, whitepapers, and political debate. First introduced in April 2014 by Fred Upton (R-MI), chairman of the US House of Representatives’ Energy and Commerce Committee, and Representative Diana DeGette (D-CO), the 21st Century Cures initiative seeks to "accelerate the pace of cures in America."
The legislative phase of the 21st [...] Read more
Earlier this year, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) released the second part of its report on neuroscience and ethics—Gray Matters: Topics at the Intersection of Neuroscience, Ethics, and Society (Gray Matters, Vol. 2). The report examines in depth several controversial topics that bring ethical issues to the fore, including cognitive enhancement, neuroscience and the law, and the ethical conduct of research with participants with impaired capacity for informed consent. Read more