Designing Oversight for Nanomedicine Research in Human Subjects: Systematic Analysis of Exceptional Oversight for Emerging Technologies
Susan M. Wolf
University of Minnesota Law School
Cortney M. Jones, JD
University of Minnesota - Twin Cities - School of Law
Journal of Nanoparticle Research, Vol.13, pp. 1449-1465, 2011
The basic procedures and rules for oversight of U.S. human subjects research have been in place since 1981. Certain types of human subjects research, however, have provoked creation of additional mechanisms and rules beyond the Department of Health & Human Services (DHHS) Common Rule and Food and Drug Administration (FDA) equivalent. Now another emerging domain of human subjects research - nanomedicine - is prompting calls for extra oversight. However, in 30 years of overseeing research on human beings, we have yet to specify what makes a domain of scientific research warrant extra oversight. This failure to systematically evaluate the need for extra measures, the type of extra measures appropriate for different challenges, and the usefulness of those measures hampers efforts to respond appropriately to emerging science such as nanomedicine.
This article evaluates the history of extra oversight, extracting lessons for oversight of nanomedicine research in human beings. We argue that a confluence of factors supports the need for extra oversight, including heightened uncertainty regarding risks, fast-evolving science yielding complex and increasingly active materials, likelihood of research on vulnerable participants including cancer patients, and potential risks to others beyond the research participant. We suggest the essential elements of the extra oversight needed.
Number of Pages in PDF File: 32
Keywords: Human Subjects Research, Human Subjects Research Regulations, Research Oversight, Exceptional Oversight, IRBs, DSMBs, IBCs, Common Rule, DHHS, FDA, NIH, Science Oversight, Health Law, Bioethics, Research Ethics, Nanotechnology, Nanomedicine
Date posted: January 23, 2011 ; Last revised: July 28, 2013