Designing Oversight for Nanomedicine Research in Human Subjects: Systematic Analysis of Exceptional Oversight for Emerging Technologies

Journal of Nanoparticle Research, Vol.13, pp. 1449-1465, 2011

32 Pages Posted: 23 Jan 2011 Last revised: 28 Jul 2013

Susan M. Wolf

University of Minnesota Law School

Cortney M. Jones, JD

University of Minnesota - Twin Cities - School of Law

Date Written: 2011

Abstract

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.

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

Suggested Citation

Wolf, Susan M. and Jones, JD, Cortney M., Designing Oversight for Nanomedicine Research in Human Subjects: Systematic Analysis of Exceptional Oversight for Emerging Technologies (2011). Journal of Nanoparticle Research, Vol.13, pp. 1449-1465, 2011. Available at SSRN: https://ssrn.com/abstract=1744336

Susan M. Wolf (Contact Author)

University of Minnesota Law School ( email )

229 19th Avenue South
Minneapolis, MN 55455
United States
612-625-3406 (Phone)
612-624-9143 (Fax)

HOME PAGE: http://www.law.umn.edu/facultyprofiles/wolfs.html

Cortney M. Jones, JD

University of Minnesota - Twin Cities - School of Law ( email )

229 19th Avenue South
Minneapolis, MN 55455
United States

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