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.
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Acknowledgments Preparation of this article was supported in part by National Science Foundation (NSF) grant #SES-0608791 on ‘‘NIRT: Evaluating Oversight Models for Active Nanostructures and Nanosystems: Learning from Past Technologies in a Societal Context’’ (Susan M. Wolf, PI; Efrosini Kokkoli, Jennifer Kuzma, Jordan Paradise, Gurumurthy Ramachandran, Co-PIs) and by National Institutes of Health (NIH), National Human Genome Research Institute (NHGRI) grant #1RC-1HG005338-01 on ‘‘Nanodiagnostics and Nanotherapeutics: Building Research Ethics and Oversight’’ (Susan M. Wolf, PI; Ralph Hall, Jeffrey Kahn, Jeffrey McCullough, Co-Is). All views expressed in this article are those of the authors and not necessarily the views of NSF, NIH, or NHGRI. Thanks for helpful discussion to members of the NIH-funded project who participated in discussion of exceptional oversight, including Linda Hogle, Jeff Kahn, George Khushf, Nancy King, Gary Marchant, and Andrea Mosher. Thanks also to Moira Keane for helpful comments.
- Exceptional oversight
- Human subjects research
- Research oversight