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. 2012 Winter;40(4):716-50.
doi: 10.1111/j.1748-720X.2012.00703.x.

Recommendations for nanomedicine human subjects research oversight: an evolutionary approach for an emerging field

Leili Fatehi  1 , Susan M Wolf, Jeffrey McCullough, Ralph Hall, Frances Lawrenz, Jeffrey P Kahn, Cortney Jones, Stephen A Campbell, Rebecca S Dresser, Arthur G Erdman, Christy L Haynes, Robert A Hoerr, Linda F Hogle, Moira A Keane, George Khushf, Nancy M P King, Efrosini Kokkoli, Gary Marchant, Andrew D Maynard, Martin Philbert, Gurumurthy Ramachandran, Ronald A Siegel, Samuel Wickline
Affiliations

Recommendations for nanomedicine human subjects research oversight: an evolutionary approach for an emerging field

Leili Fatehi et al. J Law Med Ethics. 2012 Winter.

Abstract

The nanomedicine field is fast evolving toward complex, "active," and interactive formulations. Like many emerging technologies, nanomedicine raises questions of how human subjects research (HSR) should be conducted and the adequacy of current oversight, as well as how to integrate concerns over occupational, bystander, and environmental exposures. The history of oversight for HSR investigating emerging technologies is a patchwork quilt without systematic justification of when ordinary oversight for HSR is enough versus when added oversight is warranted. Nanomedicine HSR provides an occasion to think systematically about appropriate oversight, especially early in the evolution of a technology, when hazard and risk information may remain incomplete. This paper presents the consensus recommendations of a multidisciplinary, NIH-funded project group, to ensure a science-based and ethically informed approach to HSR issues in nanomedicine, and to integrate HSR analysis with analysis of occupational, bystander, and environmental concerns. We recommend creating two bodies, an interagency Human Subjects Research in Nanomedicine (HSR/N) Working Group and a Secretary's Advisory Committee on Nanomedicine (SAC/N). HSR/N and SAC/N should perform 3 primary functions: (1) analysis of the attributes and subsets of nanomedicine interventions that raise HSR challenges and current gaps in oversight; (2) providing advice to relevant agencies and institutional bodies on the HSR issues, as well as federal and federal-institutional coordination; and (3) gathering and analyzing information on HSR issues as they emerge in nanomedicine. HSR/N and SAC/N will create a home for HSR analysis and coordination in DHHS (the key agency for relevant HSR oversight), optimize federal and institutional approaches, and allow HSR review to evolve with greater knowledge about nanomedicine interventions and greater clarity about attributes of concern.

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Figures

Figure 1
Figure 1
Baseline System of Federal and Institutional Oversight of Human Subjects Research
Figure 2
Figure 2. Inventory of Major Proposed Approaches to Oversight of Nanomedicine Human Subjects Research, 2007-11 (adapted from Wolf and Jones, 2011)
Figure 2
Figure 2. Inventory of Major Proposed Approaches to Oversight of Nanomedicine Human Subjects Research, 2007-11 (adapted from Wolf and Jones, 2011)
Figure 2
Figure 2. Inventory of Major Proposed Approaches to Oversight of Nanomedicine Human Subjects Research, 2007-11 (adapted from Wolf and Jones, 2011)
Figure 3
Figure 3. FDA, NIH, EPA, OSHA, and NIOSH Definitions of “Nanotechnology”
Figure 3
Figure 3. FDA, NIH, EPA, OSHA, and NIOSH Definitions of “Nanotechnology”
Figure 3
Figure 3. FDA, NIH, EPA, OSHA, and NIOSH Definitions of “Nanotechnology”
Figure 4
Figure 4
Baseline and Exception Oversight for the Example of Human Gene Transfer Research
Figure 5
Figure 5. Categories of Human Subjects Research that Are Subject to Added Oversight (from Wolf and Jones, 2011)
Figure 6
Figure 6
Recommended Baseline and Exceptional Oversight for Nanomedicine
Figure 7
Figure 7
Organizational Chart for the HSR/N Working Group and SAC/N
Figure 8
Figure 8
Functions of the HSR/N Working Group and SAC/N
Figure 9
Figure 9. Outline of Proposed Points-to-Consider in the Design and Submission of Protocols for Research on Nanotherapeutics and In Vivo Nanodiagnostics in Human Participants
Figure 9
Figure 9. Outline of Proposed Points-to-Consider in the Design and Submission of Protocols for Research on Nanotherapeutics and In Vivo Nanodiagnostics in Human Participants
Figure 9
Figure 9. Outline of Proposed Points-to-Consider in the Design and Submission of Protocols for Research on Nanotherapeutics and In Vivo Nanodiagnostics in Human Participants
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