TY - JOUR
T1 - Recommendations for Nanomedicine Human Subjects Research Oversight
T2 - An Evolutionary Approach for an Emerging Field
AU - Fatehi, Leili
AU - Wolf, Susan M.
AU - Mccullough, Jeffrey
AU - Hall, Ralph
AU - Lawrenz, Frances
AU - Kahn, Jeffrey P.
AU - Jones, Cortney
AU - Campbell, Stephen A.
AU - Dresser, Rebecca S.
AU - Erdman, Arthur G.
AU - Haynes, Christy L.
AU - Hoerr, Robert A.
AU - Hogle, Linda F.
AU - Keane, Moira A.
AU - Khushf, George
AU - King, Nancy M P
AU - Kokkoli, Efrosini
AU - Marchant, Gary
AU - Maynard, Andrew D.
AU - Philbert, Martin
AU - Ramachandran, Gurumurthy
AU - Siegel, Ronald A.
AU - Wickline, Samuel
PY - 2012/12
Y1 - 2012/12
N2 - 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.
AB - 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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U2 - 10.1111/j.1748-720X.2012.00703.x
DO - 10.1111/j.1748-720X.2012.00703.x
M3 - Article
C2 - 23289677
AN - SCOPUS:84872146492
SN - 1073-1105
VL - 40
SP - 716
EP - 750
JO - Journal of Law, Medicine and Ethics
JF - Journal of Law, Medicine and Ethics
IS - 4
ER -
