title: Recommendations for nanomedicine human subjects research oversight: an evolutionary approach for an emerging field.
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.
authors.affiliation: University of Minnesota, MN, USA.
authors.forename: Leili
authors.initials: L
authors.lastname: Fatehi
authors.forename: Susan M
authors.initials: SM
authors.lastname: Wolf
authors.forename: Jeffrey
authors.initials: J
authors.lastname: McCullough
authors.forename: Ralph
authors.initials: R
authors.lastname: Hall
authors.forename: Frances
authors.initials: F
authors.lastname: Lawrenz
authors.forename: Jeffrey P
authors.initials: JP
authors.lastname: Kahn
authors.forename: Cortney
authors.initials: C
authors.lastname: Jones
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Campbell
authors.forename: Rebecca S
authors.initials: RS
authors.lastname: Dresser
authors.forename: Arthur G
authors.initials: AG
authors.lastname: Erdman
authors.forename: Christy L
authors.initials: CL
authors.lastname: Haynes
authors.forename: Robert A
authors.initials: RA
authors.lastname: Hoerr
authors.forename: Linda F
authors.initials: LF
authors.lastname: Hogle
authors.forename: Moira A
authors.initials: MA
authors.lastname: Keane
authors.forename: George
authors.initials: G
authors.lastname: Khushf
authors.forename: Nancy M P
authors.initials: NM
authors.lastname: King
authors.forename: Efrosini
authors.initials: E
authors.lastname: Kokkoli
authors.forename: Gary
authors.initials: G
authors.lastname: Marchant
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Maynard
authors.forename: Martin
authors.initials: M
authors.lastname: Philbert
authors.forename: Gurumurthy
authors.initials: G
authors.lastname: Ramachandran
authors.forename: Ronald A
authors.initials: RA
authors.lastname: Siegel
authors.forename: Samuel
authors.initials: S
authors.lastname: Wickline
mesh_terms: D026683:Advisory Committees; D004781:Environmental Exposure / Q000517:prevention & control*; D033161:Government Regulation; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D050997:Nanomedicine / Q000941:ethics*; D016273:Occupational Exposure / Q000517:prevention & control; D012308:Risk Management / Q000458:organization & administration*; D014481:United States