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Recommendations for Nanomedicine Human Subjects Research Oversight: An Evolutionary Approach for an Emerging Field

Published online by Cambridge University Press:  01 January 2021

Leili Fatehi ,
Susan M. Wolf ,
Jeffrey McCullough ,
Ralph Hall ,
Frances Lawrenz ,
Jeffrey P. Kahn ,
Cortney Jones ,
Stephen A. Campbell ,
Rebecca S. Dresser  and
Arthur G. Erdman
...Show all authors
Frances Lawrenz
Affiliation:
University of Minnesota
Jeffrey P. Kahn
Affiliation:
Johns Hopkins University
Cortney Jones
Affiliation:
University of Minnesota
Stephen A. Campbell
Affiliation:
University of Minnesota
Rebecca S. Dresser
Affiliation:
Washington University in St. Louis
Arthur G. Erdman
Affiliation:
University of Minnesota
Christy L. Haynes
Affiliation:
University of Minnesota
Robert A. Hoerr
Affiliation:
Nanocopoeia, Inc.
Linda F. Hogle
Affiliation:
University of Wisconsin, Madison
Moira A. Keane
Affiliation:
University of Minnesota
George Khushf
Affiliation:
University of South Carolina
Nancy M. P. King
Affiliation:
Wake Forest School of Medicine
Efrosini Kokkoli
Affiliation:
University of Minnesota
Gary Marchant
Affiliation:
Arizona State University
Andrew D. Maynard
Affiliation:
University of Michigan
Martin Philbert
Affiliation:
University of Michigan
Gurumurthy Ramachandran
Affiliation:
University of Minnesota
Ronald A. Siegel
Affiliation:
University of Minnesota
Samuel Wickline
Affiliation:
Washington University in St. Louis
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Extract

Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions (often defined as 1-100 nm, but sometimes defined to include dimensions up to 1000 nm, as discussed further below) where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products (biologics), implantable medical devices, and combination products that are designed to function in the body in ways unachievable at larger scales. Nanotherapeutics and in vivo nanodiagnostics incorporate materials that are engineered at the nanoscale to express novel properties that are medicinally useful. These nanomedicine applications can also contain nanomaterials that are biologically active, producing interactions that depend on biological triggers. Examples include nanoscale formulations of insoluble drugs to improve bioavailability and pharmacokinetics, drugs encapsulated in hollow nanoparticles with the ability to target and cross cellular and tissue membranes (including the bloodbrain barrier) and to release their payload at a specific time or location, imaging agents that demonstrate novel optical properties to aid in locating micrometastases, and antimicrobial and drug-eluting components or coatings of implantable medical devices such as stents.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 40 , Issue 4 , Winter 2012 , pp. 716 - 750
Copyright
Copyright © American Society of Law, Medicine and Ethics 2012

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Footnotes

*

Institutions listed for identification only.

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