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Human Subjects Research RegulationPerspectives on the Future$
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I. Glenn Cohen and Holly Fernandez Lynch

Print publication date: 2014

Print ISBN-13: 9780262027465

Published to MIT Press Scholarship Online: January 2015

DOI: 10.7551/mitpress/9780262027465.001.0001

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PRINTED FROM MIT PRESS SCHOLARSHIP ONLINE (www.mitpress.universitypressscholarship.com). (c) Copyright The MIT Press, 2022. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in MITSO for personal use.date: 26 May 2022

Classifying Military Personnel as a Vulnerable Population

Classifying Military Personnel as a Vulnerable Population

(p.65) 4 Classifying Military Personnel as a Vulnerable Population
Human Subjects Research Regulation

Efthimios Parasidis

The MIT Press

The U.S. military has a long and checkered history of research involving human subjects. Although federal guidelines and military directives provide service members with procedural safeguards, the protections are diluted by military hierarchy and culture, military-specific regulatory exceptions (such as informed consent waivers and “field-test” exceptions), and legal doctrines (including sovereign immunity and the state secrets privilege). While federal regulations governing human subjects research identify certain categories of individuals as vulnerable populations and afford these sub-populations with additional protections, federal guidelines do not classify military personnel as a vulnerable population. This chapter argues that regulations governing human subjects research should identify military personnel as a vulnerable population. Such a classification not only would acknowledge that service members are a class of individuals that is subject to coercion or undue influence, it would require that regulators enact guidelines that provide service members with additional safeguards. When one considers the military’s current and emerging focus on biomedical enhancements, affording service members with additional safeguards is necessary to ensure the harmonization of national security interests, patient autonomy, and research ethics.

Keywords:   Human subjects research, Common Rule, Informed consent, Vulnerable populations, Service members, Military medical ethics, Human enhancements, Feres Doctrine, Research ethics

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