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41 J. Legal Med. 1 (2021)

handle is hein.journals/jlm41 and id is 1 raw text is: JOURNAL OF LEGAL MEDICINE
2021, VOL. 41, NOS. 1-2, 1-28
https://doi.org/10.1080/01947648.2021.1917464

-    Taylor & Francis
Taylor&Francis Group

The History and Policy Evolution of Waivers of
Informed Consent in Research
Austin Connor Kassels*    > and Jon F. Merzt M
ABSTRACT                                                   KEYWORDS
We examine the evolution of policies permitting exceptions to  research ethics; informed
or waivers of informed consent for research in the United  consent; Exception from
States. This review reveals that (1) exceptions to the duty to  Informed Consent; waiver
of informed consent

*Austin Kassels, MBe, is a Medical Student at Medical College of Wisconsin, 8701 W. Watertown Plank Road,
Wauwatosa, WI 53226. E-mail:  akassels@mcw.edu. He earned a bachelor of science degree in biology and
biomedical research from the University of California, Los Angeles and earned a master of bioethics degree from
the University of Pennsylvania. His research interests include bioethics, health policy, and research ethics.
tJon Merz, MBA, JD, PhD, is Associate Professor in the Department of Medical Ethics and Health Policy in the
Perelman School of Medicine at the University of Pennsylvania, Blockley Hall 1427, 423 Guardian Drive,
Philadelphia, PA 19104-4884. E-mail:  merz@pennmedicine.upenn.edu. He holds a B.S. in nuclear engineering
from Rensselaer Polytechnic Institute, an M.B.A. from the University of North Florida, a J.D. from Duquesne
University, and a Ph.D in engineering and public policy from Carnegie Mellon University. Dr. Merz's teaching and
research is focused generally on research ethics and regulation. He has current or completed Fogarty-funded
RCR training programs in Botswana, Guatemala, and Tanzania. From early 2003 through 2020, Dr. Merz was the
moderator and editor of the IRBForum (http://www.irbforum.org), a discussion forum and resource for IRB pro-
fessionals across the globe.
C 2021 American College of Legal Medicine

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