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Responsible Conduct of Research$
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Adil E Shamoo and David B Resnik

Print publication date: 2009

Print ISBN-13: 9780195368246

Published to Oxford Scholarship Online: May 2009

DOI: 10.1093/acprof:oso/9780195368246.001.0001

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Protecting Vulnerable Human Subjects in Research

Protecting Vulnerable Human Subjects in Research

Chapter:
(p.265) 13 Protecting Vulnerable Human Subjects in Research
Source:
Responsible Conduct of Research
Author(s):

Adil E. Shamoo

David B. Resnik (Contributor Webpage)

Publisher:
Oxford University Press
DOI:10.1093/acprof:oso/9780195368246.003.0013

This chapter discusses ethical issues and policies relating to the protection of vulnerable subjects in research. It reviews the history of human experimentation with vulnerable human subjects such as people with impaired decision-making capacities, children, fetuses, and subordinate populations (i.e., prisoners, students, employees, and soldiers). It discusses the definition of vulnerability as well as the criteria for decision-making capacity. The chapter also examines the federal regulations and the special safeguards, or lack thereof, currently available to protect vulnerable populations, and it discusses different types of research with children and examines the concept of minimal risk.

Keywords:   vulnerable research subjects, human experimentation history, impaired decision-making capacities, children, prisoners, students, employees, decision-making capacity criteria

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