Ethical Considerations for Research Involving Prisoners

Front Cover

In the past 30 years, the population of prisoners in the United States has expanded almost 5-fold, correctional facilities are increasingly overcrowded, and more of the country's disadvantaged populations—racial minorities, women, people with mental illness, and people with communicable diseases such as HIV/AIDS, hepatitis C, and tuberculosis—are under correctional supervision.

Because prisoners face restrictions on liberty and autonomy, have limited privacy, and often receive inadequate health care, they require specific protections when involved in research, particularly in today's correctional settings. Given these issues, the Department of Health and Human Services' Office for Human Research Protections commissioned the Institute of Medicine to review the ethical considerations regarding research involving prisoners.

The resulting analysis contained in this book, Ethical Considerations for Research Involving Prisoners, emphasizes five broad actions to provide prisoners involved in research with critically important protections:

• expand the definition of "prisoner";

• ensure universally and consistently applied standards of protection;

• shift from a category-based to a risk-benefit approach to research review;

• update the ethical framework to include collaborative responsibility; and

• enhance systematic oversight of research involving prisoners.

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Contents

Summary
1
1 Introduction
21
Changing Demographics Health Issues and the Current Research Environment
29
3 Federal Regulatory Landscape
73
4 Defining Prisoners and Correctional Settings
101
5 The Ethical Framework for Research Involving Prisoners
113
6 Systems of Oversight Safeguards and Protections
137
Appendixes
175
B The National Commissions Deliberations and Findings
191
C Report of the SACHRP Subcommittee and Human Subjects Protections
199
Public Welfare Part 46 Protection of Human Subjects
205
E Committee Expert Advisor Liaison Panel and Staff Biographies
239
Index
253
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