Ethical Considerations for Research Involving PrisonersCommittee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research, Board on Health Sciences Policy, Institute of Medicine National Academies Press, 22. jan. 2007 - 20 sider 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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... prisons has engendered deep distrust among prisoners and their advocates. It ... prisons today. Prisoners are particularly vulnerable to exploitation not only ... federal regulation is ethically sound and has achieved an appropriate ...
... federal rules cover only a small fraction of the research being undertaken in prisons. This is because the regulations (45 C.F.R. Part 46) do not cover human subject research unless it is funded by a few federal agencies, or the ...
... FEDERAL REGULATORY LANDSCAPE 73 Adoption of DHHS Human Subjects Protection Regulations, 74 The Common Rule, 76 Subpart C: Prisoners as Research Subjects, 79 Report of the SACHRP Subcommittee, 81 Other Federal Human Subjects Protections ...
... Federal Regulations Title 45: Public Welfare, Part 46: Protection of Human Subjects E Committee, Expert Advisor, Liaison Panel, and Staff Biographies INDEX 175 191 199 205 239 253 AE AIDS BJS BOP BRRB CDC CDCR CIA CMF CQI CONTENTS xv.
... Corrections Department of Justice Department of Health, Education, and Welfare Federal Bureau of Prisons Food and Drug Administration federal-wide assurance GAO GED HIV HIPAA HRPPP IRB IOM JPI LRRB National xvi Acronyms.
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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 |