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El. knyga: Ethical Considerations for Research Involving Prisoners

  • Formatas: 284 pages
  • Išleidimo metai: 22-Jan-2007
  • Leidėjas: National Academies Press
  • Kalba: eng
  • ISBN-13: 9780309657600
Kitos knygos pagal šią temą:
  • Formatas: 284 pages
  • Išleidimo metai: 22-Jan-2007
  • Leidėjas: National Academies Press
  • Kalba: eng
  • ISBN-13: 9780309657600
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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.
ACRONYMS xvi
SUMMARY 1
1 INTRODUCTION 21
Why Now?,
22
Committee's Task and Approach,
24
Methods and Approach,
26
Organization of This Report,
27
2 TODAY'S PRISONERS: CHANGING DEMOGRAPHICS, HEALTH ISSUES, AND THE CURRENT RESEARCH ENVIRONMENT 29
Changing Demographics and Health Issues,
30
Descriptions of Prisons, Jails, and Other Correctional Settings,
30
The Prisoner Population,
31
Summary of Findings on Changing Demographics and Health Issues,
58
Current Research Environment,
59
Current Status of Prisoner Research,
59
Results from the Surveys with Key DOC Personnel,
59
Published Literature: A Review of Selected Prisoner Studies,
61
Data Retrieval Needs Improving,
64
Summary of Findings on Current Research Environment,
66
3 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,
84
Subpart D,
85
Other DHHS Agencies: FDA Regulations,
86
DOJ Regulations,
89
Analysis,
94
Existing Authority for Broader Regulation,
95
Can the DHHS Be Guaranteed Broader Authority?,
96
Alternatives to Comprehensive Regulation,
99
4 DEFINING PRISONERS AND CORRECTIONAL SETTINGS 101
Ethical Foundations of Current Research Regulations,
101
Current Regulations Pertinent to Places of Prisoner Research,
102
Correctional Settings Encompass More than Prisons and Jails,
103
Definition of Prisoner,
105
Delineation of Settings,
109
When Proposed Regulations Should Apply,
109
When Proposed Regulations Should Not Apply,
110
When Liberty Status Changes,
110
5 THE ETHICAL FRAMEWORK FOR RESEARCH INVOLVING PRISONERS 113
The 1976 Commission's Ethical Framework,
114
Historical Context,
114
Justice and Respect for Persons,
115
An Updated Ethical Framework,
116
Respect for Persons,
117
Justice,
127
6 SYSTEMS OF OVERSIGHT, SAFEGUARDS, AND PROTECTIONS 137
Overarching Principle,
137
Defining and Reviewing Prisoner Research,
138
What Is Reviewed,
139
Who Reviews,
141
How Reviews Are Conducted,
143
When Reviews Are Done,
150
Systematic Oversight of Research with Prisoners,
151
Prison Research Subject Advocate,
153
IRB Postapproval Monitoring,
156
National Oversight,
157
Applying Safeguards for Particular Kinds of Research,
160
Sample Situations,
162
Other Categories and Types of Research Involving Prisoners Prohibited,
170
Impact of Committee Recommendations on Stakeholder Responsibilities,
170
APPENDIXES
A Data Sources and Methods
175
B The National Commission's Deliberations and Findings
191
C Report of the SACHRP Subcommittee and Human Subjects Protections
199
D Code of Federal Regulations Title 45: Public Welfare, Part 46: Protection of Human Subjects
205
E Committee, Expert Advisor, Liaison Panel, and Staff Biographies
239
INDEX 253
Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research