ACRONYMS |
|
xvi | |
SUMMARY |
|
1 | |
1 INTRODUCTION |
|
21 | |
|
|
22 | |
|
Committee's Task and Approach, |
|
|
24 | |
|
|
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 | |
|
|
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 | |
|
|
76 | |
|
Subpart C: Prisoners as Research Subjects, |
|
|
79 | |
|
Report of the SACHRP Subcommittee, |
|
|
81 | |
|
Other Federal Human Subjects Protections, |
|
|
84 | |
|
|
85 | |
|
Other DHHS Agencies: FDA Regulations, |
|
|
86 | |
|
|
89 | |
|
|
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 | |
|
|
105 | |
|
|
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 | |
|
|
114 | |
|
Justice and Respect for Persons, |
|
|
115 | |
|
An Updated Ethical Framework, |
|
|
116 | |
|
|
117 | |
|
|
127 | |
6 SYSTEMS OF OVERSIGHT, SAFEGUARDS, AND PROTECTIONS |
|
137 | |
|
|
137 | |
|
Defining and Reviewing Prisoner Research, |
|
|
138 | |
|
|
139 | |
|
|
141 | |
|
How Reviews Are Conducted, |
|
|
143 | |
|
|
150 | |
|
Systematic Oversight of Research with Prisoners, |
|
|
151 | |
|
Prison Research Subject Advocate, |
|
|
153 | |
|
IRB Postapproval Monitoring, |
|
|
156 | |
|
|
157 | |
|
Applying Safeguards for Particular Kinds of Research, |
|
|
160 | |
|
|
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 | |