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.
Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research
1 Front Matter; 2 Summary; 3 1 Introduction; 4 2 Today's Prisoners: Changing Demographics, Health Issues, and the Current Research Environment; 5 3 Federal Regulatory Landscape; 6 4 Defining Prisoners and Correctional Settings; 7 5 The Ethical Framework for Research Involving Prisoners; 8 6 Systems of Oversight, Safeguards, and Protections; 9 A Data Sources and Methods; 10 B The National Commission's Deliberations and Findings; 11 C Report of the SACHRP Subcommittee and Human Subjects Protections; 12 D Code of Federal Regulations Title 45: Public Welfare Part 46: Protection of Human Subjects; 13 E Committee, Expert Advisor, Liaison Panel, and Staff Biographies; 14 Index
National Research Council, Division of Behavioral and Social Sciences and Education, Institute of Medicine, and Families Board on Children, Youth, Steve Olson
Institute of Medicine, Board on the Health of Select Populations, and Transgender Health Issues and Research Gaps and Opportunities Committee on Lesbian, Gay, Bisexual
Institute of Medicine, Board on Population Health and Public Health Practice, Division of Health Promotion and Disease Prevention, Division of International Health
Institute of Medicine, Committee to Develop Methods Useful to the Department of Veteran Affairs in Estimating Its Physician Requirements, Joseph Lipscomb
Institute of Medicine, Board on Health Sciences Policy, and Medical Devices Roundtable on Research and Development of Drugs, Biologics, Andrew Pope, Peter Bouxsein, Frederick J. Manning, Kathi E. Hanna
Institute of Medicine, Board on Health Sciences Policy, and Translation Forum on Drug Discovery, Development, Andrea Knutsen, Adrienne Stith Butler, Cori Vanchieri
Institute of Medicine, Board on Health Sciences Policy, Committee on Guidance for Establishing Standards of Care for Use in Disaster Situations, Lawrence O. Gostin, Dan Hanfling, Sarah L. Hanson, Clare Stroud, Bruce M. Altevogt
Institute of Medicine, Board on Health Sciences Policy, Committee on Guidance for Establishing Standards of Care for Use in Disaster Situations, Lawrence O. Gostin, Kristin Viswanathan, Bruce M. Altevogt, Dan Hanfling
Institute of Medicine, Board on Health Care Services, Board on Health Sciences Policy, Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule, Lawrence O. Gostin, Laura A. Levit, Sharyl J. Nass
Institute of Medicine, Board on Health Sciences Policy, Committee on the Independent Review and Assessment of the Activities of the NIH Recombinant DNA Advisory Committee, Lawrence O. Gostin, Bruce M. Altevogt, Rebecca N. Lenzi
and Medicine National Academies of Sciences, Engineering, Division on Earth and Life Studies, Health and Medicine Division, Board on Life Sciences, Board on Global Health, Board on Health Sciences Policy, and Stockpiling of Smallpox Medical Countermeasures Committee on the Current State of Research, Development, Matthew Masiello, Shalini Singaravelu, Lisa Brown, Lawrence O. Gostin