In the past 30 years, the population of prisoners in the United States has expanded more than 4.5 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 human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS), hepatitis C, and tuberculosis—are under correctional supervision. Because prisoners face restrictions on liberty and autonomy, limited privacy, and often 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 (DHHS) Office for Human Research Protections (OHRP) commissioned the Institute of Medicine (IOM) to review the ethical considerations regarding research involving prisoners. The resulting analysis emphasizes five broad actions to provide prisoners involved in research with critically important protections: (1) expand the definition of the term prisoner; (2) ensure universally and consistently applied standards of protection; (3) shift from a category-based to a risk-benefit approach to research review; (4) update the ethical framework to include collaborative responsibility; and (5) enhance systematic oversight of research involving prisoners.

Contents

• The National Academies
• Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research
• Board on Health Sciences Policy
• Independent Report Reviewers
• Preface
• Acronyms
• Summary
  • MAJOR RECOMMENDATIONS
  • CONCLUDING REMARKS
  • REFERENCES
• 1. Introduction
  • WHY NOW?
  • COMMITTEE’S TASK AND APPROACH
  • ORGANIZATION OF THIS REPORT
  • REFERENCES
• 2. Today’s Prisoners: Changing Demographics, Health Issues, and the Current Research Environment
  • CHANGING DEMOGRAPHICS AND HEALTH ISSUES
  • CURRENT RESEARCH ENVIRONMENT
  • REFERENCES
• 3. Federal Regulatory Landscape
  • ADOPTION OF DHHS HUMAN SUBJECTS PROTECTION REGULATIONS
  • OTHER FEDERAL HUMAN SUBJECTS PROTECTIONS
  • ANALYSIS
  • REFERENCES
• 4. Defining Prisoners and Correctional Settings
  • ETHICAL FOUNDATIONS OF CURRENT RESEARCH REGULATIONS
  • CURRENT REGULATIONS PERTINENT TO PLACES OF PRISONER RESEARCH
  • CORRECTIONAL SETTINGS ENCOMPASS MORE THAN PRISONS AND JAILS
  • DEFINITION OF PRISONER
  • DELINEATION OF SETTINGS
  • WHEN LIBERTY STATUS CHANGES
  • REFERENCES
• 5. The Ethical Framework for Research Involving Prisoners
  • THE 1976 COMMISSION’S ETHICAL FRAMEWORK
  • AN UPDATED ETHICAL FRAMEWORK
  • REFERENCES
• 6. Systems of Oversight, Safeguards, and Protections
  • OVERARCHING PRINCIPLE
  • DEFINING AND REVIEWING PRISONER RESEARCH
  • SYSTEMATIC OVERSIGHT OF RESEARCH WITH PRISONERS
  • APPLYING SAFEGUARDS FOR PARTICULAR KINDS OF RESEARCH
  • OTHER CATEGORIES AND TYPES OF RESEARCH INVOLVING PRISONERS PROHIBITED
  • IMPACT OF COMMITTEE RECOMMENDATIONS ON STAKEHOLDER RESPONSIBILITIES
  • REFERENCES
• Appendixes
  • A Data Sources and Methods
  • B The National Commission’s Deliberations and Findings
  • C Report of the SACHRP Subcommittee and Human Subjects Protections
  • D Code of Federal Regulations Title 45: Public Welfare Part 46: Protection of Human Subjects
  • E Committee, Expert Advisor, Liaison Panel, and Staff Biographies

This study was supported by Award No. N01-OD-4-2139, TO #149 (DHHS-5294-249) between the National Academy of Sciences and the DHHS (Office for Human Research Protections)/National Institutes of Health and by a grant from The Greenwall Foundation. Any opinions, findings, or conclusions expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.