The protection of individuals who volunteer to participate in research is essential to the ethical conduct of human research. In response to mounting concerns about the well-being of research participants and the ability of current approaches to ensure their protection, the Department of Health and Human Services commissioned the Institute of Medicine to perform a comprehensive assessment of the national system for providing research participant protection. The resulting analysis emphasizes the responsibilities and functions of human research participant protection programs (HRPPPs), providing substantive descriptions of the activities intrinsic to a robust protection program. In its work, the committee suggests a systems approach to providing protection, offers several broad recommendations for reform, and proposes practical suggestions to improve the oversight of human research at the institutional level.

In the committee's framework, the HRPPP is a system composed of interdependent elements that come together to implement policies and practices that ensure appropriate protection of research participants. The exact structure of an HRPPP will vary among research organizations and protocols according to the protection needs intrinsic to a particular study. Despite this flexibility, however, there are basic protection functions necessary to ensure the safety of participants and it is essential that all be met. These functions include: comprehensive review of protocols (including scientific, financial conflict of interest, and ethical reviews); ethically sound participant-investigator interactions; on-going and risk-appropriate safety monitoring; and quality improvement and compliance activities. Furthermore, to be effective, HRPPPs should operate within environments that emphasize accountability for the provision of participant protection, assure adequate resources for robust protection activities, provide ethics education programs to those conducting and those overseeing research with humans, and seek open communication and interaction with all stakeholders in the research enterprise.

A series of recommendations focuses on improving ethics review of protocols, reforming the informed consent process, improving access to information by participants and those responsible for review and monitoring of protocols, enhancing safety monitoring, compensating those who are harmed as a result of their participation in research, and developing a standard of quality improvement in HRPPPs.

Recommendations focused at the national level include: extending federal requirements for protection to include every research project involving human participants, regardless of funding source or research setting; collecting, assessing, and disseminating data about the overall system; and establishing an independent, nonpartisan advisory body that includes the perspectives of participants, scientists, ethicists, and research administrators to ensure that the national protection system receives objective and ongoing assessment.

Contents

• The National Academies
• Committee on Assessing the System for Protecting Human Research Participants
• Preface
• Reviewers
• Acknowledgments
• Acronyms
• Executive Summary
  • STATEMENT OF THE PROBLEM
  • MAJOR RECOMMENDATIONS
  • CONCLUDING REMARKS
• 1. Introduction
  • CONTEXT FOR THIS REPORT
  • BASIC TENETS OF ETHICAL HUMAN RESEARCH
  • THE RANGE OF HUMAN RESEARCH
  • RECENT EVENTS
  • THEMES AND ORGANIZATION OF THIS REPORT
  • SUMMARY
• 2. A Systemic Approach to Human Research Participant Protection Programs
  • THE NEED FOR A SYSTEMIC APPROACH
  • DEFINING PROTECTION PROGRAMS
  • ESTABLISHING A BALANCED PROGRAM
  • FUNCTIONS INTEGRAL TO THE PROTECTION SYSTEM
  • SUMMARY
• 3. Back to Basics: Scientific, Conflict of Interest, and Ethical Review of Research Protocols
  • THE NEED FOR RESEARCH ETHICS REVIEW BOARDS
  • THREE-PRONGED REVIEW
  • ENSURING DISCRETE SCIENTIFIC REVIEW OF PROTOCOLS
  • FINANCIAL CONFLICTS OF INTEREST AND PROTOCOL REVIEW
  • ETHICS REVIEW: CLARIFYING THE ROLES AND RESPONSIBILITIES OF RESEARCH ERBS
  • ORGANIZING AND INTEGRATING THE REVIEW PROCESSES
  • RESOURCE NEEDS
  • SUMMARY
• 4. The Participant-Investigator Interface
  • PREPARATION OF THE INVESTIGATOR AND PROTOCOL DESIGN
  • THE INFORMED CONSENT PROCESS
  • ROLES AND EXPECTATIONS OF RESEARCH PARTICIPANTS
  • SUMMARY
• 5. Improving Protection Through Oversight and Data and Safety Monitoring
  • GOVERNMENT REGULATION OF RESEARCH
  • OVERSIGHT BY FEDERAL RESEARCH AGENCIES
  • DATA AND SAFETY MONITORING BY THE PROGRAM
  • DATA AND SAFETY MONITORING BY AN INDEPENDENT BODY
  • COMMUNICATING THE RESULTS OF DATA AND SAFETY MONITORING
  • DATA SECURITY: PROTECTING CONFIDENTIALITY
  • SUMMARY
• 6. Improving Human Research Participant Protection Program Performance and Clarifying Roles
  • CONTINUOUS QUALITY IMPROVEMENT
  • STATUS OF ACCREDITATION
  • ROLE DIFFERENTIATION WITHIN THE HRPPP
  • MANAGING CONFLICTS OF INTEREST
  • COMPENSATION FOR RESEARCH-RELATED INJURY
  • PERSONAL LIABILITY OF RESEARCH ERB MEMBERS
  • SUMMARY
• 7. Improving an Evolving National Human Research Participant Protection System
  • THE NEED FOR BETTER ADVICE AND GUIDANCE AT THE FEDERAL LEVEL
  • THE NEED FOR PUBLIC INFORMATION REGARDING ONGOING CLINICAL RESEARCH
  • COMMUNICATING RESEARCH RESULTS: A ROLE FOR PUBLISHERS
  • THE IMPACT OF THE HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996 REQUIREMENTS AND PRIVACY ISSUES ON HRPPPS
  • RESEARCH EFFORTS TO COUNTER TERRORISM
  • SUMMARY
• References
• Appendixes
  • A Data Sources and Methods
  • B Protecting Participants in Social, Behavioral, and Economic Science Research: Issues, Current Problems, and Potential Solutions, Report from the Panel on IRBs, Surveys, and Social Science Research
  • C Clarifying Protocol Accountability
  • D Committee Biographies

Support for this project was provided by N01-OD-4-2139, Task Order No. 80, received support from the evaluation of set-aside Section 513, Public Health Service Act.

The views presented in this report are those of the Institute of Medicine Committee on Assessing the System for Protecting Human Research Participants and are not necessarily those of the funding agencies.

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.