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NBAC – Clinical Trials in Developing Countries

Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries

VOLUME I

Report and Recommendations of the National Bioethics Advisory Commission

Bethesda, Maryland

April 2001

The National Bioethics Advisory Commission (NBAC) was established by Executive Order 12975, signed by President Clinton on October 3, 1995. NBAC’s functions are defined as follows:
a) NBAC shall provide advice and make recommendations to the National Science and Technology Council and to other appropriate government entities regarding the following matters:
1) the appropriateness of departmental, agency, or other governmental programs, policies, assignments, missions, guidelines, and regulations as they relate to bioethical issues arising from research on human biology and behavior; and

2) applications, including the clinical applications, of that research.
b) NBAC shall identify broad principles to govern the ethical conduct of research, citing specific projects only as illustrations for such principles.

c) NBAC shall not be responsible for the review and approval of specific projects.

d) In addition to responding to requests for advice and recommendations from the National Science and Technology Council, NBAC also may accept suggestions of issues for consideration from both the Congress and the public. NBAC also may identify other bioethical issues for the purpose of providing advice and recommendations, subject to the approval of the National Science and Technology Council.
National Bioethics Advisory Commission

6705 Rockledge Drive, Suite 700, Bethesda, Maryland 20892-7979

Telephone: 301-402-4242

Fax: 301-480-6900

Website: www.bioethics.gov

Cover photo, top right, courtesy of James V. Lavery

ISBN 1-931022-13-5

Ethical and Policy Issues in International

Research: Clinical Trials in Developing Countries

VOLUME I

Report and Recommendations of the National Bioethics Advisory Commission

Bethesda, Maryland

April 2001

Table of Contents

Letter of Transmittal to the President
National Bioethics Advisory Commission
National Bioethics Advisory Commission Staff and Consultants
Executive Summary
Chapter 1: Ethical Issues in International Research-Setting the Stage
    Introduction
    Issues Prompting This Report
    Scope and Limits of This Analysis
    Themes and Premises of This Report
    Conclusions 
    Notes 
    References 
Chapter 2: Ethical Considerations in the Design and Conduct of 
           International Clinical Trials
    Introduction
    Ethical Issues in Clinical Trial Design
    Involvement of the Community and Study Participants in the Design 
      of Research
    Other Issues in Research Design
    Conclusions
    Notes
    References
Chapter 3: Voluntary Informed Consent
    Introduction
    The Ethical Standard of Informed Consent
    Cultural Barriers Relating to Disclosure Requirements
    Other Cultural Issues Relating to the Informed Consent Process
    Voluntary Participation in Research
    Documentation of Informed Consent
    Conclusions
    Notes
    References
Chapter 4: When Research Is Concluded-Access to the Benefits of 
           Research by Participants, Communities, and Countries
    Introduction
    What Should Be Provided to Communities and Countries?
    Who Should Provide Post-Trial Benefits?
    Prior Agreements
    Conclusions and Recommendations
    Notes
    References
Chapter 5: Ensuring the Protection of Research Participants in 
           International Clinical Trials
    Introduction
    U.S. Procedures for Ensuring the Protection of Human Participants
    Building Host Country Capacity to Review and Conduct Clinical Trials
    Conclusions
    Notes
    References
Appendices
    Appendix A: Acknowledgments
    Appendix B: Comparative Analysis of International Documents 
      Addressing the Protection of Research Participants
    Appendix C: Prior Agreements
    Appendix D: Public Comments on NBAC’s September 29, 2000, Draft
    Appendix E: Public and Expert Testimony
    Appendix F: Commissioned Papers and Staff Analysis Index
Index
Letter to the President

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