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Report on Ethical and Policy Issues in Research Involving Human Participants

Volume I - Report and Recommendations

Protecting Research Participants-A Time For Change: Protecting Research Participants
Summary of Recommendations: Summary of Recommendations
Chapter 1: Introduction-The Need for Change
Chapter 2: A Proposal for Oversight
Chapter 3: Methods for Ensuring Protection: Education, Certification, and Accreditation
Chapter 4: Assessing Risks and Potential Benefits and Evaluating Vulnerability
Chapter 5: Ensuring Voluntary Informed Consent and Protecting Privacy and Confidentiality
Chapter 6: Conduct of Research Selected Issues for Local Institutions
Chapter 7
: Implications of This Report

Appendices

Appendix A
: Acknowledgments
Appendix B: May 1999 Letter from Harold T. Shapiro to President William J. Clinton and President Clinton's Response
Appendix C: The Current Oversight System: History and Description
Appendix D: The Belmont Report
Appendix E: Code of Federal Regulations, Title 45 Part 46
Appendix F: Code of Federal Regulations, Title 21 Parts 50 and 56
Appendix G: Statutory Authority for Agency Human Subjects Protection Regulations (Common Rule)
Appendix H: Food and Drug Administration Regulations Requiring Reporting of Adverse Events
Appendix I: Public Comments on NBAC's December 19, 2000, Draft
Appendix J: Public and Expert Testimony
Appendix K: Commissioned Papers and Staff Analysis
Index: Alphabetical Index of Contents of Ethical and Policy Issues in Research Involving Human Participants, Volume I

Volume II - Commissioned Papers and Staff Analysis

Research Ethics in Australia: Donald Chalmers, University of Tasmania
Location of the Office for Protection from Research Risks Within the National Institutes of Health: Problems of Status and Independent Authority: John C. Fletcher, University of Virginia
Privacy and Confidentiality in Health Research: Janlori Goldman and Angela Choy, Georgetown University
An Examiniation of Federal Oversight of Human Subject Research: C.K. Gunsalus, University of Illinois at Urbana-Champaign
The History, Function, and Future of Independent Institutional Review Boards: Erica Heath, Independent Review Consulting, Inc.
The Danish Research Ethics Committee System-Overview and Critical Assessment: Sören Holm, University of Manchester
Vulnerability in Research Subjects: A Bioethical Taxonomy: Kenneth Kipnis, University of Hawaii at Manoa
Reflections on the Organizational Locus of the Office for Protection from Research Risks: Charles R. McCarthy
Protectionism in Research Involving Human Subjects: Jonathan D. Moreno, University of Virginia
Federal Agency Survey on Policies and Procedures for the Protection of Human Subjects in Research: National Bioethics Advisory Commission
Local Institutional Review Boards: Steven Peckman, University of California-Los Angeles
Institutional Review Board Assessment of Risks and Benefits Associated with Research: Ernest D. Prentice and Bruce G. Gordon, University of Nebraska Medical Center
Oversight of Human Subject Research: The Role of the States: Jack Schwartz, Office of the Maryland Attorney General
Privacy and Confidentiality: As Related to Human Research in Social and Behavioral Science: Joan E. Sieber, California State University, Hayward
Unfulfilled Promise: How the Belmont Report Can Amend the Code of Federal Regulations Title 45 Part 46 - Protection of Human Subjects: Harold Y. Vanderpool, University of Texas Medical Branch, Galveston
The Ethical Analysis of Risks and Potential Benefits in Human Subjects Research: History, Theory, and Implications for U.S. Regulation: Charles Weijer, Dalhousie University

Charles Weijer of Dalhousie University, Halifax, Nova Scotia, Canada, prepared a paper for NBAC on the topic of protecting communities in research. That paper was published in 1999 in the journal Cambridge Quarterly of Healthcare Ethics. The reader can find the article at the following citation:

Weijer C. 1999. Protecting Communities in Research: Philosophical and Pragmatic Challenges. Cambridge Quarterly of Healthcare Ethics 8:501-513.

The papers included in this volume were edited to conform to minimal stylistic consistency. The content and accuracy of the papers are the responsibility of the authors, not the National Bioethics Advisory Commission.

Report on Ethical and Policy Issues in Research Involving Human Participants

Volume I - Report and Recommendations

Table of Contents

Appendices

Volume II - Commissioned Papers and Staff Analysis

Table of Contents