Report on Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity

Volume I - Report and Recommendations of the National Bioethics Advisory Commission

Table of Contents

Letter of Transmittal to the President

Acknowledgements

National Bioethics Advisory Commission

National Bioethics Advisory Commission Staff

Executive Summary

Chapter 1: An Overview of the Issues

Chapter 2: Informed Consent and Limitations on Decisionmaking Capacity

Chapter 3: Advance Planning, Surrogate Decision Making, and Assent or Objection

The Assessment of Risk and Potential Benefit

Chapter 5: Moving Ahead in Research Involving Persons with Mental Disorders: Summary and Recommendations

Appendices

Appendix I: History of Regulatory Efforts in This Area

Appendix II: Guidance for IRBs Reviewing Research Protocols

Appendix III: Public Comments on NBACs July 1, 1998 Draft

Appendix IV: Public and Expert Testimon

Appendix V: Commissioned Papers

Appendix VI: Commissioner Statements

Volume II - Commissioned Papers by the National Bioethics Advisory Commission

Table of Contents

Paper One: Decisionally Impaired Research Subjects

Paper Two: Research Involving Persons with Mental Disabilities: A Review of Policy Issues and Proposals

Paper Three: Relational Ethics and Research with Vulnerable Populations

Paper Four: Critical Issues Concerning Research

Paper Five: Competency to Decide on Treatment and Research: The MacArthur Capacity Instruments