Republished by the LSU Medical Reseach Law Project

Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity   December 1998   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

C H A P T E R   O N E
An Overview of the Issues

• The Purpose of This Report
• The Promise of Research on Mental Disorders
• Scope of This Report
• The Nature of Some Mental Disorders that May Affect Decisionmaking Capacity
• Values That Should Guide Research in These Populations
• Informed Consent and Decisional Impairment
• Additional Issues in Research with Persons with Mental Disorders
• The Ethics of Study Design
• The Responsibilities of Researchers and Institutions
• The Structure of This Report

C H A P T E R   T W O
Informed Consent and Limitations on Decisionmaking Capacity

• The Centrality of Voluntary and Informed Consent
• Decisional Impairment and Incapacity
• Persistent Decisional Impairments
• Procedures for Capacity Assessment and Information Disclosure
• Substantive Requirements for Research Decision Making

C H A P T E R   T H R E E
Advance Planning, Surrogate Decision Making, and Assent or Objection

• The Role of Assent and Objection
• The Role of Advance Planning and Surrogate Decision Making
• Legally Authorized Representatives and Research Decision Making
• Independent Professional Support for Subjects and Surrogates

C H A P T E R   F O U R
The Assessment of Risk and Potential Benefit

• Defining and Assessing Risk
• Defining Benefits
• Balancing Risks and Potential Benefits

C H A P T E R   F I V E
Moving Ahead in Research Involving Persons with Mental Disorders: Summary and Recommendations

• Recommendations for New Regulations
• Recommendations Regarding Review Bodies
• Recommendations Regarding Research Design
• Recommendations Regarding Informed Consent and Capacity
• Recommendations Regarding Categories of Research
• Recommendations Regarding Surrogate Decision Making
• Recommendations Regarding Education, Research, and Support
• Additional Guidance for IRBs
• Guidance for Institutions

A P P E N D I C E S

• Appendix I: History of Regulatory Efforts in This Area
• Appendix II: Guidance for IRBs Reviewing Research Protocols Involving Subjects with Mental Disorders that May Affect Decisionmaking Capacity
• Appendix III: Public Comments on NBAC’s July 1, 1998 Draft
• Appendix IV: Public and Expert Testimony
• Appendix V: Commissioned Papers
• Appendix VI: Commissioner Statements
  • Statement of Commissioner Bernard Lo, M.D.
  • Statement of Commissioner Alexander M. Capron, LL.B.