Analysis and Proposed Actions Regarding the NBAC Report: Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. Introduction

01/16/2001

The National Bioethics Advisory Commission (NBAC) presented its report entitled Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity (the “Report”) to the National Science and Technology Council (NSTC) in January, 1999. The Report makes 2I recommendations, which are variously directed to investigators or institutional review boards (IRBs); the National Institutes of Health (NIH) or other agencies and offices of the Department of Health and Human Services (HHS); other Federal agencies that, along with HHS, have adopted the Common Rule [1] ; State legislatures; health professionals; or others responsible for human subject protections.

This document presents the findings and proposals of a multi-agency Working Group (WG) convened by Office of Science Policy, Office of the Assistant Secretary for Planning and Evaluation to develop a proposed HHS response to the Report. The WG members are listed in Appendix A.

This document has two sections. Part A provides a brief overview of the Report and comments on and responds to some general issues it presents. Part B analyzes and responds to each of NBAC’s 21 recommendations.

The WG commends NBAC for its thoughtful and insightful report. The WG agrees that, despite significant improvement in human subject protection during recent decades, difficult issues related to the participation in research of individuals with impaired decisionmaking capacity need further consideration. NBAC has performed a valuable service in bringing attention to these matters.

In developing its recommendations, NBAC systematically addressed the ethical issues raised. It solicited and received a wide range of views from a variety of scientific experts, patient advocates, professional societies, government agencies involved in human subject research, bioethicists, other advisory committees reviewing protections in research on decisional impairment, and many others. NBAC also dedicated a portion of many of its meetings to hearing public testimony. The resulting Report makes a significant contribution to critically important issues in human subject research.

The WG believes, with NBAC, that our goals must be “providing protection for persons with mental disorders while allowing important research to go forward.” (Report at 41). This position is in complete harmony with Mental Health: Report of the Surgeon General, which emphasizes the “importance of a solid research base for every mental health and mental illness intervention” because “establishing mental health policy on the basis of good intentions alone can make bad situations worse; [whereas] evaluating the practicality and effectiveness of new approaches is efficient and, more critically, is accountable to those for whom an intervention is intended” [2] The WG agrees with many of NBAC’s concerns and recommendations and has developed proposals for how HHS might appropriately respond to the Report.


[1] Most federal agencies that conduct or support research involving human subjects have adopted regulations based on the language set forth in Subpart A of 45 CFR 46. This set of common regulations is referred to as the Federal Policy (Common Rule) for the Protection of Human Subjects. The FDA regulations at 21 CFR Parts 50 & 56 are FDA’s equivalent to the Common Rule.

[2] Mental Health Report, Executive Summary p. viii.

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