Republished by the LSU Medical Reseach Law Project

The National Bioethics Advisory Commission (NBAC) was established by President Clinton in October 1995 to advise him and the National Science and Technology Council on bioethics issues. The Commission has been considering concerns surrounding research on persons who have mental disorders that may affect their decisionmaking capacity. After many months of deliberation and expert and public testimony, the Commission has completed a draft report on this subject.

This notice invites your comments on the draft report below. This notice is not required by law but reflects the Commission's wish to hear from as many individuals and/or organizations as possible before finalizing the report.

The report considers ways in which ethically acceptable research can be conducted using human subjects with mental disorders, whether additional protections are required, and, if so, how they should be implemented. In addition, the report provides an opportunity for investigators, members of Institutional Review Boards, persons with mental disorders and their families, advocates for the mentally ill, and the general public to reflect on the goals of research and appropriate protections for all human subjects.

We need to receive your comments within 30 days. We realize that 30 days is not a very long time for the review of such a comprehensive document, but hope that we will receive feedback within this time frame. Also, we encourage everyone to distribute this draft to persons whose feedback might be useful to us.

Any comments we receive through this website or by mail cannot be considered confidential. They will become part of the Commission's public record and, therefore, will be available upon request under the Federal Advisory Committee Act and/or the Freedom of Information Act. You may respond through this website or by mailing your comments to the NBAC address shown above.

If you want an E-mail letter of acknowledgement, please be sure to include your E-mail address.

We will analyze all comments and concerns that we receive within the comment period and will present them to the Commission.

When the Commission has completed its deliberations and the report is published, we will disseminate the report and post it on this site.

 

Harold T. Shapiro, Ph.D. Chair

Eric M. Meslin, Ph.D. Executive Director

1. Download the Report (in Adobe Acrobat format):

• Research Involving Subjects with Mental Disorders That May Affect Decisionmaking Capacity

2. Send your Comments on the Report:

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