Research Involving Persons with Mental Disorders That May Affect Decisionmaking211 Capacity. Volume 1. Report and Recommendations of the National Bioethics Advisory 211 Commission

摘要

The report addresses a topic that follows from Executive Order 12975 which211u001edirected the Commission to consider the protection of the rights and welfare of 211u001ehuman research subjects. In this report, National Bioethics Advisory (NBAC) 211u001econsiders how ethically acceptable research can be conducted with human subjects 211u001ewho suffer from mental disorders that may affect their decisionmaking capacity; 211u001ewhether additional protections are needed; and, if so, what they should be and 211u001ehow they should be implemented. In addition, this report provides an opportunity 211u001efor investigators, IRB members, persons with mental disorders and their families, 211u001eand the general public to become better informed about the goals of such research 211u001eand what the authors believe are the appropriate protections for the human 211u001esubjects involved.