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

This document presents the findings and proposals of a multi-agency Working Group (WG) convened by the Office of Science Policy, Office of the Assistant Secretary for Planning and Evaluation to develop a proposed response by the Department of Health and Human Services (HHS) to the National Bioethics Advisory Commission (NBAC) Report entitled Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity (the "Report"). The Report makes 21 recommendations, which are variously directed to investigators or institutional review boards (IRBs); the National Institutes of Health (NIH) or other HHS agencies and offices; other Federal agencies that, along with HHS, have adopted the Common Rule; State legislatures; health professionals; or others responsible for human subject protections. [48 PDF pages]