Ethical and Regulatory Considerations Regarding Enrollment of Incompetent Adults in More Than Minimal Risk Research as Compared With Children.

The article discusses factors to be considered in enrolling incompetent adults in more than minimal risk research as compared with children. Topics covered include the minimal regulatory guidance for such enrollment, the legally authorized representative's (LAR) possible evaluation of an incompetent adult, and the proposal of relying on a substituted judgment on the subject's values that might honor his/her autonomy. Also noted is the latitude given to parents in enrolling their children.