Critical Issues Concerning Research Involving Decisionally Impaired Persons

Enrolling decisionally impaired adults in clinical research.

Progress in diagnosing, treating, and preventing medical conditions that impair decision-making abilities depends on clinical research involving individuals who may be either unable to or have diminished ability to give informed consent. Such research, however, raises ethical concern and controversy about the potential exploitation of these vulnerable individuals. This article addresses a range...

Informed consent from cognitively impaired persons participating in research trials: comparative law observations.

This article addresses the ethical requirements to be considered when conducting clinical trials involving human subjects whose mental condition limits their ability to understand the information and to express fully autonomous and informed consent. It does not address other categories of vulnerable persons, such as children, or advanced directives concerning end-of-life care. There are many et...

In harm's way: research subjects who are decisionally impaired.

Regulating research with decisionally impaired individuals: are we making progress?

Regulation of research on the decisionally impaired: history and gaps in the current regulatory system.