Surrogate consent for research involving adults with impaired decision making: survey of Institutional Review Board practices.

ABSTRACT:

Objectives

Most critically ill adults have impaired decision-making capacity and are unable to consent to research. Yet, little is known about how Institutional Review Boards interpret the Common Rule's call for safeguards in research involving incapacitated adults. We aimed to examine Institutional Review Board practices on surrogate consent and other safeguards to protect incapacitated adults in research.

Design, settings, and participants

A cross-sectional survey of 104 Institutional Review Boards from a random sample of U.S. institutions engaged in adult human subject research (response rate, 68%) in 2007 and 2008.

Interventions

None.

Measurements

Institutional Review Board acceptance of surrogate consent, research risks, and other safeguards in research in

SUBMITTER: Gong MN 

PROVIDER: S-EPMC3939835 | biostudies-literature | 2010 Nov

REPOSITORIES: biostudies-literature