Informed consent in clinical research: Consensus recommendations for reform identified by an expert interview panel.

ABSTRACT:

Background

Informed consent is the cornerstone for protection of human subjects in clinical trials. However, a growing body of evidence suggests that reform of the informed consent process in the United States is needed.

Methods

The Clinical Trials Transformation Initiative conducted interviews with 25 experienced observers of the informed consent process to identify limitations and actionable recommendations for change.

Results

There was broad consensus that current practices often fail to meet the ethical obligation to inform potential research participants during the informed consent process. The most frequent single recommendation, which would affect all participants in federally regulated clinical research, was reform of the informed consent document. The intervi

SUBMITTER: Lorell BH 

PROVIDER: S-EPMC4657389 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature