Public Approval of Exception From Informed Consent in Emergency Clinical Trials: A Systematic Review of Community Consultation Surveys.

ABSTRACT:

Importance

The US Food and Drug Administration (FDA) created the exception from informed consent (EFIC) pathway in 1996 to allow some emergency trials to enroll patients without informed consent. To protect individual autonomy and preserve public trust, the FDA requires that EFIC trial investigators consult with community members before a trial may begin.

Objectives

To analyze data from surveys conducted as part of community consultation ahead of EFIC trials and assess levels of public approval.

Data sources

All trials granted an EFIC must submit documentation of compliance with EFIC regulations to a publicly available docket at the FDA. Submissions between November 1, 1996, and October 23, 2017, were reviewed.

Study selection

Trials with survey data were inclu

SUBMITTER: Feldman WB 

PROVIDER: S-EPMC6659147 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature