Pragmatic Randomized Trials Without Standard Informed Consent?: A National Survey.

ABSTRACT:

Background

Significant debate surrounds the issue of whether written consent is necessary for pragmatic randomized, controlled trials (RCTs) with low risk.

Objective

To assess the U.S. public's views on alternatives to written consent for low-risk pragmatic RCTs.

Design

National experimental survey (2 × 2 factorial design) examining support for written consent versus general notification or verbal consent in 2 research scenarios.

Setting

Web-based survey conducted in December 2014.

Participants

2130 U.S. adults sampled from a nationally representative, probability-based online panel (response rate, 64.0%).

Measurements

Respondent's recommendation to an ethics review board and personal preference as a potential participant on how to obtain consent

SUBMITTER: Nayak RK 

PROVIDER: S-EPMC5573142 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature