Pragmatic Randomized Trials Without Standard Informed Consent? A National Survey

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 x 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 or notification in the 2 research scenarios. Results: Most respondents in each of the 4 groups (range, 60.3% to 71.5%) recommended written informed consent, and personal preferences were generally in accord with that advice. Most (78.9%) believed that the pragmatic RCTs did not pose additional risks, but 62.5% of these respondents would still recommend written consent. In contrast, a substantial minority in all groups (28.5% to 39.7%) recommended the alternative option (general notification or verbal consent) over written consent. Limitation: Framing effects could have affected respondents' attitudes, and nonrespondents may have differed in levels of trust toward research or health care institutions. Conclusion: Most of the public favored written informed consent over the most widely advocated alternatives for low-risk pragmatic RCTs; however, a substantial minority favored general notification or verbal consent.