Pragmatic Randomized Trials Without Standard Informed Consent?

Abstract

Pragmatic Randomized Trials Without Standard Informed Consent?: A National SurveyPragmatic Randomized Trials Without Standard Informed Consent? | Annals of Internal Medicine


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 for how to obtain consent or notification in the 2 research scenarios.
Results: A majority of respondents in each of the 4 groups (range, 60.3% to 71.5%) recommended written informed consent, and personal preferences were generally in line 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 impacted respondents' attitudes, and nonrespondents may have differed in levels of trust toward research or health care institutions.
Conclusion: A majority 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.