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

<bold>Background: </bold>Significant debate surrounds the issue of whether written consent is necessary for pragmatic randomized, controlled trials (RCTs) with low risk.<bold>Objective: </bold>To assess the U.S. public's views on alternatives to written consent for low-risk pragmatic RCTs.<bold>Design: </bold>National experimental survey (2 × 2 factorial design) examining support for written consent versus general notification or verbal consent in 2 research scenarios.<bold>Setting: </bold>Web-based survey conducted in December 2014.<bold>Participants: </bold>2130 U.S. adults sampled from a nationally representative, probability-based online panel (response rate, 64.0%).<bold>Measurements: </bold>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.<bold>Results: </bold>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.<bold>Limitation: </bold>Framing effects could have affected respondents' attitudes, and nonrespondents may have differed in levels of trust toward research or health care institutions.<bold>Conclusion: </bold>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.<bold>Primary Funding Source: </bold>Time-sharing Experiments for the Social Sciences and Intramural Research Program of the National Institutes of Health Clinical Center. [ABSTRACT FROM AUTHOR]