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

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

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

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

settingWeb-based survey conducted in December 2014.

participants2130 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.

resultsMost 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.

conclusionMost 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. PRIMARY FUNDING SOURCE: Time-sharing Experiments for the Social Sciences and Intramural Research Program of the National Institutes of Health Clinical Center.