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 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.

Primary funding source: Time-sharing Experiments for the Social Sciences and Intramural Research Program of the National Institutes of Health Clinical Center.

Figure 1. Survey Design Administration

The survey had a 2-by-2 factorial design. Panelists were randomized to receive either the Drug RCT Scenario or the Dose Timing RCT scenario when they were selected to participate in the study. Respondents were further randomized to the alternative option (general notification or verbal consent) to written consent when they arrived at that section of the study. 158 panelists started the survey but did not submit. Of those, 82 broke off in the Drug RCT scenario (26 before being randomized to the alternative option, 28 after being randomized to general notification, and 28 after being randomized to verbal consent), while 76 broke off in the Dose Timing RCT scenario (23 before being randomized to the alternative option, 24 after being randomized to general notification, and 29 after being randomized to verbal consent). 14 respondents were excluded from the analysis for nonresponse to our two primary outcome measures, ranging from 2 to 5 respondents in each arm.

Figure 2. Recommendations to Ethics Review Board and Personal Preferences for Written Consent and the Alternative Option

The public’s recommendation to the ethics review board and their personal preference as a patient in the healthcare system on how to obtain consent. Panel A shows the percentage of respondents who recommended written consent (definitely or probably) or the alternative option (definitely or probably). Panel B shows the percentage of respondents who personally preferred written consent (definitely or probably) or the alternative option (definitely or probably). The first set of results in both panels represents the overall study findings across the four arms. Error bars represent 95% confidence intervals.

Figure 2. Recommendations to Ethics Review Board and Personal Preferences for Written Consent and the Alternative Option

The public’s recommendation to the ethics review board and their personal preference as a patient in the healthcare system on how to obtain consent. Panel A shows the percentage of respondents who recommended written consent (definitely or probably) or the alternative option (definitely or probably). Panel B shows the percentage of respondents who personally preferred written consent (definitely or probably) or the alternative option (definitely or probably). The first set of results in both panels represents the overall study findings across the four arms. Error bars represent 95% confidence intervals.

Figure 3. Support for the Alternative Options to Written Consent

The percentage of respondents who indicated support for the alterative option (combined definitely or probably) over written consent in terms of their recommendation to the ethics review board and personal preference as patients in the healthcare system. The first set of results represents the overall study findings across the four arms. Error bars represent 95% confidence intervals.