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

Ann Intern Med. 2015 Sep 1;163(5):356-64. doi: 10.7326/M15-0817.


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.

Publication types

  • Research Support, N.I.H., Intramural
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Female
  • Humans
  • Informed Consent*
  • Male
  • Middle Aged
  • Pragmatic Clinical Trials as Topic / ethics*
  • Public Opinion*
  • Surveys and Questionnaires
  • United States
  • Young Adult