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

Annals of Internal Medicine

PubMedID: 26215125

Nayak RK, Wendler D, Miller FG, Kim SY. Pragmatic Randomized Trials Without Standard Informed Consent?: A National Survey. Ann Intern Med. 2015;163(5):356-364.
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.