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

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.

PMID:
26215125
PMCID:
PMC5573142
DOI:
10.7326/M15-0817
[Indexed for MEDLINE]
Free PMC Article
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