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

Rahul K. Nayak, BSE; David Wendler, PhD; Franklin G. Miller, PhD; and Scott Y.H. Kim, MD, PhD
[+] Article, Author, and Disclosure Information

This article was published online first at www.annals.org on 28 July 2015.


From the National Institutes of Health Clinical Center, Bethesda, Maryland.

Disclaimer: The opinions expressed herein are those of the authors and do not reflect the policies and positions of the National Institutes of Health, the U.S. Public Health Service, or the U.S. Department of Health and Human Services.

Acknowledgment: The authors thank the 2 anonymous TESS reviewers who gave critical feedback on the design of the survey and Robert Wesley, PhD, at the National Institutes of Health for help with the statistical interpretation of some findings.

Financial Support: This research was supported in part by the Intramural Research Program of the National Institutes of Health Clinical Center. Data collection was provided by TESS under National Science Foundation grant 0818839 (Jeremy Freese, PhD, and James Druckman, PhD, principal investigators). TESS provided data collection using the GfK KnowledgePanel, and GfK provided survey weights for matching participants' responses to the U.S. Current Population Survey.

Disclosures: Mr. Nayak reports a grant from TESS during the conduct of the study. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?ms Num=M15-0817.

Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer.

Reproducible Research Statement:Study protocol: Available in the Supplement. Statistical code: Available from Dr. Kim (e-mail, scott.kim@nih.gov). Data set: Available at http://tessexperiments.org or from Dr. Kim (e-mail, scott.kim@nih.gov).

Requests for Single Reprints: Scott Y.H. Kim, MD, PhD, Department of Bioethics, Clinical Center, National Institutes of Health, 10 Center Drive, Building 10, Room 1C118, Bethesda, MD 20892-1156; e-mail, scott.kim@nih.gov.

Current Author Addresses: Mr. Nayak and Drs. Wendler, Miller, and Kim: Department of Bioethics, Clinical Center, National Institutes of Health, 10 Center Drive, Building 10, Room 1C118, Bethesda, MD 20892-1156.

Author Contributions: Conception and design: R.K. Nayak, D. Wendler, F.G. Miller, S.Y.H. Kim.

Analysis and interpretation of the data: R.K. Nayak, D. Wendler, F.G. Miller, S.Y.H. Kim.

Drafting of the article: R.K. Nayak, F.G. Miller.

Critical revision of the article for important intellectual content: R.K. Nayak, D. Wendler, F.G. Miller, S.Y.H. Kim.

Final approval of the article: R.K. Nayak, D. Wendler, F.G. Miller, S.Y.H. Kim.

Provision of study materials or patients: R.K. Nayak.

Statistical expertise: R.K. Nayak.

Obtaining of funding: R.K. Nayak.

Administrative, technical, or logistic support: R.K. Nayak, S.Y.H. Kim.

Collection and assembly of data: R.K. Nayak, S.Y.H. Kim.


Ann Intern Med. 2015;163(5):356-364. doi:10.7326/M15-0817
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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.

Figures

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Appendix Figure.

Experimental design of survey.

Shows the 2 × 2 factorial design and information presented to respondents. About half received a drug RCT scenario comparing 2 first-line drugs; the others received a dose-timing RCT scenario comparing morning vs. night dosing. About half of participants in each group chose between written consent and general notification; the rest chose between written consent and verbal consent. CTD = chlorthalidone; FDA = U.S. Food and Drug Administration; RCT = randomized, controlled trial; TRT = hydrochlorothiazide.

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Figure 1.

Study flow diagram.

Q = question; RCT = randomized, controlled trial.

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Figure 2.

Recommendations to the ethics review boardtop) and personal preferences (bottom) for written consent and the alternative option.

Error bars represent 95% CIs. RCT = randomized, controlled trial.

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Figure 3.

Support for alternative options to written consent.

Error bars represent 95% CIs. RCT = randomized, controlled trial.

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