Pragmatic Randomized Trials Without Standard Informed Consent?

Abstract

Background There is significant debate over whether written consent is necessary for low-risk, pragmatic randomized controlled trials (RCT). Objective To assess the U.S. public’s views regarding alternatives to written consent for low-risk pragmatic RCTs. Design National experimental survey (2-by-2 factorial design) examining support for written consent versus general notification or verbal consent in two 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%). Measurements Respondent’s recommendation to an ethics review board and personal preference as a potential participant for how to obtain consent/notification in the two research scenarios. Results A majority in each of the four arms (ranging from 60.3% to 71.5%) recommended written informed consent. Personal preferences generally tracked that advice. Most (78.9%) believed 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 arms (28.5% to 39.7%) recommended the alternative option (general notification or verbal consent) over written consent. Limitations Framing effects could impact respondents’ attitudes and non-respondents may differ in levels of trust towards research or healthcare institutions. Conclusions A majority of the public endorsed written informed consent over the most widely considered alternatives for low-risk pragmatic RCTs; however, a substantial minority endorsed general notification or verbal consent. Primary Funding Source Time-sharing Experiments in the Social Sciences and Intramural Research Program of the National Institutes of Health, Clinical Center.

Patients' views of consent in clinical trials for acute myocardial infarction: impact of trial design

“…Such targeted processes may indeed be very brief and could likely be administered in no more than a minute or two, a crucial consideration given the need to avoid any clinical meaningful treatment delays 9 23. These data are consistent with other recent data on consent preferences in CER trials in other settings,19 20 though what processes best meet needs and expectations of patients requires empirical evaluation in the context of actual implementation.…”

“…These data echo other published reports regarding MI trial enrolment. They are also consistent with evidence suggesting that patients have a preference for some form of consent in CER studies more generally and have implications in the context of recent arguments against prospective consent for these trials 19 20. At a minimum, these findings do not support a claim that enrolment without prospective consent in AMI trials investigating treatments within the standard of care can be based on preferences of patients.…”

Comparison of Approaches for Notification and Authorization in Pragmatic Clinical Research Evaluating Commonly Used Medical Practices

“…2–8 Although some of this research is reviewed elsewhere, 1 much of it involved providing extensive education about CER/pragmatic trials prior to assessing participants’ attitudes toward it. In addition, participants in these studies were typically asked to compare different notification and authorization approaches.…”

Low risk pragmatic trials do not always require participants’ informed consent

“…In surveys on hypothetical low risk pragmatic RCTs, most of the public preferred written informed consent to verbal consent or general notification, although substantial minorities of up to 40%2021 endorsed the alternative option over the standard written consent. …”