Alternative consent models for comparative effectiveness studies: Views of patients from two institutions

Abstract

Background: Informed consent requirements generally require a lengthy process and signed documentation for patients to participate in clinical research. With growing interest in comparative effectiveness research (CER), whereby patients receive approved (nonexperimental) medicines for their medical condition, questions have been raised whether the same consent requirements should apply. Little input from patients has been part of these debates. Methods: We conducted two "deliberative engagement sessions" with patients from Johns Hopkins Community Physicians (JHCP) and Geisinger Health System (GHS). Full-day sessions introduced participants to two different CER designs (observational vs. randomized) comparing two antihypertensive medications and three disclosure or consent approaches: Opt-In, Opt-Out, and "General Approval." Sessions consisted of presentations and extensive discussion at small group tables. Pre-and posttest surveys were completed by participants before and after all-day discussions measuring attitudes about research and about each of the three disclosure/ consent options. Results: One hundred thirty-seven adults over age 40 years participated. Attitudes were similar between JHCP and GHS. Participants strongly preferred Opt-In or Opt-Out consent options to General Approval for both observational and randomized designs. For the randomized CER study, 70% liked Opt-In, 65% liked Opt-Out, and 40% liked General Approval. In discussing disclosure/consent options, patients cared most about choice, information, privacy and confidentiality, quality of the research, trust, respect, and impact of the study on patient care. Conclusions: The majority of participants from two different types of health systems liked both Opt-In and Opt-Out approaches for observational and randomized designs for low-risk CER. There were no posttest differences in the proportion liking Opt-In versus Opt-Out. Patients in this study wanted to be told about research and have a choice, but were very open to such disclosures being streamlined. Policymakers may find patients' views about what matters to them in the context of consent and CER relevant.

Stakeholder perspectives regarding alternate approaches to informed consent for comparative effectiveness research

“…Our study found stronger support for General Approval in prospective observational studies than did prior surveys with patients or the general public . For example, while over two‐thirds of this multi‐stakeholder group supported General Approval for an observational hypertension study following deliberation, only half of participants in an earlier patient‐only DES did so .…”

Proposals to Conduct Randomized Controlled Trials Without Informed Consent: a Narrative Review

“…39 Such public preferences may not be fixed: the same study noted a significant increase in participants' willingness to accept an RWOC approach after a period of deliberation on the topic. 39 The finding that almost all participants wanted to be asked for informed consent even for retrospective research further highlights the challenges in reconciling public opinion with policy. Nonetheless, these results suggest that RWOC designs cannot simply consider the material risk to patients but must also address a widespread desire for individuals to be informed and give consent.…”

“…[38][39][40][41] In a case where most participants initially rejected RWOC, they were more accepting of a streamlined consent. 39 Such public preferences may not be fixed: the same study noted a significant increase in participants' willingness to accept an RWOC approach after a period of deliberation on the topic. 39 The finding that almost all participants wanted to be asked for informed consent even for retrospective research further highlights the challenges in reconciling public opinion with policy.…”

“…Both smaller focus group studies and larger scale empirical surveys have found that a plurality of participants prefer to give informed consent to research, including low-risk pragmatic RCTs and even observational studies. [38][39][40][41] In a case where most participants initially rejected RWOC, they were more accepting of a streamlined consent. 39 Such public preferences may not be fixed: the same study noted a significant increase in participants' willingness to accept an RWOC approach after a period of deliberation on the topic.…”

Physicians’ perspectives regarding pragmatic clinical trials

“…While there is a growing body of literature regarding the ethical and regulatory challenges associated with fielding PCTs in the USA [3] and some empirical work examining patients' perspectives on pragmatic research conducted in usual care settings in the USA [8][9][10], comparatively little attention has focused on physicians' attitudes toward such research. A 2009 study found that while more than half of the physicians surveyed believed CER would improve clinical care, 65% thought it would restrict physicians' practices [11].…”