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

Abstract

Introduction Traditional informed consent approaches, involving separate discussions and lengthy consent forms, may be an imperfect fit for comparative effectiveness research (CER) that is integrated into usual care and compares non‐investigational treatments. However, systematic efforts to collect broad stakeholder perspectives about alternative streamlined approaches to disclosure and consent in this context have been limited. Methods We used a deliberative engagement method to solicit the views of a multi‐stakeholder group regarding 3 alternative models of disclosure, consent, and authorization in CER studies: Opt‐In, Opt‐Out, and “General Approval”. Participants considered the acceptability of these 3 models for observational and randomized CER studies of hypertension medications and for alternative treatments for spinal stenosis, all conducted in the context of a learning health care system. Results Fifty‐eight stakeholders participated in the all‐day deliberative engagement session. Following deliberation, a majority of stakeholders (67%) liked the General Approval model for the observational hypertension study, more than the number who reported liking Opt‐Out or Opt‐In (45% and 36%, respectively). Support was lower for General Approval model in the context of a randomized hypertension study, with 80% liking a traditional Opt‐In approach, compared with 54% liking Opt‐Out, and 11% liking General Approval. Similarly, for the spinal stenosis CER studies, while most stakeholders preferred a streamlined Opt‐Out approach for the observational design, most preferred a traditional Opt‐In approach for the randomized version. Conclusions This multi‐stakeholder group was more favorable towards streamlined models for disclosure and authorization for observational CER than randomized designs. These findings are consistent with arguments that informed consent requirements should be tailored to the context of the research design, rather than a standard “one size fits all” approach.

Use of pragmatic and explanatory trial designs in acute care research: lessons from COVID-19

“…The ethics of alteration or waiver of consent for pragmatic trials have received considerable attention. 26 , 62 , 63 , 64 , 65 Much of the debate focuses on how the risk of research is assessed in clinical trials. When trials evaluate novel therapies (eg, a new surgical technique) or therapies with substantial prior evidence of superiority, trial participation includes clear potential risks and benefits.…”

Public Attitudes toward Consent When Research Is Integrated into Care—Any “Ought” from All the “Is”?

“…Similarly, in a companion study to the Kass et al deliberative engagement study with patients, one of us (Stephanie Morain) reported, with colleagues, that a multistakeholder group—including clinicians, those responsible for ethical and regulatory research oversight, CER researchers, health system administrators, payers, and research funders—voiced strong support (80 percent) for a general notification approach to an observational study of antihypertensives. Support for general notification did not, however, persist among these same stakeholders in the context of a randomized interventional study 38 . Collectively, the findings of Kraft et al and Morain et al suggest that the views of the public may not accord with those of other stakeholders.…”

Embedded point of care randomisation for evaluating comparative effectiveness questions: PROSPECTOR-critical care feasibility study protocol

“…Faden and colleagues highlight the strong ethical arguments in favour of streamlining consent procedures in this area and the acceptability to stakeholders of the same. [24][25][26] In this study, we will investigate moving the point at which consent is obtained proximally, away from the final application of eligibility criteria and randomisation. A future model might see patients routinely consented for a range of potential trials (under a specific operational framework such as that suggested by Fiore and Lavori 14 ) on admission to hospital, before it is known whether or not they will be eligible.…”

“…There is ongoing debate as to the most appropriate consent mechanisms for facilitating comparative effectiveness research, specifically, for treatments with demonstrable variation already present in their routine use. Faden and colleagues highlight the strong ethical arguments in favour of streamlining consent procedures in this area and the acceptability to stakeholders of the same 24–26…”