Ethics and Informed Consent for Comparative Effectiveness Research With Prospective Electronic Clinical Data

Faden, Ruth R.; Kass, Nancy E.; Whicher, Danielle; Stewart, Walter; Tunis, Sean

doi:10.1097/mlr.0b013e31829b1e4b

Cited by 65 publications

(74 citation statements)

References 7 publications

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“…2 Others argue that pragmatic clinical trials which pose no added risks do not need to obtain research consent at all. 3 This approach avoids the problems with in-depth consent, but leaves patients uncertain as to whether they are in research.…”

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confidence: 99%

"Targeted" Consent for Pragmatic Clinical Trials

Wendler

2015

J GEN INTERN MED

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Research on interventions within the standard of care has enormous potential, yet it also raises several ethical and regulatory challenges. Perhaps the most important is determining what consent process is needed for these "pragmatic" clinical trials. Some argue that pragmatic clinical trials need to obtain in-depth research consent. This approach ensures that patients are informed, but may introduce substantial selection bias and disruption of clinical care. Others argue that trials limited to interventions within the standard of care do not need to obtain research consent at all. While this approach avoids the problems with in-depth consent, it results in patients not knowing whether they are in research. The present manuscript proposes a way to avoid both sets of concerns. It argues that consent for research needs to supplement appropriate consent for standard care only to the extent that the research differs from standard care. Hence, pragmatic trials designed to mirror clinical care can obtain consent with only minimal additions to consent for standard care. This conclusion suggests that it may be possible for many pragmatic trials to obtain consent that is ethically appropriate, satisfies research regulations, and does not introduce substantial selection bias or clinical disruption.KEY WORDS: informed consent; pragmatic trials; research; standard care.

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confidence: 99%

"Targeted" Consent for Pragmatic Clinical Trials

Wendler

2015

J GEN INTERN MED

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“…26 Even proposals to omit informed consent entirely for low-risk pragmatic clinical trials might be capable of moving forward under current US regulations, provided the IRB with jurisdiction felt that they met the conditions for waiver of informed consent; however, routinely obtaining such waivers might be difficult without encouragement from a high level in the federal regulatory system. 10 This review has limitations. By design, it focuses on RWOC rather than encompassing the full range of important innovation, like streamlining, in informed consent.…”

Section: Discussionmentioning

confidence: 99%

“…34,35 Concepts of patient engagement and learning health care systems appear to play a significant role in current efforts to develop RWOC designs that adequately protect patient autonomy. 10,36 The argument that RWOC is ethical in emergency research and cluster randomized trials is based on the infeasibility of obtaining informed consent. One reason that these designs have been generally accepted is that RWOC is a necessary part of the methodology, not an option chosen because it is most convenient for the investigators.…”

Section: Discussionmentioning

confidence: 99%

“…7,10,11 The idea is now raised in the specific context of learning health care systems, which are expected to conduct rigorous comparative effectiveness research at a scale and pace that some authors have argued is essential for patient wellbeing but unrealistic with current informed consent requirements. 7 However, it is unclear how often, or in what context, randomization without consent (RWOC) occurs.…”

Section: Introductionmentioning

confidence: 99%

“…These additions were intended to protect patient dignity and autonomy to a greater degree than Truog's original proposal would. 10 We are aware of two low-risk randomized controlled trials in which informed consent was omitted entirely. The first was of feedback to physicians on test ordering behavior; in this case, the rationale for omitting informed consent was not clearly stated, and potential antecedent proposals such as Truog's were not cited.…”

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confidence: 99%

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

2016

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BACKGROUND: Individual informed consent from all participants is required for most randomized clinical trials (RCTs). However, some exceptions-for example, emergency research-are widely accepted. METHODS: The literature on various approaches to randomization without consent (RWOC) has never been systematically reviewed. Our goal was to provide a survey and narrative synthesis of published proposals for RWOC. We focused on proposals to randomize at least some participants in a study without first obtaining consent to randomization. This definition included studies that omitted informed consent entirely, omitted informed consent for selected patients (e.g., the control group), obtained informed consent to research but not to randomization, or only obtained informed consent to randomization after random assignment had already occurred. It omitted oral and staged consent processes that still obtain consent to randomization from all participants before randomization occurs. RESULTS: We identified ten different proposals for RWOC: two variants of cluster randomization, two variants of the Zelen design, consent to postponed information, two-stage randomized consent, cohort multiple RCT, emergency research, prompted optional randomization trials, and low-risk pragmatic RCTs without consent. CONCLUSION: Of all designs discussed here, only cluster randomized designs and emergency research are routinely used, with the justification that informed consent is infeasible in those settings. Other designs have raised concerns that they do not appropriately respect patient autonomy. Recent proposals have emphasized the importance for RWOC of demonstrating such respect through systematic patient engagement, transparency, and accountability, potentially in the context of learning health care systems. INTRODUCTIONRandomized controlled trials (RCTs) are the gold standard for clinical research. 1 Informed consent, including disclosure of randomization, is an ethical requirement for most RCTs. 2 This principle, intended to protect participants' autonomy and dignity, is firmly embedded in guidelines and regulations. [3][4][5][6] But, critics have argued that modern consent processes often fail to convey information well, can confuse or distress participants, and may even hinder legitimate research endeavors to the point where patients are paradoxically harmed by the lack of research on the safety and effectiveness of commonly used therapies. 7,8 These arguments have led to calls to relax or eliminate informed consent requirements in certain circumstances. An example is the exception for emergency medicine studies in which it is deemed impossible to obtain informed consent and still test an emergent intervention. 9 More broadly, US Federal regulations allow a waiver of informed consent requirements for clinical research given that four requirements are met: (1) Bthe research involves no more than minimal risk to the subjects,^(2) Bthe waiver or alteration will not adversely affect the rights and welfare of the subjects,^(3) Bthe researc...

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Sharing Clinical Trial Data

2015

JAMA

145

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All patients and their relatives want the best information possible regarding the effectiveness and safety of therapies. Responsible sharing of clinical trial data serves this public interest by strengthening the science that is the foundation of safe and effective clinical care. Sharing also fosters sound regulatory decisions, generates new research hypotheses, and increases the scientific knowledge gained from the contributions of clinical trial participants, the efforts of clinical trial investigators, and the resources of clinical trial funders. However, results from about onethird of clinical trials remain unpublished 4 years after trial completion, 1 and much data from trials are never analyzed. Several large pharmaceutical companies 2 and some academic investigators are already sharing clinical trial data, and the European Medicines Agency will do so beginning in 2015. 3 There are compelling reasons to share clinical trial data. The issue now is no longer whether to share clinical trial data but instead what specific data to share, when the data should be shared, and with what controls and

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Ethics and Informed Consent for Comparative Effectiveness Research With Prospective Electronic Clinical Data

Cited by 65 publications

References 7 publications

"Targeted" Consent for Pragmatic Clinical Trials

"Targeted" Consent for Pragmatic Clinical Trials

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

Sharing Clinical Trial Data

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