What Should Be Disclosed to Research Participants?

Wendler, David

doi:10.1080/15265161.2013.851578

Cited by 27 publications

(24 citation statements)

References 17 publications

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“…Amidst controversy about how to evaluate risk and develop appropriate consent practices for ROMP, 1-5 the Office for Human Research Protections released draft guidance for ROMP's regulation in late 2014. 6 The draft guidance, however, has faced significant criticism 7–9 and has yet to be finalized, leaving the task of interpretation and application of research regulations to local institutional review boards (IRBs).…”

Section: Introductionmentioning

confidence: 99%

A comparison of institutional review board professionals’ and patients’ views on consent for research on medical practices

Kraft¹,

Cho²,

Constantine

et al. 2016

Clinical Trials

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Background/Aims In the context of research on medical practices, which includes comparative effectiveness research and pragmatic clinical trials, empirical studies have begun to raise questions about the extent to which institutional review boards’ (IRBs) interpretations and applications of research regulations align with patients’ values. To better understand the similarities and differences between these stakeholder groups, we compare and contrast two surveys: one of IRB professionals and one of patients, which examine views on consent for research on medical practices. Methods We conducted online surveys of two target populations between July 2014 and March 2015. We surveyed 601 human subjects research professionals out of 1500 randomly selected from the Public Responsibility in Medicine and Research (PRIM&R) membership list (40.1% response rate), limiting analysis to the 537 respondents who reported having had IRB experience. We also surveyed 120 adult patients out of 225 approached at subspecialty clinics in Spokane, Washington (53.3% response rate). Our survey questions probed attitudes about consent in the context of research on medical practices using medical record review and randomization. The patient survey included three embedded animated videos to explain these concepts. Results A majority of IRB professionals distinguished between consent preferences for medical record review and randomization; ranked clinicians as the least preferred person to obtain participant consent (54.6%); and viewed written or verbal permission as the minimum acceptable consent approach for research on medical practices using randomization (87.3%). In contrast, most patients had similar consent preferences for research on medical practices using randomization and medical record review; most preferred to have consent conversations with their doctors rather than with researchers for studies using randomization (72.6%) and medical record review (67.0%); and only a few preferred to see research involving randomization (16.8%) or medical record review (13.8%) not take place if obtaining written or verbal permission would make the research too difficult to conduct. Limitations of our post hoc analysis include differences in framing, structure, and language between the two surveys and possible response bias. Conclusions Our findings highlight a need to identify appropriate ways to integrate patient preferences into prevailing regulatory interpretations as IRBs increasingly apply research regulations in the context of research on medical practices. Dialogue between IRBs and research participants will be an important part of this process and should inform future regulatory guidance.

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Section: Introductionmentioning

confidence: 99%

A comparison of institutional review board professionals’ and patients’ views on consent for research on medical practices

Kraft¹,

Cho²,

Constantine

et al. 2016

Clinical Trials

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“…While conceptual work on these topics has started to address some of these complex issues (Anderson, Califf, and Sugarman 2015; Faden, Beauchamp, and Kass 2014; Feudtner, Schreiner, and Lantos 2013; Macklin and Shepherd 2013; McKinney 2013; Wendler 2013; Wilfond 2013), there remains a dearth of empirical data to further inform and contextualize these discussions. Moreover, policies and practices designed to protect the rights, interests, and welfare of those who participate in all types of research should reflect careful consideration of multiple stakeholder perspectives, particularly those of prospective participants.…”

Section: Introductionmentioning

confidence: 99%

Patients' views concerning research on medical practices: Implications for consent

Weinfurt

Bollinger

Brelsford

et al. 2015

AJOB Empirical Bioethics

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Background Comparative effectiveness research (CER) and pragmatic clinical trials commonly test interventions that are in routine use and pose minimal incremental risk or burdens to patients who participate in this research. The objective of this study was to elicit the range of patients’ views and opinions regarding a variety of different types of research on usual medical practices, especially notification and authorization for them. Methods We conducted twelve focus groups with adults in five U.S. cities—six focus groups addressing CER (“CER groups”) and six groups addressing research involving hospital operations and clinician interventions (“Operations groups”). Participants discussed hypothetical research studies and potential methods of notifying patients and obtaining their authorization to participate. Group discussions were recorded, transcribed, and coded to identify patients’ views related to research on standard medical practice. Results A total of ninety six people participated. Twelve key themes emerged from participants’ discussions of the hypothetical research studies; these themes were then grouped into four general categories: clinical care; notification and authorization; communication; and conduct and design of research. The desire to be actively notified and asked was more prominent with regard to CER studies than with regard to Operations studies. Conclusions Our data suggest that effective policy and guidance will involve balancing different patients’ interests and potentially different sets of interests for different types of research studies on usual medical practices.

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“…However, instead of attempting to avert such distress by means of concealment, Feudtner et al [33] stress that investigators should inform potential patient participants that these risks also exist for patients receiving the standard of care intervention outside the trial and that their outcomes will probably be the same if they do not participate. Wendler further elaborates on the risks that need to be disclosed in a pragmatic trial, arguing that the informed consent form should only list those risks that are unique to the research [34]. Spellecy et al add to this in that the goals of the study should also be clarified during the informed consent to comply with a patient's autonomy [35].…”

Section: Is a Waiver Of Informed Consent In Post-launch Randomized Trmentioning

confidence: 98%

Pragmatic randomized trials in drug development pose new ethical questions: a systematic review

Kalkman

Thiel

Grobbee

et al. 2015

Drug Discovery Today

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What Should Be Disclosed to Research Participants?

Cited by 27 publications

References 17 publications

A comparison of institutional review board professionals’ and patients’ views on consent for research on medical practices

A comparison of institutional review board professionals’ and patients’ views on consent for research on medical practices

Patients' views concerning research on medical practices: Implications for consent

Pragmatic randomized trials in drug development pose new ethical questions: a systematic review

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