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

Morain, Stephanie R.; Largent, Emily A.

doi:10.1002/hast.1242

Cited by 14 publications

(5 citation statements)

References 37 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Several previous surveys have investigated people's preferences for written or verbal consent to participate in pragmatic RCTs versus receiving general notice that RCTs are typically conducted at a site (Cho et al, 2015;Dal-Ré, Carcas, Carné, et al, 2017a, 2017bDal-Ré et al, 2017;Kelley et al, 2015;Morain & Largent, 2021;Nayak et al, 2015). Of these, the studies closest to ours are those that have also asked those favoring consent whether, if consent were impractical, they would prefer general notice or forgoing the trial entirely (e.g., Cho et al, 2015).…”

Section: Discussionmentioning

confidence: 99%

Objecting to consensual experiments even while approving of nonconsensual imposition of the policies they contain

Vogt¹,

Mestechkin²,

Chabris³

et al. 2023

Preprint

View full text Add to dashboard Cite

In previous survey studies using decision-making vignettes in which respondents rated and ranked the appropriateness of universally implementing one intervention for all relevant people (A), universally implementing another intervention (B), or conducting an experiment (or A/B test) to compare these interventions before implementing the superior one, we have found that people are often averse to the A/B test, even when they approve of implementing either of the interventions the experiment contains (Meyer et al., 2019, Heck et al., 2020). However, these vignettes did not say explicitly whether or not consent to the A/B test—or to universal imposition of either A or B, untested—would be obtained. In a preregistered analysis, when we asked respondents in four of our previous survey experiments to explain their ratings, 18% of those who rated the A/B test commented negatively on the apparent lack of consent, compared to fewer than 1% of participants who rated the A or B conditions offering the same objection (Meyer et al., 2019). Because implementing A and implementing B, collectively, entail imposing the same risks on people as conducting an A/B test, this contrast is puzzling. Moreover, pragmatic trials of the sort our vignettes describe are often not feasible to conduct with consent; as a result, IRBs often waive the default requirement of consent and ethicists have also argued that consent to research is not always required. Here, in three studies using previous materials, we test the effect on experiment aversion (Heck et al., 2020; cf. Mislavsky et al., 2019) and the A/B effect (Meyer et al., 2019) of stipulating that consent to the A/B test either will or will not be obtained. In both vignettes we test, we find that negative sentiments towards experiments persist even when it is explicitly stated that consent will be obtained. While these negative sentiments are substantially reduced when consent is present (compared to when consent is absent or not mentioned), significant experiment aversion and A/B effects remain: 29–31% of participants were averse to the experiment and 32–39% ranked it as the worst decision the agent could make—even when consent would be obtained from everyone involved in the A/B test and from no one involved in either policy imposition.

show abstract

Section: Discussionmentioning

confidence: 99%

Objecting to consensual experiments even while approving of nonconsensual imposition of the policies they contain

Vogt¹,

Mestechkin²,

Chabris³

et al. 2023

Preprint

View full text Add to dashboard Cite

show abstract

“…As some surveys show, many patients and citizens, respectively, generally deem the use of their health data for research acceptable. These surveys show as well that while patients and citizens might prefer traditional specific consent, they deem other forms of consent acceptable [21][22][23][24]. Finally, although there are serious risks connected to the use of health data, such as loss of data and misuse, these risks are different in kind and arguably less severe than risks of clinical research [12].…”

Section: Previous Researchmentioning

confidence: 99%

Ethical, Legal, and Practical Concerns Surrounding the Implemention of New Forms of Consent for Health Data Research: Qualitative Interview Study

Wiertz,

Boldt

2024

J Med Internet Res

View full text Add to dashboard Cite

Background: In Europe, within the scope of the GDPR, more and more digital infrastructures are created to allow for large-scale access to patients' health data and its use for research. Where this research is carried out on the basis of patient consent, traditional study-specific consent appears too cumbersome to many researchers. Alternative models of consent are currently discussed and introduced in different contexts.Objective: This study explores stakeholder perspectives on ethical, legal and practical concerns regarding models of consent for health data research at German University Medical Centres.Methods: Semi-structured focus group interviews were conducted with medical researchers at German University Medical Centres, health IT specialists, data protection officers, and patient representatives. The interviews were analysed using a softwaresupported structuring qualitative content analysis.Results: Stakeholders regard broad consent to be only marginally less laborious to implement and manage than tiered consent. Patient representatives favour specific consent, with tiered consent as a possible alternative. All stakeholders lament that information material is difficult to understand. Oral information and videos are mentioned as means of improvement. Patient representatives doubt that researchers have a sufficient degree of data security expertise to act as sole information providers. They are afraid of undue pressure if obtaining health data research consent is part of medical appointments. IT specialists and other stakeholders regard withdrawal of consent to be a major challenge and call for digital consent management solutions. Transfer of health data to non-European countries and for-profit organisations is, on the one hand, seen as a necessity for research. On the other hand, there are data security concerns with regard to these actors. Research without consent is legally possible under certain conditions, but deemed problematic by all stakeholder groups, albeit for differing reasons and to different degrees.Conclusions: More efforts should be made to determine which options of choice should be included in health data research consent. Digital tools could improve patient information and facilitate consent management. A unified and strict regulation for research without consent is required at national and EU level. Obtaining consent for health data research should be independent of medical appointments and additional personnel should be trained in data security to provide information on health data research.

show abstract

“…Even when consent is not required in PROM‐related projects, efforts should still be made to respect the autonomy and dignity of patients. Morain et al 18 proposed several dimensions for demonstrating respect for persons in pragmatic clinical trials that are applicable to research projects involving PROMs collected in routine clinical care. Specifically, the “promoting transparency and open communication” dimension 19 emphasizes the importance of providing information about research activities and study progress to patients.…”

Section: Institutional Review Board Oversight Of Promsmentioning

confidence: 99%

Patient‐Reported Outcome Measures in Routine Clinical Practice: Practical Guidance for Institutional Review Boards

Bachmann,

Shiflet,

Palacios

et al. 2024

Ethics & Human Research

View full text Add to dashboard Cite

The use of patient‐reported outcome measures (PROMs) is increasingly common in routine clinical practice. As tools to quantify symptoms and health status, PROMs play an important role in focusing health care on outcomes that matter to patients. The uses of PROM data are myriad, ranging from clinical care to survey‐based research and quality improvement. Discerning the boundaries between these use cases can be challenging for institutional review boards (IRBs). In this article, we provide a framework for classifying the three primary PROM use cases (clinical care, human subjects research, and quality improvement) and discuss the level of IRB oversight (if any) necessary for each. One of the most important considerations for IRB staff is whether PROMs are being used primarily for clinical care and thus do not constitute human subjects research. We discuss characteristics of PROMs implemented primarily for clinical care, focusing on: data platform; survey location; questionnaire length; patient interface; and clinician interface. We also discuss IRB oversight of projects involving the secondary use of PROM data that were collected during the course of clinical care, which span human subjects research and quality improvement. This framework provides practical guidance for IRB staff as well as clinicians who use PROMs as communication aids in routine clinical practice.

show abstract

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

Cited by 14 publications

References 37 publications

Objecting to consensual experiments even while approving of nonconsensual imposition of the policies they contain

Objecting to consensual experiments even while approving of nonconsensual imposition of the policies they contain

Ethical, Legal, and Practical Concerns Surrounding the Implemention of New Forms of Consent for Health Data Research: Qualitative Interview Study

Patient‐Reported Outcome Measures in Routine Clinical Practice: Practical Guidance for Institutional Review Boards

Contact Info

Product

Resources

About