Substitute consent practices in the face of uncertainty: a survey of Canadian researchers in aging

Bravo, Gina; Wildeman, Sheila; Dubois, Marie‐France; Kim, Scott Y. H.; Cohen, Carole; Graham, Janice E.; Painter, Karen

doi:10.1017/s1041610213001336

Cited by 6 publications

(8 citation statements)

References 22 publications

(27 reference statements)

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“…Uncertainty about how the legislation should be interpreted has also been reported in a survey of care home managers and key informant interviews exploring research in care homes 2425 surveyed Canadian researchers and found that there was a lack of awareness about who can act as proxy decision-maker for research 25. They called for greater clarity and education about who can act as proxy decision-maker 25.…”

Section: Discussionmentioning

confidence: 99%

“…Bravo et al 25 surveyed Canadian researchers and found that there was a lack of awareness about who can act as proxy decision-maker for research 25. They called for greater clarity and education about who can act as proxy decision-maker 25. An earlier study led by the same author examined knowledge of the legislation governing proxy consent to both treatment and research of four Canadian groups (older adults, informal caregivers of cognitively impaired individuals, researchers in ageing and members of research ethics boards) 15.…”

Section: Discussionmentioning

confidence: 99%

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Healthcare professionals’ understanding of the legislation governing research involving adults lacking mental capacity in England and Wales: a national survey

et al. 2018

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ObjectiveTo examine health and social care professionals’ understanding of the legislation governing research involving adults lacking mental capacity in England and Wales.MethodsA cross-sectional online survey was conducted using a series of vignettes. Participants were asked to select the legally authorised decision-maker in each scenario and provide supporting reasons. Responses were compared with existing legal frameworks and analysed according to their level of concordance.ResultsOne hundred and twenty-seven professionals participated. Levels of discordance between responses and the legal frameworks were high across all five scenarios (76%–82%). Nearly half of the participants (46%) provided responses that were discordant in all scenarios. Only two participants (2%) provided concordant responses across all five scenarios.DiscussionParticipants demonstrated a lack of knowledge about the legal frameworks, the locus of authority and the legal basis for decision-making. The findings raise concern about the accessibility of research for those who lack capacity, the ability to conduct research involving such groups and the impact on the evidence base for their care.ConclusionThis is the first study to examine health and social care professionals’ knowledge and understanding of the dual legal frameworks in the UK. Health and social care professionals’ understanding and attitudes towards research involving adults with incapacity may warrant further in-depth exploration. The findings from this survey suggest that greater training and education is required.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Healthcare professionals’ understanding of the legislation governing research involving adults lacking mental capacity in England and Wales: a national survey

et al. 2018

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“…A further argument in support of family members’ involvement in dementia research relates to the above-mentioned evidence that people suffering from AD can retain the capacity to appoint a proxy decision-maker even when they lose the capacity to give consent to research participation [32]. However, one study investigating consent practices of researchers in aging reported the soliciting of consent from family members to include people deemed incapable of consent in research protocols, even in jurisdictions where such authority is uncertain at law [51]. …”

Section: Discussionmentioning

confidence: 99%

Research involving subjects with Alzheimer’s disease in Italy: the possible role of family members

Porteri

Petrini

2015

BMC Med Ethics

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BackgroundAlzheimer’s disease is a very common, progressive and still incurable disease. Future possibilities for its cure lie in the promotion of research that will increase our knowledge of the disorder’s causes and lead to the discovery of effective remedies. Such research will necessarily involve individuals suffering from Alzheimer’s disease. This raises the controversial issue of whether patients with Alzheimer’s disease are competent to give their consent for research participation.DiscussionWe discuss the case of subjects with Alzheimer’s disease who may have impaired decision-making capacity and who could be involved in research protocols, taking into consideration aspects of the Italian normative framework, which requires a court-appointed legal representative for patients who are not able to give consent and does not recognise the legal value of advance directives. We show that this normative framework risks preventing individuals with Alzheimer’s disease from taking part in research and that a new policy that favours research while promoting respect for patients’ well-being and rights needs to be implemented.SummaryWe believe that concerns about the difficulty of obtaining fully valid consent of patients with Alzheimer’s disease should not prevent them from participating in clinical trials and benefiting from scientific progress. Therefore, we argue that the requirement for patients to have a legal representative may not be the best solution in all countries and clinical situations, and suggest promoting the role of patients’ family members in the decision-making process. In addition, we outline the possible role of advance directives and ethics committees.

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“…Due in part to this legal complexity, a lack of knowledge about research involving adults who lack capacity, and paternalistic attitudes generally, may result in gatekeeping practices by researchers and health and social care professionals towards this population [73,74]. Involving health and social care professionals as a consultee or legal representative relies on them having the time and willingness to be involved.…”

Section: The Challengesmentioning

confidence: 99%

Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups and a call to action

Russell

Shepherd

Woolfall

et al. 2023

Trials

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Background Informed consent is considered a fundamental requirement for participation in trials, yet obtaining consent is challenging in a number of populations and settings. This may be due to participants having communication or other disabilities, their capacity to consent fluctuates or they lack capacity, or in emergency situations where their medical condition or the urgent nature of the treatment precludes seeking consent from either the participant or a representative. These challenges, and the subsequent complexity of designing and conducting trials where alternative consent pathways are required, contribute to these populations being underserved in research. Recognising and addressing these challenges is essential to support trials involving these populations and ensure that they have an equitable opportunity to participate in, and benefit from, research. Given the complex nature of these challenges, which are encountered by both adults and children, a cross-disciplinary approach is required. Discussion A UK-wide collaboration, a sub-group of the Trial Conduct Working Group in the MRC-NIHR Trial Methodology Research Partnership, was formed to collectively address these challenges. Members are drawn from disciplines including bioethics, qualitative research, trials methodology, healthcare professions, and social sciences. This commentary draws on our collective expertise to identify key populations where particular methodological and ethical challenges around consent are encountered, articulate the specific issues arising in each population, summarise ongoing and completed research, and identify targets for future research. Key populations include people with communication or other disabilities, people whose capacity to consent fluctuates, adults who lack the capacity to consent, and adults and children in emergency and urgent care settings. Work is ongoing by the sub-group to create a database of resources, to update NIHR guidance, and to develop proposals to address identified research gaps. Conclusion Collaboration across disciplines, sectors, organisations, and countries is essential if the ethical and methodological challenges surrounding trials involving complex and alternate consent pathways are to be addressed. Explicating these challenges, sharing resources, and identifying gaps for future research is an essential first step. We hope that doing so will serve as a call to action for others seeking ways to address the current consent-based exclusion of underserved populations from trials.

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Substitute consent practices in the face of uncertainty: a survey of Canadian researchers in aging

Cited by 6 publications

References 22 publications

Healthcare professionals’ understanding of the legislation governing research involving adults lacking mental capacity in England and Wales: a national survey

Healthcare professionals’ understanding of the legislation governing research involving adults lacking mental capacity in England and Wales: a national survey

Research involving subjects with Alzheimer’s disease in Italy: the possible role of family members

Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups and a call to action

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