‘It’s a tough decision’: a qualitative study of proxy decision-making for research involving adults who lack capacity to consent in UK

Shepherd, Victoria; Hood, Kerenza; Sheehan, Mark; Griffith, Richard; Wood, Fiona

doi:10.1093/ageing/afz115

Cited by 36 publications

(57 citation statements)

References 23 publications

(26 reference statements)

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“…While empirical methods have support as a good way of grounding ethics, it is also important for ethical analysis to be grounded in the facts and reality of a situation [13]. We conducted a qualitative study to explore the experiences of family members in England and Wales who have acted as a research proxy [14], using a multiple-analytic approach to examine the data through multiple lenses. Pluralistic qualitative analyses have been found to be valuable in providing a multi-layered understanding of phenomena which possess ontological and epistemological multiplicity and multidimensionality [15].…”

Section: Developing a More Empirically Grounded Accountmentioning

confidence: 99%

“…Whilst data used for this study were collected primarily for a thematic analysis of the proxies' experiences of decision-making which has been previously reported [14,20], the aim of the interviews was also to capture ethical concepts, critically examine the previously developed framework [10], and further refine it based on updated concepts identified from the data. Interviews were conducted either face-to-face or by telephone.…”

Section: Data Collectionmentioning

confidence: 99%

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Constructing authentic decisions: proxy decision making for research involving adults who lack capacity to consent

et al. 2020

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Research involving adults who lack capacity to consent relies on proxy (or surrogate) decision making. Proxy decisions about participation are ethically complex, with a disparity between normative accounts and empirical evidence. Concerns about the accuracy of proxies’ decisions arise, in part, from the lack of an ethical framework which takes account of the complex and morally pluralistic world in which proxy decisions are situated. This qualitative study explored the experiences of family members who have acted as a research proxy in order to develop an understanding of the ethical concepts involved, and the interactions between those concepts. Proxies described a complex process of respecting the wishes and preferences of the person they represented, whist integrating preferences with what they viewed as being in the interests of the person. They aimed to make a decision that was ‘best’ for the person and protected them from harm; they also aimed to make the ‘right’ decision, viewed as being authentic to the person’s values and life. Decisions were underpinned by the relationship between the person and their proxy, in which both trust and trustworthiness were key. Proxies’ decisions, based both on respect for the person and the need to protect their interests, arose out of their dual role as both proxy and carer. The findings raise questions about accounts which rely on existing normative assumptions with a focus on accuracy and discrepancy, and which fail to take account of the requirement for proxies to make authentic decisions that arise out of their caring obligations.

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Section: Developing a More Empirically Grounded Accountmentioning

confidence: 99%

Section: Data Collectionmentioning

confidence: 99%

Constructing authentic decisions: proxy decision making for research involving adults who lack capacity to consent

et al. 2020

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“…We conducted a qualitative study with family members acting as proxies which showed that they use the patient's expressed wishes about research where these are available and, where these were not known, use their in-depth knowledge of the person's values and preferences to facilitate decisionmaking on their behalf [9]. However, other proxies described it as being a difficult and challenging decision.…”

Section: Review Of Existing Decision Aids For Proxiesmentioning

confidence: 99%

“…Improving the decision-making process was recognised as being much more than just ensuring the proxy had received adequate information. Proxies thought that greater decision support when considering research decisions would help in the future, which included orientating them towards considering the person's own views and preferences [9]. Proxies suggested that this support could take the form of a different sort of information sheet which covered their role as proxy decisionmaker, and that the DA should include items that they considered would support proxies when making decisions about research ( Table 2.…”

Section: Review Of Existing Decision Aids For Proxiesmentioning

confidence: 99%

“…Despite numerous innovations to improve informed consent processes for research, there are no interventions for proxies who arguably are faced with more complex decisions. Interventions to reduce the burden and decisional conflict experienced by proxies are needed in order to support family members through what can be an emotional and challenging decision [9], and so may help address the current exclusion of adults who lack capacity from research [10].…”

Section: Introductionmentioning

confidence: 99%

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Development of a decision support intervention for family members of adults who lack capacity to consent to trials

Shepherd

Wood

Griffith

et al. 2019

Preprint

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Background Informed consent is required for participation in clinical trials, however trials involving adults who lack capacity to consent require different enrolment processes. A family member usually acts as a proxy to make a decision based on the patient’s ‘presumed will’, but they can experience an emotional and decisional burden as a result. Decisions made on behalf of others are conceptually different from those we make for ourselves. Despite innovations to improve informed consent processes for research, including the development of decision aids, there are no interventions for proxies who arguably are faced with more complex decisions. This article outlines the development of a novel decision aid aimed at supporting families making decisions about research participation on behalf of an adult who lacks capacity to consent. Methods Decision support interventions should be developed using rigorous and evidence-based methods. This intervention was developed using the MRC guidance for the development of complex interventions, and a conceptual framework for the development and evaluation of decision aids for people considering taking part in a clinical trial. The intervention was informed by a systematic review and analysis of existing information provision. Previous qualitative research with families who had acted as proxies enabled the development of a theoretical framework to underpin the intervention. The intervention was iteratively developed in conjunction with lay advisors and relevant stakeholders. Results Previous research, theoretical frameworks, and decision aid development frameworks were used to identify and develop the intervention components. The decision aid includes information about the proxy’s role and uses a values clarification exercise and decision support methods to enable a more informed and better-quality decision. Stakeholders, including those representing implementers and receivers of the intervention, contributed to the design and comprehensibility of the decision aid and helped to ensure that it would be acceptable for use. Conclusions Frameworks for the development of decision aids for people considering participating in a clinical trial can be used to develop interventions for family members acting as proxy decision-makers. The decision support tool is acceptable to users but requires feasibility testing and outcome measure development prior to any evaluation of its effectiveness.

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Making an Advance Research Directive: An Interview Study with Adults Aged 55 and Older with Interests in Dementia Research

Ries

Johnston

2023

Ethics & Human Research

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Many people with dementia are interested in taking part in research, including when they no longer have capacity to provide informed consent. Advance research directives (ARD) enable people to document their wishes about research participation prior to becoming decisionally incapacitated. However, there are few available ARD resources. This Australian interview study elicited the views of people aged 55 years and older about the content of an ARD form and guidance booklet and processes to support research planning. Participants (n = 25; 55 to 83 years) had interests in dementia research. All participants described the ARD materials as easy to understand, and all expressed willingness to take part in future research. Nearly half believed that an ARD should be legally enforceable, while others saw it as a nonbinding document to guide decisions about their participation in research. Close family members were preferred as proxy decision‐makers. The ARD form and guidance booklet may be adapted for use elsewhere.

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‘It’s a tough decision’: a qualitative study of proxy decision-making for research involving adults who lack capacity to consent in UK

Cited by 36 publications

References 23 publications

Constructing authentic decisions: proxy decision making for research involving adults who lack capacity to consent

Constructing authentic decisions: proxy decision making for research involving adults who lack capacity to consent

Development of a decision support intervention for family members of adults who lack capacity to consent to trials

Making an Advance Research Directive: An Interview Study with Adults Aged 55 and Older with Interests in Dementia Research

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