Advance Consent in Acute Stroke Trials: Survey of Canadian Research Ethics Board Chairs

Seeger, R; Udoh, Ubong; Dewar, Brian; Nicholls, Stuart G.; Fedyk, Mark; Fahed, Robert; Perry, Jeff; Hill, Michael D.; Menon, Bijoy K; Swartz, Richard H.; Poppe, Alexandre Y; Gocan, Sophia; Brehaut, Jamie; Dainty, Katie N.; Shepherd, Victoria; Dowlatshahi, Dar; Shamy, Michel

doi:10.1017/cjn.2023.247

Cited by 2 publications

(1 citation statement)

References 7 publications

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“…Some participants accepted that there was utility in more speci c preferences which could constitute informed consent for a study, for example in time-critical trials where there is no ability to involve alternative decision-makers. This is the focus of ongoing studies in Canada that are exploring the acceptability and feasibility of advance consent in stroke trials [40,41].…”

Section: Discussionmentioning

confidence: 99%

‘It’s not making a decision, it’s prompting the discussions’: a qualitative study exploring stakeholders’ views on the acceptability and feasibility of advance research planning (CONSULT-ADVANCE)

Shepherd,

Hood,

Wood

2024

Preprint

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Background Health and care research involving people who lack capacity to consent requires an alternative decision maker to decide whether they participate or not based on their ‘presumed will’. However, this is often unknown. Advance research planning (ARP) is a process for people who anticipate periods of impaired capacity to prospectively express their preferences about research participation and identify who they wish to be involved in future decisions. This may help to extend individuals’ autonomy by ensuring that proxy decisions are based on their actual wishes. This qualitative study aimed to explore stakeholders’ views about the acceptability and feasibility of ARP and identify barriers and facilitators to its implementation in the UK. Methods We conducted semi-structured interviews with 27 researchers, practitioners, and members of the public who had participated in a preceding survey. Interviews were conducted remotely between April and November 2023. Data were analysed thematically. Results Participants were supportive of the concept of ARP, with differing amounts of support for the range of possible ARP activities depending on the context. Six main themes were identified: 1) Planting a seed – creating opportunities to initiate/engage with ARP; 2) One part of the puzzle – using preferences expressed through ARP to inform decisions; 3) Finding the sweet spot – optimising the timing of ARP; 4) More than a piece of paper – finding the best mode for recording preferences; 5) Not shutting the door on an opportunity – minimising the risk of unintended consequences; and 6) Navigating with a compass – principles underpinning ARP to ensure safeguarding and help address inequalities. Participants also identified a number of implementation challenges, and proposed facilitative strategies that might overcome them which included embedding advance research planning in existing future planning processes and research-focused activities. Conclusions This study provides a routemap to implementing ARP in the UK to enable people anticipating impaired capacity to express their preferences about research, thus ensuring greater opportunities for inclusion of this under-served group, and addressing the decisional burden experienced by some family members acting as proxies. Development of interventions and guidance to support ARP is needed, with a focus on ensuring accessibility.

show abstract

Section: Discussionmentioning

confidence: 99%

‘It’s not making a decision, it’s prompting the discussions’: a qualitative study exploring stakeholders’ views on the acceptability and feasibility of advance research planning (CONSULT-ADVANCE)

Shepherd,

Hood,

Wood

2024

Preprint

Self Cite

View full text Add to dashboard Cite

show abstract

‘It’s not making a decision, it’s prompting the discussions’: a qualitative study exploring stakeholders’ views on the acceptability and feasibility of advance research planning (CONSULT-ADVANCE)

Shepherd,

Hood,

Wood

2024

BMC Med Ethics

View full text Add to dashboard Cite

Background Health and care research involving people who lack capacity to consent requires an alternative decision maker to decide whether they participate or not based on their ‘presumed will’. However, this is often unknown. Advance research planning (ARP) is a process for people who anticipate periods of impaired capacity to prospectively express their preferences about research participation and identify who they wish to be involved in future decisions. This may help to extend individuals’ autonomy by ensuring that proxy decisions are based on their actual wishes. This qualitative study aimed to explore stakeholders’ views about the acceptability and feasibility of ARP and identify barriers and facilitators to its implementation in the UK. Methods We conducted semi-structured interviews with 27 researchers, practitioners, and members of the public who had participated in a preceding survey. Interviews were conducted remotely between April and November 2023. Data were analysed thematically. Results Participants were supportive of the concept of ARP, with differing amounts of support for the range of possible ARP activities depending on the context. Six main themes were identified: (1) Planting a seed – creating opportunities to initiate/engage with ARP; (2) A missing part of the puzzle – how preferences expressed through ARP could help inform decisions; (3) Finding the sweet spot – optimising the timing of ARP; (4) More than a piece of paper – finding the best mode for recording preferences; (5) Keeping the door open to future opportunities – minimising the risk of unintended consequences; and (6) Navigating with a compass – principles underpinning ARP to ensure safeguarding and help address inequalities. Participants also identified a number of implementation challenges, and proposed facilitative strategies that might overcome them which included embedding advance research planning in existing future planning processes and research-focused activities. Conclusions This study provides a routemap to implementing ARP in the UK to enable people anticipating impaired capacity to express their preferences about research, thus ensuring greater opportunities for inclusion of this under-served group, and addressing the decisional burden experienced by some family members acting as proxies. Development of interventions and guidance to support ARP is needed, with a focus on ensuring accessibility.

show abstract

Advance Consent in Acute Stroke Trials: Survey of Canadian Research Ethics Board Chairs

Cited by 2 publications

References 7 publications

‘It’s not making a decision, it’s prompting the discussions’: a qualitative study exploring stakeholders’ views on the acceptability and feasibility of advance research planning (CONSULT-ADVANCE)

‘It’s not making a decision, it’s prompting the discussions’: a qualitative study exploring stakeholders’ views on the acceptability and feasibility of advance research planning (CONSULT-ADVANCE)

‘It’s not making a decision, it’s prompting the discussions’: a qualitative study exploring stakeholders’ views on the acceptability and feasibility of advance research planning (CONSULT-ADVANCE)

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