Dataset Information

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

ABSTRACT:

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 these decisions can be challenging and families may experience an emotional and decisional burden. Decisions made on behalf of others are conceptually different from those made for ourselves. Innovations have been developed to improve informed consent processes for research, including a number of decision aids, however there are no interventions for proxies who are faced with more complex decisions. This article outlines the development of a novel decision aid to support 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 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 acted as proxies enabled the development of a theoretical framework to underpin the intervention. The intervention was iteratively developed with the involvement of 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 utilises 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 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. Feasibility testing and outcome measure development is required prior to any evaluation of its effectiveness.

SUBMITTER: Shepherd V

PROVIDER: S-EPMC7842028 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

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

Shepherd Victoria V Wood Fiona F Griffith Richard R Sheehan Mark M Hood Kerenza K

BMC medical informatics and decision making 20210128 1

<h4>Background</h4>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 these decisions can be challenging and families may experience an emotional and decisional burden. Decisions made on behalf of others are conceptually different from those made for ourselves. Innovations have be ...[more]

PMID: 33509169

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Project description:Most critically ill adults have impaired decision-making capacity and are unable to consent to research. Yet, little is known about how Institutional Review Boards interpret the Common Rule's call for safeguards in research involving incapacitated adults. We aimed to examine Institutional Review Board practices on surrogate consent and other safeguards to protect incapacitated adults in research.A cross-sectional survey of 104 Institutional Review Boards from a random sample of U.S. institutions engaged in adult human subject research (response rate, 68%) in 2007 and 2008.None.Institutional Review Board acceptance of surrogate consent, research risks, and other safeguards in research involving incapacitated adults.Institutional Review Boards reported that, in the previous year, they sometimes (49%), frequently (33%), or very frequently (2%) reviewed studies involving patients in the intensive care unit. Six Institutional Review Boards (6%) do not accept surrogate consent for research from any persons, and 22% of Institutional Review Boards accept only an authorized proxy, spouse, or parent as surrogates, excluding adult children and other family. Institutional Review Boards vary in their limits on research risks in studies involving incapacitated adults: 15% disallow any research regardless of risk in studies without direct benefit, whereas 39% allow only minimal risks. When there was potential benefit, fewer Institutional Review Boards limit the risk at minimal (11%; p < .001). Even in populations at high risk for impaired decision making, many Institutional Review Boards rarely or never required procedures to determine capacity (13%-21%). Institutional Review Boards also varied in their use of independent monitors, research proxies, and advanced research directives.Much variability exists in Institutional Review Board surrogate consent practices and limits on risks in studies involving incapacitated adults. This variability may have adverse consequences for needed research involving incapacitated adults. Clarification of current regulations is needed to provide guidance.

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Dataset Information

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

Background

Methods

Results

Conclusions

Publications

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

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