Inclusion under the Mental Capacity Act (2005): A review of research policy guidance and governance structures in England and Wales

Ryan, Hayley; Heywood, Rob; Jimoh, Oluseyi F; Langdon, Peter E.; Shiggins, Ciara; Bunning, Karen

doi:10.1111/hex.13165

Cited by 6 publications

(5 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The research team and working group constructed a bespoke online survey, drawing on their findings from earlier stages of the wider project 9–11 14. Demographic information about each participant was collected, along with information about their experience of working within research and with adults with conditions that have the potential to affect capacity and/or communication.…”

Section: Methodsmentioning

confidence: 99%

Inclusion of adults with conditions that have the potential to affect capacity and or communication in research: triangulation from a mixed-methods study of current practice and values across multiple stakeholders

et al. 2023

Self Cite

View full text Add to dashboard Cite

ObjectivesWe aimed to: (A) describe researcher decision-making when including or excluding adults with conditions that have the potential to affect capacity and/or communication in research and (B) explore the underlying values and reasoning of stakeholders in research which falls under the provisions of the Mental Capacity Act, 2005.DesignThe mixed-methods design included semistructured interviews with adults with conditions that have the potential to affect capacity and/or communication, supporters, researchers, research ethics committee members and an online survey with researchers. Triangulation was used to integrate the data and examine the complementarity of the findings.SettingEngland and Wales.ParticipantsThere were 61 participants who took part in semistructured interviews, of which 39 were adults with conditions with potential to affect capacity and/or communication, 6 were in support roles for adults with conditions with potential to affect capacity and/or communication (including family members and professionals in advocacy organisations), 8 were members of research ethics committees flagged under the Mental Capacity Act to review research where there could be issues of mental capacity and 8 were researchers with experience of working with adults with conditions that have the potential to affect capacity and/or communication. The online survey had 128 participants, researchers with experience of working with adults with conditions that have the potential to affect capacity and/or communication.ResultsAll stakeholders were supportive of the genuine inclusion of adults with conditions that have the potential to affect capacity and/or communication in research, and exclusion was seen as a form of discrimination. Many researchers were daunted by meeting the threshold within the legislation for including participants who may lack capacity.ConclusionFurther training, expertise and resources are required to promote the successful inclusion in research of adults with conditions that have the potential to affect capacity and/or communication.

show abstract

Section: Methodsmentioning

confidence: 99%

Inclusion of adults with conditions that have the potential to affect capacity and or communication in research: triangulation from a mixed-methods study of current practice and values across multiple stakeholders

et al. 2023

Self Cite

View full text Add to dashboard Cite

show abstract

“…Making changes to support communication needs is complex. Some researchers find current guidance such as the Mental Capacity Act Code of Practice [ 27 ] and Health Research Authority guidance [ 29 ] difficult to interpret and implement [ 30 , 31 ]. Researchers acknowledge a lack of skills, knowledge, and confidence in being able to adapt their language and communication to meet the needs of people with communication disabilities [ 31 ].…”

Section: Main Textmentioning

confidence: 99%

“…There is limited evidence relating to the inclusion of people with communication disabilities in the informed consent process. This is in part because people with communication disabilities often have been excluded from study recruitment processes [ 17 , 30 , 31 , 33 – 35 ], and because studies that have included them have tended not to report the recruitment and consent methods used [ 32 ].…”

Section: Main Textmentioning

confidence: 99%

“…Reluctance to include people with communication disabilities in the consent process may follow challenges involving people with significant communication disabilities in patient and public involvement and engagement activity, and current involvement guidance does not provide specific information about how to include this group [ 36 ]. Recent UK studies have helped to contextualise these findings, by examining the legal, policy, and governance frameworks that apply to the recruitment of people with communication disabilities [ 30 , 37 , 38 ]. Whilst not specific to trials, these frameworks provide guidance for facilitating the inclusion of this group in the informed consent process.…”

Section: Main Textmentioning

confidence: 99%

See 1 more Smart Citation

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

View full text Add to dashboard Cite

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.

show abstract

“…No guidelines exist supporting the consent-to-research processes for people with complex communication access needs (Cascella & Aliotta, 2014). Instead, a ‘protection versus empowerment’ situation emerges where people with CCAN are subject to overtly protective structures within research ethics committees (Iacono, 2006; Ryan et al, 2021).…”

Section: Introductionmentioning

confidence: 99%

Using Communication Assistants in Qualitative Health Research

Dee-Price

2023

Qual Health Res

View full text Add to dashboard Cite

Qualitative health research is hampered by narrow constructs of human communication that privilege participants with access to spoken and written (normative) language. With limited awareness of such things as augmentative and alternative communication (AAC) or the rights of people with complex communication access needs, qualitative research becomes a ‘picker and chooser’ of whose voices are included in studies and whose are not. In order for ‘voices’ to be heard, adaptations are required which include the acknowledgement and support of communication assistants (informal and formal) who can help provide a communication bridge between people with complex communication access needs and researcher(s). Yet little is known of who qualifies as a communication assistant nor the scope and limitations of this role in health research. Beginning with communication diversity arguments the article compares communication assistants with language interpreters before discussing practice and implications for health research.

show abstract

Inclusion under the Mental Capacity Act (2005): A review of research policy guidance and governance structures in England and Wales

Cited by 6 publications

References 29 publications

Inclusion of adults with conditions that have the potential to affect capacity and or communication in research: triangulation from a mixed-methods study of current practice and values across multiple stakeholders

Inclusion of adults with conditions that have the potential to affect capacity and or communication in research: triangulation from a mixed-methods study of current practice and values across multiple stakeholders

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

Using Communication Assistants in Qualitative Health Research

Contact Info

Product

Resources

About