Consent, including advanced consent, of older adults to research in care homes: a qualitative study of stakeholders’ views in South Wales

Abstract

BackgroundCare home residents, especially those lacking capacity to provide consent for themselves, are frequently excluded from research, thus limiting generalisability of study findings. We set out to explore stakeholders’ views about the ethical and practical challenges associated with recruiting care home residents into research studies.MethodsQualitative individual interviews with care home residents (n = 14), their relatives (n = 14), and general practitioners (GPs) (n = 10), and focus groups (n = 2) with care home staff. Interviews focused on the issues of older adults consenting to research in care homes, including advanced consent, in general and through reference to a particular study on the use of probiotics to prevent Antibiotic Associated Diarrhoea. Data were analysed using a thematic approach incorporating themes that had been identified in advance, and themes derived from the data. Researchers discussed evidence for themes, and reached consensus on the final themes.ResultsRespondents were generally accepting of low risk observational studies and slightly less accepting of low risk randomised trials of medicinal products. Although respondents identified some practical barriers to informed consent, consenting arrangements were considered workable. Residents and relatives varied in the amount of detail they wanted included in information sheets and consent discussions, but were generally satisfied that an advanced consent model was acceptable and appropriate. Opinions differed about what should happen should residents lose capacity during a research study.ConclusionsResearch staff should be mindful of research guidance and ensure that they have obtained an appropriate level of informed consent without overwhelming the participant with unnecessary detail. For research involving medicinal products, research staff should also be more explicit when recruiting that consent is still valid should an older person lose capacity during a trial provided the individual did not previously state a wish to be withdrawn if they lose capacity, and provided they do not indicate objection or resistance after loss of capacity.

A Pilot Randomised Clinical Trial of a Novel Approach to Reduce Sedentary Behaviour in Care Home Residents: Feasibility and Preliminary Effects of the GET READY Study

“…Compared with ageing research overall, research in long-term care remains relatively underdeveloped [9]. However, the recruitment of vulnerable older adults to research has reported low refusal rates, suggesting their willingness to be involved when given the opportunity [10,11].…”

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

“…Both the MCA and CTR require a decision based on what the person lacking capacity would have wanted, had they the capacity to choose for themselves, as their presumed will. The complexity of the current legal framework, its legislative differences and uncertainty surrounding their interpretation has resulted in confusion both for researchers and Research Ethics Committees,5 6 as well as clinicians, relatives and carers involved in decisions about adults lacking capacity participating in research 7. These differences increase the burden on those involved in making decisions about research participation and present barriers to conducting research with individuals with cognitive impairments 8 9.…”

Research involving adults lacking capacity to consent: the impact of research regulation on ‘evidence biased’ medicine

“…The complexity of the current legal framework, its legislative differences, and uncertainty surrounding their interpretation, has resulted in confusion both for researchers and Research Ethics Committees [11], as well as clinicians, relatives, and carers involved in decisions about people participating in research [7]. This issue remains one to be addressed and, unless it is done so, strategies introduced to improve the inclusion of vulnerable adults in medical research may fail.…”