Institute of Primary Care and Public Health, School of Medicine, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff CF14 4XNWales, UK.
Trials. 2013 Aug 9;14:247. doi: 10.1186/1745-6215-14-247.
Care 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.
Qualitative 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.
Respondents 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.
Research 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valid should an older person lose capacity during a trial provided the individual did not previously state a wish to be withdrawn if they lose capacity, and provided they do not indicate objection or resistance after loss of capacity.
养老院居民，尤其是那些没有能力为自己提供同意的居民，经常被排除在研究之外，从而限制了研究结果的普遍性。我们着手探讨利益相关者对在养老院招募居民参与研究时涉及的伦理和实际挑战的看法。
对养老院居民（n=14）、他们的亲属（n=14）和全科医生（GP）（n=10）进行了定性个体访谈，并对养老院工作人员进行了焦点小组（n=2）。访谈重点关注老年人在养老院同意参与研究的问题，包括事先同意、一般情况下的同意，以及通过参考一项关于使用益生菌预防抗生素相关性腹泻的研究。使用主题分析方法分析数据，该方法纳入了事先确定的主题和从数据中得出的主题。研究人员讨论了主题的证据，并就最终主题达成共识。
受访者普遍接受低风险观察性研究，对低风险药物随机试验的接受程度略低。尽管受访者确定了一些知情同意的实际障碍，但同意安排被认为是可行的。居民和亲属在信息表和同意讨论中希望包含的详细信息方面存在差异，但他们普遍认为预先同意模式是可以接受和合适的。对于居民在研究期间丧失能力时应该发生的事情，意见存在分歧。
研究人员应注意研究指南，并确保在不向参与者提供不必要细节的情况下，获得适当水平的知情同意。对于涉及药物的研究，研究人员在招募时还应更明确地表示，如果老年人在试验期间丧失能力，但事先没有表示如果丧失能力就退出的意愿，并且在丧失能力后没有表示反对或抵制，那么同意仍然有效。
