Background: Many people participating in dementia research may lack capacity to give informed consent and the relationship between cognitive function and capacity remains unclear. Recent changes in the law reinforce the need for robust and reproducible methods of assessing capacity when recruiting people for research.Aims: To identify numbers of capacitous participants in a pragmatic randomised trial of dementia treatment; to assess characteristics associated with capacity; to describe a legally acceptable consent process for research.Methods: As part of a pragmatic randomised controlled (...) trial of Ginkgo biloba for mild-moderate dementia, we used a consenting algorithm that met the requirements of existing case law and the exigencies of the new Mental Capacity Act. We decided who had capacity to give informed consent for participation in the trial using this algorithm and sought predictors of capacity.Results: Most participants with mild-moderate dementia in this trial were unable to give informed consent according to the legal criteria. When adjusted for confounding, the Mini Mental State examination did not predict the presence of capacity.Conclusion: Cognitive testing alone is insufficient to assess the presence of capacity. Researchers and clinicians need to be aware of the challenging processes regarding capacity assessment. We outline a procedure which we believe meets the ethical and legal requirements. (shrink)

The purpose of this article is to describe and reflect ethical challenges in a grounded theory study on the dynamics of hope in HIV-positive adults and their significant others. It concentrates on the justification of a research problem, sensitive research and the relationship between the researcher and the participants in data collection. The basis of ethically sound nursing research on the dynamics of hope in these two vulnerable groups lies in the relationship between the researcher and the participant. However, it (...) is also obvious that the content, the process, the methods used and the ethics of the study cannot be divorced from this relationship. In conducting grounded theory research on the dynamics of hope in this research population, the researcher has to consider the surrounding world, that is, the reality in which these people live in hope or despair. (shrink)

Conducting research with vulnerable populations involves careful attention to the interests of individuals. Although it is generally understood that informed consent is a necessary prerequisite to research participation, it is less clear how to proceed when potential research participants lack the capacity to provide this informed consent. The rationale for assessing the assent or dissent of vulnerable individuals and obtaining informed consent by authorized representatives is discussed. Practical guidelines for recruitment of and data collection from people in the middle or (...) late stage of dementia are proposed. These guidelines were used by research assistants in a minimal risk study. (shrink)

People with dementia have previously not been active participants in research, with ethical difficulties often being cited as the reason for this. A wider inclusion of people with dementia in research raises several ethical and methodological challenges. This article adds to the emerging debate by reflecting on the ethical and methodological issues raised during an interview study involving people with dementia and their spouses. The study sought to explore the impact of living with dementia. We argue that there is support (...) for the inclusion of people with dementia in research and that the benefits of participation usually far outweigh the risks, particularly when a `safe context' has been created. The role of gatekeepers as potentially responsible for excluding people with dementia needs further consideration, with particular reference to the appropriateness of viewing consent as a primarily cognitive, universalistic and exclusionary event as opposed to a more particularistic, inclusive and context relevant process. (shrink)