The Mental Capacity Act 2005 gives statutory force to the common law principle that all adults are assumed to have capacity to make decisions unless proven otherwise. In accord with best practice, this principle places the evidential burden on researchers rather than participants and requires researchers to take account of short-term and transient understandings common among some research populations. The aim of this paper is to explore some of the implications of the MCA 2005 for researchers working with 'vulnerable' populations (...) in health and social care settings. The Cyclical Consent Model is described and offered as a process by which researchers might develop good practice when engaged in research involving vulnerable people. (shrink)

This paper recognizes the complexity of the debate on informed consent and discusses the importance of the ongoing process of consent for people affected by Huntington's disease (HD). Although written information may not be the most appropriate form of obtaining informed consent in qualitative research, it remains an important part of the ethical approval process for health research in the UK. This paper draws on a study in which the information sheet and consent form were specifically designed to help obtain (...) consent from people who may be impaired by the cognitive and physical effects of HD. The forms were developed by drawing on expert opinion and relevant literature and fall in line with recommendations from the Mental Capacity Act 2005 to encourage people to make their own decisions. The paper describes the feasibility of a method for obtaining consent as an ongoing process with patients affected by HD using information sheets and consent forms specifically designed for people with potential cognitive and/or physical impairments. In conclusion, this paper adds a pragmatic approach to the debate on informed consent by describing the development of a written information sheet and consent form being used in a current social research study. Particular emphasis is placed on the importance of written information being adapted according to the needs of potential participants. (shrink)

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)