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)

Family carers of individual’s living with Huntington’s Disease (HD) manage a distinct and unique series of difficulties arising from the complex nature of HD. This paper presents the validation of the definitive measure of quality of life for this group. The Huntington’s Disease Quality of Life Battery for carers (HDQoL-C) was expanded and then administered to an international sample of 1716 partners and family carers from 13 countries. In terms of the psychometric properties of the tool, exploratory analysis of half (...) of the sample, demonstrated good internal consistency and reliability. Some items on the full version did not meet psychometric thresholds and a short version (HDQoL-Cs) was developed based on more stringent criteria. Confirmatory Factor Analysis of the model structure showed a good fit for all Factors and, indicated that the HDQoL-C and HDQoL-Cs are psychometrically robust measures of quality of life. We found that carers who lived with and looked after their spouse/partner had reduced sense of coping, hope for the future and overall quality of life. Carers with children who were at risk, carried the gene or were symptomatic also had poorer quality of life outcomes. Findings indicated the HDQoL-C and HDQoL-Cs are valid in multiple languages and across varied cultures as measures of self-reported quality of life in family carers of individual’s living with HD. These psychometrically validated tools can aid and guide the implementation of therapeutic interventions to improve life quality in this population. (shrink)