[1]I am a researcher in the School of Medicine at Cardiff University. My background is in nursing, but I have been an applied health researcher for the past 5 years, working in clinical trials and other types of studies, in different populations and settings, but more recently in care homes. I recently led a study to establish a set of research priorities in care homes, which used a modified Delphi technique to elicit priorities using care home staff as an expert panel. The study was published last year in Age and Ageing [2].
I currently hold an NIHR Doctoral Research Fellowship, in which I am exploring the involvement in research of adults who lack capacity to consent, including both ethical and legal aspects, and the experiences of those who are involved in deciding on the person’s behalf as their ‘proxy’. Decisions about research are different from those about medical treatment or care, which are based on what is in the person’s best interests.
As part of understanding the context, I have carried out a systematic review of the ethical issues involved in proxy decision making for research [3]. The findings suggest that decision-making is highly contextualised and multifactorial in nature, with the relationship between the person and their proxy playing a fundamental role. I have also conducted a survey of health and social care professionals’ knowledge and understanding of the legal frameworks governing research involving adults lacking capacity. The survey found that there was a widespread lack of knowledge about the legal frameworks. The findings raise concerns about whether adults who lack capacity to consent are being excluded from research as a result of low levels of understanding by those acting as gatekeepers.
A final part of understanding the context has been a content analysis of Participant Information Sheets provided to proxies when they are approached to be involved on the person’s behalf. This study reviewed information sheets from a random sample of 30 eligible studies, including dementia research. Considerable variation was found in the length and content of information sheets, and the (mis)information provided to proxies about their role and how they should approach decision-making. The study raises questions about the knowledge and understanding of the legal frameworks by those who conduct research, and also the ethics committees who approve research studies including adults who lack capacity.
I am now conducting a qualitative study, the DECISION Study [4], which will involve 20-25 semi-structured interviews with people who have been involved in making decisions about research for another person. The aim of the study is to explore how proxy decisions are made and what information might be helpful for people making decisions. This will include families of people living with dementia [5], and other conditions that affect the ability to make decisions either temporarily or for the longer term. Thematic analysis will be used to analyse the interview data. The study is open to recruitment (Spring 2018), and we are keen to hear from family members/friends who have been involved in deciding whether the person they care for should take part in a study (or not).
The final part of the Fellowship project (funded by the Welsh Government through Health and Care Research Wales) [6] will be to use the findings to develop a complex intervention to improve informed decision making. The intervention will be a decision support instrument (DSI), which is a tool used to help people make choices by providing information about the options and outcomes that are important to the person. This could be used by people acting as proxies in the future when deciding about whether a person lacking capacity should take part in a research study.