Title: Informed consent and proxy decision making in research involving adults lacking capacity: development of an intervention to support proxy informed decision making, set within ethical and legal frameworks
Funder: Health and Care Research Wales (Welsh Government)

Abstract: Background The coming decades are expected to see a significant rise in health challenges resulting from ageing populations, with a proportionate rise in conditions characterised by cognitive disorders. Ambitious UK research agendas have been set out in order to address these challenges, however these will require a multitude of research participants. Decisions regarding the participation of adults lacking mental capacity in medical research are complex, and raise considerable legal and ethical issues. Carers and relatives who care for adults lacking capacity are regularly called upon to make such decisions on their behalf, however little is known about the ethical basis on which decisions are made and there is a dearth of information or support available. This results in such groups commonly being denied the opportunity to participate in research designed to improve the health care they receive. Research participants, their families and carers, clinicians and researchers require a clear, evidence-based ethical framework for research enrolment of adults lacking capacity. Empirical evidence on the factors influencing these decisions, and interventions to inform and support those involved, are urgently required. Aims The aim of this research is the development of an intervention, set within ethical and legal frameworks, to support informed proxy decision making for medical research involving adults lacking decision-making capacity. Achieved through: 1. Examining the regulatory, ethical, and legal factors in research involving adults lacking capacity, and what influence these and other factors have on the operationalisation of informed consent and proxy decision making in practice 2. Determining the factors that must be included in a decision support intervention for research participation by proxy decision makers for adults lacking capacity 3. Development of an accessible, feasible intervention (set within ethical and legal frameworks) to support proxy decision making for adults lacking capacity to improve confidence and quality of proxy decision making. Plan of Investigation This study will be conducted in three stages: Stage 1: A systematic review will outline the intersecting regulatory, ethical and legal context for proxy consent in research, and the operationalisation of informed consent and proxy decision making in practice. A survey of health care professionals involved in the care of people lacking capacity will determine existing knowledge of the legislation. A review of a random sample of Participant Information Sheets from current or recent research studies will look at what information is currently provided to proxy decision makers on their role, and the ethical and legal basis for decision-making. Stage 2: Factors influencing the decision making process will be identified using qualitative research methods. 20-25 semi-structured interviews will be conducted with a wide range of proxies who have experienced decision making for an adult lacking capacity. The interviews aim to explore how proxy decisions are made, whether legal and ethical obligations are being met, and what information is required by people making decisions. It will be informed by the findings from the review. Data will be thematically analysed. Stage 3: The findings will be used to develop a complex intervention to support proxy decision making. The decision support instrument (DSI) aims to enhance proxy decision making for research involving adults lacking capacity. Informative testing will ensure that the content and format is accessible and feasible for use. Summary of potential benefits to patients and NHS This research will support proxy decision making for adults lacking capacity by improving confidence and quality of proxy decision making. The findings will facilitate health care improvements across a wide range of settings and services, by enabling and supporting the engagement in research of traditionally under-researched and hard to reach populations.


Research activity codes: 8.4 RESEARCH DESIGN AND METHODOLOGIES (HEALTH SERVICES);8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: NEUROLOGICAL;MENTAL HEALTH;GENERIC HEALTH RELEVANCE