Background: Research involving adults lacking mental capacity relies on the involvement of a proxy or surrogate, although this raises a number of ethical concerns. Empirical studies have examined attitudes towards proxy decision-making, proxies’ authority as decision-makers, decision accuracy, and other relevant factors. However, a comprehensive evidence-based account of proxy decision-making is lacking. This systematic review provides a synthesis of the empirical data reporting the ethical issues surrounding decisions made by research proxies, and the development of a conceptual framework of proxy (...) decision-making for research. Methods: A systematic review was conducted according to PRISMA guidelines. Databases including MEDLINE, EMBASE, and CINAHL were searched using a combination of search terms, and empirical data from eligible studies were retrieved. The review followed the framework synthesis approach to refine and develop a conceptual framework. Results: Thirty-four studies were included in the review. Two dimensions of proxy decision-making emerged. The ethical framing criteria of decision-making used by proxies: use of a substituted judgement, use of a best interests approach, combination of substituted judgement and best interests, and ‘something else’, and the active elements of proxy decision-making: ‘knowing the person’, patient-proxy relationship, accuracy of the decision, and balancing risks, benefits and burdens, and attitudes towards proxy decision-making. Interactions between the framing criteria and the elements of decision-making are complex and contextually-situated. Conclusions: The findings from this systematic review challenge the accepted reductionist account of proxy decision-making. Decision-making by research proxies is highly contextualized and multifactorial in nature. The choice of proxy and the relational features of decision-making play a fundamental role: both in providing the proxy’s authority as decision-maker, and guiding the decision-making process. The conceptual framework describes the relationship between the framing criteria used by the proxy, and the active elements of decision-making. Further work to develop, and empirically test the proposed framework is needed. (shrink)

IntroductionExtended decision -making through the use of proxy decision -makers has been enshrined in a range of International Codes, Professional Guidance and Statute,For example, the UK Mental Capacity Act section 9.1; The General Medical Council ; the US National Guardianship Association ; Nuffield Council on Bioethics ; CIOMS-WHO section 6. Court cases such as Re Quinlan in the US have also contributed to establishing the groundings for the legal status of the proxy, albeit in terms of who might be suitable (...) as a proxy in cases where there was no clear appointment of them by a still competent individual. and is now widely seen as a useful means through which we can exercise control over decisions that affect our lives when we have lost capacity to make these decisions for ourselves.I will here limit myself to discussion of proxy consent for adults appointed prior to the loss of competence by the person they are acting as proxy for. The issue of p. (shrink)