Acting Without Asking”: An Ethico-Legal Analysis of the Problem of Emergency Care Research with Incapacitated Adults

Abstract

Emergency care research, both internationally and in South Africa, holds great prospect for advances in clinical care that could significantly address mortality and morbidity across a wide range of conditions including severe injury, stroke and ischaemic heart disease. However, many of these conditions are associated with physiological derangements and other factors that render potential research participants incapable of providing informed consent. Moreover, in some cases, very narrow therapeutic windows make the use of proxy decision-makers impossible. The Constitution of South Africa along with the National Health Act mandate that research without informed consent is unlawful. The statutory research ethics regulator has attempted to remedy this constraint, however its guidance for research with incapacitated adults in not coherent and in certain instances contradictory. Waivers of informed consent for research in emergencies, which are in place in North America, the United Kingdom, European Union and Australia have not been implemented in South African research ethics guidelines. Thus, considering the imperative to engage in emergency care research with incapacitated adults, South African statute and research ethics guidelines are not ethically justifiable. This thesis critically analyses the ethical principle of respect for autonomy and the process of informed consent, the consideration and roles of dignity and vulnerability in research with the incapacitated and the complex interactions of ethical decision-making and risk analysis in the emergency care research context. This is followed by a detailed ethico-legal analysis of both local and international regulations and research ethics guidelines as these apply to emergency care research with incapacitated adults, especially the application of waivers of informed consent. Finally, by drawing on the preceding analysis, a novel categorisation of capacity with mappings to time-sensitive levels of informed consent modalities is presented. This is followed by a proposed ethical framework arguing for a different approach to informed consent for those in emergency situations typified by factors such as acute severe pain or anxiety which affect capacity. For emergency situations with incapacitation, and especially those where proxy consent is not viable, a proposed approach to risk analysis is given and it is argued that waivers of informed consent are ethically defensible in such situations and preferable to the current South African research ethics guidelines. A set of conditions and a framework for a waiver of informed consent is proposed.