How do we avoid being accused of ‘playing God’? Approaches to information provision for relatives in the era of emergency waiver of consent

A fundamental principle of the conduct of medical research is ‘autonomy’. This is manifested in the idea of patients giving informed consent for participation in clinical trials. Autonomy also means that they have the right to say no to enrolment, and withdraw at any time, without any negative consequences. It also means that we cannot exploit patients’ vulnerabilities to involve them in research. For example, paying patients for participation in research can be seen as exploitation of poorer individuals (and could also result in selection bias). The same concern applies to experiments that involve prisoners, who may feel that they will receive better treatment for participation. Additionally, it means that extreme care must be taken for enrolling people who have less capacity for understanding, such as individuals who are intoxicated, or patients with dementia or learning difficulties.