Maintaining respect at the margins of agency: Respect for persons and research in emergency settings
Background. The principle of respect for persons is widely considered one of the three central principles of research ethics. However, it remains unclear what respect demands when conducting research, particularly with non-autonomous persons. This problem is particularly acute in research in emergency settings, where any form of consent is often impossible.
Objective. This project's objectives were: (1) to explore the meaning of respect for persons, particularly in research with non-autonomous persons; (2) to understand the range and nature of patients' views of emergency research; and (3) to articulate practical and policy recommendations for respectful conduct of emergency research.
Methods. This project involved two principal components that were mutually informative. The first was a conceptual analysis of respect for persons and involved reviewing existing literature and developing an account of the central elements of respect. The second component was an exploratory qualitative interview study. 19 survivors of sudden cardiac death were interviewed using an interview guide including questions about the meaning of respect and seven scenarios describing different types of research conducted in emergency settings without consent.
Results. An account of the major elements of respect was developed that is based on understanding what is important and valuable about persons. Consistent with views expressed by participants, respect includes elements of care, empathy, attention, comportment, and dignity, as well as recognition of autonomy. In research with nonautonomous subjects, respect demands protections in ways that it does not with persons who are autonomous. Patients interviewed were generally accepting of research in emergency settings, including the impracticability of consent, the need for randomization, and some potential for harm. The primary criterion by which patients evaluated studies was the level of risk and benefit involved.
Conclusion. Respect for persons entails a broader range of requirements than has traditionally been acknowledged. When conducting research in emergency settings, respect requires that subjects not be exposed to unreasonable risks, that potential participants be involved in determining the acceptability of studies, and that enrolled patients are treated with concern and attention. In order to facilitate respectful research, some current regulatory requirements may need to be removed and others clarified.