Ethical Challenges in Conducting Research on Dying Patients and Those at High Risk of Dying

Abstract

Clinical research to improve care across the broad spectrum of health care has led to better quantity and quality of life for many patients. However, imposing arbitrary restrictions that might result in the exclusion from clinical research of patients who are at the end of life, or patients with a high risk of dying, is undesirable. Such exclusions may violate the principle of justice, by denying these patients a valid opportunity to make an important socio-medical contribution, and could make it difficult or impossible to advance clinical knowledge about the care of these patients. This article reviews issues relevant to the conduct of research on dying patients and those who are at high risk of dying, and outlines special considerations for ensuring that such research is ethical. In particular, precautions should be taken to ensure that informed consent is obtained from patients who are capable (or their substitute decision maker if the patient is not capable), free from coercion, and not harboring false expectations about the likelihood of benefiting from the study intervention. The unique circumstances surrounding the timing of this research (at the end of life or potentially there) may warrant that some patients be considered vulnerable, requiring special protective measures. Adhering to these principles will help ensure that dying patients or patients at high risk of dying can still participate in research that has the potential to advance knowledge and improve future care.

Keywords:

• critical care
• decision making
• end of life
• ethics
• informed consent
• palliative care
• research
• research design

ACKNOWLEDGMENT

Dr. Scales is supported by a New Investigator Award from the Canadian Institutes of Health Research.