Ethical Guidance for Research on Dying or Recently Deceased ICU Patients
A group of Canadian healthcare providers, scientists, ethicists, and legal scholars recently produced updated clinical practice guidelines for death determination.1 “During the process of guideline development, several systematic reviews were conducted to inform recommendation generation,” says Nicholas Murphy, PhD, one of the authors and a postdoctoral fellow in the departments of philosophy and medicine at Western University in London, Ontario, Canada.
Murphy and colleagues identified important knowledge gaps pertaining to the sensitivity and specificity of testing techniques for neurological determination of death, along with the characteristics of autoresuscitation and prediction of time to death in neonates and children.2
“These need to be addressed to buttress the science of death determination,” Murphy recommends.
Studies with imminently dying and/or recently deceased study populations in the ICU are needed to answer these questions. Vulnerability of study participants is a central ethical concern. Researchers also are ethically obligated to support the families of dying or recently deceased patients.3 “Studies of this kind will become more common as science and practice advances,” Murphy predicts.
Currently, there are no authoritative international ethical guidelines governing research on dying or recently deceased individuals. Murphy and colleagues sought to start a conversation about challenges and potential solutions. They developed a preliminary framework for the ethical conduct of research with imminently dying patients.4 “Further work is required to address the ethical challenges of whole-body research with the recently deceased,” Murphy notes. Murphy and colleagues examined whether nontherapeutic research with imminently dying patients in the ICU is ethically permissible — and, if so, under what circumstances? The question arose from the Neurological Physiology after Removal of Therapy (NeuPaRT) study, through which investigators are exploring brain activity during planned withdrawal of life support in the ICU.
“Surprisingly, little is known about what happens in the brain when a patient is dying,” says Charles Weijer, MD, PhD, one of the authors and a bioethicist and professor at Western University.
Advanced neuromonitoring techniques will help researchers observe activity in the patient’s brain stem and cortex in the minutes leading up to and following cardiac arrest.5 “The study would substantially advance our scientific understanding of the dying process,” notes Weijer, ethics lead and co-investigator on the NeuPaRT project.
Critical care physicians, ethicists, neurologists, and neuroscientists met to address ethical issues in the NeuPaRT study. Among other suggestions, the group offers these ethical considerations for researchers:
• Although imminently dying patients are vulnerable, they should not be excluded from research (i.e., provided adequate protections are in place). The group concluded an outright prohibition of nontherapeutic research with imminently dying patients would be paternalistic. Patients and their next of kin have the right to consent to donating their organs. “They ought to be offered opportunities to benefit others through participation in valuable scientific studies,” Weijer says.
However, since imminently dying patients are vulnerable, additional protections must be in place for research to proceed ethically.
• Researchers and attending staff should not assume the option of study participation would be unwelcome to patients, families, or surrogate decision-makers. Some family members find meaning in loss through contribution to science.6 “Researchers should create space to facilitate ‘meaning-making’ — for example, by sharing study results with families when published,” Murphy advises.
• Research “bystander” interests should be considered. A research bystander is someone who is not a study participant, but who is nonetheless directly affected by research activities. “In this context, the interests of family members, close friends, and significant others of imminently dying or recently deceased patients need to be taken into account,” Murphy explains.
The patient is the subject of the scientific study, but it is the family who will live with the effects of the study on the patient’s last moments. Steps should be taken to mitigate any potential negative fallout from study activities. “Study interventions can be made less obtrusive in a few ways,” Weijer says.
The family can be allowed to remain in the room with the patient throughout the research process, including during the set up of monitoring equipment. Monitoring can be conducted remotely, with data recorded and analyzed after the fact. This allows researchers to leave the room to give the family privacy. Monitors in the room can be set to “comfort mode,” with displays and alarms turned off.
“The family should be allowed to interact with the patient as they wish, even if this may interfere with the collection of certain data,” Murphy adds.
Because research offers no prospect of direct benefit to subjects, research participation must pose no more than minimal risk to the patient. In the NeuPaRT study, researchers use four neuromonitoring techniques. “To minimize risk to patients, however, we decided that no patient would undergo more than two of the neuromonitoring procedures,” Weijer reports.
• Acknowledge the benefits of research participation to the patient and family. Participation in research gives the patient and family “an opportunity to make the patient’s death more meaningful, by contributing to scientific knowledge and the betterment of future patients,” Weijer offers.
1. Shemie SD, Wilson LC, Hornby L, et al. A brain-based definition of death and criteria for its determination after arrest of circulation or neurologic function in Canada: A 2023 clinical practice guideline. Can J Anaesth 2023;70:483-557.
2. Maitre G, Shemie SD, Baker A, et al. Knowledge gaps in the definition and determination of death. Can J Anaesth 2023;70:610-616.
3. Murphy NB, Weijer C, Lalgudi Ganesan S, et al. Nontherapeutic research with imminently dying and recently deceased study populations: Addressing practical and ethical challenges. Can J Anaesth 2023;70:596-602.
4. Murphy N, Weijer C, Debicki D, et al. Ethics of non-therapeutic research on imminently dying patients in the intensive care unit. J Med Ethics 2023;49:311-318.
5. Gofton T, Dhanani S, Meade M, et al. Neurologic Physiology after Removal of Therapy study: Study protocol of a multicentre, prospective, observational, pilot feasibility study of neurophysiology after withdrawal of life-sustaining measures. BMJ Open 2023;13:e073643.
6. van Beinum A, Murphy N, Weijer C, et al. Family experiences with non-therapeutic research on dying patients in the intensive care unit. J Med Ethics 2022;48:845-851.
There are no authoritative international ethical guidelines governing research on dying or recently deceased individuals. A group of investigators sought to start a conversation about challenges and potential solutions. They developed a preliminary framework for the ethical conduct of research with imminently dying patients.
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