By Nicholas Murphy, Charles Weijer, Marat Slessarev, Teneille Gofton
Suppose you need to answer an important scientific question, but the only way to do so is through a research study enrolling critically ill patients who have only hours or minutes left to live. What do you do? Is such a study feasible? It is even ethical?
These are some of the questions we asked ourselves when developing the protocol for our study of the dying process in humans. Neurologic Physiology after Removal of Therapy was designed to inform the appropriate timing of death determination in deceased organ donation. The study uses nontherapeutic neurological monitors to determine when brain function stops relative to when circulation stops after the planned withdrawal of life-sustaining measures from patients in the intensive care unit. While the research promises to have social value by improving practices in organ donation, it poses difficult ethical challenges.
Guidelines for research involving critically ill patients exist, but the characteristics of the imminently dying exacerbate the ethical challenges of research in the intensive care unit. Imminently dying patients are vulnerable. They are typically unable to consent to study participation due to sedation or illness. Their families and significant others face profound emotional burdens, lack of sleep, and confusion. Further, the death of the patient should be a private, solemn time for those close to them. For these reasons, there is an intuitive resistance to research with the imminently dying patient. Health care providers, research ethics committees, and even researchers may baulk at the prospect.
None of this means that research with imminently dying patients is necessarily unethical. Indeed, we argue that there is no compelling reason to exclude this population from research. Doing so would not only deprive these patients (and their families) of the opportunity to altruistically contribute to science—it would also deprive future patients of the benefits stemming from their participation.
Justifying research with this population generally is one thing, but specifying the ethical conditions for its design and conduct is another. Faced with a dearth of guidance for this kind of research, we developed a framework for the ethical conduct of studies with the imminently dying—a question-driven approach that researchers can make use of when designing a study.
Some of the measures we propose will sound familiar. Where our framework departs from traditional research ethics guidelines is in the close attention we pay to “research bystanders,” that is, people who are not research participants, but who are nonetheless impacted by research activities. Most of the patients in our study are unconscious, and all have only minutes or hours to live. Consequently, patient families and significant others are in some ways more impacted by the research than the participants themselves. Indeed, it is the family who is approached for surrogate consent during a sensitive period; it is the family who sees the patient wearing neurological monitoring as they die; and it is the family who will remember the patient’s dying process long afterward.
Given the circumstances attending the patient’s illness, the families and significant others of imminently dying research participants are themselves vulnerable. Research should not exacerbate their distress. Hence, steps should be taken to ensure that the patient’s participation does not unduly interfere with the family’s experience of the patient’s death or negatively impact their grieving.
In our study, we worried that families may find the appearance of the patient wearing neuromonitoring sensors confronting, or even disturbing. The presence of researchers during equipment setup could also interfere with the family’s final hours with the patient. And, given that study procedures depart from usual end-of-life care practices, might involvement in research risk complicating family members’ grieving?
To mitigate these risks, we prepared families for the patient’s appearance by showing them professional illustrations of a patient wearing neurological monitoring in the informed consent process. Further, we limited intrusiveness by minimizing researcher presence to a brief setup period and placed monitors out of view. We encouraged families to remain at the bedside throughout, and social services and spiritual care were available to assist when needed.
Thankfully, all is not risk when it comes to research with the imminently dying. We know from a similar study at the end of life that families of participants often valued the experience, and some found meaning in loss knowing that something good came of it. To promote benefit to the family, we plan to communicate the results of our study to the families and significant others of patients. Consideration of family interests goes both ways: there may be negative impacts, but there can also be positive ones.
Research with the imminently dying poses ethical challenges. But researchers should remember that participants are just one piece of the puzzle. Families and significant others need our consideration and sometimes our protection too.
Authors: Nicholas Murphy,1,2 Charles Weijer,1,2,3 Derek Debicki,5,6 Geoffrey Laforge,6,7 Loretta Norton,8 Teneille Gofton,5 Marat Slessarev3,6
1. Department of Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada firstname.lastname@example.org.
2. Department of Philosophy, Western University, London, Ontario, Canada.
3. Department of Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.
4. Department of Epidemiology & Biostatistics, Western University, London, Ontario, Canada.
5. Department of Clinical Neurological Sciences, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.
6. Brain and Mind Institute, Western University, London, Ontario, Canada.
7. Department of Psychology, Western University, London, Ontario, Canada.
8. Department of Psychology, King’s University College at Western University, London, Ontario, Canada.
Competing interests: CW receives consulting income from Cardialen, Eli Lilly & Company, and Research Triangle Institute (RTI) International.
Social media accounts of post authors: @NB_Murphy @charlesweijer @MaratSlessarev @GoftonTeneille