A team of doctors, neuroscientists and philosophers from Western University have developed the first-ever ethical framework for researchers and research ethics committees to design, conduct and review functional magnetic resonance imaging (fMRI) studies for severely brain injured patients being treated in intensive care units.
The proposed ethical standards guidelines were published by Brain, an Oxford University Press journal.
A recent study indicated that the mortality rate in a group of comatose patients after brain injury was 32 per cent and in the majority of cases (70 per cent), death was preceded by the withdrawal of life-sustaining therapy. Many decisions to withdraw life-sustaining therapy were made within three days of injury and brain injuries.
Charles Weijer, a philosopher at Western’s Rotman Institute of Philosophy, an associate member at The Brain and Mind Institute, and first author of Ethical considerations in functional magnetic resonance imaging research in acutely comatose patients, says that following severe brain injury, the key challenge for neurologists and primary caregivers is to determine the prognosis of the patient, who will do well and who won’t do well.
“Families need to know the prognosis of a loved one and the healthcare provider needs to know that too, in order to make decisions regarding continuing supportive care for patients,” explains Weijer, the Canada Research Chair in Bioethics, who is also a trained physician. “And one of the most promising tools in development for the prognosis of these patients is functional magnetic resonance imaging.”
The problem, according to Weijer and his collaborators, is that conducting research on fMRI in intensive care units is very difficult and there are ethical issues that have yet to be adequately explored.
“Conducting research in the intensive care unit or taking care of patients in the intensive care unit takes time, patience and understanding throughout the whole course of research, whether it’s the informed consent process, the process of preparing to transport the patient or it’s actually doing the research protocol with a participant. It is really important that we ask the right questions and to make sure it is all done properly,” says Dr. Teneille Gofton, an assistant professor in the Department of Clinical Neurological Sciences at Western’s Schulich School of Medicine & Dentistry and co-author on the paper.
As proposed in the paper, the six ethical issues that should be addressed in any prospective fMRI study are:
(1) Is functional MRI a therapeutic or non-therapeutic procedure in the study context?
(2) Have the risks of research participation, including the risks of intrahospital transport, been minimized consistent with sound scientific design?
(3) Are the risks of non-therapeutic procedures no more than a minor increase above minimal risk?
(4) Have study participants been selected equitably?
(5) Will valid surrogate consent for study participation be obtained?
(6) Are adequate plans in place to share summary and individual research results with the responsible physician or the family?
“The end goal for introducing this framework is to try and enable functional MRI and other research in intensive care units for brain injured patients. It is very difficult research to do because of how sick [patients] are,” explains Dr. Gofton. “It is important that researchers, clinicians and research ethics boards have a framework they can work from to make these studies successful.”
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