“From Talk to Action: Canadian Leadership Ethics and Neurotechnology” was the theme of the Pan Canada Neurotechnology Ethics Collaborative’s virtual workshop held June 8, 2020.
The collaborative is a research initiative sponsored by Sunnybrook Research Institute and led by co-chairs Dr. Judy Illes, Dr. Nir Lipsman, and Dr. Patrick McDonald. It seeks to develop industry guidance for translating the development of novel surgical procedures and medical devices to patients. The group is exploring which factors to consider when determining whether a novel neurointervention is ready for human clinical trials.
Attendees from neurology, medicine, pediatrics, psychiatry, and neurosurgery were joined by scientists and attorneys. Workshop participants developed a core group and operational clusters, explored burning questions in neuroethics (see below), discussed the concept of risk, and outlined decision-making pathways for physicians and patients. Ultimately, the efforts of this group should result in publishing a book chapter.
The following were some of the burning questions considered by attendees:
The Language of Neurotechnology
- What do we (clinicians, researchers) mean by noninvasive/invasive?
- What do we mean by risk?
- How do we balance risk to patients, little-to-no benefit of intervention, with the need to develop new treatments in early phase trials?
- What are the (data/ethical/scientific) threshold to go from preclinical studies to phase 0/1 trials in humans?
- What are the differences between early phase medical trials and early phase device trials?
- How do technical advances work their way into practice?
- How do patients/clinicians decide between neuromodulation options? Enrolling in clinical trials?
- How to counsel patients on ‘Right to try’ and high risk/high reward studies; balancing desperation of patients with need to enroll in early trials?
- Which are the vulnerabilities of patient populations: children, older adults?
- Differentiating Canada and how universal health care presents different ethical questions than other countries
- Complementing similar world initiatives
“During this open forum, researchers and clinicians were able to discuss their experiences and concerns when dealing with neurological diseases,’ said Suzanne LeBlang, MD, the Foundation’s Director of Clinical Relationship. “This unique workshop explored ethical questions and topics that are simmering underneath the rapid progress in developing novel neurological treatments.” She added, “Typically, much time is devoted to new drug and device development. However, ethical questions such as how clinicians communicate potential new trials to patients without bias or conflict of interest need to be addressed.”
This workshop was supported by the Foundation via funding for Sunnybrook’s Education and Awareness component as a Center of Excellence.
Over the next few weeks, the identified clusters will be further populated, and the core group will continue to meet.