If a neurosurgeon develops a new technique, when can it be considered innovation, and when should it be considered investigation? How novel must the technique be, before specific consent is required from the patient? When should regulatory authorities review the technique?
We discussed these questions and more with two neurosurgeons experienced in innovation, bioethics, the law, and international regulation.
Thomas I. Cochrane, MD, MBA
Associate Neurologist and Senior Ethics Consultant, Brigham and Women’s Hospital
Assistant Professor of Neurology and Director of Neuroethics, Center for Bioethics, Harvard Medical School
Joseph Madsen, MD
Director, Epilepsy Surgery
Children's Hospital Boston
Marieke Broekman MD, PhD, JD
Neurosurgery, University Medical Center Utrecht