Research and Innovation

The concept of research ethics is a relatively recent phenomenon developed after the tragedies of the Second World War. In this chapter, we first give a brief overview of the historical background and describe how the current foundation of what is considered ethical research was formed. We highlight seven obligations for ethically sound research used today. Neurosurgical research does not always adhere to a clear separation of patient care and research. Surgical techniques are constantly improved and differ per surgeon and patient, and oversight is often lacking. Clear equipoise, when it is unclear what treatment is best, is rarely found in neurosurgery. To aid in the introduction and evaluation of novel treatments and techniques, the IDEAL collaboration proposed a framework that establishes a clear guide for methodologically and ethically sound research in surgical fields. With the implementation of Electronic Health Records, collecting patient data has become easier. Aggregation of patient data in large datasets has become standard, and this is changing the way research is performed. What data is exactly collected, how it is stored, and for what studies it is used are often unclear to patients and researchers and raise many ethical questions. Artificial intelligence and other forms of big data analytics offer many advantages but allow for less control over how data is used and what conclusions are drawn. The ethical implications are not yet clear. The Institute of Medicine has proposed that healthcare systems evolve into “Learning Health Systems,” blurring the lines between patient care and research, with a moral focus on learning. These characteristics require a different normative framework, with new obligations for the researcher, physician, but also patient. In the future, innovation and evaluation in neurosurgery will continue to develop and hopefully further improve the care neurosurgical patients receive. This chapter provides examples and frameworks to guide neurosurgeons, scientists, and patients in performing research that is ethically sound.