Ethics of clinical research

Abstract

This chapter describes how research ethics were born in scandal and gave rise to several codes and reports. They codify the requirements that should be met in order for research to be ethically sound and include respect for subjects, informed consent, and voluntarily participation among others. This chapter also highlights the seven obligations for ethically sound research that are today most used. Challengingly, is it not always clear when something should be considered research. Contrary to medical innovation, (neuro)surgical innovation does neither take place in a very structured manner nor is there much oversight or clear equipoise. This makes introduction and evaluation of novel treatments and devices less straight forward. To improve research in surgery, the IDEAL collaboration proposed a framework that described the stages of innovation and provides suggestions for methodologically and ethically sound studies at each stage. Because of the increased use of Big Data, facilitated by Electronic Health Records, the way research takes place is changing. Indeed, data collection, analysis, etc. take more and more place as part of standard care with the goal to improve care delivery. The Institute of Medicine proposed that health systems should evolve into a "Learning Health System. " In this system, the sharp distinction between care and research will be less evident and there is a moral focus on learning. These characteristics require a different normative framework, with obligations not only for the researcher and physician, but also the patient. Innovation and evaluation will continue to change and hopefully improve the way neurosurgical patients are treated. If followed, the codes, reports, and frameworks highlighted in this chapter will ensure that innovation and evaluation take place in an ethically sound manner to protect and support patients, neurosurgeons, and scientists.