Rose Gaiteiro

Historically, the field of research ethics analyzes the ethical and legal questions raised by research involving human subjects. Its main focus is to ensure that study participants are protected and that clinical research is conducted in a way that serves the needs of participants and society as a whole. The role of Research Ethics Boards (REBs) is to ensure that projects are reviewed and evaluated based on risk and that the study protocol adheres to the principles that govern the ethical conduct of research involving humans. But, what do we do if there is no protocol? No hypothesis? The use of Artificial Intelligence and machine learning is a rapidly advancing field in healthcare. The use and analysis of large scale data in healthcare research is beginning to challenge REBs to look at how they judge the ethical consequences of scientific research using big data. What are the risks? What about consent? What are the biases and are they different? The traditional REB review framework may not be applicable and the questions are many. So what do we do? We need to challenge ourselves to think outside the box and develop a new framework to evaluate these types of studies while maintaining the foundational principles of research ethics. Keywords: Legal, society, new framework for ethics