The use of clinical databases in disease outcomes research: Is the ethics of IRB review keeping up?

Abstract

There is a perceived tension in research ethics between protecting the interests of participants and promoting good research as a societal good. The challenge of balancing the potential benefits of large clinical databases for disease outcomes research while protecting patients’ privacy and confidentiality is an example of this dynamic. What is new about this tension in the context of “data warehousing” is the conflation of many differing interpretations of relevant ethics terminology, the proliferation of different kinds of databases, as well as the growth of research on a global level without the requisite harmonization of regulatory frameworks. The evolution of electronic medical records, the blurring of lines between clinical care and research in some rare orphan diseases, the growing trend to advocate for patient-centered research, and the advent of “open science” to facilitate global research initiatives have also contributed to challenging the existing norms for degrees of consent to this kind of research.