By Miller, F. G.
Observational research involving access to personally identifiable data in medical records has often been conducted without informed consent, owing to practical barriers to soliciting consent and concerns about selection bias. Nevertheless, medical records research without informed consent appears to conflict with basic ethical norms relating to clinical research and personal privacy. This article analyzes the scope of these norms and provides an ethical justification for research using personally identifiable medical information without consent.
Miller, F. G. (2008), Research on Medical Records Without Informed Consent. The Journal of Law, Medicine & Ethics, 36: 560â€“566. doi: 10.1111/j.1748-720X.2008.304.x