Institutional review boards (IRBs) have the responsibility to ensure the protection of human-research subjects and are legally liable if they fail to do so.
A hypothetical clinical case discusses patient demand for advanced diagnostics such as MRIs when physicians do not recommend such tests. Better patient education is the suggested approach.
Mark T. Hughes, MD, MA and Bimal H. Ashar, MD, MBA
Physicians are urged to evaluate an asymptomatic patient's request for CT screening and use the opportunity to educate the patient and determine the course of action that is in the patient's best interest.
Clinical trials for the blood substitute PolyHeme exposed the possibility for ambiguous interpretation of the FDA’s waiver of informed consent for emergency research.