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.
Clinical trials for the blood substitute PolyHeme exposed the possibility for ambiguous interpretation of the FDA’s waiver of informed consent for emergency research.
Dr Ellen L. Edens joins Ethics Talk to discuss her article, coauthored with Drs Gabriela Garcia Vassallo and Robert Heimer: "How Should the Use of Opioids Be Regulated to Motivate Better Clinical Practice?”