Does a surgeon’s complication rate in a randomized controlled trial constitute a “significant new finding” that must be reported to patients during the consent process?
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.
Physicians’ ethical obligations to disclose conflicts of interest to patients and to obtain their informed consent for treatment are particularly critical when proposed treatments are experimental.