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.
Medical malpractice pits the legal system's ethics of client advocacy against the medical profession's ethics of patient advocacy. Fear of liability may lead to defensive medicine, an aberration of both professions' intent.
Patients need to be aware that they are fully responsible for disclosing a complete medical history, and physicians may not be liable for damages if they do not comply.
An ethical case explores a lawsuit against Fred Hutchinson Cancer Center of Seattle by patients who claimed they were not told of the full risks associated with a clinical trial they participated in.