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.
Physicians have a responsibility to assess elderly patients for conditions that could affect their ability to drive safely and to be familiar with state laws that govern physician duty to report impaired drivers.
Physicians have a professional obligation and, in many states, a legal duty to report drivers whose functional or cognitive impairments may pose a safety hazard.
State laws often require physicians to report suspected abuse and assault, creating a dilemma for physicians who must not only treat the injured patient but act as an informant to police.
Clinical trials for the blood substitute PolyHeme exposed the possibility for ambiguous interpretation of the FDA’s waiver of informed consent for emergency research.