Specific advocate guidelines are needed for the protection of children in state custody who are potential research subjects in trials that would expose them to greater-than-minimal risk but also hold the prospect of direct benefit.
In “Ethics of International Research: What Does Responsiveness Mean?” Christine Grady explains how developing countries are vulnerable to exploitation by researchers and explores what “responsiveness” to the needs of those populations might entail.
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 have a professional obligation and, in many states, a legal duty to report drivers whose functional or cognitive impairments may pose a safety hazard.
A physician defends her position that children should only participate in clinical trials when they have child assent and the parents also have been educated about the purpose of the research when there is no direct benefit to the child.
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.