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.
Explanation of the Medicare and Medicaid Antikickback statute and Stark Law and their restrictions on physicians' financial interests in ancillary services.
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.
Richard L. Kravitz, MD, MSPH and Jodi Halpern, MD, PhD
Patients have a responsibility to discerningly present the drug information they receive from direct-to-consumer advertising and to be active partners with their physician in making health care decisions.
Physicians are cautioned that the two obstacles to reforming post-marketing clinical trials are the FDA's reluctance to revisit past approvals and its inability to enforce pharmaceutical companies' commitment to conduct Phase IV trials.
A physicians urges practitioners to use cost-effective alternatives to dispensing samples to patients who cannot afford to pay for their prescriptions.