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.
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.
The current Medicare operation—reimbursing medical goods and services to a growing number of people without basing the reimbursement benefit on the actual cost of the services—is unsustainable, but there are some possible remedies.
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.