Ownership rights to tissue donated for research end when the tissue leaves the body, as does all claim to benefit from commercial cell lines or other products derived from the tissue.
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.
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.
Drs Lynne Fehrenbacher and Leah Leonard-Kandarapally join Ethics Talk to discuss key roles of infectious disease pharmacists in antimicrobial stewardship.
The conventional quality-adjusted life years approach to resource allocation has greater societal value if it is distributed among many rather than concentrated on a few, assuming that severity of illness is the same.