Clinical trials for the blood substitute PolyHeme exposed the possibility for ambiguous interpretation of the FDA’s waiver of informed consent for emergency research.
When evaluating the developments and complications of a marginally viable premature infant, physicians and parents must work together to decide on treatment that is in the infant’s best interest.
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.
Physicians should seriously weigh the benefits and risks involved prior to discussing the possibility of genetic testing with a patient or referring them to a genetic counselor.
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.
Two bioethicists argue that prenatal disability screening promotes negativity toward the disabled and gives parents the ability to selectively form families.
A philosophy professor argues that prenatal genetic testing allows potentially painful afflictions to be discovered prior to birth and does not unjustly discriminate against disabled people.