Institutional review boards (IRBs) have the responsibility to ensure the protection of human-research subjects and are legally liable if they fail to do so.
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.
Clinical trials for the blood substitute PolyHeme exposed the possibility for ambiguous interpretation of the FDA’s waiver of informed consent for emergency research.
Two physicians offer commentaries about the use of prenatal predictive testing for a late-onset disease like Huntington's and question whether the pregnant woman should ultimately have the decisional autonomy to determine the quality of life of the unborn child.