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.
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.
Research is often conducted without the knowledge or consent of those whose tissues are banked and poses possible harms to social groups if information about a few members is unscientifically applied to all.
Volk v DeMeerleer may conflict with professional guidelines regarding physicians’ obligations to breach patient confidentiality to protect third parties.
AMA J Ethics. 2018;20(1):10-18. doi:
10.1001/journalofethics.2018.20.1.peer2-1801.
Federal regulations governing egg donation fall into two categories: safety testing and truth in advertising. Neither deals directly with informed consent by, for example, specifying what information donors must be given.
Developing technologies for personalized medicine may be misused to popularize the idea that one can infer a person’s genetic makeup from observer-defined or self-reported assignment to a race or ethnic group.
Some commentators say comparative trials of FDA-approved drugs are overburdened by current Common Rule regulations and that researchers should not be required to obtain explicit consent for participation in the most innocuous of these trials.