Jennifer Aldrich, MD, Jessica Kant, MSW, LICSW, MPH, and Eric Gramszlo
Estelle v Gamble (1976) reiterates that the 8th Amendment to the US Constitution requires adequate care to be offered to all people who are incarcerated.
AMA J Ethics. 2023;25(6):E407-413. doi:
10.1001/amajethics.2023.407.
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.
The 2015 proposed changes to the Common Rule for human subjects research protections, which are a response to novel methods of data collection and analysis, clarify and broaden the scope of informed consent processes, identify exemptions, and make changes to Institutional Review Board requirements.
AMA J Ethics. 2015;17(12):1147-1151. doi:
10.1001/journalofethics.2015.17.12.hlaw1-1512.
Though there are channels through which terminally ill patients can access some experimental drugs that have not yet received FDA approval for marketing to the public, in general those drugs must already be proven safe and effective.
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.
Clinical trials for the blood substitute PolyHeme exposed the possibility for ambiguous interpretation of the FDA’s waiver of informed consent for emergency research.
An ethical case explores a lawsuit against Fred Hutchinson Cancer Center of Seattle by patients who claimed they were not told of the full risks associated with a clinical trial they participated in.