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.
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.
U.S. courts have ruled that device manufacturer representatives’ presence in the operating room does not make them responsible for the supervision of physicians or liable for the practice of unauthorized medicine.
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.