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.
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.
Amy B. Cadwallader, PhD, Kavitha Nallathambi, MPH, MBA, and Carly Ching, PhD
Poor-quality antimicrobial medicines continue to proliferate across supply chains, threatening patients’ health and safety, especially in low- and middle-income regions.
AMA J Ethics. 2024;26(6):E472-478. doi:
10.1001/amajethics.2024.472.
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.