Michael Toppe, DMSc, PA-C and Lushiku Nkombua, MD, MMed
American physician assistant students trained in South Africa to study an example of a reverse innovation practice that could be incorporated in the US.
AMA J Ethics. 2023;25(5):E332-337. doi:
10.1001/amajethics.2023.332.
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.
There are numerous state and federal laws designed to protect against misuse and diversion of prescription drugs that apply to patients' behavior, physicians' prescribing practices, and dispensing.
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.
The drug Neurontin is used as an example of why it is permissible for physicians to engage in off-label prescribing, but off-label marketing by pharmaceutical companies is prohibited by the FDA.
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.