Abstract
Research with human subjects is subject to stricter legal oversight than ordinary clinical care. Clinical trials funded by the federal agencies, as well as privately sponsored investigations testing products for FDA approval, fall under the core federal research regulations, known as the Common Rule, and must secure prior approval from a research review committee, the Institutional Review Board (IRB). The IRB will generally review a proposed study to ensure that it has acceptable risk/benefit ratios for the population involved and that subjects are protected from harm and exploitation. In addition, more detailed informed consent, including making expressly clear that the intervention is experimental, is required compared to what occurs in regular clinical care. Research studies may also trigger conflict of interest regulations, which generally require disclosure and possible other safeguards, when investigators have financial relationships with commercial entities sponsoring the study. Clinicians should proceed carefully when engaged in human subjects research as inadequate compliance can lead to clinical trial shutdowns at the home institution, professional discipline, and malpractice liability.
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Saver, R.S. (2022). Human Subjects Research. In: Pasha, A.S. (eds) Laws of Medicine . Springer, Cham. https://doi.org/10.1007/978-3-031-08162-0_32
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