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Drug Discov Today. 2019 Nov;24(11):2116-2119. doi: 10.1016/j.drudis.2019.07.001. Epub 2019 Jul 6.

Regulatory sanctions for ethically relevant GCP violations.

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Centre for Medical Ethics, Institute of Health and Society, University of Oslo, Oslo, Norway. Electronic address:
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, The Netherlands.
Medicines Evaluation Board, Utrecht, The Netherlands.


Although EU inspectors and clinical assessors are mandated to identify and act upon ethical issues, regulators lack guidance on how this can be done. Hence, we propose a four-step regulatory approach on ethically relevant GCP violation findings. The first step is identification of the ethical issue. Next is analysis [i.e., identifying the gravity (intensity or severity) and the magnitude (amount and duration) of the ethics violation as well as the responsible person(s) or entity or entities]. The third step is evaluation, (i.e., the process of deliberating to determine the significance of the ethics violation, with the intention of identifying the most reasonable sanction and/or corrective or reparative action). Last is decision-making or the process of choosing and implementing a regulatory course of action.

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