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Law No. 214 of 2020: Regulating Clinical Medical Research and Protecting Subjects

Written by Kamel Kamel Sunday, October 8, 2023 08:00 AM

Law No. 214 of 2020, promulgating the Law Regulating Clinical Medical Research, aimed to establish the foundations, standards, and controls necessary for conducting clinical medical research, and protecting subjects, whether this research is preventive or diagnostic, therapeutic or non-therapeutic, interventional or non-interventional. This research is required to adhere to the provisions of relevant laws, charters and regulations, and to be consistent with recognized international ethical standards and principles. All of this is as stated in the executive regulations of this law.

Article Three of the law prohibits conducting medical research on a specific group of people, as it stipulates: “The conduct of medical research may not be limited to a specific group of people or to groups entitled to additional protection unless the research is necessary and related to diseases specific to them, and with The availability of scientific and ethical justifications for seeking their assistance, provided that informed consent is obtained from each of them. If the medical research involves one of the groups deserving of additional protection, approval must be obtained from the parents, or from the person who has guardianship or guardianship in the event of the death of one or both parents, or from the legal representative. All of this is in accordance with the controls and procedures specified by the executive regulations of this law.

2023-10-08 05:00:00

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