2023-12-16 02:00:00
Samar Salama wrote Saturday, December 16, 2023 04:00 AM Text of the law Organizing clinical medical research To form institutional committees to review the ethics of clinical medical research, as Article 8 stipulates that a committee shall be formed within each research entity, by decision of the competent authority in that entity, a committee called the “Institutional Committee for Reviewing the Ethics of Medical Research,” and it is required that this committee be registered with the Supreme Council.
This committee is specialized in the following:
– Taking care of the rights, safety and health of the subjects.
– Review the research plans (protocols) submitted to it and ensure that they complete all the necessary papers, approvals and documents in this regard according to each case.
– Issuing a decision approving the conduct of medical research or renewing it, setting its duration to not exceed one year, and following up on it until its completion or expiration.
– Monitoring the principal investigator and the research sponsor, if any, to ensure that medical research is properly carried out and that good medical practice standards are applied.
The institutional committee must notify the Supreme Council of all research submitted to it, provided that the notification includes the medical research protocol and all documents and data related to it, as well as all the procedures taken by the committee in this regard.
All of this is as stated in the executive regulations of this law
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