Books – Hisham Abdel Jalil
The Law Regulating Clinical Medical Research prohibits the conduct of medical research from being limited to a specific group of people or to groups entitled to additional protection unless the research is necessary and is related to diseases specific to them.
The law stresses the need for scientific and ethical justifications to be available for seeking their assistance, provided that informed consent is obtained from each of them. If the medical research is on one of the groups deserving of additional protection, consent must be obtained from the parents, or from the person who has guardianship or guardianship in the event of the death of one of the parents or Both of them or the legal representative, all in accordance with the controls and procedures specified by the executive regulations of this law.
The law requires, before starting to conduct any medical research, that there be a protocol that has been reviewed and approved by the competent institutional committee, provided that its approval is final in matters other than clinical medical research referred to in the following paragraph.
The law requires the approval of the Egyptian Medicines Authority, and the approval and approval of the Supreme Council in the case of clinical medical research that includes the use of new medicinal or biological compounds, new indications for use, forms, medical supplies or devices that have not been used in the human body before, and have not obtained the approval of international bodies that These are determined by the executive regulations of this law, provided that they are tested in reference countries at the same time.
It is worth noting that the law aims to establish the foundations, standards and controls necessary to conduct clinical medical research and protect 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.
2024-03-06 05:00:00
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