The law governing medical-clinical research punished with imprisonment and a fine of no less than fifty thousand lire and no more than five hundred thousand lire, both the principal researcher and the promoter of the study in the event of non-compliance with any of the provisions of art. 18 and 20 of this law.
Article 18 states:
Subject to the provisions of article (4) of this law, the principal investigator, while conducting medical research, must comply with the following:
Commitment to conduct medical research in the research organization, attending and supervising it regularly, as is customary in this field.
Adhering to relevant laws and regulations and applying the principles of good medical practice as well as agreed local and international standards in this regard.
The medical research department according to the research plan (protocol) obtained with the approval of the competent authorities, as appropriate.
Do not make changes to what is indicated in the research plan (protocol), unless after obtaining, as appropriate, the approval of the competent authorities.
Notify the respondent of any changes that will be made to the research plan that could affect his safety, as well as inform him of any unforeseen risks that may occur to him during the medical research or to other participating participants.
Adopt the necessary measures aimed at protecting the life, physical and psychological health and dignity of the subject, as well as limiting the side effects of medical research, including by making changes to the research plan in case of serious side effects that threaten the safety of the patient. subject. in this case, the principal investigator must inform the medical research sponsor and the committee.The institution, the Egyptian Medicines Authority and the Supreme Council, each under their own jurisdiction, of the occurrence of these effects and the measures taken to protect the defendant, within twenty-four hours at the latest.
Retain documents relating to medical research in the institution in which it is conducted, and with any sponsor of the medical research, and take the necessary measures to prevent the loss or destruction of such documents.
– Commitment to publish the result of medical research in one of the specialized scientific journals after its completion.
– Provide necessary medical care to participating respondents after medical research has been completed, as appropriate, whenever it becomes clear to them that any dangerous side effects or side effects associated with them have occurred and informs participating respondents of their need these treatments, all in order to reduce the damage of these effects. All this according to the procedures provided for by the management regulations of this law.
