Posted by Iman Ali
Sunday, 09 April 2023 02:00 AM
Law No. 214 of 2020 aims to issue a law regulating clinical medical research, to establish the foundations, standards, and controls necessary to conduct clinical medical research, and to protect the respondents, whether these researches are preventive or diagnostic, therapeutic or non-therapeutic, interventional or non-invasive, and it is required in this research that Adhere to the provisions of relevant laws, charters and regulations, provided that they are consistent with recognized international ethical standards and principles.
The executive regulations of the law dealt with the controls for suspension and early termination of medical research, by stipulating that the principal investigator must inform the sponsor of the research, the institutional committee, the Egyptian Medicines Authority, and the Supreme Council – each in its own jurisdiction – of the occurrence of any serious side effects that threaten the safety of the respondent and the measures taken to protect the respondent. Within 24 hours at most from the date of its occurrence, provided that all information, data and reports related to the case are made available within 7 days of the date of its occurrence, and with regard to side effects, a report must be submitted to the aforementioned authorities within 7 days of the date of its occurrence.
And she emphasized that in the event that the respondent was exposed to side effects, serious side effects, or damages that were not expected at the time of approval of the research plan (protocol) or to an improper medical practice, the main researcher, the sponsor of the research, the research body, the relevant institutional committee, and the Egyptian Medicines Authority must all With regard to him, and according to each case, take the necessary measures to ensure the safety and protection of the respondents, provided that immediate written notification is made to the Supreme Council, in order to issue the necessary decisions in this regard in accordance with Article (11) of these regulations.
The main researcher and the sponsor of the study are also obligated to notify the participating respondents and the rest of the parties referred to in the previous paragraph in writing of these procedures, and a committee or more for grievances was formed, by a decision of the President of the Supreme Council.
