Law No. 214 of 2020 promulgating the Law on Regulating Clinical Medical Research aims to lay down the foundations, standards and controls necessary for conducting clinical medical research and to protect respondents, whether this research is preventive, diagnostic, curative or non-curative, interventional or non-intrusive.
In the following, we review a number of obligations that the sponsor of medical research must observe.
Subject to the provisions of Article (4) of this law, the sponsor of the medical research is obligated to do the following :
– Obtaining all the required approvals according to the nature and type of medical research .
– Supervising the implementation and financing of medical research from its inception until its completion .
– Establishing mechanisms for monitoring performance and quality and ensuring that medical research results are extracted, documented and announced, all in accordance with the approved study protocol, and in accordance with good medical practice .
– Submit periodic reports to each of the competent institutional committee and the Supreme Council on how the medical research is conducted and its funding, as the case may be .
– Editing the agreements that he concludes with all parties to the medical research, provided that he includes them in the medical research file .
– Maintain in himself and in the database of medical research in the Supreme Council in the Arab Republic of Egypt all the main documents and private data related to medical research, after publishing their results .
– Provide medical intervention to respondents participating during and after the end of the medical research, according to each case and in whatever form it was, as well as transporting, preserving and storing it in appropriate safe ways. .
– Immediately inform the respondents participating in the medical research, and promptly, of any modifications made to it and of any results that may negatively affect the safety of the participating subjects, as well as the serious unexpected side effects of medical research. .
– Commitment to conclude an insurance contract for respondents participating in medical research with one of the insurance companies accredited in the Arab Republic of Egypt in order to face any damages that may occur to any of them that may result from participating in medical research. And so that it is valid for a year after the completion of the medical research, and that the value of this insurance is approved by the Supreme Council .
– Compensation and treatment required for respondents involved in case of infection related to medical research .
– Completion of treatment for those of the participating respondents who prove their need for this even after the end of the medical research.
All this is as determined by the executive regulations of this law.