Law No. 214 of 2020, regulating clinical medical research aims to lay the foundations, standards, and controls necessary for conducting clinical medical research, and to protect respondents, whether such research is preventive, diagnostic, curative or non-curative, invasive or non-intrusive. These researches are required to adhere to The provisions of relevant laws, charters and regulations, provided that they are consistent with recognized international ethical standards and principles, which the Council of Ministers approved a draft decision to issue the executive regulations of the law.
This approval comes in what regulates the conduct of such medical research that is private to humans, within a framework of adherence to local and international ethical standards and principles and recognized good medical practice.
The law stipulates that medical research may not be limited to a certain group of people or groups entitled to additional protection unless the research is necessary and related to their own diseases, and with the availability of scientific and ethical justifications for their use, provided that the informed consent of each of them is obtained. If the medical research is on one of the categories entitled to additional protection, consent must be obtained from the parents, or whoever has the guardianship or guardianship in the event of the death of one or both parents, or from the legal representative, all in accordance with the controls and procedures determined by the executive regulations of this law.
They mean the groups most affected by coercion or exploitation, due to the restriction of their will to give informed consent due to lack of or lack of capacity, cognitive impairment or health status.
Among the conditions that must be observed in conducting medical research are obtaining all the approvals required of it according to the nature and type of medical research, supervising the implementation and financing of medical research from its inception to its completion, setting mechanisms for monitoring performance and its quality and ensuring the extraction, documentation and announcement of medical research results, and all of that According to the approved study protocol, and in accordance with good medical practice, in addition to submitting periodic reports to the competent institutional committee and the Supreme Council on how medical research is progressing and its financing, as the case may be.
