الحماية القانونية لحقوق المبحوثين في ضوء القانون المصري 214 لسنة 2020

Abstract EN

Law No.

214 of 2020 sets the foundations, standards, and controls necessary for conducting clinical medical research.

The law also provides for means of protecting the rights of respondents, and this protection was represented in some procedural and objective rules, in all clinical medical research, whether this research is preventive, diagnostic, curative or Non-therapeutic, invasive or non-invasive.

The law dealt with the controls for starting medical research, whether in the case of using medicinal compounds for the first time, or using medical supplies and devices that were not used in the human body before.

The competent authority, and that its consent is final in cases other than clinical medical research.

He also stressed the need to obtain the approval of the Egyptian Medicines Authority, and the approval and accreditation of the Supreme Council in the case of clinical medical research that includes the use of novel or biological pharmaceutical compounds, new indications for use, or forms, supplies or medical devices that have not been used in the human body before, and the legislator required a survey The opinion of the General Intelligence Service in the case of research conducted with foreign bodies and joint global studies, and a survey of the opinion of drug control bodies and other concerned parties The legislator also specified a period of time in which all procedures would be completed, from the date of completing the documents and informing the assigned authorities, which is sixty days from the date of notification to these authorities.

Key words: Medical research - clinical - respondents - the human body - informed consent