The Clinical Research Law, known in the media as “Clinical Trials”, which President Abdel Fattah El-Sisi recently ratified and published in the Official Gazette, established regulations for conducting medical research. In Article Three it was stipulated that the conduct of medical research may not be limited to a specific group of people or to The groups deserving of additional protection, unless research is necessary, related to diseases of their own, and with the availability of scientific and ethical justifications for their help, and provided that the informed consent is obtained from each of them.
And if the medical research is on one of the categories deserving of additional protection, consent must be obtained from the parents or whoever has 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 specified by the executive regulations of this law.
The law defines the groups eligible for additional protection as “the respondents who are most affected by coercion or exploitation due to the restriction of their will to give informed consent due to lack or lack of capacity, cognitive impairment or health status.”
The law defines informed consent as “the written expression based on free and fully voluntary will that is issued by a person with full capacity and includes his explicit consent, a signature and a fingerprint to participate in clinical medical research after being informed and enlightened of all aspects of this research, and in particular the potential effects or dangers that may affect his decision. With participation, this approval is issued by his legal representative in the cases referred to in the provisions of this law.