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Special procedures for conducting clinical studies on people with additional protection

The law governing clinical medical research aims to lay the foundations, standards and controls necessary to conduct clinical medical research and to protect respondents, regardless of whether such research is preventive or diagnostic, curative or non-curative, interventional or non-invasive .

These researches are required to comply with the provisions of laws, statutes and regulations on the subject, as long as they are consistent with recognized international ethical standards and principles, all as indicated by the executive regulations of this law.

Below, we review the special procedures in case of medical research conducted on persons entitled to additional protection, in order to further secure their rights.

According to the law

Medical research cannot be restricted to a particular group of people or groups entitled to additional protection unless the research is necessary and related to specific diseases and with the availability of scientific and ethical justifications for their use, provided that the informed consent of each of them is obtained and if the medical research is Any of the categories entitled to the additional protection must obtain the consent of the parents, or those who exercise their guardianship or protection in the event of the death of one or of both parents, or by the legal representative, all according to the controls and procedures provided for by the regulations implementing this law.

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