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New Law Regulating Clinical Medical Research with Penalties for Non-Compliance

Law No. 214 of 2020 promulgating the Law Regulating Clinical Medical Research stipulates the penalty of imprisonment for anyone who conducts clinical medical research without obtaining the informed consent of the subject and the legal representative of the groups entitled to additional protection from the subjects and the approvals of the authorities specified in this law.

If this results in a permanent disability, the penalty shall be aggravated imprisonment, and the penalty shall be aggravated imprisonment for a period of not less than ten years if the aforementioned act results in the death of one or more people. The penalties vary depending on the number of victims.

Article 27 of the law also stipulates that both the principal researcher and the sponsor of the study shall be punished with imprisonment and a fine of not less than fifty thousand pounds and not more than five hundred thousand pounds if they do not comply with any of the provisions of Articles (18, 20) of this law.

Both the principal investigator and the research sponsor shall be punished with a fine of not less than ten thousand pounds and not more than fifty thousand pounds if they do not commit to providing the necessary medical care to any of the subjects during and after the medical research.

If the occurrence of the crime referred to in the previous paragraph results in side effects on the subject, the minimum and maximum limits stipulated in the previous paragraph shall be doubled.

However, if this results in serious side effects on the subject, the penalty shall be imprisonment and a fine of not less than one hundred thousand pounds and not more than five hundred thousand pounds, or one of these two penalties.

The penalties vary depending on the number of victims.

2023-12-15 01:00:00

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