Personal Data and Informed Consent in Clinical Trials

Emergency Decree No. 746/2017 and Decree No. 899/2017 named the Agency as the controlling authority of Data Protection Law No. 25,326, in replacement of the National Directorate of Data Protection (the “Directorate”) (more information here).

Recently, the Agency issued Rule No. 1-E/18, which revoked Directorate Rule No. 6/08. Rule No. 6/08 had established a procedure through which the Directorate verified the consent forms signed by individuals participating in clinical trials which require the approval of the National Authority for Drugs, Food and Medical Technology (the “ANMAT”).

In deciding to remove this procedure, the Agency took into account the existence of ANMAT Rule No. 667/10, which approved a framework of good practices related to clinical trials. It held that this regulation sufficiently protects the personal rights of the data subjects.

In addition, the Agency established that the Directorate’s practical experience demonstrated that the procedure set by Rule No. 6/08 slowed down medical investigation, while providing no further safeguard to personal data.

Therefore, and taking into account the national policy of de-bureaucratization established by Decree No. 891/17, the Agency concluded that the verification of informed consent for medical trials subject to ANMAT’s approval implied an unnecessary bureaucratization of an important administrative process.