Provision of Information to Patients and Protection During Reference Research Breast Carcinoma

Public health and the public health services organisation

 Solonitsina L.A. Sazonov S.V., Leontiev S.L.

Abstract.

This study was conducted to determine the mechanism for patients' rights to information and to ensure patient confidentiality when participating in the epidemiology program ML19870: Epidemiological screening program for HER2 status in patients with breast cancer. Relevance of research due to the adoption of the Federal Law №323-FZ of 21.11.2011. «On the basis of health protection in the Russian Federation» (hereinafter referred to as the Federal Law №323-FZ) and thus making a change in the practice of the medical practice. Since the protocol epidemiological program ML19870 in 2 version dated 20 January 2010. the analysis of his action at the present regulations, and draw conclusions about the need for informed consent of patients to be included in the program and provide epidemiological measures to protect the information in the medical secret.

Key words:

clinical trials, the right to information, informed consent, patient confidentiality, personal data.

Authors:

Solonitsina Lyubov А.

Leontev Sergey L.

GBUZSO Center providing specialized types of medical care, «Institute for Medical Cell Technologies», Ekaterinburg,

Russia, 620036, Ekaterinburg, Soboleva str., 25.

Sazonov Sergey V.

GBOUHPE Ural State Medical Academy of Health Ministry of Russia, Ekaterinburg,

Russia, 620028, Ekaterinburg, Repina str., 3.