ORIGINAL RESEARCH

Ethics and legal regulation of using large databases in medicine

Orlova NV1,2, Suvorov GN3,4,5, Gorbunov KS2
About authors

1 Pirogov Russian National Research Medical University, Moscow, Russia

2 Scientific Research Institute of Systemic Biology and Medicine of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing, Moscow, Russia

3 Federal Medical and Biological Agency, Moscow, Russia

4 Russian Medical Academy of Continuous Professional Training, Moscow, Russia

5 Moscow State Legal University named after Kutafin OE, Moscow, Russia

Correspondence should be addressed: Natalia V. Orlova
ul. Ostrovityanova, 1, Moscow, 117997, Russia, ur.xednay@513hcarv

About paper

Financing: The work was performed by the authors at the Federal Budgetary Institution of Science Research Institute of Health and Safety Management of Rospotrebnadzor within the framework of the state assignment ‘Development of methods for molecular genetic diagnostics for quantification of sanogenesis in healthy people’, code of the scientific topic ‘Norma’, number of state registration of research, development work in Unified State Information System for Accounting Research, Development and Technological Works for Civil Use 122030900062–5.

Author contribution: Orlova NV — analysis of scientific data, review of publications related to the topic of the article, making an abstract, writing an article text; Suvorov GN, Gorbunov KS — developing the article design, article editing.

Received: 2022-07-26 Accepted: 2022-08-23 Published online: 2022-12-05
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Use of information technologies in medicine resulted in formation of large databases. Analysis of large databases allows to reveal the patterns between the environmental conditions, a way of life and morbidity, that promote a progressive study of pathogenesis, clinical course, disease prognosis, and accelerate clinical trials of novel treatment options. Large databases are most in demand in bioinformatics and biomedicine. The issues of using large databases are associated with a number of ethical issues such as confidentiality, informed consent, and privacy. Ethical issues of using personal medical data were reflected in international documents. The use of large databases is associated with a dilemma of legislative protection of patients’ rights, on the one hand, and a decrease in analytical capabilities of using the data, on the other hand. Several methods of medical data safety are suggested to prevent identification of patients. Depersonilized data belong to one way of solving the issues. The options of studying secondary medical data are being discussed.

Keywords: biomedical ethics, large database, informed consent legal regulation

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