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Features of legal regulation when creating a database of international medical research for neurological and neurosurgical patients

https://doi.org/10.56618/2071-2693_2023_15_4_48

EDN: CFZQWP

Abstract

Scientific research begins with the collection of information on the subject, its systematization, which helps to come to conclusions on the issue under study. All the data obtained in this case are usually distributed in a format convenient for their detailed study, which is represented by a database (Db). When creating common databases for conducting medical research in the field of neurology and neurosurgery, taking into account the peculiarities of storing personal information, the legal aspects of both parties involved must be taken into account.

PURPOSE OF THE STUDY: to study individual problems of forming a database for conducting medical research in the field of neurology and neurosurgery, taking into account the peculiarities of storing personal information, as well as to find an approach to combining common applied concepts for conducting joint scientific research in Russia and the Republic of Belarus.

MATERIALS AND METHODS: the material for the study was the study of problems that influence the formation of the concept of a database for the purpose of conducting medical research in the field of neurology and neurosurgery, taking into account the peculiarities of saving patients’ personal data. The methodological basis of the research is the general scientific method, the method of formal logic and system analysis, synthesis, induction, the method of description and comparison.

RESULTS: when studying various databases, a number of features were systematized, which made it possible to highlight a number of common aspects. One of such system-forming aspects is the nature of the stored information. Another aspect is the way the database information is stored, which can have a decisive impact on the possible options for storing the personal data of patients participating in scientific medical projects. A distributed database operates in a local and global network. In these cases, fragments of the database may be stored on different computers or servers, which may be in conflict with the Federal Law “On Information, Information Technologies and Information Protection” (No 5 st. 4 of the Law on Information, Informatization and Information Protection of the Republic of Belarus, which must be strictly observed when planning and creating scientific projects. In neurological and neurosurgical practice, the method of morphological research is now widely used. This method is associated with a number of limitations when creating a database, since it has its own characteristics that are directly related to compliance with the Federal Law «On Information, Information Technologies and Information Protection» (dated July 27, 2006 N 149-FZ in the latest edition), and also from par. 5 st. 4 of the Law on Information, Informatization and Information Protection of the Republic of Belarus when planning joint projects. A rather serious help in the implementation of the above laws is a confidential consent, which must be filled in by patients participating in planned projects. It must be developed for both sides of the Union State, combining our capabilities and observing all conditions.

CONCLUSION. When studying certain problems of creating a database for conducting medical research in the field of neurology and neurosurgery, taking into account the peculiarities of storing personal information for conducting joint scientific research in Russia and the Republic of Belarus, the main areas of work were identified to create comfortable conditions when working on joint projects. An important area of   work is the creation of equal conditions in the creation of information resources of a medical institution, which includes the operation of an automated corporate database that includes information from patients’ medical records, data on the volume and nature of the medical care provided to them. Due to the constant increase in the information being processed at the moment, databases widely used in neurology and neurosurgery should be created taking into account the legal regulation of information relations, which will become the starting point for creating the scientific potential of joint interstate projects, which are the new reality of our time.

About the Authors

K. A. Samochernykh
Russian Research Neurosurgical Institute, them. A.L. Polenov FSBI “NMITs im. V.A. Almazov” of the Ministry of Health of Russia
Russian Federation

Konstantiin A. Samochernykh.

St. Petersburg



N. E. Ivanova
Russian Research Neurosurgical Institute, them. A.L. Polenov FSBI “NMITs im. V.A. Almazov” of the Ministry of Health of Russia
Russian Federation

Natalya E. Ivanova.

St. Petersburg



Yu. M. Zabrodskaya
Russian Research Neurosurgical Institute, them. A.L. Polenov FSBI “NMITs im. V.A. Almazov” of the Ministry of Health of Russia
Russian Federation

Yulia M. Zabrodskaya.

St. Petersburg



T. V. Zhukova
MITSO
Belarus

Tatsiana V. Zhukova.

Minsk



A. V. Beletsky
Minsk Central Regional Clinical Hospital
Belarus

Aleksandr V. Belecky.

Minsk



Yu. G. Shanko
City Clinical Emergency Hospital
Belarus

Yriy G. Shanko.

Minsk



S. A. Likhachev
Republican Scientific and practical Centre for neurology and neurosurgery
Belarus

Sergey А. Likhachev.

Minsk



Ya. O. Kuznetsov
5th City Clinical polyclinic
Belarus

Yaroslav O. Kuznetsov.

Minsk



References

1. Vershinin V. V., Solovieva S. N. database evaluation in medicine // International Student Scientific Bulletin.— 2016. — No. 3–1; URL. tps://www.spinesurgery.ru (In Russ)

2. Law on the protection of personal data of July 27, 2006 https://pravo.by/document (accessed: 15.11. 22) (In Russ)

3. Law on the protection of personal data of May 7, 2021 No. 99-Z National Center for Legal Information of the Republic of Belarus 2003–2022 https://pravo.by/document (accessed: 15.11. 22) (In Russ)


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For citations:


Samochernykh K.A., Ivanova N.E., Zabrodskaya Yu.M., Zhukova T.V., Beletsky A.V., Shanko Yu.G., Likhachev S.A., Kuznetsov Ya.O. Features of legal regulation when creating a database of international medical research for neurological and neurosurgical patients. Russian Neurosurgical Journal named after Professor A. L. Polenov. 2023;15(4):48-52. (In Russ.) https://doi.org/10.56618/2071-2693_2023_15_4_48. EDN: CFZQWP

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ISSN 2071-2693 (Print)