Features of conducting ethical review of research on artificial intelligence systems on the basis of the research and practical clinical center for diagnostics and telemedicine technologies of the Moscow Health Care Department, Moscow, Russian Federation

Ethical issues occupy a special place when conducting clinical trials of medicines, where it is impossible to predict in advance and accurately the effectiveness and safety of a new drug on the human body. Currently, during clinical trial examination, attention is paid to patients’ quality of life, and issues of compliance with patients’ rights, as well as compliance with the rules of good clinical practice and current legislation. Thanks to technological development, the number medical studies and devices using, among other things, specialized medical technologies and software is increasing.

Automation, development, improvement, and structuring of the processes involved cause an increase in the use of technical devices that use not only programs but also systems in their work. Artificial intelligence system software have a special place in medical science development.

Artificial intelligence, which was the field of science fiction 50–80 years ago, is now firmly embedded in our everyday life. By introducing artificial intelligence’s capabilities into medical software, using it as part of medical equipment, and developing medical devices with artificial intelligence systems, we get a product that requires careful study and further development, which includes a complex of works on conducting scientific research, and registration and maintenance of such systems and complexes. All work is regulated by legislation in the field of circulation of medical devices and requires a deep systematic and scientific approach, including involving ethics to monitor compliance with the rights and safety of study participants and their medical data.

The Ethics Committee is an independent body that monitors compliance with the rights and requirements of legislation and conducts ethical and scientific examination of research documentation. Ethical issues when planning any research involving a person or his/her data should be discussed and considered in detail. The ethics committees should be contacted not only at the stage of approving research materials, but also when planning the design and developing research documentation and materials for patients, as well as regularly at all stages of the study.