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

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SCIENTIFIC STUDIES: GOALS, STAGES, AND MARKETING AUTHORIZATION

An ethical review is mandatory for all scientific studies involving human subjects or their health-related data. The objective of the ethical review is to protect rights and confidentiality of study subjects while ensuring compliance that all legal requirements are met.

Not only drug products are subject to in vitro and in vivo research. Studies with medical devices are also increasingly involving human subjects or their health information.

Toxicological tests, technical tests, and other stages of research are mandated by law before medical devices can be registered. But what about software?

The software shall undergo evaluation by certain types of studies that the regulator (Federal Service for Supervision in Healthcare of Russia) uses to decide whether to approve or refuse a marketing authorization. A regulatory dossier includes a Clinical Study Report. Clinical trials of medical devices are performed mainly in special healthcare institutions and involve patients as study subjects. As we all recall, human research participation is possible only if there are document for the planned study, which is considered by the Ethics Council with granting permission for conducting the study based on council’s approval.

THE SIGNIFICANT ROLE OF ETHICS COMMITTEES AS IN THE CASE STUDY OF THE INDEPENDENT ETHICS COMMITTEE OF THE MOSCOW ORGANIZATION OF THE RUSSIAN SOCIETY OF ROENTGENOLOGISTS AND RADIOLOGISTS

A local (independent) ethical committee (IEC) of a study site reviews all materials when obtaining the study permission. Studies are typically prospective in design, and ethical committees play the significant role in conducting such studies. Based on the study results, the IEC may refuse to approve the study. For example, if there are patient safety risks, based on interim safety reports, the national ethics committee has the right to suspend the study in the site.

Studies using artificial intelligence (AI) systems are included in separate dossier block. For most AI-based studies, it is acceptable to use a retrospective design with existing databases.

Ethical issues are not clearly regulated in AI-based studies, but ethical committees are usually aware of planned retrospective studies. Although this approach does not violate any applicable laws and regulations, it involves some risks that are better to be minimized. When dealing with a patient database, it is necessary to anticipate risks of data leak and personal patient identification, as well as to obtain sufficient high-quality data for further analysis.

In Russia, not all ethical committees review AI-based studies. However, in 2019, the Scientific and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department (SPCCDTT) hosted an independent ethics committee of the Moscow Regional Branch of the Russian Society of Roentgenologists and Radiologists (RSRR MRB IEC) with the primary goal to implement good research practices for AI-based studies.

The RSRR MRB IEC has reviewed 45 studies; 60% of them were initially did not receive approval due to design errors. In just 3 yr, we managed to reduce the number of refusals to 10% using an individual approach to each application and standardizing documents and processes consistently and systematically.

Each IEC expert has more than 5 yr of research experience and has received training in good clinical practice. We evaluate study designs, including those that are retrospective, paying close attention to data security issues, data use, and possible risks, the process of obtaining data, and their storage and processing.

Due to the rapid scientific progress and wide opportunities for AI system application, the deeper approaches should be used when planning such studies for ethical analysis and assessment of potential risks. In SPCCDTT, all studies are initially (at the planning stage) considered by an IEC, regardless their design. Information on study progress is submitted at least once a year. The study is supervised by the Principal Investigator, who is also considered by the IEC.

In addition to reviewing studies, the ethics committee is responsible for peer review of scientific work of SPCCDTT members. For each paper, the IEC prepared a review and a list of recommendations, assisting authors in avoiding errors before submitting the manuscripts for publication. Therefore, the IEC is an additional scientific supervisory body, which helps authors to improve the quality of their publications for top-rated journals.

The world’s leading scientific journal do not consider manuscripts without the approval of the ethical committee. The modern scientific world places high priority on protecting patient rights, data security, confidentiality, and legitimacy of materials submitted for publication. Not only researchers are responsible for data accuracy, but also ethical committees that approve studies and review manuscripts.

The RSRR MRB IEC experts thoroughly check all documents provided by applicants. Our researchers request that we review and approve their studies. We carefully analyze documents, including at least a study plan, informed consents of patients, and curriculum vitae of the principal investigator. To avoid possible errors when conducting the study and interpreting results, we check each document and, together with the applicant, adjust the work plan.

In most documents submitted, we note the lack of the randomization process description or the lack of randomization step in controlled trials, as well as the small size of population and incorrect patient selection criteria. Special attention is paid to an informed consent because its content directly affects the rate of enrollment.

Our help is requested by graduate students and candidates for degrees. A potential thesis is comprehensively analyzed. We take into account the study’s abstract, scientific content, originality, and practical relevance. We check if the research plan reflects study goals and methods. We analyze patient data, its storage and transfer, its confidentiality, and the protecting rights of study subjects.

When reviewing documents for AI-based studies, we carefully check reference data sources, processing algorithms, and ways of health information storage and transfer. We also consider potential risks for patients and study integrity in case of partial or complete loss of data.

CONCLUSION

In addition to the comprehensive analysis of documents submitted, the ethics committee give advice on improving manuscripts for their subsequent publication in top-rated journals.

The main principle of the IEC is to comply with good research practices at each stage of the study.

The IEC provides ethical support for scientific and clinical trials of drug products and medical devices.

We are open for collaboration with candidates, graduate students, researchers, and third-party applicants.

We are always ready to help in conducting high-quality clinical and scientific studies.

ADDITIONAL INFORMATION

Funding source. This study was not supported by any external sources of funding.

Competing interests. The authors declare that they have no competing interests.

Authors’ contribution. All authors made a substantial contribution to the conception of the work, acquisition, analysis, interpretation of data for the work, drafting and revising the work, final approval of the version to be published and agree to be accountable for all aspects of the work.

O.I. Pchelintseva — literature review, analysis of literary sources, writing of the text of the article

O.V. Omelyanskaya — literature review, analysis of literary sources, correcting the article

About the authors

Olga I. Pchelintseva

Author for correspondence.
Email: ethics@npcmr.ru
ORCID iD: 0000-0002-6442-1360
SPIN-code: 2528-5803

Cand. Sci. (Biol.)

Olga V. Omelyanskaya

Email: o.omelyanskaya@npcmr.ru
ORCID iD: 0000-0002-0245-4431
SPIN-code: 8948-6152
Russian Federation, Moscow

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