Submission Guidelines — Genetic Information Regulations
On September 1, 2026, Federal Law No. 43-FZ of February 20, 2026, and Resolution of the Government of the Russian Federation No. 750 of June 15, 2026, came into force, establishing a special procedure for controlling the circulation of human genetic information. In this regard, the editorial board of the journal informs authors about the rules for preparing and submitting manuscripts.
Since the journal is distributed in open access, including outside the Russian Federation and to foreign readers, the data presented in an article acquire the status of publicly available information. Legally, this is equated to cross-border transfer of genetic information.
Depending on the nature of the study, three modes of material submission are established.
1. Without Approval (for Clinical Case Reports)
Scope: description of a unique clinical case (1–2 patients) or development of a medicinal product for specific patients (not a population-based study).
Author's actions: remove all personal data (full names, dates). Approval from the Interdepartmental Commission on the Transfer of Human Genetic Data Outside the Territory of the Russian Federation (under the FMBA of Russia) is not required. When submitting the manuscript, state in the cover letter: «The data are not population-based and comply with paragraph 4 of the Rules of Resolution of the Government of the Russian Federation No. 750 of June 15, 2026.»
2. Notification Procedure (Recommended for General Studies)
Scope: mass study (3 or more individuals), if the article contains exclusively aggregated results (graphs, mean values, gene frequencies) without individual genetic data.
Author's actions: no later than 20 working days before submitting the manuscript to the editorial board, submit an official notification to the Interdepartmental Commission on the Transfer of Human Genetic Data Outside the Territory of the Russian Federation (under the FMBA of Russia) in the form of Appendix No. 2 to Resolution No. 750. Attach a copy of the notification to the manuscript. If no comments are received from the Commission within 15 working days, the materials are considered approved for publication.
3. Permit Procedure (Strict Control)
Scope: mass study with demonstration of individual profiles (mutation tables for each patient) or uploading of «raw» sequencing files to international databases.
Author's actions: obtain official permission from the Interdepartmental Commission on the Transfer of Human Genetic Data Outside the Territory of the Russian Federation (under the FMBA of Russia) by submitting an application in the form of Appendix No. 3 to Resolution No. 750 (review period — from 15 working days). Attach a copy of the positive decision to the manuscript. If a copy of the positive decision is absent, the manuscript will not be accepted for review or publication.
Distinction Between the Notification and Permit Procedures
The editorial board of the journal is not authorized to independently determine which of the above modes a particular manuscript falls under. Classification of materials into one type or another is the exclusive responsibility of the author (author team) and/or the organization they represent.
Regulatory Documents and Forms
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| Parameter | Appendix No. 2 (Notification) | Appendix No. 3 (Application) |
|---|---|---|
| Legal regime | Notification | Permit |
| What is submitted | Notification of intent | Application for permission |
| Commission's response | Silence = consent | Positive decision required |
| Submission deadline | No later than 20 working days | Upon application |
| Review period | 15 working days (for comments) | From 15 working days |
| Result | Automatic approval if no comments | Publication/report only with permission |
| When applicable | Aggregated data (graphs, means, frequencies) | Individual profiles, «raw» files |
Note: The editorial board reserves the right to request additional documents confirming compliance with the requirements of the Federal Law and the Resolution. Authors are solely responsible for the accuracy of the classification of their materials.