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- » Section Policies
- » Publication Frequency
- » Open Access Policy
- » Peer Review
- » Publication Ethics
- » Indexing & Archiving
- » Founder
- » Ethical Oversight
- » Author Fees
- » Disclosure of Interest
- » Plagiarism Detection
- » Post-publication Discussions and Corrections
- » Preprint and Postprint Deposition
- » Research Data Sharing and Reproducibility
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Aims and Scope
Biological Products. Prevention, Diagnosis, Treatment is an open-access, peer-reviewed journal founded by the Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’). The journal is the only publication in Russia devoted to the development and use of human biological products.
Aim is to cover current issues of development of regulatory procedures, standardization, quality control, production of therapeutic, prophylactic and diagnostic biological drugs, biomedical cell products and their application, including clinical aspects, for prevention, diagnosis and treatment of infectious diseases, study of allergic and immunopathological processes.
Target audience: biotechnologists, immunologists, virologists, microbiologists, specialists in the field of molecular and cellular biology, pharmacologists, representatives of expert and regulatory institutions, specialists in the field of biopharmaceutical industry, as well as applicants for a scientific degree.
Subjects areas:
- Biological products
- Biotechnology
- Immunology
- Virology
- Microbiology
- Vaccines
- Molecular biology
- Molecular therapy
- Gene therapy
- Cell therapy
- Infectious diseases
- Laboratory diagnostics
- Standardization of products
Post-graduate students can submit the manuscripts according to the following specialties set by the Higher Attestation Commission of the Russian Federation:
- 1.5.3. Molecular biology (medical sciences);
- 1.5.6. Biotechnology (medical sciences);
- 1.5.10. Virology (medical sciences);
- 1.5.11. Microbiology (medical sciences);
- 3.2.7. Allergology and immunology (medical, biological sciences)
Article types: please see Author Guidelines for more details.
Section Policies
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Publication Frequency
Journal publication schedule
Issue number | Month of publication | Date of publication online |
No. 1 | March | End of March |
No. 2 | June | End of June |
No. 3 | September | End of September |
No. 4 | December | End of December |
Open Access Policy
All the articles published by the journal are licensed under the Creative Commons Attribution 4.0 International licence (CC BY 4.0).
The journal supports international initiatives, such as i4oc, for open access to citation data or the Barcelona Declaration on Open Research Information for open access to research data, and encourages the authors to post research data as additional information to their articles on the website of the journal and in public repositories.
Peer Review
General provisions:
- When working with manuscripts, communicating with reviewers, and managing the peer-review process at Biological Products. Prevention, Diagnosis, Treatment,the editorial staff follow the Ethical Guidelines for Peer Reviewers by the Committee on Publication Ethics (COPE), World Association of Medical Editors (WAME), and International Committee of Medical Journal Editors (ICMJE).
- The editorial staff set the content of the journal's issues and the timing of articles publication. Founders should not interfere in the evaluation, selection, scheduling, or editing of individual articles directly or by creating an environment that strongly influences editorial decisions.
- The editorial staff set the content of the journal's issues and the timing of articles publication. Founders should not interfere in the evaluation, selection, scheduling, or editing of individual articles directly or by creating an environment that strongly influences editorial decisions.
- The editorial staff makes the decisions on the integrity of the articles and its importance to the journal’s readers, not on the commercial or other implications for the journal. The editorial staff can express critical but responsible views about all aspects of medicine, even if these views conflict with the publisher’s and the founder’s commercial or other goals.
- The Editor-in-Chief has a final opinion on the acceptance or rejection of sponsored or advertising materials (if any); on the use of the journal's brand; on general policy regarding possible commercial use of the journal's content.
- Peer review is free of charge.
- The authors may suggest peer reviewers that are specialized in the area of a submission. However, the final decision on choosing a particular peer reviewer is made by the scientific editor, if necessary, after a discussion with the Executive Editor or the Editor-in-Chief
- The peer-review stages and timelines are presented in the Editorial Flowchart.
Peer review type
All the manuscripts submitted to Biological Products. Prevention, Diagnosis, Treatment are subject to mandatory double-blind peer review. This means that both the author of a submission and its reviewer are not informed of each other’s names and positions, and a scientific editor mediates all communication between them.
Mandatory peer review does not apply to informational articles and guidelines (regulatory decisions, news, etc.), as well as research data submitted as supplementary material to be published on the website of the journal. Letters and editorial articles are subject to peer review by one reviewer. All materials are subject to checks by scientific and literary editors.
Peer review duration
An average peer-review procedure takes 1–6 months at Biological Products. Prevention, Diagnosis, Treatment. This period includes initial consideration of the manuscript, search for reviewers, preparation of reviews, follow-up revision by the authors, follow-up review by the reviewers, and involvement of additional experts (Editorial Flowchart).
Peer review process
A minimum of two reviewers are assigned to each manuscript. If these two reviewers do not agree on the manuscript, the editorial staff may consult a third one.
Negative reviews do not necessarily mean rejection from the journal. Manuscripts with negative reviews are presented to the Editorial Board for consideration along with the corresponding reviewers’ and editor’s comments. The final decision to publish the manuscript is made by the Editor-in-Chief. Depending on the review outcomes, the scientific editor of the journal will inform the author of one of the following decisions:
- Accept the manuscript for publication. In this case, the manuscript will be included in one of the issues of the journal. The manuscript is transferred to the editor for further work and the author is notified of the publication date.
- Accept the manuscript for publication after correcting the manuscript in accordance with the reviewer's comments (without re-reviewing). In this case, the author will be recommended to revise the manuscript according to the reviewers’ comments within two weeks. If the drawbacks are corrected or if there is a reasonable refusal to make changes, the manuscript is accepted for publication.
- Recommend revising the manuscript in accordance with the reviewer's comments and sending it for re-review. In this case, the author will be asked to make the changes indicated by the reviewer in the manuscript within two weeks. The manuscript will be sent for a second round of a review, after which a final decision on the manuscript will be made.
- Reject the manuscript. In this case, the manuscript will be rejected, and the author will be informed of the reasons for rejection. Generally, a rejection of a manuscript does not bar authors from submitting other manuscripts to the journal. However, if the rejection is motivated by a major misconduct by an author, the Editor-in-Chief will decide to include the author to the blacklist. As a result, the editorial staff will not consider any further submissions by the author.
If, after a second round of a review procedure, the reviewer sends comments again, the scientific editor will suggest that the author to consider the possibility of publication in another journal or submit a completely revised manuscript presenting it as a new one.
If the author does not plan to revise the manuscript, he/she must notify the editors (withdraw the manuscript). Work on the manuscript will be stopped.
If the authors do not return the revised version within one month from the date of sending them the review, even in the absence of information from the authors refusing to revise the manuscript, the editors will remove it from consideration due to the expiration of the period allotted for revision. In such situations, the authors are sent a corresponding notification by e-mail.
If the author has a potential conflict of interest with an expert (a possible reviewer of the manuscript), he/she should notify the journal editor.
If any conflict arises between the author and the reviewer during the review procedure of the manuscript, the editor has the right to appoint a new reviewer and involve the Editor-in-Chief to resolve the dispute.
The journal can publish articles by the Editor-in-Chief, his/her deputies, the responsible secretary and members of the Editorial Board, but there should be no malpractice. Such manuscripts are sent for double-blind review only to external experts.
In case of controversial situations regarding the Editor-in-Chief’s manuscripts, the final decision on the possibility of publishing the article is made by the Editorial Board.
The Editor-in-Chief, Deputy Editors-in-Chief, and Editorial Board members should indicate their affiliation with the journal in the Disclosure section of the articles they submit to the journal.
There are no exceptions to peer review based on the status of the author.
Сopies of reviews are kept in the editorial office at least for 5 years.
Pool of reviewers
All the submitted manuscripts are reviewed by Editorial Board members and external reviewers experienced in the relevant field who have published works within the last 3 years on the topic of the manuscript under review.
The editorial staff regularly invite recognized experts in biotechnology, pharmacology, immunology, microbiology, and molecular biology to join the pool of reviewers for Biological Products. Prevention, Diagnosis, Treatment.
The reviewers are invited to collaborate on the recommendation of the Editor-in-Chief, Deputy Editors-in-Chief, Editorial Board members, and scientific editors.
The editorial staff of Biological Products. Prevention, Diagnosis, Treatment accounts for peer review to be a vital aspect of editorial policy and values the experience and time of the experts involved in peer review process.
Public review data
The editors submit texts of reviews and information about the reviewers to the Scientific Electronic Library (eLIBRARY.RU), which publishes these reviews and information on access-controlled pages for library users. The results of reviews are stored on the personal profiles of the reviewers and considered when assessing their performance as researchers. Quantitative data on reviewing are publicly available for registered users of eLIBRARY.RU.
Privacy policy
The editorial staff of Biological Products. Prevention, Diagnosis, Treatment keep the reviewers’ and the authors’ personal data confidential.
The editorial staff treat manuscripts as confidential documents. The reviewers are expected not to transfer the manuscripts to or discuss with third parties except if authorised by the editorial staff.
Reviewers may involve third parties in working on the manuscript and preparing the review only with the consent of the editor.
Reviewer responsibilities
By agreeing to review a manuscript for Biological Products. Prevention, Diagnosis, Treatment, the expert commits to following the journal’s policies and ethical requirements for evaluating manuscripts and preparing reviews.
The reviewer should strive to ensure the high quality of the materials published in Biological Products. Prevention, Diagnosis, Treatment, just like the editors of the journal. Therefore, the reviewer should agree to review only if they have sufficient expertise in the subject and enough time to carry out a thorough and comprehensive review.
The reviewer should inform the editor of his/her intention to review the manuscript and complete the work within the deadline specified by the editor. If for some reason he/she is unable to conduct the review, it is advisable to recommend another expert to the editor.
The reviewer is obliged to inform the scientific editor of having a conflicting interest (personal, financial, intellectual, professional, political, or religious). When in doubt, the reviewer should discuss the situation with the scientific editor.
The reviewer may refuse to work on the manuscript at any stage of the peer-review process. In this case, the reviewer should notify the editorial staff.
The reviewers should refrain from reviewing if
- they are in a superior–subordinate position or hold joint grants with the author;
- they do not intend to review the manuscript, but want to gain sight of it;
- they are going to publish an article on a similar topic.
The reviewer cannot use their status for personal purposes or impose references to their own work on the authors.
All materials received from the editor are strictly confidential. The reviewer should not share these materials with third parties or involve other specialists in the review of a manuscript, except if authorised by the editorial staff.
Recommendations for reviewers
For the reviewer’s convenience, the editors of Biological Products. Prevention, Diagnosis, Treatment recommend using the Standard Review Form. This form lists the questions that the editors need the reviewer to answer in order to decide on the manuscript.
The reviewer may provide comments in a free format.
The Confidential Comments section is intended for comments that will not be sent to the author. It should include the reviewer's conclusion on the manuscript, concerns about potential ethical issues, as well as recommendations and any comments (e.g., the reviewer may advise the editor to request additional information from the author).
The main criteria of a review process
Biological Products. Prevention, Diagnosis, Treatment has the following main criteria for submissions:
- Importans and relevance in accordance with the Aims and Scope of the journal;
- Novelty of research and methodology;
- Originality;
- Ethical rigour;
- Clear, concise, logical, and structured presentation;
- Methodological rigour;
- Validity of results;
- Reproducibility of the results;
- Adequate literature coverage;
- Practical and clinical significance.
Manuscript evaluation criteria
Relevance to the journal. It is necessary to find out whether the manuscript is relevant to the subject area of the scientific journal and the interests of its audience.
Novelty. Has the research contributed anything new to the relevant subject area?
Ethics. Has the study been approved by an institutional review board (if required) and is it unbiased in terms of conflicts of interest? The manuscript cannot be accepted for publication if it contains plagiarism or violates basic ethical principles of scientific research
Title. Does the title accurately reflect the content of the manuscript? Will the title attract readers’ attention?
Abstract. Does the abstract appropriately present the content of the manuscript? Is the abstract structured? Does the abstract describe the aim, methods, results, and significance of the work? Are there any discrepancies between the abstract and the sections of the manuscript? Is it possible to understand the abstract without reading the manuscript?
Introduction. Is the introduction adequately short? Is the aim clearly defined and the research question fomulated? Has the author justified the relevance and significance of the work based on a literature review? If so, does the introduction meet the length requirements? Has the author defined the terms that appear in the manuscript? If the manuscript is submitted to the Original Research section, does it have a clearly stated hypothesis?
Literature review. How comprehensive and complete is the literature review? Is the search strategy specified (including the databases used, the keywords in Russian and English, as well as the time coverage)?
Methods. Are the methods clear? Would another researcher be able to reproduce the study using the proposed methods? Have the authors justified their choice of research methods (e.g., their choice of visualisation, analytical tools, or statistical methods)? If the authors propose a hypothesis, have they developed methods that can reasonably test it? How is the study design presented? How does the analysis of study data help achieve the aim of the work?
Results. Are the results clear? Does the order of result presentation match the order of method description? Do the results meet expectations? Are there results not preceded by an appropriate description in the Methods section? How accurate and unbiased is the presentation of the results?
Discussion. Is the discussion adequately logic and laconic? Are the authors’ conclusions consistent with the results obtained in the study? Are the results compared with similar studies, and are similarities and differences discussed? If a hypothesis was stated, do the authors state whether it was supported or refuted? If a hypothesis was not supported, do the authors state whether the study question was answered? Are the authors’ conclusions consistent with the results obtained in the study? If unexpected results were obtained, do the authors analyze them appropriately? What potential contribution does the study make to the field and to global science? Are the results compared with similar studies, and are similarities and differences discussed? Do the authors highlight the limitations of the study? What are the authors’ views on the direction of future research? What potential contribution does the study make to the field and to global science?
Conclusions. Are all conclusions justified and are there any conclusions not included in the Discussion section? Are recommendations given on the possible use of the proposed study design?
References. Is the references list appropriate to the journal format and is it sufficient in length? Are the cited references up to date? Are the references to articles in the reference list in the text of the manuscript correct? Are there important works that are not mentioned but should be noted?
Tables. If the article contains tables, do they present the results correctly? Should one or more tables be added to the article (especially important for the reviews aimed at classifying, analyzing, and synthesizing data)? Are the data in tables in a way that facilitates their understanding?
Figures. Are the figures suitable for addressing the research question? Would different figures better illustrate the findings? Do the figures and graphs adequately reflect important findings? Should changes be made to the figures and graphs for a more accurate and clear presentation of the findings? Are the captions to the figures and graphs presented as editable text (as opposed to an uneditable raster format)? Can the figures and graphs be understood from the captions without reading the manuscript? Are graph axes labelled? Are units of measurement indicated? In the case of graphs illustrating statistics, is the p-value shown?
Disclosure (compliance with these requirements should be checked by the editors, not by the reviewer). Is the information on funding and conflicts of interest clearly disclosed in accordance with the ICMJE forms filled in by the authors?
Final decision of the reviewer
The editorial staff suggests using the following justification for the final decision of the reviewer.
Accept the manuscript for publication. The reviewer understands that the article is ready for publication in its current form. The article is substantiated, ethical, significant for the scientific community and complements already published works, the style is clear and concise.
Accept the manuscript for publication after correcting the manuscript in accordance with the reviewer's comments (without re-reviewing). The article has non-critical comments that need to be corrected, such as lack of clarity of presentation, insufficiently developed structure of the manuscript, duplication of information in figures and tables and in the text of the article, technical errors in references. After making changes, the article can be accepted for publication.
Recommend revising the manuscript in accordance with the reviewer's comments and sending it for re-review. The article contains serious shortcomings and errors that affect the reliability of the results obtained: ethical violations, poorly designed study, insufficient description of the methods, insufficient volume of results or their incorrect interpretation, contradictory conclusions, lack of literature references to important studies, insufficiently clear tables and figures that require serious revision. After re-evaluation, the article may be accepted, rejected, or sent for additional examination. Such a decision often requires collecting additional data from the author.
Reject the manuscript. The work does not meet the goals and objectives of the journal, has one or more irreparable deficiencies or serious ethical violations (lack of consent for publication in cases where it is necessary; unethical research methods), erroneous methodology. The reviewer should provide detailed comments, justifying their decision, as they can help the author significantly improve the work.
Reject the manuscript and invite the author to resubmit it. The topic or research question is interesting, but the author is using incorrect methods, and therefore the data obtained are not reliable and valid. The authors are encourage conducting the study taking into account the recommended changes and submit new results for consideration. The topic or research question (hypothesis) of the study is interesting, but the author is using incorrect methods to test the hypothesis. This decision is also possible in cases where the manuscript requires many changes or when it is not possible to obtain the requested additional information from the author. The authors are invited to correct the study taking into account the recommended changes and submit new results for consideration.
Review editing
The reviews should be written in a friendly tone and correct Russian language. The reviewers must avoid derogatory personal comments, insults to the author, and unjustified criticisms of the study aspects, the language and style of the manuscript, etc.
The editorial staff of the journal tries to redirect the reviews to the authors in their original form. However, some reviews may need to be edited without sacrificing the meaning (for example, when the editor combines comments on the same issue from several reviewers, or if the reviewer made comments that should be kept confidential from the author).
If a review has many mistakes or an unacceptable tone, the editorial staff of the journal have the right to send it back to the reviewer for revision (Reviewer's Note).
Publication Ethics
Authorship and contributions
At Biological Products. Prevention, Diagnosis, Treatment, we adhere to the following authorship criteria (developed and described in the ICMJE guidelines):
- substantial contributions to the conception or design of the work; acquisition, analysis, or interpretation of data for the work; AND
- drafting the work and/or revising it critically for important content; AND
- final approval of the version to be published; AND
- agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Apart from being accountable for the parts of the study performed on their own, an author should be able to identify which co-authors are responsible for specific other parts of the work.
In addition, the authors should have confidence in the integrity of the contributions made by their co-authors. All those designated as authors should meet all four criteria for authorship, and all who meet the four criteria should be identified as authors.
COPE lists the following types of false authorship.
Ghost authors are authors who meet the criteria for authorship but are not listed as authors.
Guest authors are authors who do not meet accepted authorship criteria but are listed because of their rank, reputation, or perceived influence to make the publication appear more impressive.
Gift authors are authors who do not meet accepted authorship criteria, but are listed through personal relationship for mutual CV enhancement (including colleagues in articles in return for being listed in theirs).
Those who do not meet all four ICMJE criteria should be included in the Acknowledgements section.
Author and non-author contributions
Those who do not meet all four ICMJE criteria should be included in the Acknowledgements section as contributors. In case of such acknowledgent, the editorial staff should make sure that the contributors have given the corresponding author their consent to being acknowledged.
Author contribution statement. To indicate the contribution of each author, we recommend using the standardised Contributor Roles Taxonomy (CRediT).
It is the responsibility of the authors to ensure that the authorship and author contribution standards are met. The authors are obliged to provide transparent and correct information about themselves and the persons who made significant contributions to their study (authors' contribution, description examples).
Authorship declaration
The editorial staff of Biological Products. Prevention, Diagnosis, Treatment expects the authors to confirm the following in their cover letter signed by all co-authors.
By signing the declaration, the authors guarantee that:
- Each author signing the declaration meets the authorship criteria as outlined in Publication ethics;
- All individuals who participated in the study but are not the authors are specified as contributors in the Acknowledgements section;
- Each author’s contribution is described (this information will be published in Biological Products. Prevention, Diagnosis, Treatment);
- The organisations and individuals mentioned in the Acknowledgements section have consented to their contribution to the manuscript being acknowledged.
Upon receipt of a manuscript, the editorial staff will verify that the authorship information and all the required documents are in place. In the absence of the authorship declaration or signatures from all the authors, the manuscript will not be accepted for consideration.
Disputes
In case of authorship dispute, the work on the article will be terminated regardless of the stage of its submission, reviewing, editing, or preparation for printing.
All the co-authors will be informed about the authorship dispute via e-mail.
The editor of the journal has the right to specify the exact period during which authors can provide clarification on the specified issues. Upon expiry of this period, the publication process is discontinued for this manuscript with an appropriate explanation. If an article has been published as an Online-First version, the clarification on withdrawal of the article from publication will be placed in the public domain.
In the case of a dispute regarding a published article, the editors of the journal will publish a correction, refutation, or retraction notice, explaining the reasons for correction, refutation, or retraction, respectively.
If it is necessary to add or remove a co-author before or after publication, the editors act in accordance with the COPE guidelines:
To prevent authorship problems, the editors use COPE flowcharts to identify the following warning signs:
- Industry funded research with no authors from the sponsor company, as these may require the editors to take a closer look at the authors’ contributions and, if necessary, to request explanations from the corresponding author;
- Co-authors list known to be from unrelated research areas, as this may indicate guest authorship;
- Unspecified roles in the Acknowledgements section;
- Questionable roles of contributors (for example, if no one appeared to draft the manuscript or to analyse the data);
- Authorship changes during pre-publication stage without notifying the editorial staff;
- Corresponding authors unable to respond to reviewers’ comments.
Complaints and appeals
The editorial staff of Biological Products. Prevention, Diagnosis, Treatment carefully considers complaints about the behavior of editors and peer reviewers, which may relate to issues such as a breach of confidentiality, an undisclosed conflict of interests, or a misuse of confidential information obtained during the peer-review process, failure to comply with editorial rules.
Complaints should be emailed to biopreparaty@expmed.ru for consideration according to the standard procedure. Normally, complaint handling takes no more than 7 days. The editorial staff will inform the complainant of the decision, as well as of the corrective actions initiated and the deadlines for their implementation.
The editorial staff adhere to the COPE Guidelines for handling complaints in each of the following cases:
- Handling of post-publication critiques,
- Post-publication discussions and corrections,
- Peer-review manipulation suspected after publication,
- Image manipulation in a published article,
- Fabricated data in a published article.
If the authors do not agree with the conclusions or particular remarks of the reviewers and/or the editorial staff, the authors may challenge the decisions. To do this, the authors will have to provide written arguments for each remark and send a letter to the editorial staff. The decision on this request is considered at the next meeting of the editorial board (4 times a year). Its decision is final and cannot be appealed further.
Handling confidential data
The right to privacy of individuals or organizations involved in research is of paramount importance; such research should not be conducted without informed consent. The authors must take all necessary precautions to protect information about study participants. If necessary, the authors must take measures to minimize any potential physical and psychological harm to study participants.
Responsibilities of the management team of the journal, including the Editor-in-Chief, the Editorial Board, the editors, and the publisher
Editorial Board recruitment
When forming the editorial board, the editorial board of the journal Biological Products. Prevention, Diagnosis, Treatment is guided by the COPE principles.
The Editor-in-Chief is appointed by the journal founder for a 3-year term. The appointment may be terminated early upon a personal application of the Editor-in-Chief or by decision of the founder of the journal.
New candidates may be recommended by current members of the editorial board, reviewers, authors. Potential candidates to Editorial Board membership are considered at regular meetings of the editorial board. The final decision on the inclusion of a potential candidate in the Editorial Board is made by the Editor-in-Chief.
Responsibilities of the Editor-in-Chief
At Biological Products. Prevention, Diagnosis, Treatment, the area of responsibility of the Editor-in-Chief of the journal includes the following:
- The Editor-in-Chief is personally responsible for the decisions to accept the articles to publication according to the recommendations of reviewers, the opinion of the members of the Editorial Board and the scientific editor.
- The Editor-in-Chief is obliged to inform the Editorial Board about all conflicts, critical errors, or accusations of authors or peer reviewers in violations of publication ethics in order to take the necessary actions, such as making amendments, withdrawing the article.
- The Editor-in-Chief should take part in the investigation of any ethical violations related to the manuscripts under review and published articles and make efforts to resolve conflicts as soon as possible.
- If necessary, the Editor-in-Chief contact with the author's organization to conduct a more in-depth investigation.
Responsibilities of Editorial Board members
The roles, tasks, and the scope of responsibility for each Editorial Board member are agreed individually and include the following:
- Peer review of submitted manuscripts in their area of expertise;
- A choice of reviewers for submitted manuscripts;
- Control of the peer-review process for submitted manuscripts;
- Decision-making on the possibility of publishing manuscripts after all rounds of peer review. The decision are passed to the Editor-in-Chief, who will make the final decision on the possibility of publication;
- Calling for the authors and peer reviewers for the journal;
- Promoting published articles on social media and industry events;
- Writing editorials and comments in the journal and on its website;
- Participating in Editorial Board meetings.
An Editorial Board member may be excluded from the for the following reasons:
- Violations of the publication ethics, such as concealing a conflict of interest, withholding information, and using the membership for personal purposes.
- Failure to fulfil the assigned duties within a year without a valid reason and without agreement with the Editor-in-Chief.
- Voluntary resignation.
Responsibilities of the Editor
- When processing the manuscripts and deciding on their publication, the Editor is guided by the journal policies.
- The Editor may discuss the manuscript and reviewers' comments with the editors and peer reviewers, if these discussions are justified and legitimate and the discussed materials are not used for personal purposes.
- The Editor is obliged to evaluate the content of manuscripts regardless of the race, sex, sexual orientation, religious views, background, citizenship, or political preferences of the authors.
- The Editor should ensure confidentiality and should not disclose information about submitted manuscripts to third parties (except for other editors of the journal, peer reviewers, the publisher, and the founder).
Responsibilities of the Publisher
- The Publisher is responsible for complying with all current guidelines and requirements to maintain the integrity of scientific materials published in the journal.
- The Publisher is obliged to implement industry standards to improve the ethical performance of the journal and adherence to the best editing practices; to ensure the comprehensive legal consulting of the editorial staff (if necessary).
Indexing & Archiving
The journal Biological Products. Prevention, Diagnosis, Treatment is included into the List of leading peer-reviewed scientific journals and publications recommended by the Higher Attestation Commission of the Russian Federation for publishing main results of the dissertation research for the candidate or doctor of sciences degree (List of the Higher Attestation Commission).
The articles published in the journal are also indexed in Russian and international abstract and full-text databases:
- Russian Index of Science Citation at the Scientific Electronic Library (ELIBRARY.RU),
- Russian Science Citation Index (RSCI)
- Chemical Abstracts Service, CAS
- NLM Catalog
- Embase
- Reaxys
- DOAJ
- Google Scholar
- Ulrichsweb
- BASE
- Dimensions
- Research4life
- Lens.org
- Scilit
- OpenAlex
- RNMJ
- CyberLeninka
The articles published in the journal are archived in the following databases:
The journal plans to deposit its content in the Portico database in 2025.
Founder
The Journal is founded / funded by The Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation.
Responsibilities of the Founder
The Founder adheres to the principle of editorial independence. The General Director or the employees of the Founder do not intervene or interfere in the editorial process.
Other responsibilities include the following:
- The Founder of the journal can recommend candidates for the Editorial Board, peer reviewers, and authors, but exclusively the Editor-in-Chief makes the final decision on the possibility of collaborating with them.
- The Founder of the journal supports the need to ensure geographic diversity among the members of the Editorial Board/Council, peer reviewers, and authors.
- The Founder does not place financial and political gain above the quality of the journal.
- If necessary and at the request of the editors, the Founder can contribute to investigating violations of publication ethics and send official requests to scientific and educational organizations, as well as other publishers.
- The Founder undertakes to conduct an external audit of editorial and publishing policies on a regular basis, as well as to facilitate the professional retraining of editorial staff, including through paying for their participation in relevant trainings and other events.
Ethical Oversight
Editorial staff of Biological Products. Prevention, Diagnosis, Treatment share COPE’s view that publication ethics includes not only ensuring the integrity and reliability of published research but also ethical behavior towards research subjects. Ethical oversight should include policies on publication with participation of vulnerable groups of population, ethical conduct of research using animals or human subjects (in the corresponding cases), handling confidential data and ethical business/marketing practices.
Informed consent and consent for publication
At Biological Products. Prevention, Diagnosis, Treatment, an informed consent/consent for publication form signed by patients (or their legal representatives) is required for every study in which one or several persons can be identified. This requirement also applies when a study involves deceased persons. Consent is required for the publication of photographs, medical histories, or other patient data, by which an individual or a group of individuals can be identified.
The authors are required to provide the editorial staff with a statement reporting that informed consent has been obtained from the patients or their legal representatives. The published article must inform that such consent has been obtained.
The informed consent for publication should include the following:
- The patient should fill in their name and surname, and sign the form. If a patient is unable to do this, the relationship of the signer to the patient must be stated. If one person is signing for a family or a group of people, that person should verify that all the members of the family/group have been informed.
- It should be stated that the person or group of persons has no legal, mental, or physical impediment to consent to publication. If such impediments exist, they should be stated (minor age, incapacity, disability, death).
- Consent forms should make it clear that, even if all the rules are followed, the journal cannot guarantee confidentiality.
- The patient should be informed that they may revoke consent at any time before the publication of the article.
- The consent form should indicate how the article will be distributed (in print, online).
- The consent form should contain a clause on whether the patient should read and approve the final version of the manuscript.
At Biological Products. Prevention, Diagnosis, Treatment, the Editorial Office supports COPE’s position statement on the publication of studies involving vulnerable groups and individuals.
Vulnerable populations include (but are not limited to) pregnant women, neonates, children, foetuses, prisoners, physically handicapped, mentally challenged, economically disadvantaged, very sick patients in hospital, etc.
According to paragraph 20 of the Declaration of Helsinki, “medical research involving vulnerable groups of population is justified only if it is relevant to the needs and priorities of health care specifically for that group of people and cannot be carried out on people who do not belong to the vulnerable group. In addition, that group of people should benefit from the theoretical and practical knowledge or new method of intervention obtained as a result of the research.”
One of the concerns about the participation of vulnerable groups in research is that not all participants, for objective reasons, can understand all the conditions of the study. If informed consent cannot be obtained from a direct research participant, his or her legal representative must sign this consent.
Ethics of research involving human subjects
At Biological Products. Prevention, Diagnosis, Treatment, we rely on the principles of the Declaration of Helsinki of the World Medical Association (Ethical Principles for Medical Research Involving Human Subjects) and endeavour to ensure compliance with ethical and data collection standards for research involving human subjects. Before beginning a study, researchers should familiarise themselves with the informed consent principles of the Declaration of Helsinki and carry out the study in strict accordance with those principles as set forth below (Articles 25‒32 of the Declaration of Helsinki). When presenting the results of experimental research involving humans, the authors should indicate in the corresponding section of the article whether the procedures performed met the ethical standards described in the Declaration of Helsinki. If the study did not follow the Declaration, the authors should justify the approach chosen for the study and provide evidence that the Ethics Committee of the organisation where the study took place had approved the chosen approach.
Ethics of animal use in research
When conducting experiments involving animals, the authors are obliged to include information on compliance with institutional and national standards on the use of laboratory animals.
To present more accurate and correct information about research involving animals, the editorial staff recommend ARRIVE guidelines . The use of these guidelines will improve the quality and reliability of published articles and allow other researchers to reproduce the results.
In preclinical and clinical studies involving only one sex, in accordance with IV guidelines ICMJE, the title, abstract, and full text of the article should clarify to which subjects the results of the study can be applied. This refers to all studies involving humans, animals, or any material obtained from humans or animals (e.g., organs, cells, and tissues). In such cases, the following should be stated:
- The title of the article should indicate the sex of the subjects studied, unless it is obvious from the topic of the article (e.g., cervical cancer)
- The introduction section should mention publications about studies that revealed differences associated with sex (e.g., higher prevalence of the disease under study in representatives of one of the sexes) or confirmed the absence of such differences.
- In the Methods section, it should be indicated on possible differences in the design of the experiment: how the representativeness of the sample was ensured, whether there were specialized inclusion/exclusion criteria, whether there were special recommendations depending on sex (e.g., recommendations for the use of contraception).
- In the Results section, if necessary, authors should provide data separately for men and women (in preclinical studies, for males and females) and discuss the results taking into account the disaggregated data.
- In the Discussion section, consider the possibility of extrapolating the data to individuals of the other sex. If data analysis by sex criteria was not performed, the chosen approach should be clearified.
Author Fees
Publication in the journal is free of charge for all the authors. The journal does not charge any fees for processing, submission, or publication of materials.
Disclosure of Interest
The section is prepared according to recommendations WAME и ICMJE
Conflict of interest are situations in which people have conflicting or competing interests that may influence editorial decisions and the interpretation of data in an article. Conflict of interest may be potential or perceived, as well as actual. Personal, political, financial, scientific, or religious factors may influence the objectivity of an opinion.
Conflicts of interest may cover the following areas:
Financial. This conflict arises when a participant in the publication process has received or expects to receive money (or other financial benefits, such as patents or shares), gifts, or favors that may influence the work associated with a particular publication. Examples: research fees, consulting fees, public speaking fees, etc.
Personal relationships. This conflict arises in the case of personal relationships with family, friends, competitors, former colleagues.
Political and religious beliefs. Commitment to one religion or political party may influence the outcome of a paper that analyzes these issues.
Institutional affiliation. This conflict arises when some of participants in the publication process is directly connected to an organization that is interested or, conversely, not interested in publishing material on a particular topic.
Journal editors may ask authors additional questions or request missing information if necessary.
Conflict of interest may affect authors, reviewers, and editors. The following policy statements are based on ICMJE recommendations.
Authors' Responsibilities in Disclosing Conflicts of Interest
When authors submit a manuscript of any type or format, they have a responsibility to disclose all relationships and activities that might influence, or be perceived to influence, their work by completing the form ICMJE containing 13 points.
The author must disclose the conflicts of interest in the appropriate section of the article based on the completed ICMJE form. If there is no conflict of interest, the author must also disclose this. For example, "The author declares that he has no conflict of interest."
Reviewers' Responsibilities in Disclosing Conflicts of Interest
Reviewers must disclose any conflict of interest that might bias their opinion of a manuscript and must recuse themselves from reviewing if there are reasons to be biased.
Editors’ Responsibilities When Disclosing Conflicts of Interest
Editors who make final decisions on manuscripts must recuse themselves from editorial decisions if they have a conflict of interest or any relationships that could create potential conflicts related to the manuscripts under consideration. Other editorial staff involved in editorial decisions must inform editors of their current interests (since they may influence editorial decisions) and recuse themselves from making decisions if they have a conflict of interest.
Editorial staff should not use information obtained while working with manuscripts for personal purposes.
Editors, deputy editors, and members of the editorial board of the journal must clearly indicate their affiliation with the journal in their articles.
If an undisclosed conflict of interest is discovered in an unpublished article, the editors of the journal will act in accordance with COPE guidelines.
If an undisclosed conflict of interest is discovered in a published article, the editorial board of the journal will act in accordance with COPE guidelines.
Plagiarism Detection
The editorial staff of Biological Products. Prevention, Diagnosis, Treatment screens all the submissions with the plagiarism detection software Antiplagiat. If plagiarism is detected, the COPE guidelines on plagiarism will be followed.
Post-publication Discussions and Corrections
Updates and post-publication discussions
Supplements to a published article
The authors may need to supplement their article after its publication. In this case, a supplement may be published. Supplements are subject to the same peer review requirements as the original manuscript.
When an article is supplemented, the editors update the file containing the original version of the article. They publish a notice about the supplement in the next issue of the journal, including information about the article and its authors, a summary of changes, a reference and link to the article.
Commentaries on a published article
A commentary is a short material that expresses an opinion or observation concerning a published article. A commentary may be published not later than within 3 months from the date of article publication on the website of the journal. A commentary is peer reviewed and sent to the authors of the article so that they can prepare their response, which will be published in the same issue of the journal as the commentary.
No more than one round of published comments and answers are allowed per article.
The final decision to publish a commentary is made by the Editor-in-Chief of the journal. Commentaries and responses should quote each other. The title of a commentary should start with the words “Comment to the article:” with a colon followed by the name of the first author of the original article and its full title in quotation marks. The title of a response should start with the words “Response to a comment to the article:” with a colon followed by the name of the first author of the original article and its full title in quotation marks.
Post-publication Corrections
In some cases, it may be necessary to change a published article. At Biological Products. Prevention, Diagnosis, Treatment, the editors support the practice of making necessary amendments to published materials and follow the COPE guidelines.
All the post-publication changes will be followed by a notification, which will always include a reference and link to the original version of the article, so that readers can be aware of any changes.
All the expression-of-concern, correction, and retraction notices are made publicly available. These practices aim to ensure the integrity of published research.
What should the authors do if they find an error in their article?
The authors may discover a technical or fundamental error after their article has been published. In this case, they should inform the editorial staff of the journal of this error as soon as possible, especially if it may affect the interpretation of the study results or cast doubt on the validity of published information. The corresponding author is responsible for reaching an agreement within the author team on further communication with the editorial staff.
The authors who believe that a published article needs to be amended, should contact the journal by e-mail at biopreparaty@expmed.ru.
Corrections
Corrections are made to an article when it is necessary to add missing information or correct an error, and the changes do not affect the scholarly integrity or the original findings.
Examples of possible corrections include amending a figure caption, adding data on research funding, or clarifying information on conflicts of interest.
If such corrections are made, the journal publishes a special correction notice. The general procedure is as follows:
- A correction is made to the original version of the article.
- The Crossmark record is updated.
- A description of the change is entered in the Abstract field of the original version of the article.
- A correction notice is published, providing information about the original version of the article, a reference and link to the article, the authors’ names, and a summary of the corrections.
The editors do not publish individual notices when correcting spelling mistakes, typos, and other minor issues. In such cases, the website will state that corrections have been made to the article (without further detail).
Retraction (withdrawal) policy
At Biological Products. Prevention, Diagnosis, Treatment, we work with article retractions according to the COPE guidelines.
At Biological Products. Prevention, Diagnosis, Treatment, articles are retracted in the following cases:
- There is clear evidence that the results are unreliable for a number of reasons, including serious errors in calculations, fabricated data, image manipulation, etc.
- Plagiarism has been found in the article.
- The results have already been published earlier in other journals, and the author has not justified the need for re-publication and has not informed the editors about the previous publication.
- The article uses materials and data without permission.
- Copyright has been violated, the list of authors includes individuals who do not fulfil the criteria for authorship, or there is another serious legal issue (e.g. breach of confidentiality).
- The integrity of research has been breached.
- The peer-review process has been compromised.
- The author did not disclose a conflict of interest that, in the opinion of the editors, may have influenced the decision of the peer reviewers or editors to publish the article
The journal adheres to the following retraction procedure:
- The editors investigate the case and make sure that the article does need to be retracted.
- The editors prepare a retraction notice with the note “Retraction” and the title of the article. They describe the reason for retraction, specify the retraction initiator, and provide a reference and link to the article being retracted.
- The editors publish the retraction notice.
- The editors replace the original version of the withdrawn article, noting the fact of its withdrawal in the pdf-file.
- They report the retraction to databases.
- They transfer information about the withdrawal to the database for retracted articles.
Retraction procedure
The retraction procedure follows the guidelines of the Council of Scientific Publication Ethics of the Association of Science Editors and Publishers (ASEP).
- If an author/group of authors finds it necessary to withdraw an article, they inform the editorial staff and explain the reason for their decision.
- If the Editorial Board decide to withdraw the article based on the results of its evaluation or the information received, the Executive Secretary will inform the author/group of authors about this decision. The author (or the corresponding author if there is a group of authors) will be informed of the retraction reasons.
- If the author/group of authors ignores the request of the editorial staff, the Editor-in-Chief or Executive Secretary will request the assistance of the ASEP’s Council of Scientific Publication Ethics.
- Having made a decision to retract an article, the editorial staff indicates the reasons for the retraction (if plagiarism is detected, the sources of borrowing should be provided) and the retraction date. The article and its description are not removed from the respective issue on the journal’s website, but a “RETRACTED” watermark and the date of retraction are added to the electronic version of the text; the same information is included in the contents of the issue.
- The ASEP’s Council of Scientific Publication Ethics, the scientific information databases (eLIBRARY.RU, CyberLeninka, etc.), and all the network libraries and databases where the journal is indexed are provided with the Editorial Board meeting minutes including the date of the meeting, a list of the board members who attended the meeting, the results of investigation, a reasoned decision, and a form filled in with the following information:
- full name(s) of the author(s) and the title of the article;
- the title of the journal from which the text is retracted;
- the initiator of the retraction;
- grounds for the retraction and the decision date;
- a link to the journal’s webpage informing about the retraction;
- the publisher’s data on the article and its DOI (if available);
- the subject area (medicine, pharmaceutics, etc.);
- the editorial policy revision date.
Removals
At Biological Products. Prevention, Diagnosis, Treatment, a removal takes place only in extreme cases where it is not possible to follow the correction, retraction, or expression-of-doubt procedures.
An article may be removed in the following cases:
- Its dissemination may pose a serious risk;
- It includes content that violates a research participant’s right to privacy;
- It violates someone’s legal rights;
- It is subject to removal by court order.
Preprint and Postprint Deposition
Preprints
At Biological Products. Prevention, Diagnosis, Treatment, we encourage uploading preprints to preprint servers. COPE defines a preprint as “a scholarly manuscript posted by the author(s) in an openly accessible platform, usually before or in parallel with the peer review process”.
A preprint publication is not considered a duplicate publication in a way that would influence the decision to publish it in Biological Products. Prevention, Diagnosis, Treatment.
When submitting a manuscript, the authors should notify the editorial staff of the journal of having posted the manuscript as a preprint, link to the preprint providing its DOI, and specify the dissemination policy.
It is the authors’ responsibility to link to the published article in the preprint record. The link must contain the DOI and URL of the article published on the journal’s website. The original text of the preprint should not be changed based on comments from the reviewers and editors, nor should the preprint text be replaced with the text of the published article or deleted after the article is published.
Postprints
At Biological Products. Prevention, Diagnosis, Treatment, the authors are allowed to archive and use their manuscripts at their own discretion; this is allowed for two versions of manuscripts:
- The version that has passed the peer-review stage and has been accepted for publication;
- The version that has been fully type-set and published online.
Any version of the manuscript may be disseminated through:
- A personal website or blog,
- Social networks,
- An institutional repository,
- A discipline-specific repository,
- Distribution of the article through personal contacts (for example, through personal contacts between teachers and students).
In any case, when using an accepted or published manuscript, the author should clarify its status and provide information about the planned publication or deposition, with an indication of the DOI, if it has already been assigned.
For example, “The article ‘Title of the Article’ has completed peer review and is accepted for publication in issue 3 (2025), of the journal Biological Products. Prevention, Diagnosis, Treatment”.
Research Data Sharing and Reproducibility
This section of the policy has been developed based on the COPE recommendations for working with data and the Guidelines for Transparency and Openness Promotion (TOP) in Journal Policies and Practices.
The authors are encouraged to make research data and protocols supporting their publications publicly available, but they are not obliged to do so. The authors’ consent to grant open access to the research data will not impact the editorial decision on publishing their manuscript.
Definition of research data
Research data include any factual materials which were used in the research, recorded on any media, in a digital or non-digital form. These include tabular data, codes, images, audio- and video files, documents, maps, raw and/or processed data. This policy applies to the research data that may be required to verify study results reported in articles published in Biological Products. Prevention, Diagnosis, Treatment. Research data include information obtained directly by the authors (“primary data”) and data from other sources analysed by the authors in their study (“secondary data”).
Definition of exceptions
This policy does not apply to research data that are not required to verify the validity of the research results reported in published articles.
Information on confidential data may be shared via publishing in research data repositories with limited access or pre-anonymisation. The authors can also grant open access only to the research metadata and/or instructions for other researchers on requesting access to the data.
Data deposition
The preferred mechanism for sharing research data is the use of data repositories. Please see the lists at https://repositoryfinder.datacite.org to find research data repositories.
Data citation
At Biological Products. Prevention, Diagnosis, Treatment, the editorial staff encourage the provision of access to research data under the Creative Commons open-copyright licences. The editorial staff do not enforce the use of open-copyright licences when data are deposited in a third-party repository. The Publisher of the journal does not claim ownership of the research data which were provided by the author together with the article.
Questions regarding the implementation of this policy may be addressed to the Executive Secretary of the journal.
Study protocols and their registration
The journal Biological Products. Prevention, Diagnosis, Treatment welcomes the preliminary publication of research protocols and their registration in the applicable registers (for example, clinicaltrials.gov). For randomized controlled trials, the protocol must be registered before the authors submit the manuscript.
Advertising
Revenue generation is not a goal of the Founder of Biological Products. Prevention, Diagnosis, Treatment. Therefore, the journal prohibits commercial advertising and other types of revenue generation activities (for example, reprints). If this policy is changed, the journal plans to be guided by the WAME Recommendations on Publication Ethic Policies for Medical Journals and the Russian Federal Law On Advertising.
Likewise, Biological Products. Prevention, Diagnosis, Treatment does not accept manuscripts with commercial content, including covert advertising, and does not publish such articles.
Direct Marketing
The Journal's policy prohibits mass mailings to potential authors for manuscript solicitation. Invitations to become an issue editor, author of an expert opinion or a review are sent individually by the editor-in-chief.
In any activities involving direct contact with the Journal’s potential target audience (to include conferences and exhibitions, social networks, etc.), the Journal strives to be appropriate, well targeted and unobtrusive. It also follows legislation about personal data and confidentiality, as well as professional communication standards, where the information provided about the publisher, or Journal shall be truthful and not mislead readers, authors or other potential partners.
Crossmark Policy
CrossMark is a multi-publisher initiative from Crossref that provides a standard way for readers to locate the current version of an article or other published content.
Biological Products. Prevention, Diagnosis, Treatment uses CrossMark to keen the content it publishes updated and to alert readers to changes if and when they occur.
Clicking the CrossMark logo at the top of an article will tell users the status of this document and give additional publication information about it.
AI-Based Technologies
Using AI tools
Due to the wide use AI in preparing, writing and peer-reviewing research papers the editorial team of the journal “Biological Products. Prevention, Diagnosis, Treatment” is committed to ensure that such use aligns with our publishing requirements and ethical standards to meet the following provisions.
- Responsibility and authorship
- Responsibility for the content of the manuscript, including the accuracy of data, correct citation and compliance with ethical standards, lies entirely with the authors, regardless of their use of generative AI tools (i.e., capable of creating new content). The authors guarantee that the final text of the manuscript is original, reflects the results of the research conducted by the authors.
- AI (chatbots, such as ChatGPT and similar tools) cannot be listed as authors of the article or as persons who contributed to the preparation of the manuscript. AI-based programs do not meet the criteria for authorship, as they are not liable for the content of the work, cannot declare conflicts of interest, or manage copyright.
- Human oversight and validity
- When using AI tools as aids for text editing, literature search, data analysis and visualization, or idea generation, users are required to ensure human control at all stages of manuscript preparation, carefully checking all AI-generated outputs, including facts, citations, and analytical conclusions, for compliance with the relevance of the research data and accepted scientific standards.
- It is allowed to use AI to generate images (diagrams) illustrating processes, concepts, and mechanisms of action. It is prohibited to use AI to generate actual research results or modify images obtained during the study.
- Transparency and disclosure
- Authors are required to indicate the use of generative AI tools when submitting a manuscript, including: the name and version of the AI tool; purpose of use (e.g. text mining/ editing, data analysis, generating processes flowcharts described in the work, used questionnaires, manuscript abstracts, etc.); prompts used in generative AI.
- Authors may not provide this information if non-generative AI was used or if generative AI did not significantly modify the content of the manuscript, for example:
- basic grammar checking;
- replacing only a few words in the text without changing the contextual meaning;
- a general literature search using AI without its interpretation and data synthesis;
- literature sources formatting without recommending/generating sources;
- general editing of images without their modification (cropping, increasing contrast, etc.).
- The editors may request additional information about the use of AI to ensure transparency and compliance with ethical standards.
- Rights and privacy protection
- Authors and reviewers must ensure that the AI tools used:
- comply with the requirements for the protection of personal/ sensible data and confidentiality;
- do not violate the rights of third parties, including intellectual property and data privacy;
- do not gain the rights to content created by authors and do not use it to train AI models without the user's consent.
- By submitting material created using AI, authors guarantee that they have the right to use the generative content under the terms of the AI licenses.
- Technical control by the editors
- The Journal uses specialized tools such as national industry leader Antiplagiat plagiarism checker to identify texts generated by AI. Manuscripts containing unjustified use of AI may be rejected or sent for revision.
- Compliance with international standards and best practices
The editorial team of the journal "Biological Products. Prevention, Diagnosis, Treatment" supports the provisions of Russian regulations, the position of the international publishing community and best practices presented in the following documents:
- Russian GOST 71657-2024 about the use of AI tools in writing scientific publications
- World Association of Medical Editors (WAME) – Chatbots, Generative AI, and Scholarly Manuscripts
- International Committee of Medical Journal Editors (ICMJE) – Recommendations, Part II, paragraph A4
- Editorial policy of Wiley and Springer Nature regarding the principles of using AI in scientific publications
Policy revision date: 14.04.2025