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Safety and Risk of Pharmacotherapy

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Editorial Policies

Aims and Scope

Safety and Risk of Pharmacotherapy is an open access, peer-reviewed, scientific and applied research 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 aim of the journal is to report on research advances and clinical implications in drug safety assurance and mitigating the risks of drug therapy.

Target audience. It is aimed at healthcare practitioners; clinical pharmacologists and specialists in other medical specialties; pharmacists; pharmacovigilance officers and pharmacovigilance managers in pharmaceutical companies and organisations; employees of expert institutions, preclinical and clinical trial centres, regulatory and supervisory bodies, and research institutes; students, post-graduate students, and lecturers of medical and pharmaceutical universities.

The journal welcomes conceptual novelty and high-quality research and publishes the following types of articles:

  • Reviews on debatable and topical issues.
  • Narrative reviews that represent an authoritative source of information on epidemiology, clinical manifestations, and specific aspects of adverse drug reactions, prevention and treatment of complications associated with the use of particular medicinal products and classes of medicinal products.
  • Results of in-depth benefit–risk assessment, data on the safety and efficacy of medicinal products in a particular therapeutic area.
  • Systematic reviews (with or without meta-analyses) that compare empirical evidence to answer a specific research question using systematic methods, as outlined in the PRISMA statement.
  • Original research papers reporting the results of appropriately designed studies in areas such as clinical pharmacology, pharmacovigilance, pharmacoepidemiology, pharmacology and toxicology, pharmacogenetics, and pharmacogenomics.
  • Case reports revealing adverse drug reactions associated with the use of medicinal products.
  • Editorials, expert opinions, and comments to published articles.

Scope. The journal welcomes manuscripts describing the improvement of the pharmacovigilance system; new classes of adverse drug reactions and peculiarities of benefit–risk assessment for innovative medicines; clinical cases of first-time adverse drug reactions supported by literature data on possible mechanisms of their development; data on the safety of using medicines in such medical fields as internal medicine, neurology, gerontology, and geriatrics.

For Safety and Risk of Pharmacotherapy, the manuscripts deducated exclusively to the quality control, standardisation, and marketing authorisation of medicines are not a priority. Research on the safety of homoeopathic medicines and dietary supplements is not a priority either.

Commentaries on current issues and expert opinions are usually published upon request or approval of the Editor-in-Chief.

The journal publishes articles in the following specialties set by the Higher Attestation Commission (HAC) of the Russian Federation for post-graduate students to publish (*,the research specialties where the journal is recommended by HAC):

  • 3.3.6. * Pharmacology, clinical pharmacology (medical and pharmaceutical sciences)
  • 3.1.17. Psychiatry and narcology
  • 3.1.18. * Internal diseases (medical sciences)
  • 3.1.20. Cardiology
  • 3.1.21. Paediatrics
  • 3.1.22. Infectious diseases
  • 3.1.24. *  Neurology (medical sciences)
  • 3.1.31.* Gerontology and geriatrics (medical sciences)

 

Section Policies

PHARMACOVIGILANCE
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SAFETY OF COVID-19 PHARMACOTHERAPY
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CLINICAL STUDIES
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PHARMACOGENETICS
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CLINICAL OBSERVATIONS
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INFORMATION TECHNOLOGY
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COCHRANE PUBLICATIONS
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MAIN TOPIC: RELEVANT SAFETY ISSUES OF ANTIMICROBIAL TREATMENT
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SAFETY OF PHARMACOTHERAPY IN INTERNAL MEDICINE
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PRECLINICAL STUDIES
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RETRACTION
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MAIN TOPIC: PHARMACOVIGILANCE
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AUTHORITATIVE OPINION
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THANK YOU FOR ALL OUR REVIEWERS
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MAIN TOPIC: NEW EAEU PHARMACOVIGILANCE REQUIREMENTS 2023
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SAFETY OF ANTIMICROBIAL TREATMENT
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MAIN TOPIC: CURRENT LIPID-LOWERING THERAPY: STATINS AND MORE
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FROM IN VITRO EXPERIMENTS TO CLINICAL STUDIES
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PRECLINICAL AND CLINICAL STUDIES
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MAIN TOPIC: CURRENT ISSUES IN PHARMACOVIGILANCE
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MAIN TOPIC: GENETICS AND PHARMACOLOGY: RESEARCH AND ADVANCES
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RATIONAL PHARMACOTHERAPY AND PHARMACOVIGILANCE
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QUALITY OF MEDICINES
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RATIONAL PHARMACOTHERAPY AND PHARMACOVIGILANCE
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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.

 

Archiving

The journal plans to deposit its content in the Portico database in 2025.

 

Peer Review

General provisions:

  • When working with manuscripts, communicating with reviewers, and managing the peer-review process at Safety and Risk of Pharmacotherapy, 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 Editor-in-Chief has full authority over the entire editorial content of the journal and the timing of publication of that content. 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 should base editorial decisions on the integrity of the work and its importance to the journal’s readers, not on the commercial or other implications for the journal. The editorial staff should be free to express critical but responsible views about all aspects of medicine without fear of retribution, even if these views conflict with the publisher’s and the founder’s commercial or other goals.
  • The Editor-in-Chief should also have the final say in decisions about which advertisements or sponsored content, including specialist supplements, the journal will and will not carry. In addition, the Editor-in-Chief should have the final say in use of the journal brand and in overall policy regarding commercial use of journal content.
  • Peer review is provided on an unpaid basis.
  • The authors may suggest peer reviewers for their submissions. 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.

Peer-review type

All the manuscripts submitted to Safety and Risk of Pharmacotherapy are subject to mandatory double-blind peer review. This means that both the submission’s author and its reviewer are not informed of each other’s names or positions, and an editor of the journal mediates all communication between them. 

Mandatory peer review does not apply to methodology articles, guidelines, and informational materials (regulatory decisions, news, etc.), as well as research data submitted as additional information 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 copy editors.

Peer-review duration

At Safety and Risk of Pharmacotherapy, an average peer-review procedure takes 1–6 months. This period includes initial consideration of the manuscript screening, selection of reviewers, preparation of reviews, follow-up revision by the authors, follow-up review by the reviewers, and involvement of additional experts. Please see full Editorial & Publishing Flowchart for more details.

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. Manuscripts with negative reviews are presented to the Editorial Board for consideration along with the copy 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:

  • Acceptance for publication In this case, the manuscript will proceed to the editing stage and will be included in the publication plan for a future issue of the journal. The author will be informed of the publication date.
  • Acceptance for publication after revision based on reviewers’ comments In this case, the author will be recommended to revise the manuscript according to the reviewers’ comments. If the author makes changes according to the reviewers’ comments or presents a reasoned refusal to change the manuscript, the manuscript will be accepted for publication.
  • Acceptance for publication after revision based on reviewers’ comments and another round of review In this case, the author will be recommended to revise the manuscript according to the reviewers’ comments. After that the manuscript will be sent for a second round of review. The author will be informed of the final decision on the manuscript within 30 days.
  • Rejection 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 may choose to blacklist the author. As a result, the editorial staff will not consider any further submissions by them.

At Safety and Risk of Pharmacotherapy, the peer-review process involves maximum three rounds of review. Therefore, when recommended to revise the manuscript according to the reviewers’ comments, the author has two attempts to revise the manuscript or to present a reasoned refusal to change it. If a reviewer is not satisfied after the third round of review, the author will be suggested to consider submitting their manuscript to another journal or resubmitting a revised version in 6 months.

The editorial staff should be informed if the author is unwilling or unable to revise the manuscript. Upon notification, the editorial staff will stop handling the manuscript. Even without notification, if the author fails to submit a revised variant of the manuscript within 1 month after receiving the reviewers’ comments, the editorial staff will stop working with the manuscript on the grounds of the revision deadline expiration. The decision will be communicated to the author by e-mail.

If the author has a conflicting interest with a potential reviewer, the author should disclose this to the editor. If necessary, the journal’s editorial staff will appoint another peer reviewer.

A conflict of interest between an author and a reviewer may arise during peer review. In such case, the editor of the journal has the right to select another reviewer for the manuscript and to appeal to the Editor-in-Chief for reconciliation.

The Editor-in-Chief, Deputy Editors-in-Chief, the Executive Secretary, and Editorial Board members may publish their articles in Safety and Risk of Pharmacotherapy, provided that they do not abuse their authority. The manuscripts by the journal’s employees are assigned for double-blind peer review exclusively to external reviewers. Disagreements and conflicts are resolved exclusively by external experts. If there are conflicting views regarding a manuscript submitted by the Editor-in-Chief, the final decision on its publication will be 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 external reviewers experienced in the relevant field who have published works on the topic of the manuscript under review within the last 3 years.

If the topic of the manuscript is very narrow and/or its author declares a potential conflict of interest with external reviewers, the editors may involve Editorial Board members in the peer-review process.

Reviewer selection and actions by the journal’s editorial staff to ensure high quality service

The editorial staff ensure timely rotation of the reviewers working for the journal and regularly invite recognised experts in pharmacology, clinical pharmacology, and clinical medicine to join the pool of reviewers for Safety and Risk of Pharmacotherapy.

The reviewers are invited to work for the journal on the recommendation of the Editor-in-Chief, Deputy Editors-in-Chief, Editorial Board members, and scientific editors.

New peer reviewers

The first reviews prepared by a new peer reviewer are evaluated using the following Review Quality Instrument (In Russia):

  1. Did the reviewer discuss the importance of the research question?
  2. Did the reviewer discuss the originality of the manuscript?
  3. Did the reviewer clearly identify the strengths and weaknesses of the research (study design, data collection, and data analysis)?
  4. Did the reviewer make specific useful comments on the writing, organisation, tables, and figures of the manuscript?
  5. Were the reviewer’s comments constructive?
  6. Did the reviewer supply appropriate evidence using examples from the article to substantiate the comments?
  7. Did the reviewer comment on the author's interpretation of the results?
  8. How would you rate the overall quality of the review?

The marking scale is 1–5, where 1 is the lowest score and 5 is the highest score.

If the journal’s editors are not happy with a review, they stop working with the reviewer.

The editors are entitled to use the above instrument to evaluate the quality of an unrestricted number of reviews by any reviewer working for Safety and Risk of Pharmacotherapy.

Reviewer engagement

At Safety and Risk of Pharmacotherapy, the editors consider peer review one of the most important processes for the journal; they value the expertise and time of the reviewers involved.

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

At Safety and Risk of Pharmacotherapy, the editors 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.

Only with the consent of their editor may the reviewers involve third parties in the peer-review process.

Reviewer responsibilities

By agreeing to review a manuscript for Safety and Risk of Pharmacotherapy, 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 Safety and Risk of Pharmacotherapy, 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 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 reviewer 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 should inform the editor of their consent to review the manuscript, and they should complete the review within the time limits specified by the editor. If unable to review, the reviewer should recommend another expert to the editor.

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 Safety and Risk of Pharmacotherapy 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 editors of the journal ask the reviewer to pay particular attention to the section on the shortcomings of the work and recommendations for its correction.

The reviewer may provide comments in a free format.

Review content and structure

Safety and Risk of Pharmacotherapy has the following main criteria for submissions:

  • Novelty of research and methodology;
  • Originality;
  • Ethical rigour;
  • Methodological rigour;
  • Clear, concise, logical, and structured presentation;
  • Validity of results;
  • Importans and relevance in accordance with the Aims and Scope of the journal;
  • Reproducibility of the results;
  • Adequate literature coverage;
  • Practical and clinical significance.

Comments for editors. The Disclosure section should describe actual or potential conflicts of interest related to the content of the manuscript or its authors, which may lead to a biased conclusion. 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, assumptions, concerns about potential ethical issues, recommendations, and comments (e.g., the reviewer may advise the editor to request additional information from the author). The Proposed Decision section should contain a brief recommendation on manuscript publication (i.e., “accept for publication”, “accept for publication after minor revision”, “accept for publication after major revision”, “reject”, “reject and invite the author to resubmit the manuscript for reconsideration”).

Comments for authors. The Introduction section should contain the main conclusions and describe the value of the article to readers. The Key Comments section is intended for comments on relevance of the article to the aims and objectives of the journal, the level of credibility and the ethical conduct of research. The Specific Comments section is for the reviewer to evaluate the article by individual sections (Abstract, Introduction, Materials and Methods, Results, Discussion) or to comment on specific pages, paragraphs, or lines. The Recommendations for the Author section should contain the reviewer’s suggestions to the author for improving the manuscript and, possibly, future research. The Concluding Comments section should briefly describe the strengths and weaknesses of the manuscript without giving any additional recommendations.

Manuscript evaluation criteria

Relevance to the journal. The reviewer should not waste their time reviewing irrelevant manuscripts, regardless of the quality of such manuscripts. Therefore, the first step is to determine whether the manuscript to be reviewed is pertinent to the subject area of the journal and relevant to the interests of the journal’s target audience.

Integrity. Does the work meet the necessary requirements for the study design, methods, structure, content, and depth of analysis? Is research bias free? Are the results reproducible? Has the study sample been adequately selected? Has the author analysed the sample in sufficient detail to be able to make generalisations from the study findings?

Novelty. Has the research contributed anything new to the relevant subject area?

Ethics. Does the study meet the originality requirements? Does it manipulate data and falsify results? Has the study been approved by the Ethics Committee (if required)? Is it biased by conflicts of interest? Regardless of its perceived significance, the manuscript cannot be accepted if it is a redundant publication, contains plagiarism, or violates the basic ethical principles of scientific research (including justice, beneficence, and respect for persons).

Evaluation of manuscript elements. The editors of Safety and Risk of Pharmacotherapy recommend using the following questions to speed up the process of preparing an expert opinion and provide the most complete information about the article to the editor and the author.

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 short? If not, how can it be shortened? If a hypothesis has been stated, is there a report on whether it has been confirmed or not? If the research has not confirmed the hypothesis, have the authors answered the research question? Are the authors' conclusions consistent with the results obtained? If the research has provided unexpected results, have the authors analysed them appropriately? What potential contribution does the study make to the field of research and science? Have the study results been compared with the results of similar studies? Have the authors discussed the similarities and differences? Have the authors acknowledged the limitations of their work? Are there any additional limitations that should be pointed out? What is the authors' opinion on the limitations? What is the authors’ opinion on the directions for future research?

Conclusions. Are the main provisions of the article presented? Are all the conclusions justified? Are there any conclusions that have not been mentioned in the Discussion section? Are the extrapolations justified? Have the authors given recommendations on further research?

References. Does the list of references conform to the requirements of the journal? Are there errors in the reference list? Are the references cited correctly in the text? Are there any additional important publications that should be referenced? Are there too many references? Are the referenced publications still relevant? Are they scientifically valid?

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, analysing, and synthesising data)? Are the data tabulated 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?

Editing of reviews

The reviews should be written in a friendly tone and correct 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.

 

Publication Ethics & Malpractice Statement

Authorship and contributions

Authorship

At Safety and Risk of Pharmacotherapy, we adhere to the following authorship criteria (developed and described in the ICMJE guidelines):

  • Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
  • Drafting the work or reviewing it critically for important intellectual 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 (see credit.niso.org).

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.

Authorship declaration

The editorial staff of Safety and Risk of Pharmacotherapy 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 Safety and Risk of Pharmacotherapy);
  • 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 editors of the journal are entitled to set a precise deadline for the authors to provide clarification on the issues specified by the editors. 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

At Safety and Risk of Pharmacotherapy, the editorial staff carefully considers complaints about the behaviour of editors and peer reviewers, which may relate to issues such as a breach of confidentiality, an undisclosed conflict of interest, or a misuse of confidential information obtained during the peer-review process. The authors may also disagree with decisions regarding expressions of doubt on certain articles and complain about non-compliance with the editorial policies.

Complaints should be emailed to birf@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:

If the authors do not agree with the decision of the Editorial Board, they may file a written reasoned complaint (once per manuscript). The editorial staff is obliged to consider the complaint within 3 weeks and make a final decision, which is not a subject to review.

Handling confidential data

The right to privacy of individuals or organisations 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 minimise any potential physical and psychological harm to research participants.

Responsibilities of the management team of the journal, including the Editorial Board, the editors, the publisher, and the founder

Editorial Board recruitment

When forming the editorial board, the editorial board of the journal Safety and Risk of Pharmacotherapy 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, as well as the candidates themselves by application.

A candidate for the editorial board shall send an application to the editor-in-chief, who makes the final decision on including the candidate in the editorial board.

Candidates shall accept the following conditions:

  • Priority is given to candidates with an academic degree (PhD, Doctor of Science) and scientific publications for past 3 years relevant to the journal scope.
  • The term is 3 years with renewal possibility. It may be terminated early (with 10-day notice to the editor-in-chief).
  • The candidate must disclose all potential and actual conflicts of interest (e.g. any activity in publishing scientific journals and books, membership in the editorial boards/councils of other journals) and any conflicts of interest that may arise after joining the editorial board.
  • Participation in multiple editorial boards/councils is permitted only if the candidate has different decision-making powers or article commissioning responsibility in each editorial board.

Potential responsibilities of Editorial Board members

The roles, the tasks, and the amount and scope of responsibility for each member of the Editorial Board are agreed individually and may include the following:

  • Peer review of incoming manuscripts in their area of expertise/with consideration of their proficiency in the language of the manuscript (in the absence of external reviewers);
  • Selecting reviewers for incoming manuscripts;
  • Control of the peer-review process for incoming manuscripts;
  • Deciding on the possibility of publishing manuscripts after all rounds of peer review; The opinions will be passed to the Editor-in-Chief, who will make the final decision on the possibility of publication;
  • Calling for 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.

A member may be excluded from the Editorial Board 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-in-Chief

  • The Editor-in-Chief is personally responsible for the decisions to publish articles.
  • The Editor-in-Chief makes the final decision on publication.
  • When reviewing manuscripts and deciding on their publication, the Editor-in-Chief is guided by the journal policies. The Editor-in-Chief may discuss the manuscript and reviewers' comments with the editors and peer reviewers, provided that these discussions are justified and legitimate and the discussed materials are not used for personal purposes.
  • The Editor-in-Chief 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-in-Chief 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).
  • 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 actions necessary in such cases, such as making amendments, publishing retractions, withdrawing articles, and expressing doubts.
  • 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 every effort to resolve conflicts as soon as possible.
  • If necessary, the Editor-in-Chief liaises with the author's organisation to conduct a more in-depth investigation.

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 in the editorial work to improve the ethical performance of the journal and adherence to the best editing practices;
  • to provide comprehensive legal support to the editorial staff of the journal if necessary.

 

Ethical Oversight

At Safety and Risk of Pharmacotherapy we shares the view of COPE that publication ethics ensures not only ethical principles and good research practices, but also ethical behaviour with respect to vulnerable populations, laboratory animals, and confidential data, business practices, and marketing policies.

Informed Consent for Publication

Safety and Risk of Pharmacotherapy requires informed consent for publication to be provided by patients (or their legally authorised representatives) for any study in which there is a risk that an individual or group of individuals may be identified, including publication of photographs, medical history, and other data. According to the ICMJE (Section II.E, Protection of Research Participants), masking part of the face in photographs does not guarantee the anonymity of the subject and requires consent for publication. Consent for publication from the patient's legally authorised representatives is also required when deceased individuals are involved in the study. If necessary, at the request of the editors the authors must a confirmation of the informed consent obtained from the patient or their legal representative.

The published article must contain information about the availability of informed consent from the authors.

The information required in the informed consent for publication:

  1. Full name and signature of the patient or person signing the form. If this is not the same person, it is necessary to indicate their relationship to the patient. If a person signs consent on behalf of a family or group of people, he/she must confirm that all family members or group participants have been informed.
  2. Indication of the absence of legal, mental, or physical obstacles to giving consent for publication. If such obstacles exist, they must be indicated (minor children, incapacity, disability, death).
  3. Indication of the impossibility of guaranteeing anonymity even if the rules are followed.
  4. Indication of the possibility of revoking consent at any time before the publication of the article.
  5. Indication of the method for distributing the article (in print, online).
  6. A clause on whether the patient must review and approve the final version of the manuscript.

Research involving human subjects

At Safety and Risk of Pharmacotherapy we rely on the provisions of the WMA Declaration of Helsinki (Ethical Principles for Medical Research Involving Human Subjects) and strive to ensure compliance with ethical standards and rules for data collection for studies conducted with human subjects. Before starting a study, the researcher shall read the provisions on informed consent in the Declaration of Helsinki and conduct the study in strict accordance with the principles set out in paragraphs 25-32. When presenting the results of the experimental studies on humans, the authors must indicate whether the procedures followed were in accordance with the ethical standards prescribed in the Declaration of Helsinki. If the study was conducted without taking into account the principles of the declaration, the authors must justify the chosen approach to conducting the study and ensure that the ethical committee of the institution in which the study was conducted approved the chosen approach.

Research involving vulnerable populations

The editors of the journal Safety and Risk of Pharmacotherapy support the COPE statement on the publication of research involving these populations.

Vulnerable groups include (but are not limited to): pregnant women, foetuses in the womb, newborns, children, prisoners, people with disabilities, with intellectual disabilities (developmental disabilities), the economically disadvantaged, hospitalised patients in serious condition, etc.

According to paragraph 20 of the Helsinki Declaration, "Medical research with individuals, groups, or communities in situations of particular vulnerability is only justified if it is responsive to their health needs and priorities and the individual, group, or community stands to benefit from the resulting knowledge, practices, or interventions. Researchers should only include those in situations of particular vulnerability when the research cannot be carried out in a less vulnerable group or community, or when excluding them would perpetuate or exacerbate their disparities."

One of the main concerns when including vulnerable groups in scientific research is that not all participants may fully understand the conditions of the experiment due to objective factors. If informed consent cannot be obtained from a direct research participant, this consent must be signed by their legal representative.

Animal studies

When conducting experimental studies on animals, the authors must provide information on compliance with institutional and national standards for the use of laboratory animals.

To provide more accurate and correct information on animal studies, the editors of the journal Safety and Risk of Pharmacotherapy recommend using the ARRIVE guidelines to improve the quality and reproducibility of published research.

Preclinical and clinical studies where only one sex is used

In accordance with Chapter IV of the ICMJE recommendations, the text of the article on studies involving people, animals, or any material obtained from people and animals (e.g., organs, cells, tissues) should include the following:

  • Specify sex in the title of the article if it is not obvious from the topic of the article (e.g., cervical cancer).
  • In the introduction, mention publications on studies that have revealed differences related to sex (e.g., a higher prevalence of the disease under study in representatives of one of the sexes), or confirmed the absence of such differences.
  • In the Methods, indicate how possible differences were taken into account when planning the experiment: how the representativeness of the sample was ensured, whether there were specialised inclusion/exclusion criteria, and whether there were special recommendations depending on sex (e.g., recommendations on the use of contraception).
  • In the Results, if necessary, provide data separately for males and females and discuss the results considering the disaggregated data.
  • In the Discussion section, consider the possibility of extrapolating the data to the other sex. If data analysis by sex was not carried out, the chosen approach should be justified.

 

Founder

The Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation (FSBI “SCEEMP” of the Ministry of Health of the Russian Federation)

Responsibilities of the Founder

The Founder of Safety and Risk of Pharmacotherapy adheres to the principle of editorial independence. (Neither the General Director nor the employees of the Founder organization do not intervene not 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 the final decision on the possibility of working with them is made exclusively by the Editor-in-Chief.
  • 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 organisations, 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.

 

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

This section was prepared according to the ICMJE and WAME recommendations

A conflict of interest exists when an individual holds contradictory or competing interests that could bias editorial decisions on a manuscript as well as the interpretation of data in it. Conflicts of interest may be potential or perceived, or they may be actual. The impartiality of opinion may be influenced by personal, political, financial, scientific, or religious considerations.

Conflicts of interest may include:

  • Financial ties. This conflict is present when a participant in the publication process has received or expects to receive money (or other financial benefits, such as patents or stocks), gifts, or services that may influence their work on a specific publication. Examples of financial ties include but are not limited to payment for research, fees for advice, and honoraria for public speaking.
  • Personal relationships. This conflict arises from personal relationships with family members, friends, competitors, and former colleagues.
  • Political or religious beliefs. Commitment to a particular religion or political party may pose a conflict of interest for a publication on religious or political issues.
  • Institutional affiliations. This conflict of interest arises when a participant in the publication process is directly affiliated with an institution wishing to publish (or to prevent the publication of) a material on a particular topic.

At Safety and Risk of Pharmacotherapy, the editors may ask the authors additional questions or request lacking information (if necessary).

Conflicts of interest may involve the authors, peer reviewers, and editors. The following policy statements are based on the ICMJE recommendations.

Responsibility of the authors to disclose conflicts of interest

The authors submitting a manuscript of any type or format are responsible for disclosing all relationships and activities that might bias or be seen to bias their work (by filling in the ICMJE form containing 13 sections.

The author is obliged to disclose conflicts of interest in the relevant section of the article, based on the completed ICMJE form. If there are no conflicts of interest, the authors should also report this. For example: “The authors declare no conflicts of interest.”

Responsibility of the reviewers to disclose conflicts of interest

The peer reviewers must inform the editors of any conflict of interest that may influence their assessment of a particular manuscript. If there are grounds for bias, the reviewers should recuse themselves from reviewing.

Responsibility of the editors to disclose conflicts of interest

The editors involved in making final editorial decisions should refrain from making decisions on a manuscript if they have a conflict of interest or if their actions may give rise to potential conflicts of interest in relation to this manuscript. Other editorial staff involved in making editorial decisions should inform the editors of their current interest, and if there is a conflict of interest, the editorial staff should recuse themselves from making editorial decisions on the manuscript (as they can influence editorial decisions).

The editorial staff should not use the information obtained during the work on manuscripts for personal purposes.

The Editor-in-Chief, Deputy Editors-in-Chief, and Editorial Board members should indicate their affiliation with the journal in their submissions to Safety and Risk of Pharmacotherapy.

If an undisclosed conflict of interest is discovered in an unpublished manuscript, the editorial staff of Safety and Risk of Pharmacotherapy will follow the applicable COPE recommendations.

If an undisclosed conflict of interest becomes clear after publication, the editorial staff of the journal will follow the applicable COPE recommendations.

 

Plagiarism Detection

The editorial staff of Safety and Risk of Pharmacotherapy 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

In some cases, it may be necessary to change a published article. At Safety and Risk of Pharmacotherapy, 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.

At Safety and Risk of Pharmacotherapy, the editors use Expressions of Concern, Corrections, and Retractions. These practices aim to ensure the integrity of published research.

All the expression-of-concern, correction, and retraction notices are made publicly available.

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.

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 birf@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).

Expressions of doubt

At Safety and Risk of Pharmacotherapy, the editorial staff report an expression of doubt in the following cases:

  • Serious concerns have been raised about a published article, but these concerns have not been proven through investigation yet.
  • For some reason, the investigation will not or cannot be completed for a long time.

In this case, readers should be notified as soon as possible.

Once the investigation is completed, the article may be amended or retracted.

Removals

At Safety and Risk of Pharmacotherapy, 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.

Retraction (withdrawal) policy

At Safety and Risk of Pharmacotherapy, 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 Russian database for retracted articles.

At Safety and Risk of Pharmacotherapy, we work with article retractions according to the COPE guidelines.

Retraction procedure

The retraction procedure follows the guidelines of the Council of Scientific Publication Ethics of the Association of Science Editors and Publishers (ASEP).

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.

 

Preprint and Postprint Deposition

Preprints

At Safety and Risks of Pharmacotherapy, 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 Safety and Risks of Pharmacotherapy.

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 Safety and Risks of Pharmacotherapy, 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,
  • Direct interactions with faculty members or students by providing them with the final version of the manuscript for personal use.

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, 2021, of the journal Safety and Risks of Pharmacotherapy”.

 

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 Safety and Risk of Pharmacotherapy. 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 Safety and Risk of Pharmacotherapy, 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 Editor of the journal.

Study protocols and their registration

The journal Safety and Risk of Pharmacotherapy welcomes the preliminary publication of research protocols and their registration in the applicable registers (for example, clinicaltrials.gov). For randomised controlled trials, the protocol must be registered before the authors submit the manuscript.

 

Advertising

Revenue generation is not a goal of the Founder of Safety and Risk of Pharmacotherapy. 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.

Safety and Risk of Pharmacotherapy 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.

Safety and Risk of Pharmacotherapy 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 you the current status of this document and may also give you additional publication-record 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 “Safety and Risk of Pharmacotherapy” is committed to ensure that such use aligns with our publishing requirements and ethical standards  to meet the following provisions.

  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. Compliance with international standards and best practices

The editorial team of the journal "Safety and Risk of Pharmacotherapy" 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



Publisher: Scientific Centre for Expert Evaluation of Medicinal Products

 

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