Aim and Scope

The journal mission is to provide healthcare managers, researchers and medical practitioners with up-to-date high-quality scientific and practical information about the most advanced and effective management and organizational solutions in urban healthcare and clinical practice.

The journal serves as a platform for publishing research results, summarizing work experience and expressing opinions of health professionals on topical issues for urban healthcare:

• management of health care delivery systems in the city;
• city health economics;
• patient routing, screening and prevention of the most socially significant diseases;
• influence of a healthy lifestyle on the health indicators of city residents;
• social assistance and rehabilitation programs in the city;
• mental health of city residents;
• environmental and technogenic factors influencing the health indicators of city residents;
• IT solutions in health monitoring and management of urban health systems, etc.

The editorial office pays much attention to publishing research results of healthcare workers on topical areas of urban health.

Section Policies

ORIGINAL RESEARCHES

Open Submissions

Indexed

Peer Reviewed

REVIEWS

Open Submissions

Indexed

Peer Reviewed

BRIEF REPORTS

Open Submissions

Indexed

Peer Reviewed

EXPERIENCE EXCHANGE

Open Submissions

Indexed

Peer Reviewed

ANNIVERSARY OF THE N.A. SEMASHKO NATIONAL RESEARCH INSTITUTE

Open Submissions

Indexed

Peer Reviewed

VIEWS AND DISCUSSIONS

Open Submissions

Indexed

Peer Reviewed

RESEARCH BRIEFS

Open Submissions

Indexed

Peer Reviewed

PUBLICATIONS OF N.A. SEMASHKO NATIONAL RESEARCH INSTITUTE OF PUBLIC HEALTH

Open Submissions

Indexed

Peer Reviewed

Publication Frequency

4 issues per year

Open Access Policy

The City Healthcare Journal gives open access to its content, adhering to the principle that free open access enhances the global exchange of knowledge.

Our open access policy aligns with the definition outlined by the Budapest Open Access Initiative (BOAI). This means that articles are freely available online, allowing users to read, download, copy, distribute, print, search for, or link to the full texts of these articles, crawl them for indexing, process them with software, or use them for any other lawful purpose. Access is provided without any financial, legal, or technical barriers, apart from those inherently linked to internet access.

Archiving

• Russian State Library (RSL)
• National Electronic-Information Consortium (NEICON)

Reviewer Guidelines

Last updated 31.03.2025

To assist reviewers, the editorial board of City Healthcare journal provides a rapid review form containing key questions required for editorial decision-making. Reviewers are encouraged to prioritize the "Comments" section to help authors improve both the current manuscript and future work.

Review Content and Structure

 This section aligns with methodological recommendations from NEICON (with permission granted to City Healthcare for use in the journal’s peer-review policy).

10 Manuscript Assessment Criteria:

• Originality
• Logical rigor
• Statistical rigor
• Clarity and conciseness of writing
• Theoretical significance
• Reliable results
• Relevance to contemporary research fields
• Reproducibility of results
• Literature coverage
• Practical applicability of findings

In addition to the rapid review form, City Healthcare recommends the following review structure:

Comments for the editor

Conflict of Interest — Describe any actual or potential conflicts of interest related to the manuscript or its authors that could lead to biased conclusions.

Confidential Comments — These comments will not be shared with authors. This section includes the reviewer's final recommendation regarding the manuscript's disposition, any concerns about potential ethical violations, suggestions for the editor (such as requesting additional information from authors), and the proposed decision - typically a brief conclusion about the manuscript's fate (accept, accept with minor revisions, accept with major revisions, reject).

Comments for authors

 Introductory Section — This section describes the main conclusions and the article's value for readers.

Major Comments — This section addresses the relevance to the journal's aims and scope, the reliability of results, and ethical conduct.

Specific Comments — The reviewer evaluates individual article sections (abstract, introduction, methods, results, discussion) or provides comments on specific pages, paragraphs, or lines.

Recommendations for Authors — The reviewer provides suggestions to improve the manuscript quality and potentially for future research.

Concluding Remarks — A brief description of the manuscript's strengths and weaknesses without additional recommendations.

Manuscript Evaluation Criteria

Relevance to the Subject Area

Do not spend time reviewing an irrelevant manuscript, regardless of its quality. First and foremost, determine whether the manuscript aligns with the journal's subject area and the interests of its audience.

Scientific Validity

Does the study meet all necessary requirements in terms of research design, scientific methods, structure, content, and depth of analysis? Does it adhere to the principles of unbiased scientific research? Are the results reproducible? Was the study sample properly constructed? Has it been analyzed in sufficient detail to allow for generalization of the research findings?

Novelty

Has the study contributed something new to the relevant field?

Ethical Compliance

Does the research meet originality requirements? Is it free from bias in terms of conflicts of interest? Regardless of the perceived significance of the manuscript, it cannot be accepted for publication if it contains redundant material, plagiarism, or violations of fundamental ethical principles of scientific research: legality, beneficence, and respect for individuals.

Evaluation of Manuscript Elements

The editorial board of City Healthcare journal suggests using the following questions to expedite the preparation of expert reviews and provide the most comprehensive information about the article to the editor and authors.

Title

Does the title accurately reflect the manuscript’s content? Will the title capture readers' attention?

Abstract

Does the abstract adequately summarize the manuscript's content (structured format, clear description of objectives, methods, results, and significance)? Are there discrepancies between the abstract and the manuscript sections? Can the abstract be understood without reading the full manuscript?

Introduction

Is the introduction concise? Does it clearly state the research objectives and aims? Does the author justify the study's relevance and significance through a literature review? If so, does this section meet length requirements? Does the author define key terms used in the manuscript? For submissions to the "Original Research" section, is there a clearly formulated hypothesis?

Literature Review

Is the literature review comprehensive and coherent?

Methods

Can another researcher replicate the study using the described methods, or are the methods unclear? Do the authors justify their methodological choices? If a hypothesis is stated, are the methods designed to test it rigorously? How is the research design presented? Does the data analysis support the study objectives?

Results

Are the results clearly explained? Does the order of results presentation match the methods section? Are the results justified and expected, or unexpected? Are there results without corresponding methods descriptions? How precise is the results presentation?

Discussion

Is the discussion concise? If not, how could it be shortened? If a hypothesis was stated, do the authors confirm or refute it? If unconfirmed, do they address the research question? Do the authors' conclusions align with the obtained results? Are unexpected results properly analyzed? What potential contribution does the study make to the field and global science?

Conclusions

Do the authors acknowledge study limitations? Are there additional limitations to note? What are the authors' views on these limitations? What future research directions do they suggest?

References

Does the reference list comply with the journal's format? Are there bibliographic errors? Are in-text citations accurate? Are there important works omitted that should be cited? Are there excessive references? Are cited sources up-to-date?

Tables

If present, do tables accurately describe results? Should additional tables be added? Are the data in tables appropriately processed to aid comprehension rather than complicate it?

Figures

Are tables and figures suitable for addressing the research objectives? Could results be better presented differently? Do figures and graphs reliably display key findings? Do they require modifications for clearer representation? Can figure captions be understood without referring to the main text?

Conflict of Interest Disclosure

Is funding and conflict of interest information clearly stated?

Reviewer’s Final Decision

The journal editorial board requests that reviewers pay special attention to the "Comments" section to assist authors in improving both the current manuscript and future work. Below are the recommended justifications for the reviewer's final decision:

Accept for Publication

The reviewer confirms that the manuscript is ready for publication in its current form. The article is scientifically valid, ethically sound, significant for the academic community, and contributes to existing literature. The writing style is clear and concise.

Accept After Minor Revisions

The manuscript requires non-critical adjustments. Upon implementing the suggested changes and re-evaluation, the article may be accepted for publication.

Accept After Major Revisions and Re-Review

The manuscript contains substantial flaws or errors affecting the reliability of the results. After revision and re-evaluation, the article may be accepted, rejected, or sent for additional expert review. This decision often requires the author to provide supplementary data.

Reject

The submission does not align with the journal's aims and scope, exhibits one or more irreparable shortcomings, or raises serious ethical concerns, such as lack of required publication consent, unethical research methods, or discredited methodology (e.g., ignoring processes that significantly impact results). Authors should not resubmit a revised version without explicit editorial request. The reviewer must provide detailed comments justifying this decision, as they may help the author substantially improve the work.

Review Editing

 The editorial board of the City Healthcare journal expects all reviews to be written in a constructive and professional manner, adhering to proper Russian language standards (or English standards for reviews written in English). Reviewers must avoid personal remarks, offensive language, or unjustified criticism of any aspect of the research, manuscript language, or writing style. Reviews violating these guidelines will be returned for revision.

While City Healthcare generally transmits reviews to authors in their original form, the editorial board reserves the right to make necessary editorial adjustments to the review text while preserving its original meaning. Such adjustments may include consolidating comments from multiple reviewers on the same issue or handling confidential remarks.

Reviewer Responsibilities

By agreeing to review manuscripts for City Healthcare, reviewers acknowledge their commitment to follow the journal's policies regarding manuscript evaluation, review preparation, and ethical conduct.

Reviewers share responsibility with editors for maintaining the high quality of publications in City Healthcare and should only accept review assignments when they possess sufficient expertise in the relevant field and adequate time to conduct a thorough, comprehensive evaluation of the manuscript.

Reviewers are required to disclose any potential conflicts of interest to the editor, including personal, financial, intellectual, professional, political, or religious conflicts. In cases of uncertainty regarding a potential conflict, reviewers must consult with the editor before proceeding with the review.

Ethics of Scientific Publications

Last updated: March 20, 2025

The editorial board of the quarterly journal City Healthcare adheres to ethical standards established by international scientific associations (COPE, ICMJE, Elsevier and others).

Responsibility for Ethical Compliance

The journal's editorial board monitors adherence to publication ethics, basing its policies on respect for authors' personal rights and intellectual property rights. It assumes responsibility for ensuring all participants follow ethical standards and preventing unethical publishing practices. The journal guarantees:

• Compliance with authorship ethics in scientific publications
• Compliance with peer review ethics in scientific publications
• Compliance with editing ethics in scientific publications
• Data access and storage protocols

Editorial Policy

The journal guarantees consideration of all submitted manuscripts, maintaining editorial independence and integrity in making objective decisions. The editorial board's decision to publish (or reject) a manuscript must not be influenced by the author(s)' race, gender, age, nationality, citizenship, social status, sexual orientation, religious beliefs, or political views. The sole criterion for publication decisions is the scientific merit of the article.

Core Principles of Editorial Policy:

• Equal treatment of all articles (authors) by editors and reviewers
• Objective evaluation of all submissions
• Zero tolerance for plagiarism and author misconduct
• Reliability of presented data and originality of articles
• Absence of conflicts of interest
• Confidentiality

Responsibilities and Ethical Standards for Editorial Board Members and Journal Staff

The editorial office guarantees confidentiality of all information received from authors, reviewers, and other participants involved in manuscript evaluation.

The journal only considers previously unpublished articles representing original scientific research or comprehensive reviews relevant to the journal's scope. If a submitted article is found to duplicate more than 20% of content from previously published works, the editorial board reserves the right to reject the submission.

Editorial board members must thoroughly review original data contained in manuscripts but are prohibited from using such information for personal research or other unauthorized purposes prior to official publication. Such data may only be used after publication with proper citation according to established academic standards.

The editorial office ensures that manuscript materials will not be exploited for personal gain by editorial board members, reviewers, or other involved parties without the author's written consent.

The editorial team is committed to making objective and impartial decisions on all submitted manuscripts. All author interactions are based on principles of fairness, honesty, and professional courtesy.

When errors or inaccuracies are identified in published articles, the editorial office will promptly issue corrections, retractions, or clarifications as appropriate.

Complete guidelines for authors, reviewers, and editors are available in dedicated sections of the journal's website at www.city-healthcare.com.

All articles are published under open access terms with a Creative Commons Attribution-ShareAlike 4.0 International license, permitting reading, citation, reproduction, and adaptation for educational and research purposes with mandatory attribution to both the journal and authors. Articles are available through the journal and the eLibrary scientific database.

The editorial office adheres to guidelines from the Committee on Publication Ethics (COPE) and operates according to principles of scientific rigor, objectivity, professionalism, and impartiality.

Ethical Guidelines for Authors

• Authors are fully responsible for the content of their articles.
• Articles must contain only original scientific data. Any borrowed material must be properly cited. Reported results must meet reproducibility criteria. All data processing methods and interpretation logic must be completely transparent.
• Authors are accountable for plagiarism. Unauthorized use of any article elements (text, graphics, raw data, etc.) is strictly prohibited. Plagiarism detection occurs through:
• Peer review process
• Antiplagiat system (https://www.antiplagiat.ru/) for Russian texts
• org (http://www.plagiarism.org/) for English texts
• Post-publication reader reports
• Submission confirms the manuscript isn't under review elsewhere and hasn't been previously published.
• For any previously published elements, authors must cite prior work and specify new contributions.
• Authors must ensure the byline includes all qualifying contributors (significant intellectual input) and excludes no deserving researchers.
• Authors are responsible for proper source attribution, including their own prior work.
• When criticizing third-party research, authors must maintain professional ethics.
• Manuscripts must comply with journal formatting guidelines.
• Authors must disclose any conflicts of interest during the review process.
• Authors must immediately notify the journal about significant errors in published work and cooperate on corrections/retractions. If third parties report errors, authors must promptly provide corrections or evidence supporting their original data.
• Authors must acknowledge all funding sources and research contributors.
• Authors must respectfully address editorial/reviewer feedback by either implementing suggestions or providing reasoned counterarguments.

Ethical Guidelines for Reviewers

• Peer review is conducted by members of the journal's editorial board with relevant scientific expertise. The editorial office reserves the right to engage leading scientists and highly qualified practitioners in fields corresponding to the article's subject matter.
• The sole criterion for article evaluation is scientific merit. Decisions based on personal preferences are prohibited. Reviewers must immediately notify the journal of any conflicts of interest with authors and recuse themselves from the review process.
• Reviewers must not disclose information about manuscripts under review to unauthorized parties.
• City Healthcare employs double-blind peer review: neither authors nor reviewers know each other's identities.
• Reviewers are prohibited from using unpublished manuscript information for personal research or other purposes prior to publication.
• Manuscripts under review must be treated as confidential documents that cannot be shared with unauthorized third parties.
• Reviewers must report any circumstances compromising their ability to provide fair, impartial evaluations.
• Reviewers recognizing their lack of subject expertise or inability to complete timely reviews must immediately decline the assignment.
• Reviewers should alert the editor-in-chief about substantial similarity between the manuscript and other works and/or missing citations of previously published findings by the same or other authors.
• Reviews should presume authors' good faith. When assessing manuscripts containing scientifically valuable but imperfect research, reviewers should focus on constructively identifying substantive issues while suggesting specific, actionable improvements to strengthen the work.
• All substantive critiques should be presented in the initial review. New objections during re-review may only address significantly revised portions of the text.
• Evaluations must be fact-based and evidenced, provide objective, reasoned assessments and focus exclusively on scientific content (personal criticism is unacceptable)
• Based on review outcomes, the editorial board decides to either accept the manuscript, request revisions or reject the submission.

Ethics of Editing Scientific Articles

• Editors are responsible for all materials published in City Healthcare and must:
• Ensure freedom of expression (within current legislation and ethical standards);
• Ensure compliance with academic standards and recognized international ethical standards for scientific publications;
• Promote adherence to ethical responsibilities by the editorial board, reviewers, and authors in accordance with these requirements;
• Be prepared to publish corrections, retractions, and apologies when necessary.
• Editors bear full responsibility for decisions to accept or reject submitted articles.
• Editors must avoid conflicts of interest regarding articles they must approve or reject.
• Editors should actively work to improve the quality of published articles, identifying and correcting errors and inaccuracies.
• Editors must remain open to criticism from authors and to appeals of article rejection decisions; such requests must be carefully considered, and rejections must be well-justified.
• As a rule, editors do not reconsider decisions to reject publications, except in cases of serious violations of the review process.
• Editors must ensure confidentiality of personal information about authors and reviewers and not disclose it without their written permission.
• Editors should, whenever possible, identify unethical and duplicate publications, excluding those containing plagiarism and unreliable data, primarily at the pre-publication stage.
• When handling complaints and disputes, editors must follow the guidelines of the international Committee on Publication Ethics (COPE).
• Authors submitting complaints to the journal's editorial office should be confident that these complaints will be considered within a reasonable timeframe.

Article Retraction

The retraction of a published article is initiated by the editorial board of City Healthcare when instances of data fabrication, falsification, misappropriation of data, plagiarism, use of erroneous or incorrect data, duplicate publication, or serious errors compromising the article's scientific validity are identified. The editorial board will only consider retracting an article when presented with conclusive evidence that the reported findings are unreliable. Such unreliability may stem from either genuine error or deliberate misconduct by the authors. All retractions are executed through an official editorial procedure.

The fundamental purpose of retracting a published article is to correct the scholarly record and maintain the reliability of scientific information.

The retraction process may be initiated by the authors themselves, reviewers, or any reader who identifies potential violations of research ethics. Registered users of https://city-healthcare.com and/or http://elibrary.ru may submit formal requests for retraction through the commentary system, providing detailed explanations of the suspected violations. Should the authors refuse to retract the article, the editorial board reserves the right to proceed with retraction without their consent, following a decision by the Conflict Resolution Commission convened by the editorial board of City Healthcare. This authority stems from the journal's ultimate responsibility for all published content.

A retraction constitutes formal acknowledgment by the journal that the article contains substantive violations. Notice of retraction appears in a dedicated section of the journal's table of contents.

Retraction does not entail removal of the article from the journal's website or bibliographic databases. The article remains accessible in all platforms with a prominent "RETRACTED" watermark in the upper right corner of the first page, including the retraction date. The digital object identifier (DOI) or other permanent links are preserved to maintain the scholarly record, as researchers may have previously cited the work. Immediately following the English abstract, a "Retraction Notice" section must detail the specific reasons for retraction, the parties who initiated the retraction process and the date of the retraction decision.

The journal notifies all indexing databases of the retraction.

While authors may disagree with the editorial decision, this does not affect the journal's right to execute the retraction procedure.

Retracted articles are excluded from the Russian Science Citation Index (RSCI) and are not included in bibliometric calculations.

Access to Raw Data and Data Retention Policy

The editorial board reserves the right to request raw (unprocessed) research data from authors, including for the purpose of sharing such data with reviewers and editors. Authors must be prepared to provide this information to editorial staff in accordance with the ALPSP-STM Statement on Data and Databases and must retain these data.

Publication Archiving and Accessibility

The editorial office guarantees permanent archiving of all published scientific articles, ensuring their continued accessibility and proper submission of mandatory publication copies as required by regulations.

Founder

Scientific Budgetary Institution “Research Institute for Healthcare Organization and Medical Management of Moscow Healthcare Department”.  Website: https://niioz.ru/ 

The journal is registered by the Federal Service for Supervision of Communications, Information Technology, and Mass Media on December 05, 2019. Registration number Эл No. ФС77-77330

Author fees

Publication in “City Healthcare" is free of charge for all the authors.

The journal doesn't have any Article processing charges.

The journal doesn't have any Article submission charges.

Disclosure and Conflict of Interest

Unpublished materials disclosed in a submitted manuscript must not be used in a reviewer’s own research without the express written consent of the author. Privileged information or ideas obtained through peer review must be kept confidential and not used for personal advantage.

Reviewers should not consider manuscripts in which they have conflicts of interest resulting from competitive, collaborative, or other relationships or connections with any of the authors, companies, or institutions connected to the papers.

Plagiarism detection

“City Healthcare" use native russian-language plagiarism detection software Antiplagiat to screen the submissions. If plagiarism is identified, the COPE guidelines on plagiarism will be followed.

Preprint and postprint Policy

The editorial board of the “City Healthсare” allows authors to post the manuscript as a preprint before submission for review and to archive independently their articles in disciplinary and institutional repositories.

Preprints

The editorial board of the “City Healthсare” encourages uploading preprints on preprint servers. The Committee on Publication Ethics (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 shall not be considered duplicate publication nor shall it influence the editor's decision to publish it in the “City Healthсare”.

The author must notify the editorial board of the “City Healthсare” about the posted preprint at submission of the manuscript for review, furnishing a link to the preprint with its DOI identifier and the dissemination terms and conditions.

It is the author’s responsibility to add a link to the published manuscript in the preprint record. The link must contain the DOI and the URL of the article published on the journal's website. The original preprint should not be modified based on the reviewer’s and editor’s comments. The preprint should not be replaced with the text of the published article.

Do not delete the preprint text.

Manuscripts Accepted for Publication

The editorial board of the “City Healthсare” allows manuscripts that have been reviewed and are accepted for publication to be archived independently.

This version of the manuscript may be disseminated through:

• personal website or blog;
• institutional repository;
• disciplinary repository;
• direct interactions with faculty or students by providing this version of the manuscript for personal use.

The text of the manuscript should contain the author’s clarifications about its status and information about the planned publication.

Example: The ARTICLE TITLE has been reviewed, accepted for publication, and will be published in 2021 (3) of the “City Healthсare”.

Once the final version of the manuscript is published, it is the author’s responsibility to add a link to the published article to the publication record. The posted text should not be modified based on the reviewer’s and editor’s comments. Do not replace the text of the posted manuscript. Do not delete the text of the posted manuscript.

Final Versions of Manuscripts

The editorial board of the “City Healthсare” allows manuscripts that have been peer-reviewed, accepted for publication, edited and ready for publication (proofread and typeset) to be archived independently.

This version of the manuscript may be disseminated through:

• personal website or blog;
• institutional repository;
• disciplinary repository;
• direct interactions with faculty or students by providing this version of the manuscript for personal use.

 Once the final version of the manuscript is published, it is the author’s responsibility to add a link to the published article to the publication record. The posted text should not be modified based on the reviewer’s and editor’s comments. Do not replace the text of the posted manuscript. Do not delete the text of the posted manuscript.

Revenue Sources

The journal is funded by its founding organization.

Data sharing policy

Authors are encouraged to make the research data that support their publications available but are not required to do so. The decision to publish will not be affected by whether or not authors share their research data.

Definition of research data

This policy applies to the research data that would be required to verify the results of research reported in articles published in the journal “City Healthсare”. Research data include data produced by the authors (“primary data”) and data from other sources that are analysed by authors in their study (“secondary data”). Research data includes any recorded factual material that are used to produce the results in digital and non-digital form. This includes tabular data, code, images, audio, documents, video, maps, raw and/or processed data.

Definition of exceptions

The data that is not a subject to public disclosure may be delivered as follows: deposited in science data repositories with limited access or preliminary anonymised. An author can also publicly deliver metadata only and/or description of the method of access to the data under requests from other scholars.

Data repositories

The preferred mechanism for sharing research data is via data repositories. Please see or https://repositoryfinder.datacite.org/ for help finding research data repositories.

Data citation

The Editorial Board of the Journal “City Healthсare” welcomes access to data under Creative Commons Licenses. Editorial Board of the Journal “City Healthсare” does not insist on the obligatory use of Creative Commons in case when the data is deposited in the repositories of the third party. The Publisher of the Journal “City Healthсare” does not assert any copyrights for the data submitted by the author together with the article.  

Questions regarding the observation of that policy shall be sent to the executive secretary of the Journal “City Healthсare”: verzilinann@zdrav.mos.ru

Policy on Use of Artificial Intelligence in Manuscript Preparation

In response to the integration of generative AI and AI-assisted technologies in scientific writing, including chatbots, the City Healthcare journal has introduced the Policy on Use of Artificial Intelligence in Manuscript Preparation that applies to all article types, including original research, literature reviews, and scientific reports.

1. Generative AI is not considered an author. AI-driven software cannot be credited as an author, co-author, or included in author contributions.
2. It is prohibited to use generative AI for data analysis, drawing scientific conclusions, and drafting manuscripts or metadata.
3. AI technologies could be used to identify uncredited sources, improve the language of the text, search for additional references, or structure data. Authors must be aware that chatbots may provide false information and refer to non-existent publications. Authors should rigorously verify information obtained using generative AI.
4. We uphold the principle of transparency: authors should disclose the use of generative AI for manuscript preparation in Introduction, Materials and Methods, or in a designated section at the end of the article. It is recommended to include the text of requests made to the chatbot and to provide a hyperlink to the AI software used.
5. The author bears full responsibility for the final manuscript submitted to the City Healthcare Journal, regardless of how AI was employed.
6. Our Editorial Office uses the Antiplagiat system (https://antiplagiat.ru/en/) to detect AI-generated text.
7. Manuscript is a confidential document. Reviewers and editors are prohibited from using generative AI or sharing any confidential manuscript information with chatbots.

The journal will continuously monitor developments in AI usage and will revise this policy as necessary.

Informed Consent Requirements

City Healthcare journal is committed to the principles of the WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects and ensures research compliance with ethical standards and rules for data collection for medical research involving human beings. Before starting the work, researchers should familiarize themselves with the provisions of informed consent of the Declaration of Helsinki and strictly adhere to the principles set out below (see the provisions of the Declaration of Helsinki 25-32):

25. Free and informed consent is an essential component of respect for individual autonomy. Participation by individuals capable of giving informed consent in medical research must be voluntary. Although it may be appropriate to consult family members or community representatives, individuals capable of giving informed consent may not be enrolled in research unless they freely agree.
26. In medical research involving human participants capable of giving informed consent, each potential participant must be adequately informed in plain language of the aims, methods, anticipated benefits and potential risks and burdens, qualifications of the researcher, sources of funding, any potential conflicts of interest, provisions to protect privacy and confidentiality, incentives for participants, provisions for treating and/or compensating participants who are harmed as a consequence of participation, and any other relevant aspects of the research. (в сравнении с версией 2013 г. пункт сокращен!)

The potential participant must be informed of the right to refuse to participate in the research or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information and communication needs of individual potential participants as well as to the methods used to deliver the information.

After ensuring that the potential participant has understood the information, the physician or another qualified individual must then seek the potential participant’s freely given informed consent, formally documented on paper or electronically.  If the consent cannot be expressed on paper or electronically, the non-written consent must be formally witnessed and documented.

All medical research participants should be given the option of being informed about the general outcome and results of the research.

27. When seeking informed consent for participation in research the physician or other researcher must be particularly cautious if the potential participant is in a dependent relationship with them or may consent under duress. In such situations, the informed consent must be sought by an appropriately qualified individual who is independent of this relationship.
28. In medical research involving human participants incapable of giving free and informed consent, the physician or other qualified individual must seek informed consent from the legally authorized representative, considering preferences and values expressed by the potential participant.

Those persons incapable of giving free and informed consent are in situations of particular vulnerability and are entitled to the corresponding safeguards. In addition to receiving the protections for the particularly vulnerable, those incapable of giving consent must only be included if the research is likely to either personally benefit them or if it entails only minimal risk and minimal burden. (в сравнении с версией 2013 г. пункт сокращен!)

29. When a potential research participant who is incapable of giving free and informed consent is able to give assent to decisions about participation in research, the physician or other qualified individual must seek that assent in addition to the consent of the legally authorized representative, considering any preferences and values expressed by the potential participant. The potential participant’s dissent should be respected.
30. Research involving participants who are physically or mentally incapable of giving consent (for example, unconscious patients) may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group. In such circumstances the physician or other qualified individual must seek informed consent from the legally authorized representative. If no such representative is available and if the research cannot be delayed, the research may proceed without informed consent provided that the specific reasons for involving participants with a condition that renders them unable to give informed consent have been stated in the research protocol and the research has been approved by a research ethics committee.

Free and informed consent to remain in the research must be obtained as soon as possible from a legally authorized representative or, if they regain capacity to give consent, from the participant.

31. The physician or other researcher must fully inform potential participants which aspects of their care are related to the research. The refusal of a patient to participate in research or the patient’s decision to withdraw from research must never adversely affect the patient-physician relationship or provision of the standard of care.
32. Physicians or other qualified individuals must obtain free and informed consent from research participants for the collection, processing, storage, and foreseeable secondary use of biological material and identifiable or re-identifiable data. Any collection and storage of data or biological material from research participants for multiple and indefinite uses should be consistent with requirements set forth in the WMA Declaration of Taipei, including the rights of individuals and the principles of governance. A research ethics committee must approve the establishment and monitor ongoing use of such databases and biobanks.

Where consent is impossible or impracticable to obtain, secondary research on stored data or biological material may be done only after consideration and approval of a research ethics committee.