Research Ethics Policy

Georgian Medical Journal · Publication Policy

Public Health Institute of Georgia (PHIG) · COPE Core Practices & Flowcharts · ICMJE · Declaration of Helsinki · WAME · EQUATOR Network · CC BY 4.0 · editor@gmj.ge

The Georgian Medical Journal (GMJ) is committed to the highest standards of research ethics, publication integrity, and transparency throughout the research and publication process. This policy establishes the comprehensive ethical framework governing the conduct, reporting, review, and publication of research at GMJ. It applies to all individuals involved in the publication process — authors, co-authors, reviewers, editors, editorial board members, and editorial staff — and to all manuscript types.

GMJ adheres to the ICMJE Recommendations, COPE Core Practices and Flowcharts, the WMA Declaration of Helsinki (2024 revision), WAME principles, the CIOMS International Ethical Guidelines, ICH Good Clinical Practice (GCP), and the EQUATOR Network reporting guidelines.

Chapter I — Conflict of Interest

A conflict of interest exists when professional judgement concerning a primary interest — such as the validity of research or the welfare of patients — may be influenced, or may reasonably appear to be influenced, by a secondary interest such as financial gain, personal relationships, academic competition, or intellectual commitments.

I-1. Author Disclosure Requirements

All authors must disclose all relationships and activities that could be perceived as influencing the submitted work. Disclosures must be made at submission and updated if circumstances change.

Financial interests that must be disclosed include: grants, contracts, or research funding from any source; consulting fees, lecture fees, honoraria, or expert testimony; employment or leadership positions (current, anticipated, or held within the prior 36 months); stock ownership, options, or equity interests; patents, royalties, or licensing fees; board membership or advisory roles; travel or accommodation expenses paid by a third party.

Non-financial interests include: personal relationships or rivalries; academic competition; intellectual commitments or advocacy affiliations; membership in organisations with a direct interest in the outcome; political, religious, or ideological interests relevant to the work.

Disclosure form. All authors must complete the ICMJE Disclosure of Interests Form (icmje.org) at submission. Disclosures are published with each article.

I-2. Funding and Role of Funders

Authors must identify all funding sources (name, grant number) and specify the funder's role in study design, data collection, analysis, manuscript preparation, and the decision to submit. If the funder had no role, this must be explicitly stated. Authors must not enter agreements that restrict independent data access or publication.

I-3. Reviewer, Editor, and Staff Obligations

Reviewers must disclose conflicts before agreeing to review and recuse themselves when conflicts exist (financial relationships, recent collaboration within 36 months, personal relationships, institutional overlap, competitive interests). Editors and editorial board members must provide up-to-date disclosures, recuse themselves from conflicted manuscripts, and not use editorial information for personal advantage. When the Editor-in-Chief submits a manuscript to GMJ, the entire process is managed by an independent editor. Editorial staff must not use information from manuscripts for personal or commercial gain.

Failure to disclose. Purposeful concealment of conflicts is misconduct, handled per COPE guidelines. Actions may include correction, rejection, institutional notification, submission ban, or retraction.

Chapter II — Human and Animal Rights

II-1. Human Research

All research involving human participants must comply with the Declaration of Helsinki (2024 revision), ICH-GCP E6(R2), and applicable national regulations. The welfare and rights of participants take precedence over all other interests.

Ethics approval. All human-participant research must have been approved by an independent ethics committee (EC) or IRB before initiation. The manuscript must state: the full name of the approving body, the approval/protocol reference number, the date of approval, and confirmation of compliance. If an exemption/waiver was granted, this must be stated with the rationale. If no formal ethics committee exists, authors must explain the regulatory framework and demonstrate Helsinki compliance. Ethics approval does not preclude editors from forming their own judgement about the research's appropriateness.

Clinical trial registration. All interventional trials must be registered prospectively in a WHO-approved or ICMJE-accepted registry (ClinicalTrials.gov, ISRCTN, EudraCT/CTIS, ANZCTR, or ICTRP-listed registries). The registry name, number, and URL must appear in the abstract and methods.

Privacy and confidentiality. Identifying information must not be published without written consent. Eye-masking alone is insufficient. Data must comply with applicable data-protection legislation (e.g., GDPR). Authors must inform identifiable participants that material will be available online.

Vulnerable populations. Research involving children, pregnant women, prisoners, persons with cognitive impairment, refugees, and others with diminished autonomy must demonstrate additional safeguards per Helsinki and CIOMS guidelines. Human tissue and genetic data research requires ethics approval regardless of whether samples were collected prospectively or from biobanks.

II-2. Animal Research

All animal research must be approved by an IACUC or equivalent before initiation. GMJ endorses the 3Rs principle (Replacement, Reduction, Refinement). The manuscript must state: the approving body and reference number; compliance with applicable guidelines (EU Directive 2010/63/EU, US PHS Policy, UK Animals Act 1986, or equivalent); measures to minimise pain, suffering, and distress; and housing, anaesthesia, analgesia, and euthanasia details.

Reporting. Authors must follow ARRIVE 2.0 guidelines, including species, strain, sex, age, weight, sample size justification, randomisation, blinding, and adverse events. For client-owned animals, authors must follow IAVE Consensus Author Guidelines.

Chapter III — Informed Consent

III-1. Consent to Participate

Informed consent to participate must be obtained before enrolment from each participant (or parent/legal guardian). The consent process must cover: study purpose, design, and duration; procedures including experimental ones; foreseeable risks and benefits; alternatives; confidentiality measures; compensation for injury; contacts for questions; and the right to withdraw without penalty. Consent must be documented in writing unless an alternative is approved by the ethics committee.

Waivers. Consent may be waived by an EC/IRB for retrospective studies using de-identified data, large existing datasets, emergency research, or publicly available data. The waiver, its grounds, and safeguards must be stated in the manuscript.

III-2. Consent to Publish

Written consent for publication is required separately from consent to participate, whenever identifiable information is included (names, initials, record numbers, dates, photographs, rare diagnoses, pedigrees, genetic data). The patient must see the manuscript before submission and be informed that material will be available online under CC BY 4.0. Eye-masking alone is not adequate. Consent forms are retained by authors and available to editors on request.

Special populations: Children (parental consent + child assent where appropriate); incapacitated adults (legally authorised representative; re-consent if capacity returns); deceased individuals (next-of-kin consent or legal basis); emergency research (deferred/proxy consent framework described). Case reports require both consent-to-participate and consent-to-publish statements.

III-3. Required Manuscript Statements

Methods section: "Informed consent was obtained from all individual participants [or their parent/legal guardian] included in the study." Or if waived: "The [ethics committee name] waived the requirement for informed consent because [reason]."

Declarations section: "Written informed consent was obtained from the patient(s) for publication of this article and any accompanying images. A copy of the consent form is available for review by the Editor-in-Chief."

Chapter IV — Research Integrity and Misconduct

IV-1. Definitions

Research misconduct is defined as fabrication, falsification, or plagiarism (FFP) in proposing, performing, reviewing, or reporting research. It does not include honest error or differences of opinion.

— Fabrication: Making up data, results, or records and reporting them as genuine
— Falsification: Manipulating materials, equipment, processes, or data such that the research is not accurately represented
— Plagiarism: Appropriating another's ideas, text, images, or work without credit, including self-plagiarism (undisclosed text recycling)

Additional prohibited practices: image manipulation without disclosure; duplicate/redundant publication; citation manipulation; peer-review manipulation (fabricated reviewers, impersonation); authorship misconduct (gift, guest, or ghost authorship); concealment of competing interests or contradicting data.

IV-2. Plagiarism Screening

All manuscripts are screened with Crossref Similarity Check / iThenticate or Turnitin at initial submission and after major revision if warranted. No fixed percentage threshold defines plagiarism; reports are evaluated in context. Standard Methods text may be acceptable with attribution. Unattributed copying of results, discussion, or conclusions is plagiarism regardless of percentage.

IV-3. Image and Data Integrity

Image adjustments (brightness, contrast, colour) must be applied uniformly to the entire image. Grouping from different experiments must be labelled. No features may be added, moved, removed, or obscured. Original unprocessed files must be provided on request. All processing must be described in Methods or figure legends. Editors may use forensic image analysis tools.

Chapter V — Use of Artificial Intelligence (AI)

— AI systems cannot be listed as authors (they cannot meet ICMJE criteria or bear accountability)
— Any use of AI tools (language editing, translation, data analysis, figure generation, literature search) must be disclosed in the Methods and/or Declarations section, including tool name, version, developer, and purpose
— Authors remain fully responsible for accuracy, originality, ethical compliance, and integrity of all content
— Authors must not upload confidential patient data or unpublished research into AI tools without ethical approval
— Reviewers and editors must not upload manuscript content into AI tools (confidentiality breach)
— AI-generated images, figures, or data are prohibited unless disclosed and approved by the editor

Chapter VI — Handling Allegations of Misconduct

All allegations are investigated following COPE flowcharts, regardless of when they arise.

Sources: Editors, reviewers, readers, authors, institutions, whistleblowers, or editorial screening. Anonymous allegations accepted if sufficiently detailed.

Process: (1) Initial assessment by Editor-in-Chief. (2) If substantive: corresponding author contacted in writing, given 14–30 days to respond. (3) Response evaluated; external advisors consulted if needed; peer review paused if applicable. (4) All communications documented confidentially.

Outcomes (escalating): Letter of education; request to amend; rejection; correction; expression of concern; retraction; institutional notification; submission ban; reporting to professional/regulatory bodies.

For detailed correction, retraction, and expression of concern procedures, see Corrections, Retractions, and Expressions of Concern.

Chapter VII — Whistleblower Protection

GMJ encourages any individual who suspects misconduct to report concerns to the Editor-in-Chief at editor@gmj.ge. The reporter's identity will be kept confidential to the fullest extent possible. GMJ will not retaliate against, or tolerate retaliation against, any individual who makes a good-faith report. Anonymous reports are accepted and investigated if they contain sufficient detail.

Chapter VIII — Reporting Standards

Authors must follow the appropriate EQUATOR Network reporting guideline and submit the completed checklist with the manuscript:

— CONSORT — Randomised controlled trials · STROBE — Observational studies · PRISMA — Systematic reviews/meta-analyses · CARE — Case reports · STARD — Diagnostic accuracy · SQUIRE — Quality improvement · ARRIVE 2.0 — Animal research · COREQ — Qualitative research · SPIRIT — Study protocols · TRIPOD — Prediction models

Chapter IX — Responsibilities of Authors, Reviewers, and Editors

Authors: Conduct research ethically; report accurately without FFP; disclose all competing interests and funding; meet ICMJE authorship criteria with CRediT statements; provide ethics approval, consent, and data availability statements; submit only original work; cooperate with investigations; correct errors promptly.

Reviewers: Review objectively, constructively, and promptly; maintain strict confidentiality; disclose conflicts and recuse when appropriate; not use manuscript information for personal advantage; report suspected misconduct; not upload content into AI tools.

Editors: Decide based on scientific merit and ethics alone; maintain confidentiality; manage conflicts transparently; investigate misconduct per COPE; issue corrections/retractions promptly; ensure the integrity of the published record.

Chapter X — Appeals and Complaints

Authors may appeal editorial decisions with a written, point-by-point response to the Editor-in-Chief at editor@gmj.ge. Appeals are handled by an editor not involved in the original decision where possible. The appeal decision is final. Ethical or procedural complaints are handled per COPE guidance. Unresolved cases may be escalated following COPE procedures.

Reference Standards

— ICMJE Recommendations (icmje.org)
— ICMJE Disclosure of Interests Form (icmje.org)
— WMA Declaration of Helsinki — 2024 revision (wma.net)
— COPE Core Practices (publicationethics.org)
— COPE Flowcharts (publicationethics.org)
— COPE Retraction Guidelines (publicationethics.org)
— WAME Policy Statements (wame.org)
— CIOMS International Ethical Guidelines (cioms.ch)
— ICH-GCP E6(R2)
— EQUATOR Network (equator-network.org)
— ARRIVE 2.0 (arriveguidelines.org)
— IAVE Consensus Guidelines on Animal Ethics
— EU Directive 2010/63/EU
— CARE Guidelines (care-statement.org)
— CRediT Taxonomy (credit.niso.org)
— EU GDPR — Regulation 2016/679
— COPE / DOAJ / OASPA / WAME — Principles of Transparency (cope.org)

New COPE membership applications are temporarily paused. GMJ intends to apply at the earliest opportunity once applications reopen and eligibility criteria are met.

This policy is reviewed periodically and updated to reflect evolving international standards in research ethics and publication integrity.

Editorial Office — Georgian Medical Journal (GMJ) · Published by the Public Health Institute of Georgia (PHIG) · editor@gmj.ge · gmj.ge