Policies on Conflict of Interest, Human and Animal rights, and Informed Consent

Georgian Medical Journal · Publication Policy

Policies on Conflict of Interest, Human and Animal Rights, and Informed Consent

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

The Georgian Medical Journal (GMJ) is a peer-reviewed, open-access medical journal committed to the highest standards of research integrity, transparency, and accountability. This page sets out GMJ's policies on three foundational areas of publication ethics: conflicts of interest, the protection of human and animal rights, and informed consent. These policies apply to all manuscript types and to all participants in the publication process — authors, reviewers, editors, editorial board members, and editorial staff.

GMJ adheres to the ICMJE Recommendations, COPE Core Practices, the World Medical Association (WMA) Declaration of Helsinki (2024 revision), WAME principles, the Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines, ICH Good Clinical Practice (GCP), and reporting guidelines promoted by the EQUATOR Network.

 

 

Chapter I — Conflict of Interest

A conflict of interest exists when professional judgement concerning a primary interest — such as the validity of research, the welfare of patients, or the integrity of the scientific record — 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. The mere existence of a relationship does not necessarily constitute a conflict; however, the potential for conflict must be disclosed so that others may judge its significance.

GMJ requires full transparency regarding any relationships, activities, or financial interests that could be perceived as influencing — or that give the appearance of potentially influencing — what an author, reviewer, or editor writes in a submitted manuscript or published article. This policy follows the ICMJE Recommendations, COPE Core Practices, and the World Association of Medical Editors (WAME) principles on conflicts of interest.

I-1. Author Disclosure Requirements

All authors must disclose all relationships and activities that could be perceived as having influenced or that give the appearance of potentially influencing the submitted work. Disclosures must be made at the time of manuscript submission and must be updated if circumstances change during the review or publication process.

I-1.1 Financial interests and relationships that must be disclosed include, but are not limited to:

— Grants, contracts, or other research funding (from any source, including government, non-profit, and industry)
— Consulting fees, lecture or speaking fees, honoraria, or expert testimony
— Employment or leadership positions (current, anticipated, or held within the prior 36 months)
— Stock ownership, stock options, or equity interests
— Patents (planned, pending, or issued), royalties, or licensing fees
— Board membership or advisory roles (paid or unpaid) in relevant entities
— Travel or accommodation expenses paid by a third party
— Any other financial relationship that could be perceived as relevant

I-1.2 Non-financial interests and relationships that must be disclosed include:

— Personal relationships or rivalries with persons involved in the work or its evaluation
— Academic competition or collaboration that may affect objectivity
— Intellectual commitments (e.g., strongly held beliefs or affiliations with advocacy organisations) related to the work
— Membership or leadership roles in organisations with a direct interest in the outcome of the work
— Political, religious, or ideological interests relevant to the work

I-1.3 Disclosure form. All authors must complete the ICMJE Disclosure of Interests Form (available at icmje.org) at the time of submission. Completed forms are retained by the Editorial Office and made available to reviewers and editors. Relevant disclosures are published with the article in the "Declarations" or "Competing Interests" section.

I-2. Funding and Role of Funders/Sponsors

Authors must identify all sources of financial support for the work, including governmental, institutional, commercial, and non-profit funders. For each source, the following must be specified:

— Name of the funding organisation and grant or contract number
— The role of the funder/sponsor in study design, data collection, data analysis, data interpretation, manuscript writing, and the decision to submit the manuscript for publication
— If the funder/sponsor had no involvement in any of the above, this must be explicitly stated

Authors must not enter into agreements with study sponsors — whether for-profit or non-profit — that interfere with the authors' access to all study data or that restrict their ability to independently analyse, interpret, prepare, and publish manuscripts. GMJ considers such agreements incompatible with the principles of academic freedom and scientific integrity.

I-3. Reviewer Obligations

Peer reviewers must disclose to the handling editor any conflicts of interest that could bias their assessment of a manuscript before agreeing to review. Situations that require recusal include, but are not limited to:

— A financial relationship with any entity that has an interest in the manuscript's subject matter
— A recent (within the past 36 months) collaboration or co-authorship with any of the manuscript's authors
— A personal relationship (family, mentorship, close friendship, or rivalry) with any author
— Employment at the same institution as any author, unless the institution is very large and there is no departmental overlap
— A direct competitive interest in the manuscript's findings

Reviewers who are uncertain about whether a conflict exists should err on the side of disclosure and consult the handling editor. Reviewers must not use information obtained during the peer-review process for personal or third-party advantage.

I-4. Editor and Editorial Board Obligations

Editors (including the Editor-in-Chief, Deputy Editors, Section Editors, and Guest Editors) and editorial board members who participate in editorial decisions must:

— Provide the journal with an up-to-date description of their financial and non-financial relationships and activities
— Recuse themselves from handling any manuscript in which they have a conflict of interest — whether as an author, as a close colleague of an author, as a competing researcher, or through any financial or personal relationship
— Not use information obtained through editorial work for personal or financial advantage
— Ensure that manuscripts submitted by editorial board members or their close associates are handled by an independent editor with no knowledge of the identity of the submitting editor/board member where possible

The Editor-in-Chief's own disclosures are published annually on the journal website. When the Editor-in-Chief submits a manuscript to GMJ, the entire review and decision process is managed by an independent editor with full authority over the editorial decision.

I-5. Editorial Staff Obligations

All editorial staff who participate in or support editorial decisions must disclose any financial and non-financial interests that might be relevant to their role. Staff members must not use information gained through working with manuscripts for personal or commercial advantage. Any staff member with a potential conflict must inform the Editor-in-Chief and be excluded from the handling of the relevant manuscript.

I-6. Publication of Disclosures

Author conflict-of-interest disclosures are published with every article in the "Declarations" section. Where no conflicts exist, a statement reading "The authors declare that they have no competing interests" is published. GMJ publishes the following information for each article:

— All financial and non-financial competing interests declared by each author
— All funding sources and grant or contract numbers
— The role (or non-role) of funders in the study and manuscript
— A data availability statement

I-7. Industry-Sponsored Research

GMJ applies heightened scrutiny to manuscripts reporting research funded in whole or in part by for-profit entities (pharmaceutical, biotechnology, medical device, or other healthcare industry companies). For such manuscripts:

— At least one author must have had full, independent access to all study data and must take responsibility for data integrity and accuracy of the analysis
— Authors must explicitly confirm that the sponsor did not have the right to approve or disapprove the final manuscript, nor the right to prevent submission or publication
— The role of the sponsor in study design, conduct, analysis, and manuscript preparation must be described in detail
— The journal may request the study protocol, statistical analysis plan, or data-sharing agreements for editorial review

I-8. Advertising, Supplements, and Sponsored Content

Advertising, promotional activities, and sponsorship have no influence on editorial decisions at GMJ. Sponsored supplements, if any, are clearly labelled and subject to the same peer-review, ethical, and disclosure standards as regular content. Editors have full authority over all content and will not allow advertising adjacent to editorial content in a way that implies endorsement.

I-9. Failure to Disclose and Misconduct

Purposeful failure to report conflicts of interest is a form of misconduct and will be handled according to COPE guidelines. Actions may include:

— Publication of a correction notice if the article has already been published
— Rejection of the manuscript if still under review
— Notification to the authors' affiliated institution(s)
— A ban on future submissions to GMJ for a defined period
— In serious cases, retraction of the published article

All allegations of undisclosed conflicts are investigated confidentially following COPE flowcharts. Authors are given the opportunity to respond before any action is taken.

 

 

Chapter II — Human and Animal Rights

GMJ is committed to ensuring that all published research involving human participants or animals has been conducted ethically, with full respect for the rights, dignity, safety, and welfare of every individual and animal involved. This chapter follows the ICMJE Recommendations, the WMA Declaration of Helsinki (2024 revision), the CIOMS International Ethical Guidelines for Health-related Research Involving Humans, and the EQUATOR Network reporting standards.

II-A. Research Involving Human Participants

II-1. General Principles

All investigators must ensure that the planning, conduct, and reporting of research involving human participants are in accordance with the Declaration of Helsinki as revised in 2024, applicable national and institutional regulations, and the principles of Good Clinical Practice (GCP) as defined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH-GCP E6(R2)).

The welfare and rights of research participants take precedence over all other interests, including the interests of science and society. No consideration of the potential scientific value of a study may ever override the rights and safety of individual research participants.

II-2. Ethics Committee / Institutional Review Board Approval

All research involving human participants submitted to GMJ must have been approved by an independent ethics committee (EC), institutional review board (IRB), or equivalent body before the research was initiated. The manuscript must include:

— The full name of the approving ethics committee or IRB
— The approval or protocol reference number
— The date of approval
— Confirmation that the study was conducted in accordance with the approved protocol

If the study was granted an exemption or waiver from full ethical review (e.g., for use of de-identified, publicly available data), the name of the body granting the exemption, the nature of the exemption, and the rationale must be stated. Studies using existing, de-identified datasets must still declare the source of ethical approval or exemption.

If no formal ethics committee exists in the country or institution where the study was conducted, the authors must explain the regulatory framework under which the research was approved and demonstrate that the ethical principles of the Declaration of Helsinki were observed.

Approval by an ethics committee does not preclude the editors from forming their own judgement about whether the conduct of the research was appropriate. If doubt exists whether the research was conducted in accordance with the Declaration of Helsinki, the authors must explain the rationale for their approach and demonstrate that the local, regional, or national review body explicitly approved the questionable aspects of the study.

II-3. Clinical Trial Registration

In accordance with the ICMJE policy, GMJ requires that all interventional clinical trials be registered prospectively (before recruitment of the first participant) in a publicly accessible, WHO-approved or ICMJE-accepted clinical trial registry. Acceptable registries include:

— ClinicalTrials.gov
— International Standard Randomised Controlled Trial Number Register (ISRCTN)
— European Union Drug Regulating Authorities Clinical Trials Database (EudraCT / CTIS)
— Australian New Zealand Clinical Trials Registry (ANZCTR)
— WHO International Clinical Trials Registry Platform (ICTRP)-listed registries

The registry name, registration number, and URL must be reported in the manuscript abstract and methods section. Failure to register a clinical trial may result in rejection.

II-4. Protection of Participant Privacy and Confidentiality

Patients and research participants have a right to privacy that must not be violated without informed consent. Authors must ensure that:

— Identifying information — including names, initials, hospital or record numbers, dates of birth, and geographic details — is not published unless the information is essential for scientific purposes and the participant (or parent/legal guardian) gives written informed consent for publication
— Photographs, imaging, or video recordings of patients do not include identifiable features unless written consent has been obtained and the inclusion is scientifically justified
— Masking the eye region in photographs alone is insufficient to protect anonymity
— If identifying characteristics are altered to protect anonymity (e.g., modifying images of genetic conditions), the authors provide written assurance to the editors that the alterations do not distort scientific meaning
— Data are stored and managed in compliance with applicable data-protection legislation (e.g., GDPR in the EU/EEA, national data-protection laws)

Authors should disclose to identifiable participants whether any material might be available on the Internet as well as in print after publication. Where consent for publication of identifiable data has been obtained, this must be noted in the published article.

II-5. Vulnerable Populations

Research involving vulnerable populations — including children, adolescents, pregnant women, prisoners, persons with cognitive impairment, refugees, and other individuals with diminished autonomy — must demonstrate additional safeguards appropriate to the specific vulnerability, as outlined in the Declaration of Helsinki and the CIOMS International Ethical Guidelines. These safeguards, and the rationale for involving vulnerable participants, must be described in the manuscript.

II-6. Studies Using Human Tissue, Biological Samples, or Genetic Data

Research involving human tissue, biobank samples, or genetic/genomic data must have ethics committee approval. The manuscript must state whether the samples were collected prospectively with specific informed consent for the present study or were obtained from existing collections (biobanks) under an approved protocol. For secondary use of existing samples, the nature of the original consent and any additional ethics approval must be described.

II-B. Research Involving Animals

II-7. General Principles

GMJ requires that all research involving animals be conducted humanely, with proper regard for animal welfare, and in compliance with institutional, national, and international standards. Authors must indicate in the manuscript whether institutional and national guidelines for the care and use of laboratory animals were followed. GMJ endorses the 3Rs principle (Replacement, Reduction, Refinement) as the foundational framework for ethical animal research.

II-8. Ethics Approval for Animal Research

All experimental research on vertebrates or any regulated invertebrates must have been approved by an appropriate institutional animal care and use committee (IACUC) or equivalent ethics committee before the research was initiated. The manuscript must include:

— The name of the approving committee or authority
— The approval or protocol reference number
— Confirmation that the study complied with the relevant institutional, national, or international guidelines (e.g., EU Directive 2010/63/EU on the protection of animals used for scientific purposes; the US Public Health Service Policy on Humane Care and Use of Laboratory Animals; the UK Animals (Scientific Procedures) Act 1986; or equivalent national legislation)
— A description of measures taken to minimise pain, suffering, distress, and lasting harm
— Details of housing, husbandry, anaesthesia, analgesia, and method of euthanasia where applicable

II-9. Reporting Standards for Animal Research

Authors reporting animal research should follow the ARRIVE 2.0 guidelines (Animal Research: Reporting of In Vivo Experiments). GMJ strongly encourages complete compliance with ARRIVE 2.0, including:

— Species, strain, sex, age, and weight of animals used
— Source and health/immune status of animals
— Sample size justification and power calculation where applicable
— Randomisation, blinding, and allocation concealment methods
— Detailed description of experimental procedures, anaesthesia, and analgesia
— Primary and secondary outcomes
— Adverse events and humane endpoints

II-10. Studies Involving Client-Owned Animals

For studies involving client-owned animals (e.g., veterinary clinical research), authors must document informed client consent, describe the measures taken to ensure animal welfare, and provide evidence of institutional ethical review. Authors should follow the International Association of Veterinary Editors (IAVE) Consensus Author Guidelines on Animal Ethics and Welfare.

II-C. Editorial Oversight of Ethical Compliance

GMJ editors screen all submissions for ethical compliance as part of the initial editorial assessment. Manuscripts that lack an ethics approval statement, that raise ethical concerns, or that appear to have been conducted without appropriate ethical oversight may be:

— Returned to authors with a request for clarification or documentation
— Referred to the Editor-in-Chief for further assessment
— Rejected if satisfactory evidence of ethical compliance cannot be provided
— Reported to the relevant institution or ethics committee in accordance with COPE guidelines if research misconduct is suspected

 

 

Chapter III — Informed Consent

GMJ requires that all research involving human participants adhere to the highest standards of informed consent, as set out in the WMA Declaration of Helsinki (2024 revision), the ICMJE Recommendations, and applicable national and institutional regulations. Informed consent is a fundamental ethical and legal requirement that protects individual autonomy, dignity, and the right to make voluntary decisions about participation in research and the publication of personal data.

This chapter distinguishes between two related but distinct forms of informed consent: consent to participate in research and consent to publish identifiable information. Both must be addressed in the manuscript where applicable.

III-1. Consent to Participate in Research

III-1.1 General requirement. For all research involving human participants, informed consent to participate must be obtained from each participant (or their parent, legal guardian, or legally authorised representative) before the individual's enrolment in the study. A statement confirming that informed consent was obtained must appear in the Methods section of the manuscript.

III-1.2 Elements of valid informed consent. The informed consent process must ensure that prospective participants receive, in language and terms they can understand, adequate information about:

— The purpose, design, and duration of the study
— The procedures to be followed, including any that are experimental
— Reasonably foreseeable risks, discomforts, and potential benefits
— Alternative procedures or treatments available, if applicable
— The extent to which confidentiality of records identifying the participant will be maintained
— Compensation and/or treatment available if injury occurs (for more-than-minimal-risk research)
— Contact persons for questions about the study, participants' rights, and research-related injuries
— The voluntary nature of participation and the right to withdraw at any time without penalty or loss of benefits to which the participant is otherwise entitled

III-1.3 Documentation. Consent must be documented in writing (signed consent form) unless the ethics committee has approved an alternative method (e.g., oral consent with a witness signature, electronic consent). Consent forms must be retained by the investigator and/or institution in accordance with local regulations. GMJ editors may request a copy of the consent form or the ethics committee documentation at any time.

III-2. Waivers of Informed Consent

In certain circumstances, informed consent may be waived by an ethics committee or IRB. Common situations include:

— Retrospective studies using de-identified medical records or routinely collected data where obtaining individual consent is impractical and the research poses no more than minimal risk
— Research involving large, existing datasets where participants cannot reasonably be contacted
— Emergency research situations where participants are unable to consent and no legally authorised representative is available, provided that the study has been approved under applicable emergency research regulations
— Studies using publicly available data

When a waiver has been granted, the manuscript must clearly state the name of the ethics committee that approved the waiver, the specific grounds for the waiver, and the protections in place to safeguard participant welfare and privacy. A waiver of consent does not relieve authors of the obligation to protect participant confidentiality and privacy.

III-3. Consent to Publish

III-3.1 General requirement. Consent to publish is required in addition to (and separate from) consent to participate. Written informed consent for publication must be obtained from any identifiable individual whose personal data, clinical details, photographs, imaging, videos, pedigrees, or genetic information are included in a manuscript submitted to GMJ.

III-3.2 What constitutes identifiable information. A person is considered identifiable if the manuscript includes any combination of information by which the individual could be recognised, including but not limited to:

— Name, initials, or hospital/record numbers
— Dates (of birth, admission, discharge, death, or treatment) in combination with other details
— Photographs of the face or other distinguishing features
— Rare diagnoses or conditions in combination with geographic or institutional information
— Radiological images, pathological slides, or other clinical images showing identifiable features
— Pedigrees or family trees
— Genetic sequences or data that could enable re-identification

III-3.3 Requirements for consent to publish. Where identifiable data are included:

— The identifiable patient or participant (or parent/legal guardian for minors) must be shown the manuscript — including all images and supplementary material — before submission and must give written consent for publication
— Authors must inform the patient that the material will be freely available on the Internet as well as in print, under a CC BY 4.0 licence, and that complete anonymity cannot be guaranteed
— A statement confirming that written informed consent for publication was obtained must appear in the manuscript (typically in the Declarations section)
— Consent forms for publication must be retained by the authors and made available to GMJ editors on request; they will be treated confidentially

III-3.4 Masking and de-identification. Masking the eye region in photographs alone is not considered adequate protection of anonymity. Complete anonymity is difficult to guarantee, and informed consent should be obtained whenever there is any doubt that anonymity can be maintained. If identifying characteristics are intentionally altered (e.g., changing ages, modifying images), authors must provide written assurance that the alterations do not distort the scientific meaning of the work.

III-4. Consent in Special Populations and Situations

III-4.1 Children and adolescents. For participants under the age of 18 (or the legal age of majority in the jurisdiction where the research was conducted), informed consent must be obtained from a parent or legal guardian. Where the child has sufficient understanding (typically from around age 7, though this varies by jurisdiction and maturity), the child's assent should also be obtained and documented. For consent to publish, both parental consent and, where appropriate, the minor's assent are required.

III-4.2 Incapacitated adults. For participants who lack the capacity to provide informed consent (e.g., due to cognitive impairment, critical illness, or altered consciousness), consent must be obtained from a legally authorised representative in accordance with applicable laws. If the participant later regains capacity, consent should be sought from the participant directly for continued participation and for publication.

III-4.3 Deceased individuals. Identifiable information about deceased individuals may be published only with the written consent of the next of kin or legal representative, or where specific legal provisions permit publication without consent. The basis for publication must be stated in the manuscript.

III-4.4 Emergency research. In studies conducted under emergency research protocols (where prior informed consent is not possible), the manuscript must describe the regulatory framework under which the study was conducted, the ethics committee approval, the process for deferred or proxy consent, and the safeguards in place to protect participant rights.

III-5. Case Reports and Small Case Series

Case reports and small case series inherently carry a high risk of participant identification. For all case reports submitted to GMJ:

— Written informed consent for publication must be obtained from every identifiable patient (or parent/legal guardian)
— The patient must be shown the manuscript, including all images, before submission
— A statement of consent must appear in the published article
— All non-essential identifying information must be removed
— If the patient has died or cannot be traced, the manuscript must state how reasonable efforts were made to obtain consent and/or provide justification for publication without consent, supported by ethics committee approval

III-6. Consent in Survey, Questionnaire, and Interview Research

For research involving surveys, questionnaires, focus groups, or interviews, authors must describe how informed consent was obtained (e.g., written consent form, ticking a consent box in an online survey, verbal consent before interview). The manuscript must state whether the study received ethics committee approval or exemption. Even where consent was implied (e.g., return of an anonymous questionnaire), the manuscript must describe the information provided to participants about the study purpose, voluntary participation, data handling, and confidentiality.

III-7. Manuscript Requirements Summary

 

All manuscripts reporting research involving human participants must include the following statements, as applicable:

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

In the Declarations section: "Written informed consent was obtained from the patient(s) [or parent/legal guardian] for publication of this article and any accompanying images. A copy of the consent form is available for review by the Editor-in-Chief." If consent was not obtained: "The requirement for informed consent for publication was waived by [name of ethics committee] because [reason]."

For case reports: Both a consent-to-participate and a consent-to-publish statement are required.

III-8. Editorial Enforcement

GMJ editors verify informed consent statements during the initial editorial assessment. Manuscripts that lack required informed consent documentation may be:

— Returned to authors for completion prior to peer review
— Rejected if consent cannot be demonstrated and no valid waiver exists
— Subject to post-publication correction or retraction if consent deficiencies are identified after publication

 

 

Reference Standards
 

— ICMJE Recommendations — Disclosure of Financial and Non-Financial Relationships and Activities, and Conflicts of Interest (icmje.org)
— ICMJE Recommendations — Protection of Research Participants (icmje.org)
— ICMJE Disclosure of Interests Form (icmje.org/disclosure-of-interest)
— WMA Declaration of Helsinki — Ethical Principles for Medical Research Involving Human Subjects, 2024 revision (wma.net)
— COPE Core Practices (publicationethics.org)
— WAME — Conflict of Interest in Peer-Reviewed Medical Journals (wame.org)
— CIOMS — International Ethical Guidelines for Health-related Research Involving Humans, 2016 (cioms.ch)
— ICH-GCP E6(R2) — Guideline for Good Clinical Practice
— ARRIVE 2.0 Guidelines (arriveguidelines.org)
— IAVE Consensus Author Guidelines on Animal Ethics and Welfare
— EU Directive 2010/63/EU — Protection of Animals Used for Scientific Purposes
— CARE Guidelines — for Case Reports (care-statement.org)
— EU General Data Protection Regulation (GDPR) — Regulation 2016/679
— EQUATOR Network — Reporting Guidelines (equator-network.org)

GMJ may request copies of ethics committee approval letters, consent forms, ICMJE Disclosure of Interests Forms, study protocols, or other supporting documentation at any stage of the editorial process. All such documents are treated as strictly confidential.

 

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