CONTENTS

1. Scope and purpose
2. Definitions
3. General ethical principles
4. Ethics committee approval: general requirements
5. Ethics committee approval: exemptions and waivers
6. Informed consent: general requirements
7. Informed consent: waivers, incapacity, and emergency research
8. Secondary use of data, medical records, and biological samples
9. Vulnerable populations: general principles
10. Pregnant women, fetuses, and neonates
11. Minors in reproductive and gynecological research
12. Participants with diminished decision-making capacity
13. Case reports and patient privacy
14. Clinical trial registration
15. Genetic and genomic research
16. Research in public health emergencies
17. Research in low-resource settings and global justice
18. Scientific integrity in research
19. Data protection in research: GDPR provisions
20. Reporting standards
21. Post-publication ethics concerns
22. Annual review
23. Cross-references within the Editorial Policy Framework
24. Normative references

 

1. SCOPE AND PURPOSE

This Research Ethics Policy establishes the ethical requirements applicable to the conduct, reporting, and publication of research submitted to European Gynecology and Obstetrics (EGO). (EGO). It applies to all persons who submit manuscripts to the Journal, to all members of the editorial leadership, and to the Publisher.

The Policy operationalizes the foundational commitment to research ethics established in Section 10 of the Editorial Policy Statement. It provides the detailed framework within which all research involving human participants, human data, human biological materials, and identifiable medical information is assessed for publication. In the event of inconsistency between this Policy and the Editorial Policy Statement on matters of research ethics, this Policy governs.

The Publisher issues the Policy on behalf of the European Society of Gynecology (ESG) and applies to all manuscript types published by the Journal that involve human subjects research, including original research articles, systematic reviews and meta-analyses, case reports, clinical trial reports, study protocols, data notes, and guidelines and consensus statements. It applies without exception to all submitted manuscripts from the date of its entry into force.

2. DEFINITIONS

For this Policy, the following definitions apply:

- Research involving human participants: any systematic investigation designed to contribute to generalizable knowledge, in which a human being participates as a subject, including interventional and observational studies, surveys, interviews, and any use of identifiable human data or biological material obtained from living or deceased persons.

- Ethics committee: an independent body, constituted and operating in accordance with applicable national and international regulations, responsible for evaluating the scientific and ethical acceptability of research involving human participants, including Institutional Review Boards (IRB), Research Ethics Committees (REC), Ethical Committees (EC), and equivalent bodies recognized under national law.

- Informed consent: a voluntary, specific, informed, and unambiguous expression of agreement by a person with decision-making capacity to participate in a research study, given after receiving adequate information about the study's purpose, procedures, risks, benefits, alternatives, and rights, including the right to withdraw without consequence at any time.

- Vulnerable population: any individual or group whose capacity to provide free and fully informed consent may be compromised by power imbalances, dependency relationships, diminished decisional capacity, or systemic disadvantage, including but not limited to pregnant women and their fetuses, neonates, minors, persons with cognitive or mental impairments, persons in emergency care settings, and individuals in economically or socially disadvantaged conditions.

- Secondary use of data: any use of data originally collected for a purpose other than the specific research being reported, including use of existing medical records, administrative databases, disease registries, birth registries, assisted reproduction databases, and national health surveys.

- Clinical trial: any research study that prospectively assigns human participants to one or more interventions - including control interventions such as placebo or no intervention - to evaluate the effects of those interventions on health outcomes, as defined by the ICMJE and the WHO.

- Biobank: a structured collection of human biological samples (including tissue, blood, urine, DNA, and other materials) and associated data, stored for research purposes.

- Waiver of consent: a formal determination by a competent ethics committee that the requirement for individual informed consent may be modified or dispensed with in specified circumstances, consistent with applicable regulations and ethical guidelines.

- Anonymized data: data that has been processed in such a manner that the individual to whom it relates can no longer be identified, directly or indirectly, in an irreversible manner, as defined under the GDPR and its recitals.

- Pseudonymized data: data that has been processed in such a manner that it can no longer be attributed to a specific individual without the use of additional information kept separately, and which constitutes personal data subject to the GDPR.

- Dual-use research: research whose results could potentially be misused to threaten public health, safety, or stability, including research producing information that could facilitate harm to individuals or populations if misapplied.

3. GENERAL ETHICAL PRINCIPLES

European Gynecology and Obstetrics (EGO) adheres to the following ethical principles as the foundational framework governing all research submitted to the Journal:

3.1  Declaration of Helsinki 2024.  The Journal requires that all research involving human participants be conducted in accordance with the 2024 Revision of the Declaration of Helsinki (WMA, 75th General Assembly, Helsinki, 19 October 2024). This revision introduces strengthened provisions on scientific integrity, distributive and global justice, protection of vulnerable populations, community engagement, environmental sustainability, and research involving health databases and biobanks. It supersedes the 2013 version as the applicable reference standard. Authors are responsible for ensuring compliance with the version of the Declaration of Helsinki in force at the time the research was conducted; where an earlier version was applicable, this must be stated in the manuscript.

3.2  CIOMS Guidelines.  The Journal applies the International Ethical Guidelines for Health-Related Research Involving Humans issued by the Council for International Organizations of Medical Sciences (CIOMS, 2016), particularly regarding vulnerable populations, research in low-resource settings, and equity in research design and benefit distribution.

3.3  Scientific integrity.  Consistent with the 2024 Revision of the Declaration of Helsinki, the Journal affirms a zero-tolerance stance toward research misconduct in all forms, including fabrication, falsification, and plagiarism. All persons involved in research submitted to the Journal warrant that the research was conducted with the highest standards of scientific integrity. Provisions governing research misconduct are further developed in the Publication Ethics Policy and the Complaints, Appeals and Whistleblowing Policy.

3.4  Distributive and global justice.  Consistent with the 2024 Revision of the Declaration of Helsinki, the Journal encourages research that equitably distributes benefits, risks, and burdens across populations, and that addresses the health needs of underserved and underrepresented groups, including women from low- and middle-income countries.

3.5  Community engagement.  The Journal recognizes the value of community engagement in the design, conduct, and reporting of research involving human participants. It encourages authors to describe their community engagement processes where applicable and relevant.

3.6  Environmental sustainability.  Consistent with the 2024 Revision of the Declaration of Helsinki, the Journal recognizes its responsibility to promote rigorous study designs that prevent research waste and encourages authors to consider environmental sustainability in planning research.

3.7  Research involving AI-based tools.  Research evaluating AI-based diagnostic systems, clinical decision support tools, or algorithmic interventions in gynecological or obstetric practice constitutes an interventional study within the meaning of this Policy and is subject to the same ethics committee review requirements as any other interventional research. Additional provisions governing the reporting of AI in clinical research are contained in the Artificial Intelligence Policy.

3.8  Animal studies.  European Gynecology and Obstetrics (EGO) focuses on human subjects research. Where a manuscript includes components involving animal models, authors must declare institutional ethics committee or equivalent body approval for the animal component and confirm compliance with the ARRIVE 2.0 reporting guidelines, consistent with Section 10 of the Editorial Policy Statement.

4. ETHICS COMMITTEE APPROVAL: GENERAL REQUIREMENTS

4.1  All research involving human participants submitted to the Journal must have been approved by a competent and independent ethics committee, institutional review board, or equivalent body, before the initiation of the research. Ethics committee approval obtained after the initiation of the research does not satisfy the requirements of this Policy, except where an explicit prospective approval for emergency or expedited research was in place, and a post-initiation review was part of the approved protocol.

4.2  Authors must include the following information in all manuscripts reporting research involving human participants:

- the name of the approving ethics committee or institutional review board;

- the reference number or protocol number of the approval;

- the date of the approval decision;

- a statement that the research was conducted in accordance with the Declaration of Helsinki (specifying the applicable version); and

- where applicable, a statement that ethics committee approval covered all amendments to the original protocol.

4.3  Where a study was conducted in multiple countries or institutions, the approvals from all competent bodies must be declared, or a reasoned explanation must be provided as to why a single approval applied to the entire study population and scope.

4.4  Ethics documentation is not submitted to the Journal at the time of manuscript submission, in accordance with the standard ICMJE-aligned editorial process. However, authors must retain all relevant ethics approval documentation and make it available to the editorial leadership upon request at any stage of the editorial process, including post-publication. The request may be made by the responsible Associate Editor, the Editor-in-Chief, or the Publisher in the context of a formal ethics inquiry.

4.5  Manuscripts that do not include the required ethics committee approval statement are returned to authors for correction before entering the peer review process. Authors who cannot provide evidence of ethics committee approval for research conducted before the entry into force of this Policy must provide a reasoned explanation to the Editor-in-Chief, who assesses the situation on a case-by-case basis applying the standards applicable at the time of the research.

4.6  Where applicable law or institutional regulations exempt specific categories of research from formal ethics committee review, authors must explicitly identify the applicable exemption provision and the legal basis for applying it to their study. The burden of demonstrating the applicability of an exemption lies with the authors, and the Editor-in-Chief makes the final determination on the acceptability of the claimed exemption.

5. ETHICS COMMITTEE APPROVAL: EXEMPTIONS AND WAIVERS

5.1  Retrospective studies and secondary data analysis.  Research conducted entirely on anonymized secondary data, existing administrative databases, or previously published datasets may be exempt from ethics committee review under the law of the jurisdiction where the research was conducted. Authors must declare the exemption and its legal basis. The Journal does not independently assess the validity of the claimed exemption under foreign law. Still, it reserves the right to reject a manuscript if the claimed exemption appears inconsistent with applicable ethical standards or if the data are potentially re-identifiable.

5.2  Quality improvement studies and service evaluation.  Research conducted as part of standard clinical practice or quality improvement, using data collected solely for that purpose, may be exempt from full ethics committee review in certain jurisdictions. Authors must declare this status and confirm that no personally identifiable information is reported in the manuscript.

5.3  Case reports.  Case reports and small case series are exempt from formal ethics committee review in many jurisdictions. Authors of case reports must obtain and document patient consent for publication instead of ethics committee approval, in accordance with Section 13 of this Policy. Where patient consent cannot be obtained, Section 13.3 applies.

5.4  Formal waiver of consent.  Ethics committees may grant a formal waiver of the individual informed consent requirement for research that meets all of the following conditions: (a) the research poses no more than minimal risk to participants; (b) the waiver will not adversely affect the rights and welfare of participants; (c) the research could not practicably be carried out without the waiver; and (d) where appropriate, participants are provided with pertinent information after participation. The formal grant of a waiver by the competent ethics committee must be declared in the manuscript.

6. INFORMED CONSENT: GENERAL REQUIREMENTS

6.1  All research involving direct human participation must be conducted only after the free, specific, informed, and unambiguous consent of participants has been obtained, in accordance with the Declaration of Helsinki 2024, the ICMJE Recommendations, and applicable national law. The consent process must be documented and verifiable.

6.2  Every manuscript must include an explicit statement confirming that informed consent was obtained from all participants, specifying whether consent was written or verbal, and indicating that participants were informed of the right to withdraw without consequence at any time. Where verbal consent was obtained instead of written consent, the reasons must be explained and assessed by the Editor-in-Chief for consistency with applicable standards.

6.3  Informed consent must cover all procedures to which participants were subjected in the context of the research, including any secondary use of their data or biological samples for research purposes related to the original study. Where the original consent does not cover secondary use, Section 8 applies.

6.4  Authors are responsible for retaining original informed consent documentation and making it available upon request at any stage of the editorial process, including post-publication, for a period consistent with applicable institutional and legal requirements and in any case for not less than 10 years from the date of publication.

6.5  Images, clinical photographs, video material, and any other individually identifiable content depicting research participants must be accompanied by a specific informed consent for publication. Such content must be appropriately anonymized before publication, or the specific consent for publication must explicitly cover the content as it will be published, including any identifying features that cannot be removed without impairing the scientific value of the material. Section 13 governs case reports.

Standard wording for ethics statement:  This study was conducted in accordance with the Declaration of Helsinki (2024 Revision) and was approved by [name of ethics committee], protocol number [number], on [date]. Written informed consent was obtained from all participants before enrolment.

7. INFORMED CONSENT: WAIVERS, INCAPACITY, AND EMERGENCY RESEARCH

7.1  Participants with diminished decisional capacity.  Research involving participants who lack full decisional capacity must be conducted in accordance with the applicable ethics framework, with consent obtained from a legally recognized representative. The manuscript must confirm that: (a) legally valid representative consent was obtained; (b) the participant's assent was sought to the extent of their capacity; and (c) the ethics committee approval specifically covered the enrollment of participants with diminished capacity. Section 12 provides additional provisions.

7.2  Emergency research.  Emergency obstetric and gynecological research may necessitate a waiver of prior informed consent due to the urgency of the situation and participants' incapacity at the time of enrollment. Research conducted under a consent waiver in emergency settings must: (a) have received prior ethics committee approval covering the emergency waiver; (b) demonstrate that obtaining prior consent was not feasible; (c) confirm that consent was sought retroactively as soon as practicable; and (d) demonstrate that the research was likely to benefit the participant directly or to produce knowledge essential for the treatment of persons with the same condition.

7.3  Deferred consent.  Where a research protocol involves deferred consent - consent obtained after emergency enrollment - the manuscript must specify the time limit within which deferred consent was sought, the proportion of participants from whom retrospective consent was obtained, and the ethics committee authorization covering the deferred consent procedure.

7.4  Research involving deceased persons.  Research using data, biological samples, or other materials from deceased persons is subject to ethics committee review. Authors must declare whether ethics committee approval was obtained and identify the applicable legal framework in the jurisdiction where the research was conducted.

8. SECONDARY USE OF DATA, MEDICAL RECORDS, AND BIOLOGICAL SAMPLES

8.1  General principle.  Research based entirely or in part on secondary use of data collected for other purposes - including clinical records, administrative databases, cancer registries, birth registries, assisted reproduction databases, and national health surveys - must have received ethics committee approval or a documented exemption. The type of approval or the specific exemption provision must be declared in the manuscript.

8.2  Consent for secondary data use.  Where the secondary use of personal data for research purposes is not covered by the original consent of the individuals concerned, the research must either: (a) have received explicit authorization from the relevant ethics committee for the use of the data without specific individual consent, in accordance with applicable national law; or (b) be conducted on truly anonymized data as defined in Section 2. The use of pseudonymized data without specific consent may be permissible only where expressly authorized by the competent ethics committee.

8.3  Biobank and biological sample research.  Research using biological samples stored in biobanks or tissue banks must be accompanied by a declaration confirming that: (a) the samples were collected under an informed consent that explicitly covers the research use for which they are now employed, or that a competent ethics committee has authorized the use under a broad consent or waiver framework; (b) the biobank operates under an ethics approval covering storage and research use of the samples; and (c) the specific research use complies with the governance framework of the relevant biobank. The Journal applies the provisions of the WMA Declaration of Taipei on the governance of health databases and biobanks, as cross-referenced in the 2024 Revision of the Declaration of Helsinki.

8.4  Re-identification risk.  Where research uses ostensibly anonymized datasets, authors must confirm that they have assessed and, to the extent reasonably practicable, minimized the risk of participant re-identification, consistent with the GDPR data minimization principle. The editorial leadership may request a brief description of the de-identification methodology applied.

8.5  Data linkage studies.  Research involving the linkage of data from different sources requires specific ethics committee approval covering the linkage procedure, the combined dataset, and any additional re-identification risks arising from the linkage. Authors must confirm that the linked dataset was created and handled in compliance with applicable data protection law.

9. VULNERABLE POPULATIONS: GENERAL PRINCIPLES

Consistent with the 2024 Revision of the Declaration of Helsinki and the CIOMS Guidelines, the Journal recognizes that certain populations require additional ethical protection in the design, conduct, and reporting of research. Research involving vulnerable populations requires a higher standard of justification, heightened scrutiny of the benefit-risk balance, and specific procedural safeguards.

The Journal applies the following general principles to research involving vulnerable populations:

- research that can be conducted on non-vulnerable populations must not instead be conducted on vulnerable populations for reasons of convenience or ease of access;

- the research must offer a direct benefit to the participant, or must produce knowledge applicable to conditions affecting the specific vulnerable population, which cannot otherwise be produced;

- the ethics committee approval must specifically address the vulnerability of the participant group and the safeguards in place; and

- the informed consent process must be adapted to the specific characteristics of the vulnerable population.

The specific vulnerable populations most frequently involved in research published in the Journal, and the provisions applicable to each, are addressed in Sections 10, 11, and 12.

10. PREGNANT WOMEN, FETUSES, AND NEONATES

10.1  Research involving pregnant women.  Consistent with CIOMS Guideline 19 (2016) and the 2024 Revision of the Declaration of Helsinki, the Journal applies the following framework to research involving pregnant women:

- pregnant women must not be considered as inherently vulnerable solely by reason of pregnancy; their systematic exclusion from research without scientific justification is itself an ethical harm that creates knowledge gaps directly relevant to their healthcare;

- research involving pregnant women must demonstrate a scientifically justified reason for including pregnant women and not solely non-pregnant populations;

- the benefit-risk assessment must explicitly address potential risks to both the pregnant woman and the fetus as distinct stakeholders with distinct interests;

- the informed consent process must address the potential implications for the fetus; and

- where national law requires additional consent (such as paternal consent), the applicable legal framework must be declared in the manuscript. The Journal notes that mandatory paternal consent requirements that result in the exclusion of women from research that may benefit them raise concerns under the principles of distributive justice and autonomy.

10.2  Research involving fetuses.  Research involving fetuses - whether in utero or ex utero - requires ethics committee approval that specifically addresses the fetal dimension of the research. The manuscript must confirm that the research was conducted in compliance with applicable national law governing fetal research in the jurisdiction where the study was conducted.

10.3  Research involving neonates.  Research involving neonates, particularly preterm neonates and neonates in intensive care settings, requires: (a) ethics committee approval covering the specific neonatal population; (b) legally valid parental or guardian consent; (c) a justification for conducting the research in neonates rather than older pediatric or adult populations; and (d) demonstration that the intervention or procedure poses no more than minimal risk unless it offers a prospect of direct benefit to the neonate.

10.4  Post-trial provisions.  Consistent with the 2024 Revision of the Declaration of Helsinki, research involving pregnant women or neonates in clinical trials must address post-trial access provisions for participants who benefited from an experimental intervention. Authors must declare whether post-trial access provisions were established and, if not, provide a reasoned justification reviewed by the ethics committee.

11. MINORS IN REPRODUCTIVE AND GYNECOLOGICAL RESEARCH

11.1  Research involving minors (persons under 18 years of age, or under the age of majority in the applicable jurisdiction) in the context of reproductive and gynecological care raises specific ethical challenges at the intersection of autonomy, protection, and adolescents' right to access information and healthcare.

11.2  Research involving minors requires: (a) ethics committee approval specifically addressing the enrollment of minors; (b) consent from parents or legal guardians, as required by applicable law; and (c) assent from the minor to the extent of their age-appropriate capacity, consistent with the CIOMS Guidelines and applicable national law. Where the minor has sufficient maturity and decision-making capacity, their assent must be specifically documented in addition to parental consent.

11.3  Where parental consent is not required under applicable law due to the nature of the research - for example, research on reproductive health services provided to emancipated minors or mature minors in jurisdictions that recognize healthcare autonomy for adolescents - the applicable legal framework must be cited, and the ethics committee approval must specifically address this situation.

11.4  Research involving minors may be published only where: (a) the research was conducted in compliance with the ethical standards applicable at the time of the study; (b) appropriate consent and assent documentation was obtained; and (c) any personally identifiable information relating to minors is removed or adequately anonymized in the published text and accompanying materials.

11.5  The Journal applies heightened sensitivity in the reporting of research involving minors in connection with contested areas of reproductive health, including studies on adolescent sexuality, contraception access, pregnancy in minors, and reproductive choices. Authors and the editorial leadership exercise particular care to ensure that reporting is conducted in a manner consistent with the protection of the minors' rights and dignity.

12. PARTICIPANTS WITH DIMINISHED DECISION-MAKING CAPACITY

12.1  Research involving participants who lack decision-making capacity at the time of enrollment - including participants with dementia, severe mental illness, acute obstetric emergency, or other incapacitating conditions - requires: (a) specific ethics committee approval covering the enrollment of participants without capacity; (b) consent from a legally recognized representative; (c) a procedure for seeking retrospective consent from participants who regain capacity during or after the study; and (d) a justification that the research cannot be conducted on participants with full decision-making capacity.

12.2  The manuscript must explicitly confirm compliance with all elements listed in 12.1 and identify the applicable national legal framework governing research on persons without decision-making capacity.

12.3  Research protocols systematically involving participants without decision-making capacity must demonstrate that the ethics committee specifically addressed the additional safeguards applied to protect participants' welfare and dignity, and that the potential benefit of the research justifies any additional risk associated with the enrollment of this population.

13. CASE REPORTS AND PATIENT PRIVACY

13.1  Case reports and case series published in European Gynecology and Obstetrics (EGO). must include explicit patient consent for publication. The consent must cover: (a) the use of clinical information, including medical history, laboratory and imaging results, surgical and pathological findings; (b) the publication of any identifying visual material, including clinical photographs, radiological images, and pathological specimens; and (c) the patient's awareness that the published article will be freely and permanently accessible internationally under the CC BY 4.0 licence.

13.2  Patient consent for publication is distinct from consent to participate in research and must be documented separately where both are required. A statement confirming that written consent for publication was obtained from the patient - or, in the case of a minor, from the parent or legal guardian and, where applicable, from the minor - must appear in the manuscript.

13.3  Where patient consent for publication cannot be obtained because the patient is deceased, cannot be located despite reasonable efforts, lacks decision-making capacity and has no available legal representative, or has explicitly refused consent, authors must: (a) inform the Editor-in-Chief at submission; (b) provide documentation of the steps taken to obtain consent; and (c) demonstrate that the clinical information has been sufficiently anonymized to make re-identification not reasonably possible. The Editor-in-Chief makes a case-by-case determination and may seek the opinion of COPE's ethics advisory resource.

13.4  Anonymization of case reports must not compromise the scientific integrity of the case presentation. Where full anonymization would remove information essential to the scientific value of the case, the Editor-in-Chief may authorize the inclusion of identifying details only where explicit patient consent for those specific details has been obtained. In all such cases, a statement to this effect is included in the published article.

13.5  Case reports describing minors apply enhanced anonymization: ages are given in general terms (for example, 'adolescent' or 'early adolescent'), specific dates are removed, and institutional identifiers are suppressed, in addition to standard anonymization measures.

Standard wording for case reports:  Written informed consent for publication of this case report and accompanying images was obtained from the patient. A copy of the consent is available for review by the Editor-in-Chief.

14. CLINICAL TRIAL REGISTRATION

14.1  Consistent with ICMJE requirements and COPE recommendations, European Gynecology and Obstetrics (EGO) requires that all clinical trials be prospectively registered in a publicly accessible primary registry before the enrollment of the first participant. Retrospective registration does not satisfy the Journal's requirements, regardless of the circumstances of the delay.

14.2  Acceptable registries are all primary registries participating in the WHO International Clinical Trials Registry Platform (WHO ICTRP), including but not limited to: ClinicalTrials.gov (USA); the EU Clinical Trials Register and CTIS (European Union); the ISRCTN Registry (UK); the Australian New Zealand Clinical Trials Registry (ANZCTR); the German Clinical Trials Register (DRKS); the Iranian Registry of Clinical Trials (IRCT); the Brazilian Registry of Clinical Trials (ReBec); and all other WHO ICTRP primary registries. Registries not participating in the WHO ICTRP network are not acceptable without prior agreement with the Editor-in-Chief.

14.3  The registration number must be reported in the manuscript abstract and in the methods section. The trial record must be publicly accessible and must contain at minimum the 24 data fields specified in the WHO ICTRP Minimum Dataset. Incomplete or uninformative registration records do not satisfy the requirements of this Policy.

14.4  The Journal does not accept submissions of unregistered clinical trials regardless of the reasons for non-registration. Authors who discover at submission that their trial was not prospectively registered must contact the editorial leadership before submitting. Such manuscripts will not be considered. No exceptions to the prospective registration requirement are granted.

14.5  Amendments to registered trial protocols must be documented in the trial registry. Discrepancies between the registered protocol and the reported outcomes must be identified and explained in the manuscript. Unexplained discrepancies between the registered primary endpoint and the reported results raise concerns about outcome switching. They are subject to the provisions of the Publication Ethics Policy and the Corrections and Retractions Policy.

14.6  The ICMJE definition of clinical trial is applied broadly by the Journal. The Journal endorses but does not require the prospective registration of observational studies and other non-interventional research designs. For systematic reviews, registration in PROSPERO or an equivalent registry is encouraged. Where non-interventional research has been pre-registered, the registration number should be reported.

14.7  For diagnostic accuracy studies involving AI-based tools or clinical decision support systems, registration of the study protocol - whether in ClinicalTrials.gov, ISRCTN, or an equivalent registry - is strongly encouraged before data collection.

15. GENETIC AND GENOMIC RESEARCH

15.1  Research involving genetic or genomic data requires ethics committee approval explicitly covering the collection, processing, storage, and potential secondary use of genetic data. Authors must confirm that participants were informed of: (a) the nature of genetic data and its potential to reveal information relevant to the participant's health, identity, and family members; (b) the intended storage period and future research uses of the genetic material and data; and (c) any plan to share genetic data in a public or controlled-access repository.

15.2  Consistent with the WMA Declaration of Taipei and the 2024 Revision of the Declaration of Helsinki, research depositing genetic data in public repositories must include evidence that: (a) the informed consent obtained from participants covers the intended repository deposit and the access conditions of that repository; or (b) appropriate authorization from the competent ethics committee has been obtained for open or controlled deposition of the data.

15.3  The Journal does not require the deposit of raw genetic data in open-access repositories where such deposit was not covered by participant consent, recognizing the particular re-identification sensitivity of genetic data. In such cases, a summary or aggregate data deposition, or a controlled-access arrangement, may satisfy the data availability requirements set out in the Data Availability and Sharing Policy.

15.4  Research producing findings of potential clinical significance for participants or their family members - including incidental findings with diagnostic or therapeutic implications - must address in the manuscript the protocol applied for managing such findings, the policy applied regarding disclosure to participants, and any ethics committee guidance on this matter.

16. RESEARCH IN PUBLIC HEALTH EMERGENCIES

Consistent with the 2024 Revision of the Declaration of Helsinki, the Journal affirms that the ethical principles governing research involving human participants must be fully upheld during public health emergencies. The existence of a public health emergency does not justify the suspension of informed consent requirements, ethics committee review, clinical trial registration, or the other requirements established in this Policy.

Where urgency made prior ethics committee approval infeasible, a retrospective review must have been initiated as soon as practicable, and the circumstances of the emergency research must be fully disclosed in the manuscript. Research conducted during a public health emergency in which standard ethical safeguards were modified or waived must: (a) identify the applicable regulatory framework under which those modifications were authorized, such as national emergency research regulations or applicable EU law; (b) confirm the independence of the ethics committee involved in any review; and (c) address whether post-emergency access to any beneficial intervention was arranged for participants.

The Journal notes that public health emergencies historically affecting gynecology and obstetrics - including pandemic-related disruptions to maternal and reproductive healthcare - may generate urgent research questions. The ethical standards applicable in non-emergency contexts remain the reference standard; justified departures must be explained and documented.

17. RESEARCH IN LOW-RESOURCE SETTINGS AND GLOBAL JUSTICE

17.1  Consistent with the CIOMS Guidelines and the 2024 Revision of the Declaration of Helsinki, the Journal requires that research conducted in low- or middle-income countries, or in populations with historically limited access to research benefits, meet the following conditions:

- the research must be responsive to the health needs and priorities of the host population, and not designed or conducted primarily for the benefit of populations in higher-income countries;

- the research must respect the applicable national regulatory and ethical framework, and must not seek to conduct in low-resource settings research that would not be permissible in the country of the sponsoring investigators;

- the benefit-risk balance must be assessed specifically from the perspective of the host community, and not solely from the perspective of external funders or researchers; and

- community engagement and involvement in study design, conduct, and dissemination must be described where applicable and relevant.

17.2  The Journal does not publish research that applies lower ethical standards in low-resource or low-income settings than would be applied in the countries of the sponsoring investigators or institutions. Manuscripts in which ethics committee approval was obtained solely from an institution in a high-income country while the research was conducted on populations in a different country must confirm that ethics committee approval was also obtained - or was not required under local law - in the country where the research was conducted.

17.3  Manuscripts reporting research conducted without the involvement of local investigators or local ethics review are assessed by the Editor-in-Chief with particular attention to the principles of global justice and non-exploitation established by the CIOMS Guidelines and the Declaration of Helsinki 2024.

18. SCIENTIFIC INTEGRITY IN RESEARCH

18.1  General principle.  Consistent with the 2024 Revision of the Declaration of Helsinki, all persons involved in the conduct and reporting of research published in the Journal - including authors, co-investigators, and the funders of the research - must not engage in research misconduct in any form. Fabrication, falsification, plagiarism, selective reporting, and undisclosed outcome switching constitute reportable violations under the Publication Ethics Policy and the Complaints, Appeals and Whistleblowing Policy.

18.2  Protocol amendments.  Any material amendments to the approved research protocol must be documented and submitted to the relevant ethics committee for review before implementation. Material amendments not submitted for ethics committee review must be disclosed in the manuscript and may result in rejection of the manuscript or post-publication corrective action.

18.3  Dual-use research.  Where the editorial leadership identifies potential dual-use concerns - situations in which findings could plausibly be misused to cause harm to individuals or populations - the Editor-in-Chief, in consultation with the Publisher, may: (a) request that authors modify the manuscript to reduce or remove the most sensitive information; (b) add an editorial note to the published article; (c) seek the opinion of an external bioethics expert; or (d) decline to publish the manuscript, such situations are inherently rare in gynecology and obstetrics but may arise in research on biological agents relevant to reproductive toxicology, pharmacological manipulation of reproductive function, or genetic modification technologies.

18.4  Research involving AI-based interventions in clinical settings.  Research evaluating AI-based diagnostic tools, clinical decision support systems, or algorithmic interventions in gynecological or obstetric practice requires ethics committee approval covering the specific AI intervention and its risk profile. The manuscript must describe the evaluated AI system, its intended clinical use, any applicable regulatory clearance (such as CE marking or FDA clearance), and any specific ethics committee assessment. Additional provisions governing the use of AI in research and publication workflows are contained in the Artificial Intelligence Policy (AIP).

19. DATA PROTECTION IN RESEARCH: GDPR PROVISIONS

19.1  Legal basis.  The collection, processing, storage, and disclosure of personal data in research submitted to the Journal must comply with EU Regulation 2016/679 (GDPR), applicable national data protection law (including Italian Legislative Decree 196/2003 as amended), and, where applicable, the national law of the jurisdiction in which the research was conducted. Authors must confirm that a valid legal basis existed for the processing of personal data. In the research context, the applicable legal bases are typically: (a) explicit consent of the data subject (Article 9(2)(a) GDPR); or (b) scientific research purposes under Article 89 GDPR in conjunction with any applicable national exemption.

19.2  Special categories of data.  Health data, genetic data, biometric data, and data concerning sexual life and sexual orientation are special categories under Article 9 GDPR subject to heightened protection. These categories represent the primary data types involved in gynecological and obstetric research. Their processing requires one of the specific legal bases under Article 9(2) GDPR, typically either explicit consent or processing for research purposes authorized under national law with appropriate safeguards.

19.3  Anonymization and pseudonymization.  The Journal distinguishes between truly anonymized data - which is not subject to GDPR requirements - and pseudonymized data, which remains personal data under the GDPR. Authors must identify whether their data is truly anonymized or pseudonymized, and confirm that any pseudonymized data was handled in compliance with the applicable legal basis and safeguards.

19.4  Data minimization and storage limitation.  Authors must confirm that only the data necessary for the specific research purposes was collected and processed (data minimization principle, Article 5(1)(c) GDPR), and that a specific retention period for the research data was established and will be respected (storage limitation principle, Article 5(1)(e) GDPR).

19.5  Third-country transfers.  Where research data was transferred from the European Economic Area to a third country, authors must confirm that the transfer was conducted in compliance with the applicable GDPR transfer mechanism - adequacy decision, standard contractual clauses, or binding corporate rules - or an applicable derogation under Article 49 GDPR.

20. REPORTING STANDARDS

Authors are required to use the reporting guidelines published by the EQUATOR Network applicable to their study design. Compliance with the relevant reporting standard must be demonstrated by submitting a completed checklist as a supplementary file to the manuscript. The applicable reporting standards include, but are not limited to:

- CONSORT 2010 (with applicable extensions): randomized controlled trials;

- STROBE: observational studies (cohort, case-control, cross-sectional);

- PRISMA 2020 (with applicable extensions): systematic reviews and meta-analyses;

- CARE: case reports and case series;

- STARD 2015: diagnostic accuracy studies;

- TRIPOD (including TRIPOD+AI): prediction model studies and AI-based prediction models;

- SPIRIT: study protocols for clinical trials;

- SAGER: sex and gender reporting in health research;

- CHEERS: health economic evaluations.

The specific provisions governing reporting standards for each article type, the submission process for checklists, and the procedure for handling deviations from reporting standards are outlined in the Statistical Reporting and Reproducibility Policy and the Submission Guidelines. Where a manuscript involves a study design not addressed by any existing EQUATOR reporting standard, the Editor-in-Chief and the responsible Associate Editor determine the applicable standards on a case-by-case basis.

21. POST-PUBLICATION ETHICS CONCERNS

Where concerns arise after publication regarding the ethical conduct of the research reported in a published article - including concerns about the adequacy of ethics committee approval, the validity of informed consent, the appropriate management of vulnerable participants, or the accuracy of clinical trial registration - the procedures established in the Corrections, Retractions and Expressions of Concern Policy and the Complaints, Appeals and Whistleblowing Policy apply.

The Editor-in-Chief, supported by Edikta S.r.l. where necessary, manages post-publication ethics concerns in accordance with the COPE flowcharts for handling suspected ethical violations in published articles. Where concerns are confirmed, the appropriate corrective action - Correction, Expression of Concern, or Retraction - is applied in accordance with the Corrections and Retractions Policy. Substantiated post-publication ethics concerns may result in institutional referral and, where relevant, in notification of the ethics committee that approved the research.

22. ANNUAL REVIEW

This Policy is reviewed annually by the Editor-in-Chief and Edikta S.r.l. The annual review assesses: (a) updates to the Declaration of Helsinki, ICMJE Recommendations, CIOMS Guidelines, COPE Core Practices, and other relevant international standards; (b) developments in research ethics applicable to gynecology and obstetrics, including any new guidance on research involving pregnant women, neonates, genetic data, or AI-based interventions; (c) the Journal's experience in applying this Policy, including recurring patterns of non-compliance or ambiguity; (d) developments in EU law governing clinical trials (EU Regulation 536/2014 and the CTIS system) and data protection that may affect the requirements of this Policy.

Material revisions to this Policy are communicated to authors, reviewers, and editorial board members through the Journal's official communication channels. A versioned record of all editions of this Policy is maintained and publicly accessible on the Journal's website.

23. CROSS-REFERENCES WITHIN THE EDITORIAL POLICY FRAMEWORK

This Policy is part of the integrated editorial policy framework of European Gynecology and Obstetrics (EGO). The following cross-references apply:

- World Medical Association (WMA). Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Participants. 2024 Revision, adopted by the 75th WMA General Assembly, Helsinki, Finland, 19 October 2024. Available at: www.wma.net.

- World Medical Association (WMA). Declaration of Taipei on Ethical Considerations Regarding Health Databases and Biobanks. WMA, 2016.

- Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Health-Related Research Involving Humans. Geneva: CIOMS, 2016.

- International Committee of Medical Journal Editors (ICMJE). Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. Updated January 2026. Available at: www.icmje.org.

- International Committee of Medical Journal Editors (ICMJE). Clinical Trials Registration. ICMJE Policy. Available at: www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html.

- Committee on Publication Ethics (COPE). Core Practices and Flowcharts on Research Ethics. Current version. Available at: publicationethics.org.

- Committee on Publication Ethics (COPE). Flowchart: What to do if you suspect a study did not receive ethics approval—current version.

- Directory of Open Access Journals (DOAJ). Principles of Transparency and Best Practice in Scholarly Publishing. Version 4.

- EQUATOR Network. Reporting guidelines for health research (CONSORT, STROBE, PRISMA, CARE, STARD, TRIPOD, SPIRIT, SAGER, CHEERS). Current versions. Available at: www.equator-network.org.

- WHO International Clinical Trials Registry Platform (WHO ICTRP). International Standards for Clinical Trial Registries. Version 3.0, 2018.

- EU Clinical Trials Regulation. Regulation No. 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use. OJ L 158, 27 May 2014.

- European Union. Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 (General Data Protection Regulation - GDPR).

- Italy. Personal Data Protection Code (Legislative Decree 196/2003, as amended by Legislative Decree 101/2018).

- Springer Nature. Journal Policies: Research Ethics. Current version. Available at: link.springer.com.

- Elsevier. Research Ethics and Informed Consent Policy. Current version. Available at: www.elsevier.com.

- Wiley. Best Practice Guidelines on Publishing Ethics: Research Ethics. Current version. Available at: authorservices.wiley.com.

- PLOS. Human Subjects Research Policy. Updated March 2023. Available at: plos.org.

- BMJ. Research Ethics Guidance. Current version. Available at: www.bmj.com.