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Informed consent policy

As a researcher and member of a reputable academic community, you are ethically obligated to conduct your research in strict accordance with both national and international research ethics frameworks. This includes adherence to the ethical principles established by your discipline and any relevant regulatory authorities. Transparency in research methodology is essential to ensure that all stakeholders involved in the publication process can evaluate the work fairly and appropriately.

Informed consent requires that all participants (or their legal representatives) are fully apprised of the purpose of the research, the extent to which their anonymity will be preserved, the methods by which their data will be stored and utilized, and any potential risks associated with participation. Authors must confirm within their submitted work that informed consent was obtained and clearly describe the procedures followed. This requirement applies to all research involving human participants and is not limited to medical studies. Researchers must also comply with any applicable legal or institutional regulations concerning data protection.

Ethical Approval

Ethical clearance must be secured prior to the commencement of any research activity. For studies involving human participants—whether identifiable or not, and including biological samples or personal data—approval from an institutional ethics review board is mandatory. Researchers should be aware that many jurisdictions require ethical approval for all human-related studies, regardless of identifiability.

Furthermore, researchers must affirm that internationally recognized ethical standards, such as the World Medical Association's Declaration of Helsinki, have been observed to minimize potential harm to participants. In accordance with the guidelines of the International Committee of Medical Journal Editors (ICMJE), the privacy and welfare of human subjects must be respected at all times.

Authors must be prepared to provide supplementary documentation upon request, including anonymized datasets, details of the study design, ethical approval documentation, and the informed consent process. These materials may be requested during peer review or post-publication. Therefore, it is imperative that researchers retain written records of participant consent.

Ethical Statement Requirements

All submitted manuscripts must include a comprehensive ethical statement confirming that the research received appropriate institutional and national (or international) ethical approval and complies with all relevant regulations governing studies involving human subjects, data, or biological samples. The statement should specify:

  • The name and location of the ethics review committee or board
  • The approval number and date of approval
  • The national or international ethical guidelines followed
  • Any additional relevant information

If ethical approval was not obtained, authors must provide a clear and justified explanation for exemption from this requirement. The manuscript must also include a description of how informed consent was secured, ensuring that the anonymity of both authors and participants is preserved.

Manuscripts lacking a suitable ethical statement and documentation of informed consent, where applicable, will be returned to the authors and will not proceed through the review process until adequate information is provided. The journal reserves the right to reject submissions that fail to demonstrate sufficient ethical compliance, particularly regarding informed consent from human participants.

Illustrative Examples of Ethical Approval and Informed Consent Statements

Ethical Approval

This study, entitled "[Title]," was conducted in full compliance with applicable ethical standards. Ethical approval was granted by the [Name of Institutional Ethics Committee] on [Date], under approval number [Approval Number]. The research adhered to the ethical principles outlined in [Specify National/International Guidelines].

Informed Consent

Prior to data collection, participants were thoroughly informed about the study's objectives, procedures, and their rights, including the right to decline participation or withdraw at any time. Measures to ensure confidentiality and anonymity were clearly communicated. Written informed consent was obtained from all participants (or their legal representatives) prior to their involvement in the study.

The authors confirm that the study complies with all relevant ethical guidelines for research involving human participants, including:

  • Respecting participant autonomy, confidentiality, and anonymity throughout the research process via [Description of Data Collection Methods].
  • Using collected data exclusively for the purposes stated in the study.
  • Ensuring transparency in data management and reporting.
  • Avoiding coercion or undue influence in securing participation.

Consent to Publish

If your research includes any material that could potentially identify individual participants—such as case histories, clinical data, diagnostic images (e.g., X-rays), direct quotations, identifiable photographs, audio or video recordings, or any other content that may reveal a participant's identity—you are required to obtain explicit consent to publish. This must be documented through a completed consent to publish form. The form must confirm that the individual(s) providing consent have reviewed the content intended for publication, understand how the findings will be disseminated, and have agreed to the publication of the material.

In accordance with the guidance provided by the International Committee of Medical Journal Editors (ICMJE), all non-essential identifying information should be excluded from the manuscript. Notably, masking the eye region in photographs or videos is insufficient to ensure anonymity and still necessitates formal consent. Additionally, if your work includes audio or video content, you may need to obtain copyright clearance in accordance with the journal's permissions policy.

It is essential to distinguish between consent to participate in research and consent to publish. Both must be obtained where applicable. The manuscript must clearly state that consent to publish has been secured, outline the scope of that consent, and describe the method by which it was obtained.

Consent must be obtained from the participants themselves or, where appropriate, from a parent, legal guardian, or legally authorized representative—particularly in the case of minors or vulnerable populations. For deceased individuals, consent must be obtained from the next of kin. All consent must be given voluntarily, without coercion or inducement, and in accordance with ethical standards such as those outlined by the Belmont Report. For research involving potentially vulnerable groups, as defined by the Icelandic Human Rights Center, special care must be taken to ensure that informed consent has been appropriately obtained. In cases where written consent is not feasible, verbal consent may be acceptable, but this must be justified and documented within the manuscript.

Research Involving Identifiable Companies, Individuals, or Organizations

If your research involves detailed analysis of a specific company, individual, or organization—particularly where you have conducted fieldwork, interviews, or spent time within the organization—you must obtain formal permission to publish using the consent to publish form.

Anonymization is only acceptable if the subject cannot be reasonably identified from the manuscript or associated contextual information, including the authors' affiliations or professional background. The following conditions apply:

  • Identifiability is not limited to the content of the manuscript but may also arise from the authors' institutional affiliations or publicly available information.
  • If the research is based solely on publicly accessible sources (e.g., news articles, published reports), formal permission is not required.
  • Where permission is required, it must be granted by the named individual, their legal representative, a board member, or an authorized representative (e.g., from the HR department) of the organization.
  • If the manuscript undergoes substantial changes during peer review that significantly alter the content initially approved, updated consent may be required. It is the author's responsibility to ensure that permission to publish the final version has been obtained.

Use of Third-Party Datasets

For research utilizing third-party datasets, authors must obtain permission from the data owner unless the dataset is publicly available and unrestricted. All data must be anonymized unless otherwise permitted by the data provider. The manuscript must include a statement confirming that the necessary permissions for data use have been secured.