Ethics and Biosecurity

Informed Consent

Every individual has rights that must not be infringed. Research participants have the right to decide what happens to their identifiable personal data, their spoken or written statements during a study or interview, and any photographs taken. This is especially important for images of vulnerable people (e.g., minors, patients, refugees) or images used in sensitive contexts. In many cases, authors must obtain written consent before including such images.

Identifying details (names, dates of birth, identity numbers, biometric characteristics, and other information) should not be published in written descriptions, photographs, or genetic profiles unless the information is essential for scholarly purposes and the participant (or parent/guardian/legal representative) has given written informed consent for publication. Complete anonymity can be difficult to achieve; detailed descriptions may lead to identification. If identifying characteristics are altered to protect anonymity (e.g., in genetic profiles), authors must confirm that such alterations do not distort meaning.

Exceptions where consent is not necessary:

  • Images such as X-rays, laparoscopic images, ultrasound scans, brain scans, and pathology slides, unless identifying information is a concern.

  • Reused images from prior publications (the publisher assumes the original publication obtained consent; proper attribution is required).

Consent for Already Available Data and/or Biological Material

Regardless of whether material is collected from living or deceased patients, prior written consent must be obtained from the patient (or family/guardian if the deceased did not make a pre‑mortem decision). Confidentiality and any wishes of the deceased must be respected.

Data Protection, Confidentiality, and Privacy

When biological material is donated or data is generated as part of a research project, authors must ensure, through the informed consent process, that participants are aware of what personal data will be processed, how it will be used, and for what purpose. For data acquired from a biobank or biorepository, broad consent may be acceptable if it meets the standards of research ethics committees. Authors should always verify the specific policies of the biobank or data provider.

Consent to Participate

For all research involving human subjects, freely given informed consent to participate must be obtained from participants (or their parent/legal guardian for children under 16). A statement to this effect must appear in the manuscript.

For articles describing human transplantation studies, authors must state that no organs/tissues were obtained from prisoners and name the institution(s)/clinic(s)/department(s) through which organs/tissues were obtained.

Consent to Publish

Individuals may consent to participate in a study but object to having their data published. Authors must seek consent to publish data before submitting a paper, particularly for case studies.

Summary of Requirements for Consent Statements

These declarations should be included in a section titled "Declarations" before the reference list, under headings such as "Consent to participate" and "Consent to publish." Sample statements:

  • Informed consent was obtained from all individual participants included in the study.

  • Written informed consent was obtained from the parents.

  • The participant has consented to the submission of the case report to the journal.

  • Additional informed consent was obtained from all individual participants for whom identifying information is included in this article.

If a section is not relevant, include the heading and write "Not applicable." Authors are responsible for the correctness of these statements. The Editor‑in‑Chief may reject submissions that do not comply.

Images will be removed if informed consent was not obtained; the paper may be removed and replaced with a notice explaining the reason.

Sex and Gender in Research

Use the terms sex (biological attribute) and gender (socially and culturally shaped) carefully. Article titles/abstracts should clearly indicate the sex(es) to which the study applies. Authors should describe expected sex/gender differences, report how sex/gender were accounted for in study design, provide disaggregated data where appropriate, and discuss results. If no sex/gender analysis was conducted, a rationale should be given in the Discussion. These guidelines apply to studies involving humans, vertebrate animals, and cell lines.

Research Involving Human Participants, Their Data, or Biological Material

Ethics Approval

Authors must include a statement confirming that the study was approved (or granted exemption) by the appropriate institutional and/or national research ethics committee (including the committee’s name) and that the study was performed in accordance with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. If a study was exempt from ethics approval, this must be detailed with reasons.

Retrospective Ethics Approval

If a study did not receive ethics approval prior to commencement, retrospective approval is usually impossible, and the manuscript may not be considered for peer review. The Editor has discretion in such cases.

Ethics Approval for Retrospective Studies

Retrospective studies on already available data or biological material may still require ethics approval depending on national laws and guidelines. Authors should check with their institution.

Ethics Approval for Case Studies

Case reports require ethics approval. Authors should follow their institution’s policies and obtain approval where needed. Informed consent from the individual (or parent/guardian) is also required.

Cell Lines

If human cells are used, authors must declare: the source of the cell line, when and where it was obtained, whether it has been recently authenticated, and by what method. For purchased cells, provide the company name, cell type, line number, and batch. Authors are encouraged to check the NCBI database for misidentification and contamination. A statement confirming ethics approval and informed consent from the donor or next of kin is required.

Declarations Summary for Human Research

Include a section titled "Declarations" with subheading "Ethics approval." Sample statements:

  • *All procedures performed were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration. The study was approved by the Bioethics Committee of University A (No. ...).*

  • Ethical approval was waived by the local Ethics Committee of University A due to the retrospective nature of the study.

  • No ethical approval was required because this was an observational study using de‑identified samples.

If a section is not relevant, write "Not applicable."