Informed Consent Policy

1. Ethical Principles

• All BM-Publisher journals follow the Declaration of Helsinki, the Belmont Report, and the International Council for Harmonisation – Good Clinical Practice (ICH-GCP).
• Authors must comply with national and institutional research-ethics regulations.
• Consent procedures must respect participants’ autonomy, privacy, and the right to withdraw at any time without consequence.

2. Requirements for Informed Consent

• Written informed consent must be obtained from all participants before participation in the study.
• Consent should cover:
  • The purpose, procedures, potential risks, and benefits of the study;
  • The intended publication or data sharing;
  • Rights to anonymity and withdrawal.
• If consent could not be obtained, authors must provide an explanation approved by an institutional ethics committee.
• Copies of signed consent forms must be retained by the authors or their institutions and available to editors on request (not submitted for publication).

3. Identifiable Information and Images

• No identifying details (names, initials, hospital numbers, images, or recognizable data) should be published without explicit written consent from the participant or legal guardian.
• When faces or distinctive features appear in clinical images, written permission for publication must be obtained.
• If identifying details are altered to protect anonymity, authors must confirm that such changes do not distort scientific meaning.

4. Consent Statement in Manuscripts

All manuscripts involving human subjects must include a clear statement in the Methods or Ethics section, such as:

"Written informed consent was obtained from all individual participants included in this study.
The study protocol was approved by the Institutional Review Board of [Institution Name] (Approval No. XXXX)."

If consent was obtained from a parent or guardian, this must be clearly stated.

5. Vulnerable Populations

• Special care must be taken when research involves minors, pregnant women, prisoners, cognitively impaired individuals, or economically disadvantaged groups.
• Consent must be obtained from legally authorized representatives in accordance with national regulations.
• Assent from minors (where appropriate) should accompany guardian consent.

6. Retrospective and Secondary Data Use

• For retrospective chart reviews or secondary data analyses where obtaining consent is impractical, authors must confirm that an ethics committee granted a consent waiver.
• All personal identifiers must be fully anonymized before analysis and publication.

7. Editorial and Peer-Review Responsibilities

• Editors and reviewers must ensure that manuscripts contain an appropriate informed-consent statement before acceptance.
• If adequate consent cannot be confirmed, the manuscript will be rejected or returned for clarification.
• In cases of doubt, the Editor-in-Chief may request documentation of consent or ethics approval.

8. Data Protection and Confidentiality

• All human data must comply with the EU General Data Protection Regulation (GDPR) and other applicable data-protection laws.
• Patient data must be anonymized, encrypted, or coded to prevent re-identification.
• Editors and reviewers are bound by confidentiality and will not share or use unpublished participant information.

9. Ethics Committee Approval

• Authors must state the name of the ethics committee or institutional review board (IRB) granting approval and provide the approval number or code.
• Studies conducted outside institutional frameworks must follow recognized national or international ethics guidelines, and authors must provide proof of compliance.