Human Participants, Ethics Approval & Informed Consent

Policy basis

Research involving humans must follow the World Medical Association Declaration of Helsinki (Fortaleza 2013; endorsed again by the 75th WMA General Assembly, Helsinki, October 2024) and the ICMJE Recommendations (updated January 2024). In India, researchers must also comply with the ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017) and local regulations/IEC requirements.

Ethics committee approval

Authors must state prior approval by an independent ethics committee (IEC/IRB), including the name of the committee, approval number/date, and protocol title/version. When a study is exempt, provide the written exemption and rationale. ICMJE

Informed consent for participation

Confirm that voluntary, informed consent (or legally authorized representative assent/consent, as applicable) was obtained before participation; describe how consent/assent was documented and any compensation/reimbursement. For vulnerable populations, describe additional safeguards consistent with ICMJE/ICMR guidance.

Privacy and confidentiality in publications

Identifying information (names, initials, hospital numbers, exact dates, images, or unique personal details) must not be published unless essential for scientific purposes and the participant (or guardian) has given written informed consent for publication. De-identification alone is not sufficient. Case reports require explicit publication consent; best practice is to show the final manuscript (or relevant images/text) to the patient/guardian before consent. 

Required statements (paste into manuscript)

• Ethics Approval: “The study protocol was approved by the [Full name of IEC/IRB], [Approval No., date]. All procedures were in accordance with the Declaration of Helsinki (2013; 2024 WMA adoption) and ICMJE recommendations.”

• Consent to Participate: “Written informed consent was obtained from all participants (or their legally authorized representatives).”

• Consent for Publication (when applicable, e.g., case reports, images): “Written informed consent for publication of clinical details and images was obtained from the patient/guardian after review of the material to be published.” This is as per The CARE Guidelines: Consensus-based Clinical Case Reporting Guideline Development.

Submission checklist (authors)

• COI: ICMJE Disclosure Form uploaded for each author; COI/Funding statements drafted in the manuscript.

• Human studies: IEC/IRB letter/number; consent to participate obtained; consent for publication if any identifiable information/case report.