Brieflands | Informed Consent

Informed consent is the participant’s or patient’s documented agreement, given freely and with understanding, to take part in research and to have the resulting material published. It is separate from ethics committee approval: approval permits the study, consent permits the participation and the publication. Where both apply, both are required.

Which manuscript types require consent, and which require an ethical approval code, is set out in one place — the requirements table in Ethical Oversight. This page covers what consent must contain, the cases needing particular care, and the templates.

Case reports and case series — required, no exceptions

Written, signed consent for publication is required for every case report and case series. Obtain it from the patient, from the legal guardian where the patient is a minor or unable to consent, or from the next of kin where the patient has died or cannot be traced. Upload the signed form at submission and state in the manuscript that consent was obtained.

A case report cannot be published on the grounds that the patient is unidentifiable instead of on consent. De-identification is a separate duty, not a substitute — the checklist is in Case Report.

Case reports are not obliged to carry an ethical approval code. That exemption covers the approval code only; it has never covered consent.

Identifiable data, images and video

Separate, explicit consent for publication is required for anything that could identify a person, however small the risk: photographs and clinical images, radiographs and scans carrying patient data, pathology slides, video and audio recordings, pedigrees, and verbatim quotations.

Tell the participant plainly that the material will be published open access, on the internet, permanently, and may be reused by others under the article’s Creative Commons licence. Consent given for a conference presentation or held in the clinical record does not cover open-access publication.

Vulnerable participants and consent by proxy

Children and minors — consent from the parent or legal guardian, plus the child’s own assent where they are old enough to give it. Record both.
Adults unable to consent — consent from the legally authorised representative, with the reason for incapacity stated in the Methods.
Relationships of dependency — students, employees, patients of the investigator, detained persons. State what was done to ensure participation was genuinely voluntary.
Deceased participants — consent from the next of kin for any identifiable material.

Withdrawal of consent

A participant may withdraw consent at any time before publication; the manuscript is then revised to remove their data and material, or withdrawn. Once the article is published the record is permanent and consent cannot be retracted. Where a participant raises a concern after publication, the case is handled under Complaints and Appeals and may lead to a correction or, in the rare cases the law requires, removal.

Tell participants this before they sign. A consent form implying material can be taken down later is misleading.

What to write in the manuscript

Put the statement in the Methods section, naming the approving committee and its code where one applies:

Written informed consent was obtained from all participants (or their legal guardians) before enrolment. The study was approved by the [name] Research Ethics Committee (approval code [code]) and conducted in accordance with the Declaration of Helsinki. Written consent for publication of identifiable clinical images was obtained separately.

Where a study genuinely required no consent — fully anonymised existing data, for instance — state that, give the reason, and cite the committee’s waiver. Do not omit the statement.

Consent templates

Adapt these to your study; do not submit them unchanged.

Informed consent for clinical studies (English)
Consent form for case reports
Informed consent template (Persian) — 1
Informed consent template (Persian) — 2
WHO Research Ethics Review Committee templates — six forms, including assent for children and parental consent for clinical and qualitative research.

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