Consent for Publication
The journal respects every patient’s right to privacy, confidentiality, dignity, and control over the publication of identifiable personal or clinical information.
Information that may identify an individual must not be published unless its inclusion is scientifically justified and the required written informed consent for publication has been obtained from the patient or, where applicable, from a parent, legal guardian, or other legally authorized representative.
ICMJE states that identifying information—including names, initials, hospital numbers, photographs, and pedigrees—should not be published unless the information is essential for scientific purposes and written informed consent for publication has been obtained.
When Consent for Publication Is Required
Written consent for publication is required when a person could reasonably be identified from the material to be published.
This may include:
- case reports and case series containing identifiable details;
- clinical photographs, facial images, videos, or audio recordings;
- radiological, pathological, dermatological, ophthalmological, surgical, or other images containing identifying information;
- rare diagnoses or unusual combinations of clinical circumstances that may permit indirect identification;
- names, initials, hospital or medical-record numbers, dates, locations, or other direct identifiers;
- pedigrees and family information;
- genetic or genomic information capable of contributing to identification;
- identifiable information contained in supplementary files or other material published with the article.
The possibility of identification should be considered from the combined information in the article, not only from a single obvious identifier.
Consent to Research Is Not Consent to Publication
Consent to participate in research does not automatically constitute consent to publish identifiable information.
Research consent and publication consent serve different purposes. Where identifiable information is to be published, specific consent for publication must be obtained unless an applicable legal and ethical framework clearly provides otherwise.
This distinction is particularly important for case reports, clinical images, genetic information, and other patient-specific material.
Information Given Before Publication Consent
A person providing consent should be informed, in understandable terms, about the nature of the information or material intended for publication.
For an identifiable patient, the individual should be given an appropriate opportunity to understand what information will be published and in what context.
ICMJE specifically recommends that an identifiable patient be shown the manuscript to be published and be informed that potentially identifiable material may become available on the Internet as well as through other publication formats.
Consent should be given voluntarily and without coercion or inappropriate pressure.
Pediatric Patients
For identifiable information concerning newborns, infants, children, or adolescents, written publication consent must be obtained from the parent, legal guardian, or other person legally authorized to provide such consent when the child cannot legally consent independently.
Where the child or adolescent has sufficient maturity and understanding, their views and developing autonomy should also be appropriately respected in accordance with applicable ethical and legal requirements.
If the participant is legally capable of providing their own consent, the applicable consent should be obtained directly from that participant.
Publication should not proceed merely because an adult representative has agreed when significant ethical concerns about the child’s privacy or welfare remain.
Clinical Images
Clinical images require particular care because removal of names alone may not make a patient anonymous.
Authors should remove unnecessary identifying information while preserving the scientific integrity of the image.
If there is any reasonable doubt that anonymity can be maintained, publication consent should be obtained.
ICMJE specifically notes that simply masking the eye region in a patient photograph is not sufficient protection of anonymity.
Images must not be altered solely to disguise identity in a manner that distorts clinically or scientifically relevant information.
De-Identification
Authors should remove nonessential identifying information from manuscripts and associated files.
De-identification may include removal or appropriate generalization of direct identifiers where this does not impair scientific meaning.
However, de-identification does not remove the requirement for publication consent when the individual remains reasonably identifiable from the combination of clinical, demographic, photographic, genetic, familial, temporal, geographic, or other information.
If identifying characteristics have been modified to protect privacy, the modification must not distort the scientific meaning of the report. ICMJE requires authors to provide assurance where identifying characteristics have been altered.
Genetic and Family Information
Genetic information and pedigrees require heightened attention because they may reveal information not only about the participant but also about biological relatives.
Authors must consider whether the combination of genetic, clinical, family, geographic, or demographic information could permit identification.
The 2024 Declaration of Helsinki applies to research involving identifiable human data and emphasizes protection of participants’ privacy and confidentiality.
Where identifiable genetic or familial information is published, appropriate publication consent and other applicable ethical safeguards must be in place.
Documentation and Retention
Consent for publication should be written and appropriately documented.
Unless specifically requested by the journal, authors should normally retain the original consent documentation securely rather than upload identifiable consent forms with the manuscript.
The manuscript should contain a clear statement confirming that appropriate consent for publication was obtained.
The journal may request confirmation or appropriate documentation where necessary to verify compliance. Any such material must be handled confidentially.
ICMJE provides that written publication consent should be archived by the journal, the authors, or both, according to applicable local laws and regulations.
Manuscript Statement
Where publication consent is required, the manuscript should contain an appropriate statement, for example:
“Written informed consent for publication of the relevant clinical information and/or images was obtained from the patient or the patient’s parent/legal guardian, as applicable.”
The statement should accurately reflect the consent actually obtained.
Authors must not claim that publication consent was obtained if the relevant documentation or process does not support that statement.
Withdrawal Before Publication
If a patient or legally authorized representative withdraws publication consent before publication, authors must promptly inform the journal.
Material requiring that consent should not be published unless another valid ethical and legal basis clearly permits publication.
Authors should therefore obtain publication consent sufficiently early in manuscript preparation and should not assume that research participation alone authorizes publication.
Confidentiality of Consent Documentation
Consent documentation may itself contain highly sensitive personal information.
Authors and the journal must therefore avoid unnecessary transfer or disclosure of identifiable consent records.
Where the journal needs verification, it may request an appropriate declaration, redacted documentation, or other evidence sufficient to establish compliance while minimizing disclosure of personal data.
Journal Assessment
The journal may request clarification when:
- identifiable information appears to be present without an adequate consent statement;
- the adequacy or authenticity of publication consent is uncertain;
- a clinical image or case description may allow identification despite attempted anonymization;
- consent appears not to cover the material actually submitted for publication;
- there are concerns regarding consent obtained on behalf of a child or another person unable to provide independent consent.
The journal may require additional de-identification, removal of unnecessary identifying material, appropriate documentation, or confirmation of publication consent.
Where required consent cannot be established, the identifying material may be removed or the manuscript may be rejected.
Fabrication of consent documentation, false declarations of consent, publication of identifiable patient information without required permission, or deliberate concealment of such deficiencies may be addressed under the journal’s Research Misconduct, Editorial Actions, and Corrections and Retractions policies.