Patient Consent for Case Report Publication

The written authorization a patient (or parent/guardian/legally authorized representative) gives before a clinical case report describing their presentation, treatment, images, or outcome is submitted to a journal -- required whenever the report contains identifiable information, per ICMJE's patient-privacy recommendations and CARE Guidelines checklist item 13, independent of any separate IRB determination about the underlying case.

ByCASRAI Editorial Board

· Last updated 23 Jul 2026

Worked examples

Is an instance

A case report including a patient photograph with the eyes masked still requires a signed consent form authorizing the identifiable image, since ICMJE explicitly treats eye-masking alone as inadequate anonymization.

Is an instance

A journal (e.g. BMJ Case Reports) requires authors to upload a completed patient consent form -- the journal's own template or an ICMJE-aligned model form -- as a supplementary file before manuscript review can proceed.

Looks similar, but isn't

Not an instance

A fully de-identified retrospective case series drawn from a chart review, with no detail specific enough to permit re-identification, may not require individual publication consent -- but genuine de-identification, not just omission of the patient's name, is the test.

Not an instance

Obtaining IRB approval or exemption for a case report does not substitute for patient consent to publish; the two serve different purposes -- research-ethics oversight versus publication authorization -- and ICMJE/CARE requires both to be considered separately.

Patient consent for case report publication is the written authorization a patient (or their parent, guardian, or legally authorized representative) gives before a clinical case report describing their presentation, history, treatment, images, or outcome is submitted to a journal. It is required whenever the report contains information — a name, initials, hospital number, photograph, or a combination of clinical details — specific enough that the patient could plausibly be re-identified, and it is required regardless of whether the institution’s IRB has separately reviewed or exempted the underlying case.

What ICMJE and CARE actually require

The requirement comes from two directions that converge on the same practice. The ICMJE Recommendations state that patients “have a right to privacy that should not be violated without informed consent,” and that identifying information “should not be published in written descriptions, photographs, or pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication.” ICMJE is explicit that masking the eye region in a photograph is not adequate anonymization on its own, that consent should be obtained if there is any doubt anonymity can be maintained, that authors should show the patient the manuscript before publication and disclose whether identifiable material may be accessible online as well as in print, and that written consent should be archived with the journal, the authors, or both, per local law. Separately, the CARE (CAse REport) Guidelines — the 13-item reporting checklist most clinical case reports are written to — list informed consent as checklist item 13, meaning a CARE-compliant case report cannot omit a statement about how and whether consent was obtained.

How it differs from IRB/ethics approval

Patient consent to publish and institutional review board (IRB) approval answer different questions and one does not substitute for the other. IRB review asks whether the underlying activity constitutes human-subjects research requiring oversight (many institutions treat a single retrospective case report as not meeting that threshold and exempt it, though this determination is institutional and varies). Patient consent to publish asks something narrower and separate: has the specific person described in this manuscript agreed to have their identifiable clinical details made public in a journal, potentially indefinitely and potentially indexed online. An IRB exemption for the underlying chart review does not remove the ICMJE/CARE obligation to obtain and document publication consent if the write-up remains identifiable.

Practical mechanics

Most medical and biomedical journals require a completed consent form — either the journal’s own template or the model consent form some journals adopt following ICMJE’s framework — to be uploaded as a supplementary file at submission, separate from the manuscript itself and not visible to peer reviewers in a way that would identify the patient during review. The form typically covers what will be published (text, photographs, imaging), where it will be published (print, online, potentially indexed and searchable), and confirms the patient has seen the material intended for publication. For a minor, consent is obtained from a parent or legal guardian, and many journals also expect the child’s assent where developmentally appropriate. Authors should retain the signed consent and be prepared to produce it if a journal, editor, or institution later requests it — a documented gap here is one of the more common issues editors flag at submission or, worse, discover only after publication.

References

ICMJE, “Protection of Research Participants” (Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals).
Gagnier JJ, Kienle G, Altman DG, Moher D, Sox H, Riley D; CARE Group, “The CARE guidelines: consensus-based clinical case reporting guideline development,” 2013 — checklist item 13, informed consent.

Use in your systems

JATS XML <role> element

xml

<role vocab="credit"
      vocab-identifier="https://casrai.org/dictionary/"
      vocab-term="Patient Consent for Case Report Publication"
      vocab-term-identifier="https://casrai.org/dictionary/term/patient-consent-case-report-publication" />

Schema.org DefinedTerm (JSON-LD)

json

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  "identifier": "https://casrai.org/dictionary/term/patient-consent-case-report-publication",
  "description": "The written authorization a patient (or parent/guardian/legally authorized representative) gives before a clinical case report describing their presentation, treatment, images, or outcome is submitted to a journal -- required whenever the report contains identifiable information, per ICMJE's patient-privacy recommendations and CARE Guidelines checklist item 13, independent of any separate IRB determination about the underlying case.",
  "inDefinedTermSet": "https://casrai.org/dictionary/domain/clinical-research#set",
  "url": "https://casrai.org/dictionary/term/patient-consent-case-report-publication",
  "sameAs": [],
  "license": "https://creativecommons.org/licenses/by/4.0/",
  "publisher": {
    "@id": "https://casrai.org/#organization"
  },
  "dateModified": "2026-07-23T09:36:23",
  "inLanguage": "en"
}