Guidelines on Informed Consent and Patient Data Protection

  1. Fundamental principle

The Electronic Medical Journal requires the highest level of respect for the dignity, privacy, and autonomy of patients whose clinical data, images, or histories are used in scientific articles. The publication of potentially identifiable information requires explicit, written, and archivable informed consent, without exception.

  1. When is informed consent required?

Written informed consent is mandatory in the following cases:

  • Case presentations that include detailed clinical data, evolution, diagnoses, or treatments.
  • Research articles containing photographs, diagnostic images (X-rays, MRIs, ultrasounds, etc.), microphotographs, genetic data, or any other material that, alone or in combination, could allow patient identification.
  • Case series reports or qualitative studies with direct quotes or detailed descriptions of participants.

Note: Even if data such as name, medical record number, or date of birth are omitted, consent is still required if there is a reasonable risk of identification (e.g., rarity of the condition, unique physical characteristics, limited geographic context).

  1. Characteristics of informed consent

The consent document must:

  • Be specific for scientific publication purposes (consent for medical treatment alone is insufficient).
  • Include a clear statement that the patient authorizes the publication of their clinical information and/or images in printed and electronic scientific journals, national and international.
  • Explicitly mention that the data may be openly accessible (open access) on the internet.
  • Be signed by the patient or, in case of incapacity, by their authorized legal representative, with date and signature.
  • Not require notarization, but must be archivable by the authors for at least 5 years (the editorial committee may request it at any time).

Suggested statement in the manuscript:
"Written informed consent was obtained from the patient for the publication of this case and the associated images."

  1. Protection of patient identity

In addition to consent, authors must actively take measures to minimize the risk of identification:

  • Remove or mask identifiable data in images:
    • Faces (in clinical photographs),
    • Scars, tattoos, or distinctive marks (if relevant to the case, they must be partially pixelated),
    • Identifiers in diagnostic images (name, ID, date, institution).
  • Modify or generalize non-essential demographic data:
    • Age: use ranges (e.g., "60-year-old woman" → "woman in her sixth decade of life"),
    • Location: use region or country instead of specific city, if possible.
  • Avoid unique combinations of clinical, social, and geographic characteristics that could identify the patient.
  1. Exceptional cases: Can publication occur without consent?

No. The journal will not accept the publication of identifiable data without written informed consent, even if:

  • The patient has died,
  • The case is of great scientific interest,
  • Attempts were made to locate the patient without success,
  • The scientific benefit is considered to justify publication.

The only exception is when all data are completely anonymous (i.e., impossible to link to a real person, even by the authors). In such cases, it must be explicitly stated:
"The data presented are completely anonymous and do not allow patient identification, not even by the authors."

  1. Editorial review
  • The editorial team will verify the inclusion of the consent statement in all manuscripts that require it.
  • In case of doubt, the original consent document will be requested from the authors.
  • Lack of consent or an insufficient statement will be grounds for immediate rejection of the manuscript.
  1. Normative basis

These guidelines are based on:

  • Declaration of Helsinki (World Medical Association),
  • ICMJE Recommendations (International Committee of Medical Journal Editors),
  • COPE Guidelines (Committee on Publication Ethics),
  1. Final statement for authors

By submitting their manuscript, authors certify that:

  • They have complied with all ethical requirements of their institution,
  • They have obtained written informed consent when required,
  • They have protected patient identity in accordance with these guidelines,
  • They assume full responsibility for any violation of privacy or patient rights.