Two different consents are required of research that involves people, and a manuscript must account for both: consent to take part in the research, and consent to publish material by which a participant could be identified. Ethics committee approval does not replace either. This page applies to every discipline the journal publishes, not only to clinical work.
Consent to take part
Participants must have agreed to take part freely, knowing what the research was about, what participation involved, what would happen to their data, who was funding the work, and that they could refuse or withdraw at any point without giving a reason and without disadvantage. Consent must have been obtained in a language and form the participant understood, and recorded — in writing, or by another documented method the ethics committee approved, such as recorded oral consent in fieldwork.
- Children and people who cannot consent for themselves — consent comes from the parent or legally authorized representative, with the participant's own assent wherever they are able to give it, and their objection respected.
- Waivers — where an ethics committee waived consent, for example for secondary analysis of existing records, state that it did, which committee, and on what ground. A waiver you granted yourself is not a waiver.
- Existing data and archives — reusing a dataset, an archive, or platform content does not remove the obligation. State the terms under which the material was collected and whether they cover your use.
Describe the consent procedure in the Methods and summarize it in the Ethics approval and consent declaration; see Research Involving Humans and Animals.
Consent to publish identifiable material
Separate, explicit, written consent is required from every identifiable individual — or their legally authorized representative — before you submit material of this kind:
- photographs, video, audio recordings, or any image in which a person can be recognized;
- case descriptions, clinical histories, or life histories with enough detail to identify someone;
- direct quotations that identify the speaker by role, employer, location, or circumstance, even under a pseudonym;
- genetic data, pedigrees, and rare conditions or events that identify a person or a family;
- material about a named institution, small community, or workplace where individuals could be picked out.
The consent must cover publication in a journal that is open access and freely available on the internet, without expiry and without geographic limit, and the person must have been told what will be published. Consent given only for use in research, in teaching, or in a clinical record does not extend to publication.
The right test is not whether a stranger could identify the person, but whether the person could identify themselves, or be identified by someone who knows them. Masking the eyes, cropping an image, changing a name, or altering incidental details is not a substitute for consent; nor is a statement that the data were "anonymized" when the description remains recognizable. Where consent cannot be obtained, remove the identifying material or do not report the case. Do not alter facts that matter to the science in order to disguise a participant; say instead what has been withheld.
What to send the journal, and what to keep
Do not upload completed consent forms, which contain participants' personal data, unless the journal asks for them. Instead, state in the manuscript that written consent for publication was obtained, from whom, and when. Retain the signed forms securely, for as long as your institution and the applicable law require, and be ready to supply the editor with a blank copy of the form used or with a redacted confirmation. Where the editor needs to see an individual form, it is requested through a secure channel, viewed, and not retained. The journal is governed by Romanian law and Regulation (EU) 2016/679 (GDPR) and keeps no more personal data about participants than it needs; questions go to [email protected].
Deceased persons
Identifiable material about a deceased person requires the consent of the next of kin or the estate's legal representative, and the applicable national rules on confidentiality after death still apply. Where consent cannot reasonably be obtained, put the position to the editor before submission; the Editor-in-Chief decides, weighing the scholarly value against any risk of harm or distress to surviving relatives, and may require the material to be removed.
If consent is missing or withdrawn
- A manuscript whose identifiable material is not covered by consent is not published. The editor asks you either to obtain consent or to remove the material.
- If a participant withdraws consent before publication, remove their material. Withdrawal from the study itself is governed by the consent they were given.
- If a participant withdraws consent after publication, tell the journal at once. The journal will consider the remedies available under Publication Ethics — a published correction, a retraction, or, where the law requires it, removal of the article with a notice of the grounds left in its place. The published version is not edited silently. Be aware that publication cannot always be undone: copies already downloaded, cached, or reposted are outside the journal's control, and the journal will not promise an author or a participant what it cannot deliver.
- Publishing identifiable material without consent is a breach of these policies and is handled under Publication Ethics. It may lead to retraction and to notification of the authors' institution.