Ethical approval is one of the key elements of preparing a medical publication, especially if the study is related to patients, their personal data, etc. For the author, this is not only a formal journal requirement, but also an important mechanism for confirming that the study was conducted responsibly and in compliance with international standards of scientific ethics. We will discuss this in more detail in our article.
Why is ethical approval important for medical articles?
First of all, ethical approval in a medical publication is important for protecting patients or study participants. It helps assess whether the study creates unnecessary risks, whether informed consent is obtained correctly, whether confidentiality is violated, etc.
In addition, it helps protect the author. If, after publication, it becomes clear that the study should have undergone ethical review but this was not done, the journal may request explanations or even retract the article.
It is also a requirement for publication in a journal and for obtaining indexing. The editorial offices of most international medical journals often require a separate statement on ethical approval to be added to the Methods section.
For which medical publications is ethical approval required?
Clinical studies involving humans
Such works may include studies of medicinal products, treatment methods, medical procedures, rehabilitation programmes, diagnostic methods, surgical interventions or medical devices. Such works almost always require prior approval by an ethics committee and the informed consent of participants. The Declaration of Helsinki directly provides that medical research involving humans must comply with ethical principles and undergo proper ethical oversight.
Observational studies
These may be retrospective studies in which authors analyse patients’ condition, treatment outcomes, the course of disease, laboratory indicators, examination data, etc. Even if the authors simply analyse data, ethical approval is often required because it concerns the medical information of real people.
Clinical cases
For clinical cases, what is often required is not so much a full ethical approval procedure as the patient’s written informed consent for publication, especially if there are photos, images, a rare diagnosis, treatment details or any information by which the patient can be identified. The ICMJE emphasises that identifying information about patients should not be published without written informed consent unless it is necessary for the scientific purpose.
Questionnaires, interviews and surveys
If authors collect people’s responses, especially regarding health status, psychological state, treatment, professional experience or personal data, ethical review is often required. For example, the BMJ states that ethical assessment may apply to any work involving people, regardless of how the authors interpret or name it.
Animal studies
If an article describes experiments on laboratory animals, approval from the relevant animal ethics committee is usually required. In many journals, this is as mandatory a requirement as ethical approval for studies involving humans. The journal Nature Portfolio, for example, requires an ethical statement in the manuscript indicating the committees that approved the experiments.
Risks for the author in the absence of ethical approval for the study
- Journal rejection or withdrawal of the article from consideration. If the absence of ethical approval is identified at the manuscript checking stage, the editorial office may reject the article without peer review or ask for documents to be provided: the protocol number, the name of the ethics committee, the approval date, the informed consent form or confirmation of exemption from ethical review. Many publishers require transparent information about ethical approval and participant consent for studies involving humans.
- Retraction of an already published article. If the article has already been published, but after publication it becomes clear that the required ethical approval was not obtained, the editorial office may publish a correction, an expression of concern or retract the article. Retraction may be applied when editors no longer have confidence in the results or when there are serious ethical violations.
- Loss of academic reputation. For the author, this may appear to be a violation of research ethics, even if the mistake was unintentional. Retraction or an ethical scandal may negatively affect the trust of editorial offices, reviewers, colleagues, the university, grant providers and future coauthors.
- Problems with indexing and the scientometric profile. If the article is retracted, it may remain in databases with a retraction notice or cease to be counted as a full scientific publication. This is risky if the publication is needed for reporting, dissertation defence, a grant competition or confirmation of scientific activity.
- Legal risks and breaches of confidentiality. If personal data or other information by which a patient can be identified is used in the article, claims regarding a breach of privacy may arise without proper consent. Identifying information about patients should not be published without written informed consent unless it is necessary for the scientific purpose.
- Risks for coauthors. Responsibility may concern not only the first or corresponding author. If all authors are listed as responsible for the content of the work, an ethical issue may affect the reputation of all authors.
In addition, in many cases ethical approval must be obtained before the study begins, not after the work has been completed or published. If approval was not required, it is better to have official confirmation from the ethics committee or institution regarding exemption from such review. Some journals directly require authors to indicate not only the fact of exemption, but also the name of the committee and an explanation of why approval was not required.
When may ethical approval not be needed?
Ethical approval is usually not required for review articles, theoretical materials, letters to the editor without patient data, systematic reviews and meta-analyses if the authors work only with already published anonymised data. If the situation is doubtful, it is better to obtain official confirmation from the ethics committee that approval is not required.
To summarise, ethical approval is an extremely important aspect for most medical studies. Its absence may jeopardise the success of the publication and the author’s reputation, so we recommend taking this aspect into account in the study even before it begins.
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