Informed patient consent in a medical article is confirmation that, when working with clinical data and results, the authors complied with the necessary ethical requirements. Such a description is especially important for preparing clinical studies, comprehensive analyses and any materials where the patient can be identified. How should informed patient consent be prepared for a medical article? We will discuss this in our material.
Why is informed consent mandatory in medical articles?
Informed consent is necessary to protect the rights, dignity and privacy of the patient. In medical publications, authors often work with individual patient information, for example diagnoses, medical history, laboratory test results, images and so on. Even if the patient’s name is not indicated, the combination of certain clinical details can sometimes help identify a person.
The Declaration of Helsinki of the World Medical Association states that a participant in medical research must be properly informed about the purpose, methods, possible risks and ways in which the information they provide will be used. Participation must be voluntary, and consent must be given without pressure or coercion, since patients have the right to privacy, which must not be violated without their agreement.
The declaration also states that information by which a person can be identified, including their name, initials or hospital number, must not be published in written descriptions, photographs and so on. This does not apply to cases where these data are important for scientific purposes and the patient (or parents or guardian) gives consent for publication. Informed consent also requires that the patient who can be identified has been shown the manuscript for publication.
In which part of the article is informed patient consent described?
Usually, informed patient consent is described in the “Materials and methods” section, in the part on ethical aspects, or at the end of the paper as a separate section. The title of the section may differ depending on the journal’s requirements.
The following options are mostly used:
- Ethics statement – if it is necessary to briefly describe the ethical aspects of the study.
- Ethical approval – if the study was approved by an ethics committee.
- Informed consent – if the main emphasis should be placed specifically on the participants’ consent.
- Consent for publication – if it concerns the publication of a clinical case, photos, images or personalised clinical data.
- Declarations – if the journal combines ethics, consent, conflict of interest, funding and author contributions in one block.
For a clinical case, it is better to specify consent for publication separately, since the patient must agree not only to participate in treatment or research, but also to the disclosure of clinical information in a scientific journal.
What information should be indicated when describing informed patient consent?
The description of informed consent should be sufficiently clear and specific. It is worth indicating that the patient or legal representative received understandable information about the purpose of using the clinical data, the nature of the materials that will be used, the possibility of publication and measures to protect confidentiality. It is advisable to indicate in the text:
- whether the consent was written
- who provided it – the patient, parents, guardian or another legal representative
- what exactly the consent was given for – participation in the study, use of data, publication of a clinical case, use of photos or medical images
- whether the data were anonymised
- whether the study was approved by an ethics committee
- whether there is a protocol number or ethics committee decision number
The International Committee of Medical Journal Editors (ICMJE) recommends not publishing identifying patient information without written consent if such information is not necessary for the scientific purpose. The ICMJE also states that if there is any doubt about maintaining anonymity, consent must still be obtained. For example, simply covering the eyes in a photo is not considered sufficient protection of anonymity.
Typical mistakes when preparing informed consent
The most common mistake is wording that is too general. In this way, the editorial office may not understand exactly what consent was obtained: for treatment, participation in the study, use of data or publication of a clinical case.
Another mistake is promising complete anonymity where it cannot be guaranteed. If the case is rare or contains detailed clinical data, it is more appropriate to write that the authors took measures to protect confidentiality, rather than guaranteed absolute anonymity.
It is also not worth mixing different concepts: ethical approval and informed consent, since they are not the same thing. Approval by an ethics committee does not replace informed patient consent, and patient consent does not replace ethical approval of the study if it is required.
In summary, informed patient consent is one of the most important aspects of medical research. The absence of the necessary information on this matter may put the publication of the work at risk and cause problems for the author if there is no patient consent for the disclosure of personal data.
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