Informed consent is one of the most essential pillars of medical research ethics (1). It encompasses the medical ethical principle of autonomy which enables the participants to decide on whether or not to partake in a study without any coercion (2). It also enables patients to make informed decisions after critically analyzing the implications of the facts presented by the surgeon (3). It is of great importance that surgeons apply specific informed consent rules for specific study designs they undertake. The majority of studies submitted to surgical journals are case reports, but the process for obtaining quality informed consent is still insufficient. In addition, some journals do not have well-defined informed consent protocols for case report studies. This editorial thus aims to highlight case report specific rules for informed consent for surgeons to employ prior to commencement of their research.

 

Case studies differ significantly from other types of research in several ways. Recruiting fewer participants, as opposed to original studies or surgical trials, is one of them. As a result, some surgical researchers fail to recognize the importance of developing an individualised consent form. Most authors tend to use standard templates that may be used for different study types when acquiring informed consent in case report studies. This however should not be the case as there are important considerations to be made in case report studies prior to consent. Unlike most study designs, in case reports, the surgical researcher is heavily involved in the recruitment of patients. This provides an opportunity for the principal investigator to synthesize and simplify the protocol in their detailed consent form for each patient (4). In cases that need illustration, the surgeon is able to do so with ease as the participants are few. It has been established that participants’' understanding of research appears to improve significantly when sufficient time is spent explaining the study's information.

 

An ideal case report needs to have explicit informed consent from the participant if they are of age. In cases where the participants are minors, the parent or legal guardians, consent on their behalf and they have the right to decline the request. Further, some authors clearly state that informed consent of teenagers needs to be obtain from both the subject as well as the legal guardian despite them being minors (5). This acquisition of consent needs to be mentioned in the main text before submission for publication in most journals. Many case reports use photographs of patients to illustrate a pathology or intervention of interest. In order to fully uphold the terms of the informed consent, the investigator needs to ensure anonymity of the subjects. When photographing a surgical area of interest, the investigator should only photograph the area of pathology or interest. For example, in the case of head and neck surgery, if the pathology is limited to the neck, the photograph does not need to include the facial structures. This ensures that patients' anonymity is maintained. The inclusion of areas that add minimal or no value to the study should be considered unethical and avoided. Some authors have designed specific informed consent forms for photographs and some suggest that this form needs to be entirely separate from the general consent form for publishing (6). Unlike in previous decades, when cases were published in journals only available in medical libraries, data is now freely available in open access journals on the internet (7). As a result, the surgical researcher must inform the patient about the consequences of consenting to the publication of their photographs in open access journals.

 

Deidentification of patient documents and scans is an integral part of informed consent. The anonymity of diagnostic imaging films that the surgeon intends to include in their report must be considered by the surgeon. They must ensure that each film has been purposefully filtered to remove any patient identifiers. This principle applies not only to radiographs, but also to laboratory results, patient histories, and follow-up charts (8). This principle is clearly stated in the CARE case report checklist and is an essential component of informed consent (9).

 

Informed consent to publish is an essential component of any surgical case report (5). Prior to submission of a case report, the researcher needs to confirm that the patient sufficiently consented to publication and shared a copy with them. Some authors believe that the participants may not understand the contents of the manuscript, especially if it is not written in their first language (7). However, the principal investigator should meet with the participant and attempt to simplify the detailed consent form while emphasizing the most vital components. To this effect it is also vital to have the patient sign a separate form consenting to publication in the stated journals the author would like to submit to.

 

​​We recommend for patient deidentification, the rules spelt out in the CARE guideline must be followed to the letter. For surgical case reports that require attachment of photographs to highlight a pathology or intervention of interest, subjects need to fill in a separate form to authorize photograph use such as the tool developed by Cunniff et al. (8). Further, we call onto other surgical journals to be vigilant of case reports submitted without adequate quality informed consent acquisition. Journals should ensure that authors submit sufficient proof of adequate informed consent acquisition (9). It is ethically unacceptable and should be illegal to publish research findings that clearly exhibit blatant disregard to standardised informed consent regulations.

 

Declaration of interests

The authors declare no conflict of interest

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References

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