Human Ethics Commitee

All researchers who wish to submit their studies related to human health to the Brazilian Journal of Case Reports (BJCR) must follow all guidelines of Ethical Principles for Medical Research Involving Human Subjects established by the World Medical Association - Declaration of Helsinki.

For Brazilian and Foreign researchers are requested to send the patient's consent form authorizing the study to be carried out. In Research Ethics Committee Approval, we recommend that you describe the following sentence (suggestion only): 

We declare that the patient approved the study by signing an informed consent form and the study followed the ethical guidelines established by the Declaration of Helsinki

For Brazilian researchers, we suggest that everyone should follow the guidelines established in the document entitled "Circular Letter No. 166/2018-CONEP / SECNS / MS" provided by the National Research Council (Brazilian) for the consideration of "Clinical Case Reports", "Clinical Images Reports", "Experience Reports" and "Experimental Reports" involving research with humans.  As highlights points of the referred document, it is seen that: 

1) “Case report” is understood as the study modality in the biomedical area with a descriptive design, without a control group, with a narrative and reflective character, whose data come from daily practice or professional activity. Therefore, at the time of elaboration of the case report, the events narrated will be consummated, with no experiments planned as the object of the study. Its purpose is to highlight an unusual or relevant fact, expanding knowledge or suggesting hypotheses for other studies. 

2) Descriptions of a new procedure or surgical technique, new device or new medication are not included in the “case report” modality. 

3) Studies carried out with information from everyday life or professional practice, such as case reports, are ethically acceptable, as long as the precepts related to the privacy of participants, data confidentiality and human dignity are respected. 

4) The “case report” is not without risks, and there may be a breach of confidentiality. This can bring damages, material and moral, to the participant and third parties. No form of identification of the participant is permitted without his consent. Any information that enables identification must be avoided, such as: name, code name, initials, individual records, postal information, telephone numbers, electronic addresses, photographs, figures, morphological characteristics, among others. Whenever the case report requires the use of the participant's image, authorization to use the image must be obtained in the ICF or in a separate document, preserving the authorship of the person who collected the image, under the terms of the law. 

5) The consent of the participant (or legal guardian) for the elaboration of the “case report” is essential and must be obtained prior to publication or disclosure, by means of a free and informed consent form (IC), accompanied by the consent form when necessary . The waiver of the consent form will be analyzed by the Research Ethics Committee, upon presentation of the relevant justification. 

In view of the above, it is emphasized that for the purpose of protecting the Brazillian researcher and others involved, the BJCR states that it is mandatory to send your manuscript for evaluation of the CEP/Conep by Plataforma Brasil system due to the specificities of each study. Therefore, it is suggested to send the approval of the local human research ethics committee authorizing the execution of the research by Brazilian researchers.

Click here to access a step-by-step guide to submit your case report to the ethics committee via Plataforma Brasil.

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