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Clarifications regarding the processing of studies of the “case report” type in the CEP/Conep System for the biomedical area

Due to the numerous doubts about the way in which case report type studies should be processed in the System, it is necessary to clarify and provide guidance on the subject.

1. “Case report” is understood as a study modality in the biomedical area with a descriptive design, without a control group, of a narrative and reflective nature, whose data come from daily practice or professional activity. Therefore, at the time of elaboration of the case report, the narrated events will be consummated, and experiments are not foreseen as the object of the study. Its purpose is to highlight an unusual or relevant fact, expanding knowledge or suggesting hypotheses for further studies. 
2. Descriptions of a new procedure or surgical technique, new device or new medication do not fall under the “case report” modality.
3. Studies carried out with information from daily life or professional practice, such as case reports, are ethically acceptable, as long as the precepts related to the participants' privacy, data confidentiality and human dignity are respected.
4. The “case report” is not risk-free, and breach of confidentiality may occur. This can bring material and moral damages to the participant and third parties. No form of identification of the participant is allowed without their consent. Any information that enables identification should 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 for the use of the image must be obtained in the TCLE or in a separate document, preserving the authorship of who collected the image, under the terms of the law.
5. The consent of the participant (or legal guardian) for the preparation of the “case report” is essential and must be obtained prior to publication or disclosure, through the Free and Informed Consent Form (TCLE), accompanied by the Assent Form when necessary . The waiver of the Free and Informed Consent Form will be analyzed by the Research Ethics Committee, upon presentation of relevant justification.

6. It should be noted that CNS Resolution No. 510 of 2016, Art. 1st sole paragraph, determines: “The following will not be registered or evaluated by the CEP/CONEP system: VII – research that aims at the theoretical deepening of situations that emerge spontaneously and contingently in professional practice, provided that they do not reveal data that can identify the subject”🇧🇷 This information does not apply to studies that use methodologies characteristic of the area of ​​Human and Social Sciences.

The proposal must be submitted via Plataforma Brasil (PB) and analyzed by the CEP/CONEP system, prior to its publication or disclosure.

The Research Ethics Committee has the prerogative to request clarifications and modifications to the case report and any document attached to the Plataforma Brasil.