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.
- “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.
- Descriptions of a new procedure or surgical technique, new device or new medication do not fall under the “case report” modality.
- 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.
- 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.
- 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.
- 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.
How to submit a case report in the Plataforma Brasil system?
The proposal must be submitted via Plataforma Brasil (PB) and analyzed by the CEP/Conep system, prior to its publication or disclosure.
- The “case report” in the final form that will be submitted for publication or dissemination must be attached to the BP, as a type of document “Detailed Project”;
- Consent and assent (when applicable) must be formally obtained BEFORE submitting the proposal in the PB, and must be signed by the participant (or legal guardian) and attached as a type of document “TCLE/Term of Assent”. When relevant, adjustments to the terms presented will be requested, with the need for a new consent with the corrected version of the document;
- The content presented as a “case report” and approved by the CEP must be identical to what will be submitted for publication or dissemination. Proposed additions to the content of the report must be processed through an amendment.
- The field “Main Purpose of the Study (WHO)” (located on tab 2 of the BP) must be filled in as 'observational and single-arm study';
- The fields in the BP about the details of the study (tab 4) must be filled in consistent with the reported case, and the fields that are not relevant must be filled in with the information “not applicable” or an equivalent expression;
- If it is impossible to obtain consent and assent (when applicable), the researcher must request waiver of the application of the term, presenting relevant justification in the field located on tab 5 of the BP;
- The TCLE and the Term of Assent (when applicable) must contain: the reason for publishing the case report, the guarantees related to confidentiality, privacy and, when necessary, use of the participant's image. It must clearly and affirmatively state that, in case of damage resulting from the case report, the right to full and free assistance will be ensured, for as long as necessary, in addition to the right to seek compensation;
- In situations where it is essential to identify the participant, this fact must be fully justified in a specific document (attached to the BP as “others” in the option “type of document” and explicitly described in the TCLE and in the Term of Assent. In this situation, the formal consent of the participant (or legal representative) is required;
- The schedule (located on tab 5 of the BP) must be completed indicating the phases that will be developed from the approval and the probable date on which the intention is to publish or disclose the report;
- The budget (located on tab 5 of the BP) must contain the costs related to the preparation, publication or dissemination.