Ethics review is not paperwork added at the end. It is the step that decides whether the study can be conducted at all — and, for the journal, whether it can be published.
The written consent form explains, in plain language, what the participant will go through, the risks, the alternatives and the right to withdraw at any time without losing care. It is signed before any study procedure.
For retrospective studies using records already collected, the committee may waive consent when contacting patients is impracticable and risk is minimal. The waiver is granted by the committee — the researcher never grants it — and must be stated in the manuscript.
Identifiers stay out of the database; the linkage key, when it exists, is kept separately and destroyed at the end. In Brazil this follows the LGPD, and images of patients require specific authorisation.
Name of the committee, approval number (CAAE), the statement that consent was obtained or waived, and adherence to the Declaration of Helsinki. ABCD asks for all of this in the title page.
Yes. Using records already collected is still research on human data. What the committee may waive is the signed consent form.
The Certificate of Presentation for Ethical Consideration, the number generated by Plataforma Brasil when the protocol is submitted. It identifies the study in every subsequent document.
No. Approval must precede data collection, and the number is required at submission.
Written by Francisco Tustumi, digestive system surgeon (FMUSP), associate editor of ABCD.
Developed by Surya MKT