Chart 1. Items evaluated for the preparation of the Ethics Requirement Score.
Approval by CEP | Require approval by a CEP, as per the Declaration of Helsinki, published in 1964 |
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Declaration of Helsinki and/or Resolution 196/96 | Mention some of these documents that regulate ethics in research |
Recommendations alerting about plagiarism | Contain an item recommended by the author as to plagiarism |
ICF | Require that signing of an ICF be applied to all research subjects, as per the Declaration of Helsinki published in 1964 |
Confidentiality of patients and data | Contain an item recommending confidentiality about the data from the subjects involved in the research and their data |
Recording in databases for clinical trials | Contain recommendations of a register of clinical trials in a database |
Declaration of conflicts of interests | Contain orientation in reference to the interests of the said study |
Declaration of funding | Contain orientation that makes clear the financial sources of the said study |
ICMJE/COPE | Refer to the ICMJE or the COPE, which are related to ethics in scientific publications |
CEP: Research Ethics Committee; ICF: Informed Consent Form; ICMJE: International Committee of Medical Journal Editors, COPE: Committee on Publication Ethics.