Revisão ética e termo de consentimento livre e esclarecido nas publicações de pesquisas cardiovasculares na Argentina

Abstract

SummaryBackground: Requirements for Institutional Review Board approval and informed consent for research involving human subjects have existed for more than 2 decades. However, evidence of fulfillment of these requirements is sometimes lacking in cardiovascular research reports in Argentina. Since ethical standards vary between committees, there may be some confusion among researchers regarding the need for an ethical review when conducting low risk research.

Ética em pesquisas com seres humanos: do conhecimento à prática

“…Some authors defend that observational epidemiological researches, based on pre-existing data, obtained through the retrospective review of medical files are exempt from ethical review 8 . This reasoning represents a return to Resolution 01/88, admitting that scientific integrity is a synonym of ethical integrity.…”

Comitê de ética em pesquisas: necessidade obrigatória. Obrigatoriedade necessária

“…However, evidence indicates that these requirements are not always followed in publications [3]. Apparently, some researchers have no clear idea of the need for assessment by the REC in the case of research involving humans indirectly (i.e., the reviews of medical records, retrospective analysis) or even directly (case reports or simple application questionnaires) [3].…”

“…Apparently, some researchers have no clear idea of the need for assessment by the REC in the case of research involving humans indirectly (i.e., the reviews of medical records, retrospective analysis) or even directly (case reports or simple application questionnaires) [3]. Likewise, the legal requirements that ensure the confidentiality of personal data may be missed [3].…”

“…In this case, there is a mistaken consensus that researchers should only ensure the confidentiality of personal data without the need of assessment by the REC [3].…”

“…As exemplified by the cases of abstracts that are presented at scientific meetings in categories known as free topics, in which there is no requirement for proof of appreciation by a REC. The editors and scientific organizations must rectify this problem by requiring adherence to ethical standards of national and international studies that the authors submit for review and publication, whether in regular or scientific events, regardless of type of study carried out [3,4].…”