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Borracci, R.A.; Calderón, G.; Seoane, M.R.; Perez, A.C.; Doval, H.C. "Ethical review and informed consent in cardiovascular research reports in Argentina " (2008) Arquivos Brasileiros de Cardiologia. 90(5):290-293+317-321
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Abstract:

Background: 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. Objective: To examine the frequency of obtaining an ethical review and informed consent in cardiovascular research in Argentina. Methods: Through a questionnaire, we contacted authors of 100 reports submitted to our annual scientific meeting during 2006. Results: Thirty six per cent of questionnaires were resubmitted with confirmation of ethical review, 34% responded that ethical review was not obtained, 23% reported as being exempt and 7% were never resubmitted. Most articles obtaining ethical review were pharmacological trials or research involving assessment of new devices. On the other hand, most articles reporting lack of or exemption from ethical review come from epidemiological research or studies evaluating non-invasive methods. Sixty percent of phase IV pharmacological trials, research on cellular implantation or assessment of new devices met federal regulations requirements. Conclusion: The rate of ethical review and use of informed consent in cardiovascular reports in Argentina vary among articles. Most research involving prospective observational studies and nearly 50% of protocols including intervention or invasive procedures do not report ethical review. This high proportion of articles lacking ethical review suggests the presence of legal and ethical flaws which should be discussed and overcome.

Registro:

Documento: Artículo
Título:Ethical review and informed consent in cardiovascular research reports in Argentina
Autor:Borracci, R.A.; Calderón, G.; Seoane, M.R.; Perez, A.C.; Doval, H.C.
Filiación:La Pampa 3030 1B, 1428 - Buenos Aires, Argentina
Palabras clave:Argentina; Ethical review; Informed consent; Publications for science diffusion; Argentina; article; controlled study; human; implantation; informed consent; invasive procedure; medical ethics; medical instrumentation; medical research; questionnaire; risk assessment; Argentina; Biomedical Research; Cardiology; Clinical Trials as Topic; Congresses as Topic; Ethical Review; Human Experimentation; Humans; Informed Consent; Periodicals as Topic; Prospective Studies; Therapeutic Human Experimentation
Año:2008
Volumen:90
Número:5
Página de inicio:290
Página de fin:293+317-321
DOI: http://dx.doi.org/10.1590/S0066-782X2008000500002
Título revista:Arquivos Brasileiros de Cardiologia
Título revista abreviado:Arq. Bras. Cardiol.
ISSN:0066782X
CODEN:ABCAA
Registro:https://bibliotecadigital.exactas.uba.ar/collection/paper/document/paper_0066782X_v90_n5_p290_Borracci

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Citas:

---------- APA ----------
Borracci, R.A., Calderón, G., Seoane, M.R., Perez, A.C. & Doval, H.C. (2008) . Ethical review and informed consent in cardiovascular research reports in Argentina . Arquivos Brasileiros de Cardiologia, 90(5), 290-293+317-321.
http://dx.doi.org/10.1590/S0066-782X2008000500002
---------- CHICAGO ----------
Borracci, R.A., Calderón, G., Seoane, M.R., Perez, A.C., Doval, H.C. "Ethical review and informed consent in cardiovascular research reports in Argentina " . Arquivos Brasileiros de Cardiologia 90, no. 5 (2008) : 290-293+317-321.
http://dx.doi.org/10.1590/S0066-782X2008000500002
---------- MLA ----------
Borracci, R.A., Calderón, G., Seoane, M.R., Perez, A.C., Doval, H.C. "Ethical review and informed consent in cardiovascular research reports in Argentina " . Arquivos Brasileiros de Cardiologia, vol. 90, no. 5, 2008, pp. 290-293+317-321.
http://dx.doi.org/10.1590/S0066-782X2008000500002
---------- VANCOUVER ----------
Borracci, R.A., Calderón, G., Seoane, M.R., Perez, A.C., Doval, H.C. Ethical review and informed consent in cardiovascular research reports in Argentina . Arq. Bras. Cardiol. 2008;90(5):290-293+317-321.
http://dx.doi.org/10.1590/S0066-782X2008000500002