Ethical review and informed consent in cardiovascular research reports in Argentina

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...

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Autores principales:	Borracci, R.A., Calderón, G., Seoane, M.R., Perez, A.C., Doval, H.C.
Formato:	JOUR
Materias:	Argentina Ethical review Informed consent Publications for science diffusion article controlled study human implantation informed consent invasive procedure medical ethics medical instrumentation medical research questionnaire risk assessment 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
Acceso en línea:	http://hdl.handle.net/20.500.12110/paper_0066782X_v90_n5_p290_Borracci
Aporte de:	Biblioteca Digital - Facultad de Ciencias Exactas y Naturales (UBA) de Universidad de Buenos Aires

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spelling	todo:paper_0066782X_v90_n5_p290_Borracci2023-10-03T14:53:08Z Ethical review and informed consent in cardiovascular research reports in Argentina Borracci, R.A. Calderón, G. Seoane, M.R. Perez, A.C. Doval, H.C. 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 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. JOUR info:eu-repo/semantics/openAccess http://creativecommons.org/licenses/by/2.5/ar http://hdl.handle.net/20.500.12110/paper_0066782X_v90_n5_p290_Borracci
institution	Universidad de Buenos Aires
institution_str	I-28
repository_str	R-134
collection	Biblioteca Digital - Facultad de Ciencias Exactas y Naturales (UBA)
topic	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
spellingShingle	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 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
topic_facet	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
description	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.
format	JOUR
author	Borracci, R.A. Calderón, G. Seoane, M.R. Perez, A.C. Doval, H.C.
author_facet	Borracci, R.A. Calderón, G. Seoane, M.R. Perez, A.C. Doval, H.C.
author_sort	Borracci, R.A.
title	Ethical review and informed consent in cardiovascular research reports in Argentina
title_short	Ethical review and informed consent in cardiovascular research reports in Argentina
title_full	Ethical review and informed consent in cardiovascular research reports in Argentina
title_fullStr	Ethical review and informed consent in cardiovascular research reports in Argentina
title_full_unstemmed	Ethical review and informed consent in cardiovascular research reports in Argentina
title_sort	ethical review and informed consent in cardiovascular research reports in argentina
url	http://hdl.handle.net/20.500.12110/paper_0066782X_v90_n5_p290_Borracci
work_keys_str_mv	AT borraccira ethicalreviewandinformedconsentincardiovascularresearchreportsinargentina AT calderong ethicalreviewandinformedconsentincardiovascularresearchreportsinargentina AT seoanemr ethicalreviewandinformedconsentincardiovascularresearchreportsinargentina AT perezac ethicalreviewandinformedconsentincardiovascularresearchreportsinargentina AT dovalhc ethicalreviewandinformedconsentincardiovascularresearchreportsinargentina
_version_	1807317126225068032

Ethical review and informed consent in cardiovascular research reports in Argentina

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