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 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.


CONCLUSIONS
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.
Borracci
Raúl A
RA
Research Area, Argentine Society of Cardiology, Ethical Board, Argentine Society of Cardiology, Dept. Drugs & Clinical Trial Evaluation, A.N.M.A.T., Argentina. borracci@univerisa.com.ar
Calderón
Gustavo
G
Seoane
Martín R
MR
Perez
Analía C
AC
Doval
Hernán C
HC
D001118:Argentina; D035843:Biomedical Research / Q000941:ethics / Q000706:statistics & numerical data*; D002309:Cardiology / Q000941:ethics / Q000706:statistics & numerical data*; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D003226:Congresses as Topic / Q000706:statistics & numerical data; D026724:Ethical Review; D006805:Human Experimentation / Q000941:ethics* / Q000706:statistics & numerical data; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000706:statistics & numerical data; D010506:Periodicals as Topic; D011446:Prospective Studies; D036302:Therapeutic Human Experimentation / Q000941:ethics