Borracci Raúl A, Calderón Gustavo, Seoane Martín R, Perez Analía C, Doval Hernán C
Research Area, Argentine Society of Cardiology, Ethical Board, Argentine Society of Cardiology, Dept. Drugs & Clinical Trial Evaluation, A.N.M.A.T., Argentina.
Arq Bras Cardiol. 2008 May;90(5):290-3. doi: 10.1590/s0066-782x2008000500002.
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.
To examine the frequency of obtaining an ethical review and informed consent in cardiovascular research in Argentina.
Through a questionnaire, we contacted authors of 100 reports submitted to our annual scientific meeting during 2006.
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.
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.
涉及人类受试者的研究需经机构审查委员会批准并获得知情同意，这一要求已存在20多年。然而，阿根廷心血管研究报告中有时缺乏满足这些要求的证据。由于各委员会的伦理标准不同，研究人员在进行低风险研究时对于是否需要伦理审查可能存在一些困惑。
调查阿根廷心血管研究中获得伦理审查和知情同意的频率。
通过问卷调查，我们联系了2006年提交至我们年度科学会议的100份报告的作者。
36%的问卷重新提交并确认已进行伦理审查，34%回复未获得伦理审查，23%报告为豁免审查，7%从未重新提交。大多数获得伦理审查的文章是药物试验或涉及新设备评估的研究。另一方面，大多数报告缺乏伦理审查或豁免审查的文章来自流行病学研究或评估非侵入性方法的研究。60%的IV期药物试验、细胞植入研究或新设备评估符合联邦法规要求。
阿根廷心血管报告中伦理审查率和知情同意的使用在不同文章中有所不同。大多数涉及前瞻性观察性研究的研究以及近50%包括干预或侵入性程序的方案未报告伦理审查。如此高比例的文章缺乏伦理审查表明存在法律和伦理缺陷，应予以讨论并克服。
