Pilot protocol to evaluation of the informed consent form : accompaniment and support for research / Protocolo piloto de avaliação do termo de consentimento livre e esclarecido : acompanhamento e suporte ao pesquisador

AUTOR(ES)
DATA DE PUBLICAÇÃO

2009

RESUMO

The importance of research with human subjects is universally accepted. To ethically guide this kind of research there is the last revision of the Declaration of Helsinki, an international document, and the Resolution 196/96 in Brazil, from the National Health Council. Their main objective is to protect subjects undergoing research. In Brazil, it is mandatory to submit all research protocols for approval of legal, ethical, scientific and social aspect of the project by a Ethics Committee/ Institutional Review Board (REC/IRB). This thesis deals with the ethical aspects, specially the informed consent, defined as the voluntary authorization by a subject to participate in a research. In the "REC/IRB Meeting in São Paulo state", the informed consent was considered the major reason for non-approval of projects. The main goal of our project was to establish a protocol providing evaluation, guidance and support to the investigator aiming to improve the quality of the informed consents submitted to evaluation at the IRB/EC-UNICAMP. The project was divided in three main areas all related to the informed consent: 1 - Characterization of research protocols sent to the IRB/EC-UNICAMP; 2 - Action at non-approved informed consents: guidance and support to investigator to meet the requirements as per IRB/EC. 3 - Audit: ethical aspects of research protocols approved by the IRB/EC. Each one of those areas had a different set of subjects, materials and instruments in accordance with its goals and characteristics. We followed methodological integration. In the observation of 1,639 projects, 675 received recommendations regarding the methodology (25%), the informed consent (39%) or both (36%). In the informed consent the problems fell into two categories: language and lack of information, such as objective, procedures, justifications for the protocol and forms of assistance. Regarding the ethical aspects there were lack of clarification that participation was voluntary, on the use and storage of biological material, contact information for the investigator and the IRB, investigator identification, confidentiality and even the lack of informed consent. All consent forms referred for aid exhibited a high level of difficulty for understanding, requiring an average of 16.52 years of schooling and average rate of readability of 19.47, which is considered a high level of difficulty in reading. In addition to difficulty with complex words, we observed that subjects with low education have little interest or focus on technical terms even when they are part of the procedures to be performed. In the audit part of the project we observed that three projects did not include informed consent for all research subjects, three did not use the informed consent approved by the IRB-UNICAMP and eighteen were inadequately completed. Our findings demonstrated a high level of non-compliance with IRB/EC requirements regarding the informed consent, the investigator s need for guidance in the documentation process and the importance of IRB/EC follow-up on approved projects is evident. Providing continuous ethical education for the professionals involved in research with human subjects is an important step towards investigators with ethical attitudes when confronted with scientific developments, shifting moral patterns and new ethical questions

ASSUNTO(S)

comite de revisão etica Ética ethical review committee on research ethics

ACESSO AO ARTIGO

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