Résumé
【Objective:】 To investigate the construction status of biomedical research ethics committee involving human beings in medical institutions in Guangzhou, and to provide the basis for the standardized management of ethics committee. 【Methods:】 The convenience sampling method was conducted to investigate the construction status of biomedical research ethics committee involving human beings in 58 medical institutions in Guangzhou. The SPSS 21.0 statistical software was used to analyze the data, and the chi-square test was used for difference analysis. 【Results:】 58 medical institutions had set up biomedical research ethics committee involving human beings. 50.00% of the ethics committees hired full-time secretaries, 33.96% of the ethics offices were administratively independent, 52.83% of the ethics offices were equipped with full-time staff, 79.17% of the ethics committees submitted paper documents for review, and 48.61% of ethics committees organized training irregularly. Comparison of the management of ethics committees of drug clinical trials and non-drug clinical trials was statistically significant (P<0.05). 【Conclusion:】 The management of ethics committee is generally good, but the standardization construction still needs to be further strengthened. It is recommended to strengthen the discipline construction and informatization construction of ethics committee, standardize the special training of ethics, improve the supervision systems of ethics committee, unify the construction standards of ethics committee, so as to improve the ability of ethics review, and effectively protect the safety, rights and interests of subjects.
Résumé
Este artigo discute a qualidade das evidências científicas publicadas no campo da medicina. Atualmente, existe uma dificuldade em avaliar a qualidade dessas publicações, visto que grandes ensaios clínicos são patrocinados pela indústria da saúde, em especial a indústria farmacêutica, a qual exige cláusula de confidencialidade dos dados brutos obtidos nas pesquisas. Isso gera importantes repercussões tanto para a prática dos profissionais de saúde como para a produção de diretrizes de atenção à saúde. Diante dessa incerteza de informações em saúde, a prevenção quaternária surge como uma proposta para fortalecer a relação médico-paciente como espaço para atividades preventivas e outras ações em saúde.
This article discusses the quality of scientific evidence published in the medical field. Currently, there is a difficulty in assessing the quality of these publications, since large clinical trials are sponsored by the health industry, particularly the pharmaceutical industry, which requires confidentiality clause of the raw data obtained in the research. This creates significant implications for both the practice of health professionals and the production of health care guidelines. Given these uncertainties of health information, quaternary prevention emerges as a proposal to strengthen doctor-patient relationship as space for preventive activities and other health actions.
En este artículo se discute la calidad de la evidencia científica publicada en el campo de la medicina. En la actualidad, hay una dificultad en la evaluación de la calidad de estas publicaciones, ya que los grandes ensayos clínicos son patrocinados por la industria de la salud, en particular la industria farmacéutica, que requiere cláusula de confidencialidad de los datos brutos obtenidos en la investigación. Esto crea importantes implicaciones tanto para la práctica de los profesionales de la salud y como para la producción de guías de atención de salud. Dada esta incertidumbre de la información en la salud, la prevención cuaternaria surge como una propuesta para fortalecer la relación médico-paciente como espacio para actividades preventivas y otras acciones de salud.
Sujets)
Conflit d'intérêts , Recherche biomédicale , Éthique , Industrie pharmaceutiqueRésumé
Todas las normativas internacionales sobre ética de la investigación biomédica, definen al consentimiento informado como requisito básico. Este debe permitir que los participantes potenciales reciban y comprendan toda la información relevante sobre la investigación, de modo tal que puedan tomar una decisión libre e informada. Nuremberg, Helsinki y CIOMS, documentos centrales de las regulaciones vigentes, reconocen que la participación en una investigación biomédica implica riesgos y beneficios potenciales vinculados a la salud, loscuales deben ser incluidos en el consentimiento informado. Sin embargo, los riesgos y beneficios tienen también una dimensión social y económica y atañen no sólo a los participantes, sino también a la sociedad. Esta cuestión, directa o indirectamente reconocida en dichos documentos internacionales, obliga a los Comités de Ética de la Investigación a considerar estos aspectos en la evaluación de los protocolos, y su posterior inclusión en el proceso de consentimiento informado.
International regulations on biomedical research ethics, define informed consent as a basic requirement. Informed consent must allow potential research participants both, receiving and understanding all the information relevant to the research, in order to make a free and informed decision. Nuremberg, Helsinki, and CIOMS, the main documents among current regulations, recognize that participation in biomedical research entails health related both, risks and potential benefits, which must be included in the informed consent. However, risks and benefits have a social and economical dimension, regarding not only to the participants, but also to the society. This issue, that is directed or undirected established in such international documents, forces Research Ethics Committees to consider these aspects in the evaluation of protocols, and their later inclusion in the informed consent process.