Ethical Research on Quality Control in Drug Clinical Trials / 中国医学伦理学

Guided by good clinical practice ( GCP) , M hospital cooperated with the Ethics Committee in quali-ty management of clinical trials and took the specific measures including perfecting the institution and standard op-erating procedures, implementing three level quality control institution, strengthening the training of GCP, and closely cooperating with drug and data management of clinical trials, quality control in the clinical trial, ethical re-view and supervision, quality control in the whole process (seamless connection). Seamless connection from the beginning of project acceptance and quality control in the whole process of clinical trials can effectively solve the ex-isting problems in clinical trials and improve the quality of clinical trials.

Conflicto de ineerés en investigación biomédica / Conflict of intrrest in biomedical rseearch / Conflto de interresses em pesquisa biomédcaa

A diario el hombre se enfrenta a situaciones que debe poner en la balanza para definir qué decisión tomar. Estas encrucijadas definen un conflicto de interés en donde una situación, juicio o acción que debería estar determinado por un valor primario establecido por razones profesionales o éticas, puede ser influido o parecer sesgado para obtener un beneficio secundario. En investigación biomédica cada vez es más factible enfrentarse a conflictos de interés, producto de los avances científicos y tecnológicos. Es preponderante entender en qué consisten, qué tipos de conflictos se pueden generar y cómo pueden poner en tela de juicio la calidad y veracidad de los resultados obtenidos ante la opinión pública, sobre todo cuando intereses económicos o beneficios personales son expuestos por terceros. Es necesario establecer mecanismos de control de cualquier tipo de conflicto de interés antes de ejecutar un protocolo de investigación si es que existiese. Estos mecanismos pueden ser: declaración pública, formularios mejorados y adaptados para la comunidad, unidades de apoyo a los comités de ética de investigación o el reporte de ingresos. Como conclusión se puede afirmar que, aunque se generen nuevos mecanismos o formas de manejo de conflictos de interés para la investigación biomédica, siempre será la conciencia del investigador, la virtud fundamentada por su propia moral y los principios éticos los que deben regir su actuar durante todo el tiempo que realice su vocación, en pos de proporcionar un bien al prójimo y a la sociedad en la que participa.

Man is confronted daily with situations he needs to weigh on to determine what decisions to make. These crossroads define a conflict of interest where a situation, suit or action, which should be determined by a primary value established by professional or ethical reasons, can be influenced or appear biased to obtain a secondary benefit. In biomedical research it is becoming more and more feasible to deal with conflicts of interest that result from scientific and technological advances. It is preponderant to understand what they are, what types of conflicts can be generated, and how these can challenge the quality and accuracy of the results obtained in the eye of the public opinion, especially when economic or personal interest gained are being exposed by third parties. It is necessary to set up mechanisms to control any type of conflict of interest before executing a research protocol, should any exist. These mechanisms could include: public declarations, forms improved and adapted to the community, support units to research ethics committees, or the earnings report. In conclusion, we can say that although new mechanisms or ways of managing conflicts of interest for the biomedical research are being generated, the researcher's conscience will always be the virtue based on its own moral and ethical principles that should govern his /her actions throughout the time they live out their vocation, towards offering or providing a good service to other beings and the society in which they participate.

Todos os dias, o homem enfrenta situações que deve pôr na balança para definir qual decisão tomar. Essas encruzilhadas definem um conflito de interesses no qual uma situação, juízo ou ação, que deveria estar determinado por um valor primário estabelecido por razões profissionais ou éticas, pode ser influído ou conduzido de forma inepta para obter um benefício secundário. Em pesquisa biomédica, cada vez é mais factível enfrentar-se conflitos de interesses, produto dos avanços científicos e tecnológicos. É preponderante entender em que consistem, que tipos de conflitos se podem gerar e como podem pôr em causa a qualidade e veracidade dos resultados obtidos ante a opinião pública, principalmente quando interesses econômicos ou benefícios pessoais são expostos por terceiros. É necessário estabelecer mecanismos de controle de qualquer tipo de conflito de interesses antes de executar um protocolo de pesquisa, se é que exista. Esses mecanismos podem ser: declaração pública, formulários melhorados e adaptados para a comunidade, unidades de apoio aos comitês de ética de pesquisa ou o relatório de ingressos. Como conclusão, pode-se afirmar que, embora se gerem novos mecanismos ou formas de manejo de conflito de interesses para a pesquisa biomédica, sempre será a consciência do pesquisador, a virtude fundamentada por sua própria moral e os princípios éticos os quais devem guiar seu agir durante todo o tempo que realizar sua vocação, em prol de proporcionar um bem ao próximo e à sociedade da qual participa.

Institutional Review Board (IRB): its role and responsibility in making research ethical.

ABSTRACT: This is a review article prepared as a part of the assignment in the educational activity and training on research ethics titled “Ethical and Regulatory Aspects of Clinical Research” arranged by the Bangladesh Bioethics Society (BBS), Dhaka, Bangladesh, in collaboration with the Department of Bioethics of National Institutes of Health (NIH), Bethesda, Maryland, USA, through video conferencing between September 25 and November 13 of 2013. The search was confined to ‘Google’, ‘HINARI’ and ‘PubMed’ published articles. Besides, some guidelines on roles and responsibilities of Institutional Review Board (IRB) were taken into consideration. Key words used for searching were ‘institutional review board’, ‘ethical review committee’ and ‘ethical research’. A total of 18 journal articles and some guidelines were selected for this writing. The systemic review from the databases revealed some important discussions on research, ethical research, roles and responsibilities of IRB/ERC and its challenges, and national/institutional research strategies.

Strengthen the Ethical Research on Nursing Management at Grass-Roots Healthcare Centers / 中国医学伦理学

Objective: Explore approaches to strengthening the ethical research on nursing management at grass-roots healthcare centers,to regulate the nursing care at grass-roots healthcare centers.Methods: Regulations,procedures and technology criteria are formulated based on the status quo and practical problems of grass-roots healthcare centers.Results: It is an effective way to improve the quality of hospital medical service by enhancing nursing management.Conclusion: It is necessary for enhancing overall nursing quality to take full advantage of nursing management skills,and improve nursing quality and management effect.

Historical Development of Ethical Research in Psycho-Counseling and Psycho-therapy in Developed Countries / 中国医学伦理学

According to the overview of historical development of ethical research in psycho-counseling and psycho-therapy in developed countries,this paper aims to summarize the research experience and outcome,in order to promote related Chinese ethical research based on China's realistic situation.