Construction and Operation of the Human Research Protection Program for Clinical Research on Traditional Chinese Medicine / 中国医学伦理学

It is the responsibility of a clinical research institution to protect the rights and interests of research subjects. For the full process supervision of clinical research projects, the construction of a Human Research Protection Program (HRPP) which is suitable to the hospital’s situation can gradually improve the ethical review quality, and provide comprehensive protection measures for participants and potential participants throughout the entire clinical research process. Combined with the characteristics of clinical research and ethical review of Traditional Chinese Medicine(TCM), this paper introduced the construction of an HRPP system that highlights TCM characteristics. At the same time, this paper systematically analyzed the division of responsibilities, communication and cooperation of different committees and departments within the HRPP system to ensure the effective operation of the entire HRPP system, improve the quality of TCM clinical research and the protection level of the HRPP system, in order to achieve the goal of promote the healthy, orderly and scientific development of clinical research.

The Construction and Improvement of the Protection System for the Rights and Interests of Human Subjects in Trial Institutions from the Ethical Perspective: Taking a Hospital in Anhui Province as an Example / 中国医学伦理学

This paper took a hospital in Anhui province as an example, aimed at the problems existing in the protection of human subjects’ rights and interests in China, and put forward relevant suggestions from the ethical perspective. The suggestions included shaping the international vision, playing the core role of ethics committee, strengthening the construction of legal and regulatory protection mechanism, setting up the human research protection committee and actively promoting the construction of subject protection system. These measures will effectively promote the construction and improvement of the rights and interests protection system of human subjects in China.

Construction and Operation of the Human Research Protection Program for Clinical Research on Traditional Chinese Medicine / 中国医学伦理学

It is the responsibility of a clinical research institution to protect the rights and interests of research subjects. For the full process supervision of clinical research projects, the construction of a Human Research Protection Program (HRPP) which is suitable to the hospital’s situation can gradually improve the ethical review quality, and provide comprehensive protection measures for participants and potential participants throughout the entire clinical research process. Combined with the characteristics of clinical research and ethical review of Traditional Chinese Medicine(TCM), this paper introduced the construction of an HRPP system that highlights TCM characteristics. At the same time, this paper systematically analyzed the division of responsibilities, communication and cooperation of different committees and departments within the HRPP system to ensure the effective operation of the entire HRPP system, improve the quality of TCM clinical research and the protection level of the HRPP system, in order to achieve the goal of promote the healthy, orderly and scientific development of clinical research.

The Construction and Improvement of the Protection System for the Rights and Interests of Human Subjects in Trial Institutions from the Ethical Perspective: Taking a Hospital in Anhui Province as an Example / 中国医学伦理学

This paper took a hospital in Anhui province as an example, aimed at the problems existing in the protection of human subjects’ rights and interests in China, and put forward relevant suggestions from the ethical perspective. The suggestions included shaping the international vision, playing the core role of ethics committee, strengthening the construction of legal and regulatory protection mechanism, setting up the human research protection committee and actively promoting the construction of subject protection system. These measures will effectively promote the construction and improvement of the rights and interests protection system of human subjects in China.

New Thoughts on the Construction of Hospital Ethics Review Committee / 中国医学伦理学

Advanced technology not only brings good news to patients, but also causes a series of ethical issues. Subject risk/benefit assessment is the core of ethical review in clinical research. By combing the development status of China ethics review committee, analyzing the problems existing in the current ethical review, this paper proposed to standardize the establishment and independence of ethics review committee, improve the relevant laws and regulations of the ethics review committee, establish the administrative access and evaluation mechanism of the ethics review committee, build a multi-center mutual recognition alliance, improve the standardized operating procedures of the ethics review committee, set up an ethical personnel training system, and strengthen the review capacity building of the ethics review committee, so as to provide new ideas for the review work of the committee, then better protect the rights and interests of subjects and promote the development of medical science.

Establishing human research protection program and its influence on promoting the whole process management of clinical research / 中华医学科研管理杂志

Objective:Improve the quality of clinical research at different stages for better protection of human subject.Methods:Introduce the operational and the administrative experiences of establishing the human research protection program in our hospital.Results:Establish human research protection program can promote the direct communication and cooperation among relevant departments of clinical research, strengthen the whole process management of clinical research.Conclusions:Developing comprehensive human research protection program and related policies play a positive role in promoting the high-quality development of clinical research in hospitals.

Ética em pesquisa no sistema CEP-CONEP brasileiro: reflexões necessárias / Research ethics in the Brazilian CEP-CONEP system: necessary reflections

Resumo O Brasil conta com um reconhecido sistema de avaliação ética das pesquisas envolvendo seres humanos - Sistema CEP-CONEP, em funcionamento há 20 anos. Entretanto, observa-se que as suas eficácia e efetividade, nestes últimos anos, vêm sendo questionadas, criticadas e colocadas em xeque. Trata-se de um ensaio, com base em vivências da autora enquanto docente na área de bioética, pesquisadora e ex-coordenadora de CEP, com o objetivo de refletir, de forma crítica, a respeito do papel da ética como fio condutor de todas as etapas do processo de pesquisa e discutir alguns impasses, lacunas e questões desafiadoras que deverão ser considerados e enfrentados com urgência pelo Sistema CEP-CONEP. Discutem-se questões que merecem ser reavaliadas permanentemente para se enfrentar os inúmeros desafios, propiciando um real avanço científico aliado ao avanço ético-social, por exemplo: a questão da importância social do estudo e seu retorno e/ou contribuição à sociedade; os aspectos éticos e políticos envolvidos nas prioridades de pesquisas; o avanço da básica apreciação inicial da pesquisa e da simples avaliação normativa; a necessidade de valorização e reconhecimento do trabalho dos Comitês; o descrédito do Sistema por precariedade de infraestrutura, os cuidados pós-estudo, dentre outros.

Abstract Brazil counts with a well-known human research ethics evaluation system - the CEP-CONEP System, which has been in operation for 20 years. However, its efficacy and effectiveness have been questioned, criticized and put in check, especially in recent years. This work is based on the author's experiences as faculty member in the field of bioethics, researcher and former coordinator of a CEP and aims to critically reflect on the role of ethics as a driving force of all the steps of the research process, and discuss some deadlocks, gaps, and challenging issues which must be urgently considered and addressed by the CEP-CONEP System. Issues that deserve to be permanently and critically reevaluated are discussed to cope with several challenges, providing a real scientific advance, linked to the social and ethical advance of science, such as the issue of social relevance of the study and its yield/contribution to society; the ethical and political aspects involved in research priorities; the advance of the basic initial appreciation and of the simple normative evaluation; the need for the valorization and recognition of the Ethics Committees' work; the System's discredit due to poor infrastructure, post-study care, among others.

Exploration of application for AAHRPP accreditation in perfecting the human research protection program of the hospital / 中华医院管理杂志

The paper introduced the preparations of the hospital in applying for AAHRPP accreditation, and the positive push on improving the human research protection program. This proved that such application can learn from overseas experiences in scientific management and improve our human research protection system in a short timeframe. The accreditation can promote the understanding of both administrators and investigators for the importance of protecting human subjects in research, especially the detailed protection procedures, and promoting clinical researches in world class quality.

Investigation and Analysis of Current Situation of Human Research Ethical Management in Beijing Medical and Health Institutions / 中国医学伦理学

Through the questionnaire survey on the current situation of human research ethical management in Beijing medical and health institutions, this paper analyzed the problems existing in ethical management of Beijing medical and health institutions and put forward corresponding countermeasures and suggestions. The results showed that overall status of human research ethical management in Beijing medical and health institutions was satisfying. But the ethical management levels of different types of medical and health institutions were quite different, and medical and health institutions, health family planning administration departments and academic teams should all make corresponding contributions.

Practice and experience of ethical review of human body research in hospital / 中华医学科研管理杂志

Objective To improve the ethics review process and ethical standards,strengthen the implantation of ethical review of research involving human subject in our hospital.Methods Evaluating the review practice of research involving human subject in our hospital practices,learn and bring in the latest international experiences.Results As China's Ethical Committee is in its initial stage,the regulatory ability is still in defective and insufficient.A healthy and operable ethic review mechanism needs to be perfected gradually along with the practice.Conclusions In the aspect of improving the ethical review work of human subject research,some new methods and ideas were discussed.In addition to strengthen the current organizational system,we should clarify the elements of the review of different types of research and carry out multi level ethical trainings.The establishment of a unified,specific evaluative system,combined with this information platform is continuously monitoring the clinical study.This will ensure the human research projects comply with ethical requirements,and further promote the sustainable development of clinical research.

Developing a research ethics Comittee the case of Manaus health system / Desarrollando un comité de ética de investigación: el caso del sistema de salud de Manaus / Desenvolvimento de um comitê de ética da investigação: o caso do sistema da sa·de de Manaus

La creciente complejidad de la investigación biomédica con seres humanos genera muchos conflictos éticos que se suman a la dificultad de cumplir con todos los requisitos impuestos por una legislación en bioética. La Secretaría Municipal de Salud de Manaus (MHCO, en inglés), en el la Región Norte de Brasil, ya tenía un intercambio con universidades locales que no era gestionado por ningún sector en específico, por lo que los proyectos de investigación se autorizaban sin análisis de viabilidad o relevancia y sin ningún seguimiento de acciones dentro del sistema de salud local. En 2008, la MHCO creó la Co-misión de Ética de la Investigación (RECO, en inglés). Entonces, ¿constituye la MHCO un campo para la investigación? Hay que decir que sí en el sentido de que, del sistema local de salud, parten temas y servicios que caracterizan por completo a la salud y a la ciudad en sí. Entre 2008 y 2011, el total de proyectos presentados para trabajar dentro de los establecimientos de salud asciende a 282, relacionados con trabajos de pregrado y postgrado. La MHCO representa una acción del gobierno local para supervisar las actividades de investigación en el sistema local de salud y, al mismo tiempo, atrae la atención de los empleados públicos como investigadores de su propio entorno laboral. Dicha acción contribuye a identificar problemas a nivel interno y revela la forma en que la sociedad de Manaus ve al sistema de salud. Articulo de reflexión.

The growing complexity of biomedical investigation with human beings generates many conflicts regarding ethical values that add up to the difficulty of fulfilling all the requirements imposed by the legislation on bioethics. Manaus Health City Office (MHCO), in North Brazil, had already had a long time exchange program with local universities which was not managed by a specific sector, so research projects were authorized without further analysis of feasibility, relevance, or a follow-up of its actions within the local health system. In 2008, MHCO created the Research Ethics Commission (RECO). So, is MHCO a field for research? We ought to say yes inasmuch as from the local health system stem subjects and services completely characterizing the health and the city itself. From 2008 to 2011, the number of submitted projects intended to be implemented inside the health establishments was 282, concerning undergraduate and graduate papers. MHCO represents an action of the local government in monitoring research activity in the local health system and, at the same time, catches the attention of public employees as researchers of their own environment of work. This action helps to identify internal problems and shows the impression Manaus society has in relation to the health system.

A crescente complexidade da pesquisa biomédica com seres humanos gera muitos conflitos éticos que contribuem para a dificuldade de satisfazer todas as exigências impostas pela legislação sobre bioética. A Secretaria Municipal de Saúde de Manaus, na região norte do Brasil, já tinha um intercâmbio com universidades locais que não eram geridos por qualquer sector específico, para que os projectos de investigação foram autorizados sem análise de viabilidade ou de relevância e de quaisquer acções de acompanhamento no âmbito do sistema de saúde local. Em 2008, a Secretaria criou o Comitê de ética da pesquisa. E ben, ¿constitui o Secretariado um campo de pesquisa? Deve ser dito que sí, por causa do sistema de saúde local partem assuntos e serviços que caracterizam completamente para a saúde e para a cidade. Entre 2008 e 2011, o número total de projetos apresentados para o trabalho em estabelecimentos de saúde foi 282, do trabalho de graduação e pós-graduação. A Secretaria representa a ação do governo local para monitorar as atividades de pesquisa no sistema de saúde local e, ao mesmo tempo, atrai a atenção dos funcionários públicos, como os pesquisadores em seu próprio ambiente de trabalho. Esta ação ajuda a identificar problemas internamente e revela a maneira em que a sociedade de Manaus vê o sistema de saúde.

O consentimento livre e esclarecido e a vulnerabilidade do sujeito de pesquisa / El consentimiento libre y esclarecido y la vulnerabilidad de los sujetos humanos de investigación / Free and Informed consent and vulnerability of human research subjects

A Resolução CNS 196/96 normatiza a pesquisa envolvendo seres humanos e estabelece a proteção do voluntário com o termo de consentimento livre e esclarecido (TCLE). O trabalho investigou o perfil de sujeitos de pesquisas de uma instituição de ensino buscando estabelecerrelação entre sua condição socioeconômica e o entendimento sobre a pesquisa. O CEP intermediou o contato entre pesquisadores, revelando apenas a identidade dos que aceitaram participar da investigação. Os voluntários mais frequentes são pacientes, trabalhadores dos serviços públicos de saúde, estudantes da instituição e grupos de idosos e residentes de instituições de longa permanência. Destes, 75% pertencem às classes D e E, e apesar da alta escolaridade de 49% dos voluntários, 60% não leram o TCLE. Os resultados apontam a necessidade de resgatar o valor do TCLE mediante ações de educação, tornando a comunicação mais eficiente entre pesquisador e voluntário, além de propiciar maior consideração à vulnerabilidade social.

La Resolución CNS 196/96 regula la investigación en seres humanos y proporciona protección a los voluntarios con consentimiento informado. El estudio investigó el perfil de los sujetos de investigación de una institución de enseñanza para establecer la relación entre sus condiciones socio-económicas y la comprensión de la investigación. El CEP medió el contacto entre investigadores, revelando solamente la identidad de los que aceptaron participar en la investigación. Los voluntarios más frecuentes son los pacientes, los trabajadores de los servicios de salud pública, los estudiantes de la institución y grupos de ancianos y residentes de instituciones de larga permanencia. De éstos el 75% pertenecen a las clases D y E, y pese al alto nivel de escolaridad del 49% de los voluntarios, un 60% de ellos no había leído el TCLE (Término de consentimiento libre y esclarecido). Los resultados indican la necesidad de recuperar el valor del TCLE mediante actividades de educación, haciendo la comunicación más eficaz entre los investigadores y voluntarios, además de dar propiciar mayor consideración a la vulnerabilidad social.

The Resolution CNS 196/96 of Brazilian Health Ministry establishes conditions for research involving human subjects and it establishes subject?s protection with free and informed term of consent (FITC). The paper investigated subjects? profile, establishing the relationship betweensubjects? knowledge about the research and their social background. To safeguard confidentiality and privacy of researchers, the institutional ethics committee invited researchers to participate in the study, but only released their contact information upon their acceptance to be in the study.The population more frequently investigated includes patients, health workers, health course students and elderly both from groups of patients and from nursing homes. 75% of subjects were from lower income classes (D and E) and despite higher education of 49% of subjects, 60%never read the informed consent. It is necessary to renew the importance of informed consent as to educate volunteers, including information about their health conditions, thus allowing for better communication between subjects and researchers and further consideration of social vulnerability.

El consentimiento informado en la práctica quirúrgica / The written informed consent in surgical practice

Se realizó una investigación exploratoria a partir de la revisión de artículos y bibliografía especializada sobre el tema, además de la experiencia del colectivo de autores que en su quehacer diario utilizan el consentimiento informado. Se valoró la repercusión del desarrollo científico-técnico en los aspectos éticos de los procedimientos quirúrgicos, específicamente en la toma de decisiones del paciente después de haber sido informado correctamente. Se resalta la importancia del consentimiento informado en la práctica asistencial, en especial en el área de la cirugía, y se analiza la experiencia cubana en la aplicación del consentimiento informado en las investigaciones. Se destacan las limitantes de su uso, como premisa necesaria para iniciar un proceso de perfeccionamiento en su aplicación(AU)

An exploratory research was performed from the article reviews and specialized references on this subject in addition to the experience of authors staff that in his daily practice use the written informed consent. The repercussion of scientific-technical development in the surgical procedure ethical features is assessed, specifically in the decision-making by patient after being appropriately informedSignificance of written informed consent is emphasized in assistance practice, especially in surgical area and Cuban experience is analyzed in application of this type of consent in related to researches highlighting the limitations of its use as a necessary premise to start a improvement process in its application(AU)

Protocolo de pesquisa: o desafio do aprimoramento ético / Research protocol: the challenge of ethical improvement

O trabalho analisa protocolos de pesquisas no âmbito universitário submetidos nos últimos três anos ao Comitê de Ética em Pesquisa da Escola Superior de Ciências da Santa Casa de Misericórdia de Vitória (CEP/Emescam). Este CEP avalia 200 projetos/ano. Os dados foram restritos ao título dos projetos e número de sujeitos. Os achados foram agrupados conforme a Biblioteca Virtual de Saúde (BVS). As pesquisas concentram-se nas categorias saúde do trabalhador; aleitamento materno, saúde materna e da mulher; adolescência, criança e idoso. Economia, indicadores de saúde, alta complexidade e ciência e tecnologia estão ausentes. Considerando que a preferência pela área temática advém da familiaridade com o tema, os dados levantados foram comparados com a experiência dos pesquisadores, registrada na Plataforma Lattes. Sabe-se que hoje as pesquisas são resultado dos esforços passados dos pesquisadores e conhecer o cenário atual da pesquisa acadêmica é importante para planejar o futuro da pesquisa em saúde no país.

Clinical trials and ethics

Based on recently developed biotechnology, many new drugs have been developed for improving patient treatment outcomes. To develop novel drugs, proper clinical trials are essential. As clinical trials involve humans in research, the protection of participants is important not only for the participants' safety but also for future patients. Ethics in a clinical trial is not the same as in clinical practice with enough evidence. Hence, the whole procedure of a clinical trial should be well organized, scientifically and ethically planned, and monitored properly by an Institutional Review Board (IRB). Here the importance of ethics in clinical trials, related issues, and the monitoring system will be discussed.