Guidelines for Ethical Review Entrustment Contract of Life Science and Medical Research Involving Humans / 中国医学伦理学

The passing of ethical review is a necessary conditions and prerequisite for the development of life science and medical research involving humans. At present, some medical and health institutions have no or insufficient ethical review capabilities. The lack of ethical review ability has become a bottleneck restricting the development of life science and medical research involving humans. According to documents such as Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices, Opinions on Strengthening the Ethical Governance of Science and Technology, institutions can entrust competent institutional ethics review committees or regional ethics review committees in writing to conduct ethical review. Entrustment ethical review provides a viable solution for institutions that need to carry out life science and medical research involving humans but do not have an ethics (review) committee or the ethics (review) committee is not competent to review. To conduct the entrustment ethical review, the entrustment between the principal and the trustee is required. According to The Measures for Ethical Review of Life Sciences and Medical Research Involving Humans, if medical and health institutions and their ethical review committees do not accept the formal entrustment to provide the ethical review opinions for other institutions, the local health authorities at or above the county level will impose administrative penalties and sanctions on the relevant institutions and personnel in accordance with the law. Signing the entrustment ethical review contract, implementing legal compliance entrusted ethical review to protect the rights and interests of the trustee and the principal, and protect the research participants.

Guidelines for Ethical Review Project Entrustment of Life Science and Medical Research Involving Humans / 中国医学伦理学

The seventh article of Measures for the Ethical Review of Biomedical Research Involving Humans (2016) stipulated that medical and health institutions without an ethics committee shall not carry out biomedical research involving Humans. The Opinions on Strengthening the Governance of Ethics in Science and Technology, issued in March 2022, clearly stated that the institutions that do not meet the conditions for establishing a scientific and technological ethics (review) committee should entrust other institutions to conduct the review. The fourteenth article of Measures for Ethical Review of Life Science and Medical Research Involving Humans (2023) proposes that if an institution, which carries out life science and medical research involving humans, has not established an ethics committee or its ethics committee is not competent for ethics review, it can entrust a competent ethics committee or regional ethics committee in writing to carry out ethical review. Most medical institutions at or above the second level in China have set up ethics committees. While most universities and colleges, scientific research institutions, enterprises and grass-roots medical and health institutions have not set up ethics committees, which lack a working system to protect the safety and interests of the participants, and is difficult to conduct life sciences and medical research involving humans. At present, there is a need for some research institutions that do not have the conditions to establish ethics committees to entrust their projects of life science and medical research involving humans to other institutions for ethical review. The entrusted review is still in the exploratory stage, and there is no relevant specification. The hasty implementation of entrusted review may not achieve the goal of effectively protecting the safety and interests of the participants, and even cause legal disputes. Based on the thematic discussion, with reference to the relevant laws and regulations, departmental rules, ethical standards, and the experience of the ethics committees of some domestic institutions in implementing the entrusted review, the guideline was formulated for the reference of the current entrusted review to ensure the safety and interests of the participants.

Thinking from the Perspective of Medical Institutions on Measures for Ethical Review of Life Science and Medical Research Involving Humans / 中国医学伦理学

From the perspective of medical institutions, this paper sorted out the background of the promulgation and important changes of Measures for Ethical Review of Life Science and Medical Research Involving Humans, and summarized the changes that may significantly affect the ethical review of medical institutions. It involved terminology changes and expansion of the scope of ethic review, clarification of the responsibilities and independence of the ethics committee, the refinement of the ethical review process, the emphasis on the protection of personal information and the rights and interests of subjects, and first proposal to exempt from ethical review. In addition, based on the concept of strengthening the ethical governance of science and technology in the new version of regulations, this paper shared the consideration on the governance of ethical review within medical institutions, including safeguarding the dignity and rights of subject, clarifying the role and position of ethical review, exempting the implementation of ethical review, and managing entrusted ethical review. With a view to providing a certain reference for the ethics practitioners and researchers in various medical institutions.

Interpretation and Reflection on Measures for Ethical Review of Life Science and Medical Research Involving Humans / 中国医学伦理学

With the progress of life sciences and medicine and the improvement of laws, regulations and rules, to meet the objective needs and further standardize the ethical review of life sciences and medical research involving humans, it is necessary to refer to international ethical standards to integrate with international standards. On February 18, 2023, the National Health Commission, together with the Ministry of Education, the Ministry of Science and Technology, and the National Administration of Traditional Chinese Medicine, issued the Measures for the Ethical Review of Life Sciences and Medical Research Involving Humans. The scope of this revision is large, the content is more detailed, and many details and specific requirements are added. It expanded the extent of jurisdiction to include colleges and universities, scientific research institutes and other institutions; the scope of review included the field of life sciences; the ethical review and supervision efficiency problems caused by the requirement of multiple departments coordinated supervision required the cooperation of the National Health Commission, the Ministry of Education, the Ministry of Science and Technology, and the National Administration of Traditional Chinese Medicine to strengthen communication and implement supervision. It emphasized the management of conflict of interest, strengthened the protection of privacy and data management, clarified the application of summary procedure review, as well as added the ethical review exemption and the submission of initial review materials, key review content, approval criteria and informed consent content, which improved the operability. It proposed solutions or directions for urgent needs and issues of close concern, allowed commissioned review, strengthened follow-up review, registration and filing, and explored three-level supervision, ethical review collaboration mechanisms, and the construction of regional ethics committees. By continuously improving ethical review and supervision to ensure the safety and rights of research participants, promote the quality of life science and medical research in China, and enhance the international competitiveness of life science and medical research involving humans in China.

Operation and Reflection on Exemption from Ethical Review / 中国医学伦理学

Ethical review is an important protective measure for research participants when conducting life sciences and medical research involving humans. "Exemption from ethical review" was proposed in The Measures for Ethical Review of Human Life Sciences and Medical Research Involving Humans issued in February 2023. To implement the exemption from ethical review within the permitted scope of laws and regulations, and to protect the privacy and rights of research participants when utilizing their data information and biological samples, multiple factors need to be considered, including the person responsible for exemption from ethical review, the conditions for exemption from ethical review, and the specific process for exemption from ethical review. As with other review procedures, exemption from ethical review also required the development of corresponding systems, implementation of responsibilities, and reliance on the construction of subject protection systems. It is hoped that this discussion can provide considerations for the implementation of exemption from ethical review.

Reflection and Practice on Exemption from Ethical Review / 中国医学伦理学

According to the Ethical Review Measures for Life Sciences and Medical Research Involving Humans jointly issued by the National Health Commission, the Ministry of Education, the Ministry of Science and Technology and the State Administration of Traditional Chinese Medicine in 2023, to optimize the ethical review process and reduce the burden on clinical researchers, it is proposed that some eligible situations can be "exempted from ethical review". This is a breakthrough progress in China’s ethical review management measures that firstly aimed at "exemption from ethical review". This paper reviewed and sorted out the relevant situations about exemption from review at home and abroad, focused on analyzing and exploring the four situations of exemption from review, especially discussed and analyzed the understanding of anonymization and personal sensitive information in exemption from review, and proposed practical suggestions for the four situations. Based on the actual situation of ethical review work, this paper also explored the establishment of practical standards and processes for exemption from review, providing reference for other medical institutions to implement the exemption from ethical review process.

New Requirements and Improvement Suggestion for the Protection of Vulnerable Groups in Ethical Review Measures for Life Science and Medical Research Involving Humans / 中国医学伦理学

In February 2023, the National Health Commission, together with the Ministry of Science and Technology, the Ministry of Education, and the State Administration of Traditional Chinese Medicine issued the Ethical Review Measures for Life Science and Medical Research Involving Humans, which emphasizes that research participants involving vulnerable groups such as children, intellectual disabilities, and mental disabilities should be given special protection. This paper expounded the current situation of protecting vulnerable groups from six aspects: inadequate protection of vulnerable groups by relevant laws and regulations, unclear definition of vulnerable groups, insufficient supervision by relevant departments, insufficient review ability of ethics committee to satisfy the protection of vulnerable groups, difficulty in fair inclusion of vulnerable groups, and the need to improve the ethical awareness of researchers and vulnerable groups. This paper also analyzed the new requirements for the protection of vulnerable groups in the Ethical Review Measures for Life Science and Medical Research Involving Humans from the following three aspects: expanding attention to potentially vulnerable research participants, paying more attention to the consent of research participants without or with limited capacity for civil conduct, and re-informed consent after the improvement of civil capacity level. Finally, suggestions on strengthening the protection of vulnerable groups were put forward from six aspects: improving the relevant legal system, clarifying the category of vulnerable groups, strengthening the implementation by regulatory departments, establishing a research participant protection system by research institutions, improving the ethical review capacity of ethics committees, formulating review guidelines by industry associations, and strengthening the education and training of all parties, so as to minimize the risk of vulnerable groups participating in clinical research and boost the quality and speed of clinical research in China.

Análisis comparativo de las pautas del consejo de organizaciones internacionales de ciencias médicas (CIOMS) 2016: (Parte 2 de 3) / Comparative analysis of the standards of the council of international organizations of medical sciences (CIOMS) 2016. (Part 2 of 3)

Como parte de la evaluación de la asignatura Bioética e Investigación de la Maestría en Bioética, se solicitó a los estudiantes de la VI Cohorte que realizarán un análisis comparativo de las Pautas CIOMS 2016 con documentos anteriores. En esta segunda parte, se presentan las pautas relacionadas con el consentimiento informado, la recolección, almacenamiento y uso de materiales biológicos y datos relacionados, así como la rendición pública de cuentas y la publicación de las investigaciones. Estas pautas son fundamentales para la realización de investigaciones científicas en seres humanos por eso el objetivo de estos trabajos es proporcionar a los investigadores un aporte en su formación y una rápida adaptación a la nueva propuesta CIOMS(AU)

As part of the evaluation of the Bioethics and Research subject of the Master in Bioethics, students of the VI Cohort were asked to make a comparative analysis of the CIOMS 2016 Guidelines with previous documents. In this second part, the guidelines related to informed consent, collection, storage and use of biological materials and related data, as well as public accountability and publication of research are presented. These guidelines are fundamental for carrying out scientific research on human beings, and for this reason the objective of this work is to provide researchers with a contribution in their training and a rapid adaptation to the new CIOMS proposal(AU)

Una misma deontología para distintas ciencias?: revisión de pautas nacionales e internacionales en ética de la investigación científica / Uma mesma deontologia para distintas ciências? Revisão de pautas nacionais e internacionais em ética da investigação científica / One same deontology for different sciences? Review of national and international guidelines in ethics of scientific research

Se realizó una revisión de normas jurídicas chilenas y códigos éticos internacionales asociados a la investigación científica con seres humanos, a través de una metodología mixta de análisis de contenido, con el propósito de identificar la presencia de vocablos asociados a la psicología, comprendida como una ciencia intermedia entre la biomedicina y las ciencias sociales. Se busca conocer las consideraciones éticas presentes en ambos tipos de normativas, para delimitar las diferencias entre aquellas asociadas a las ciencias biomédicas y las que corresponden a la psicología. Los resultados muestran una escasa presencia de normas ligadas a las particularidades de la psicología y un limitado y pobre uso de sus conceptos, evidenciando que la bioética, mayoritariamente basada en los desarrollos de la biomedicina, no responde adecuadamente a las necesidades de resolución de conflictos éticos en el contexto investigativo de la ciencia psicológica.

A review of legal Chilean norms and international ethical codes about research involving human beings was carried out, through a mix methodology of content analysis, with the purpose of identifying the presence of words associated to psychology, as an intermediate science between biomedicine and social sciences. Finding ethical issues present in both types of norms was looked out to delimit the differences between those associated to biomedical sciences and those to psychology. Results show a scarce presence of norms linked to the particularities of psychology and a limited and poor use of concepts, demonstrating that bioethics, mainly based on biomedical developments, does not respond adequately to the needs for conflict resolution in the research context of psychology.

Foi realizada uma revisão de normas jurídicas chilenas e códigos éticos internacionais associados à investigação científica com seres humanos, através de uma metodologia mista de análise de conteúdo, com o propósito de identificar a presença de vocábulos associados à psicologia, compreendida como uma ciência intermediária entre a biomedicina e as ciências sociais. Busca-se conhecer as considerações éticas presentes em ambos os tipos de normativas, para delimitar as diferenças entre aquelas associadas às ciências biomédicas e as que correspondem à psicologia. Os resultados mostram uma escassa presença de normas ligadas às particularidades da psicologia e um limitado e pobre uso de seus conceitos, evidenciando que a bioética, majoritariamente baseada nos desenvolvimentos da biomedicina, não responde adequadamente às necessidades de resolução de conflitos éticos no contexto investigativo da ciência psicológica.

Reflexividade como éthos da pesquisa qualitativa / Reflexivity as the ethos of qualitative research

Este ensaio, cuja finalidade é subsidiar a reflexão sobre a ética em pesquisa antropológica e qualitativa, busca ressaltar o caráter compreensivo, relacional e reflexivo desse processo, assim como as vantagens e os problemas que advêm das lógicas diferentes e, muitas vezes, dos interesses conflitantes entre o pesquisador e seus interlocutores. O texto se divide em quatro partes e contempla: (a) o sentido ético dessas formas de abordagem; (b) o comportamento ético do pesquisador no campo; (c) a ética na análise do material empírico; (d) cuidados éticos na elaboração dos resultados de estudos antropológicos e qualitativos, valendo-se de alguns exemplos clássicos da literatura internacional. O texto conclui refletindo sobre a distinção entre as exigências dos Comitês de Ética e a Ética da pesquisa propriamente dita: é preciso ter claro que o sentido abrangente da ética que inclui a responsabilidade do pesquisador não pode ser condensado nos instrumentos exigidos para julgamento dos projetos porque estão em jogo, além do desenvolvimento da pesquisa, o sentido social do trabalho, as relações institucionais com os financiadores, a forma de tratar a equipe de pesquisa, os estudantes nela incluídos e os compromissos com a comunidade científica.

This paper seeks to promote reflection on ethics in anthropological and qualitative research and emphasize the comprehensive, relational and reflective character of this process, as well as the advantages and problems that arise from different logic and often conflicting interests between researchers and their interlocutors. The text is divided into four parts and addresses the ethical: (a) significance of these approaches; (b) behavior of the researcher in the field; (c) analysis of the empirical material; and (d) considerations in the preparation of results of anthropological and qualitative studies, using some classic examples from the international literature. The paper concludes by reflecting on the distinction between the requirements of the Ethics Committee and the Ethics of research itself. It must be clear that the comprehensive sense of ethics which includes the responsibility of the researcher cannot be condensed in the instruments required for the judgment of projects because the following elements are involved in the development of research, namely the social significance of the work, the institutional relations with fund providers, how to treat staff and research students in academic work and commitments with the scientific community.

Análise da dignidade penal e carência de tutela penal nas pesquisas envolvendo seres humanos / Analysis of criminal dignity and the lack of criminal protection in relation to research involving human beings

A evolução da humanidade estimula o desenvolvimento das tecnologias, notadamente no que tange às pesquisas envolvendo seres humanos. Nesse âmbito reside a proteção das pessoas ante os riscos das pesquisas. Este artigo analisa a dignidade penal e carência de tutela penal nas pesquisas envolvendo seres humanos. Nele é constatada a existência de situações graves que demonstram a necessidade desta tutela e a carência de instrumentos aptos a garantir a imperatividade de documentos que regulam a matéria. O artigo afirma que o Direito Penal é o meio estatal mais eficaz para a tutela da vida e integridade física. Salienta que a existência de termo de consentimento para a realização dessas pesquisas é necessária, mas não afasta, contudo, a responsabilidade penal eventualmente existente.

The evolution of humanity encourages the development of technologies, especially in regard to researchinvolving human beings. In this context lies the protection of people from the risks of research. The articleanalyzes the criminal dignity and the lack of criminal protection in relation to research involving human beings. It notes serious situations that demonstrate the need for this protection and the lack of instruments thatguarantee the imperativeness of documents about this subject. It states that Criminal Law is the most effective way to protect life and physical integrity. The article says the consent form is necessary, but it doesn’t avoidthe criminal responsibility.

Ocho años en bioética / Oito anos em bioética / Eight years of bioethics

Este trabajo presenta la experiencia que significó el paso por el Programa Internacional de Formación en Ética de la investigación biomédica y psicosocial del Centro Interdisciplinario de Estudios en Bioética de la Universidad de Chile (2003-2004) y algunas reflexiones respecto de la integración de lo aprendido en mi posterior labor en comités de ética y programas académicos de ética de investigación. Asimismo, en la elaboración de regulaciones que permitan una mejor evaluación ética y científica.

This article presents the experience acquired by participating in the international ethics of biomedical and psychosocial research training program of the Interdisciplinary Center for Studies on Bioethics of the University of Chile (2003-2004) and some reflections about the integration of knowledge acquired in my posterior work at scientific ethical review committees and ethics of research academic programs. Furthermore, in the elaboration of regulations for improving scientific and ethical review.

Este trabalho apresenta a experiência que significou a passagem pelo Programa Internacional de Formação em Ética da Pesquisa Biomédica e Psicossocial do Centro Interdisciplinar de Estudos em Bioética da Universidade do Chile (2003-2004) e algumas reflexões a respeito da integração do que foi aprendido em meu posterior labor em comitês de ética e programas acadêmicos de ética em pesquisa; assim como na elaboração de regulamentações que permitam uma melhor avaliação ética e científica.

O comitê de ética em pesquisa na Universidade Federal de Santa Maria: um breve histórico / The research ethics committee at Universidade Federal de Santa Maria: a brief historical review

A análise da validade ética das pesquisas se concretiza nos Comitês de Ética em Pesquisa (CEP) das instituições. Este trabalho apresenta o histórico de organização e implementação do Comitê de Ética em Pesquisa na Universidade Federal de Santa Maria (UFSM), a demanda de análise de projetos e divulga a sua importância na universidade. Os dados foram obtidos através de um levantamento histórico realizado pela análise de arquivos internos do CEP. Foi pesquisado o número de projetos submetidos à avaliação pelo CEP desde sua fundação até dezembro de 2009, assim como de seu local de origem.

The analysis of the ethical validity of research materializes in the Research Ethics Committee (CEP) of institutions. The objective of the present article was to briefly present the history of the organization and implementation of the Research Ethics Committee at Universidade Federal de Santa Maria (UFSM), as well as the trends in demand for project analysis, in addition to disclosing its importance to the institution. Data were collected by means of a historical research based on the analysis of internal files of the CEP. We investigated the number of projects submitted for review by the CEP from its implementation to December 2009.