Study on the Protection of the Rights and Interests of Tumor Subjects in Clinical Trials in the Prevention and Control of the COVID -19 / 中国医学伦理学

The outbreak of the COVID -19 has had a big impact on the implementation of clinical trials of tumor drugs and the prevention and control measures such as traffic control and home isolation has caused clinical trials couldn’t proceed normally, so the protection of tumor subjects in clinical trials faces many new challenges. Based on Western and Chinese policies and guidelines on the management of clinical trials during the COVID -19, this paper expounded the impacts of the COVID -19 on tumor patients and tumor clinical trials, analyzed the challenges faced by the protection of tumor subjects in the prevention and control of the COVID -19, and then protected tumor subjects from aspects of optimizing the allocation of health resources, improving non-face-to-face informed consent procedures, strengthening subject visit management, and enhancing clinical trial safety evaluation. It is hoped that these optimization measures can face the future and continue to protect subjects after the end of the epidemic or in new public health emergencies.

The Relevant Regulations of Vulnerability in Foreign Biomedical Research Ethics and Its Enlightenment to China / 中国医学伦理学

The advancement of medicine and biotechnology is based on biomedical research. The rights and safety protection of subjects in biomedical research is one of the core issues of research ethics,and the protection of vulnerable subjects should be the top priority importantly,research ethics should provide special protection for vulnerable subjects. Chinese laws and regulations have not yet given a clear definition of the concept of vulnerability,and the content and regulations related to vulnerability are relatively rough and not perfect. By drawing on the main international and foreign research ethics policies and guidelines,introducing the definition of vulnerability,clarifying the source of vulnerability,and applying vulnerability to the process of biomedical research in China. When applying vulnerabilities,one should avoid using the label approach to include people with common characteristics into vulnerable groups,but mainly analyze the types and sources of vulnerability,and includes as many vulnerable subjects of different types as possible to provide them with more comprehensive and adequate protection in biomedical research.

Enhancing medical ethics education for medical students in clinical research: considerations and strategy analysis / Mejorando la educación ética médica para los estudiantes de medicina en la investigación clínica: consideraciones y análisis de estrategias / Melhorando a educação de ética médica para estudantes de medicina em pesquisa clínica: pensamentos e análise de estratégia

In recent years, the vigorous development of clinical researches carried out by medical schools is inseparable from the effective participation of medical students. However, as the number and categories of clinical research projects that medical students participate in increase, medical ethics related issues gradually occur. This article sorts out the ethical issues that arose in clinical researches, in which medical students participated, analyzes the underlying causes, and proposes solutions for the above-mentioned ethical issues, aiming to provide reference for medical ethics education and research project management for medical schools.

La participación efectiva de los estudiantes de medicina ha contribuido en gran medida al desarrollo exitoso de la investigación clínica en las escuelas de medicina de China en los últimos años. Sin embargo, con el creciente número y tipos de proyectos de investigación clínica en los que participan estudiantes de medicina, las cuestiones éticas se exponen gradualmente. Este trabajo enumera las cuestiones éticas que han surgido en la participación de los estudiantes de medicina en la investigación clínica en los últimos años, analiza las causas subyacentes y propone soluciones a las cuestiones éticas mencionadas anteriormente, con el objetivo de proporcionar referencia para la enseñanza de la ética médica y la gestión de proyectos de investigación para las escuelas de medicina.

A participação efetiva dos estudantes de medicina tem contribuído muito para o próspero desenvolvimento da pesquisa clínica nas escolas médicas da China nos últimos anos. No entanto, com o aumento do número e tipos de projetos de pesquisa clínica dos quais os estudantes de medicina participam, questões relacionadas à ética e à alfabetização são gradualmente expostas. Este artigo lista as questões éticas que surgiram na participação de estudantes de medicina em pesquisas clínicas nos últimos anos, analisa as causas subjacentes e propõe soluções para as questões éticas acima mencionadas, com o objetivo de fornecer referência para o ensino de ética médica e gestão de projetos de pesquisa para escolas médicas.

The Dilemma and Consideration about the Construction of the Subject Protection System / 中国医学伦理学

Relying only on the ethics committee to protect subjects is not enough, and the construction of the subject protection system is an inevitable trend for the protection of subjects’ rights. This paper elaborated on the current situation of Chinese subject protection system from four aspects: the lack of laws and regulations and administrative supervision, the insufficient attention of hospitals, poor construction of the subject protection system, and the absence of responsibilities of relevant personnel. Then this paper put forward countermeasures from three aspects: improving laws and regulations and strengthening supervision, mobilizing relevant departments to participate, and strengthening relevant training, in order to standardize the construction of the subject protection system and promote the development of the subject protection work.

Discussion on Quality Assurance and Improvement Mode of Ethics Committee / 中国医学伦理学

With the continuous improvement of the ethics committee status and the rapid growth of ethical review projects, the ethics committee urgently needs to establish an evaluation mechanism for continuous improvement. In view of a series of problems faced by the ethics committee in its daily management and operation, this paper discussed the concept and measures of introducing quality assurance and quality improvement into the ethics committee. Through comparing the advantages and disadvantages of the three models of quality assurance and quality improvement, this paper summarized the practical experience, further determined the internal evaluation, improvement model and evaluation elements of ethics committee, constantly improve the internal evaluation system of the ethics committee, strengthen the education and training of the ethics committee, and implement the whole chain electronic review, so as to improve the operation efficiency and review ability of the ethics committee, and provide sufficient ethical protection for the protection of the rights and interests of subjects.

Discussion on the moral responsibilities of investigators from the perspective of human subject protection / 中华医学科研管理杂志

Objective According to the discussion of investigator responsibilities for human subject protection,to provide possible reference for the construction of human subject protection framework calls for more collaboration between investigators and Institutional Review Board (IRB).Methods Systematically analyze the investigator responsibilities during the whole process of research including design,implementation and closure,identify key ethical issues that need attention at different stages.Results Currently,the culture of regulatory compliance,though good for the human subject protection from regulatory perspective,is still not optimal for encouraging more innovative protection from investigator perspectives.Conclusions Human subject protection is not only the responsibility of IRBs,investigators should also be more responsible and bring in more ethical considerations in human subject research.

Analysis of Standardization of Clinical Trial Contract Audit from the Perspective of Subject Protection / 中国医学伦理学

Carrying out clinical trial contract audit can audit the authenticity,legality and effectiveness of the contract and timely avoid the potential risks,clarify the responsibilities,rights and obligations of all parties participating in the clinical trials and clear the responsibility of each party in protecting the subjects,guarantee that the contracts include contents of subject protection and put them into practice.From the perspectives of establishing relevant documents,defining the main implementer,making the process,and confirming the core elements,this paper introduced how Xijing Hospital standardized clinical trial contract audit and expounded its significance in promoting the protection of subjects.

Suggestion for Improving Subject Protection in Clinical Trail / 中国医学伦理学

Clinical trials for medical research subjects of protection in China is still the researchers and sub-jects′cognitive biases, informed consent to carry out the difficult and the lack of follow-up tracking examination questions.Based on the experience and the domestic exploration of a hospital, put forward the Suggestions of per-fecting our country′s subjects protection: establish multi-sectoral cooperation of the subjects protection system, improve the legal consciousness and the consciousness of the subjects, the ethics committee should be field trips, build system of compulsory insurance, adverse drug reaction relief system is established.

Introduction and Enlightenment of the Human Subject Protection Program in U.S / 中华医学科研管理杂志

As human subject protection become more and more significant in China,it' s imperative for China to learn more experiences from U.S for which developed a normative and well designed HRPP system during past decades.In this article,we gave a brief introduction of the Human Subject Protection Program at Duke University to help us have a better understanding of the HRPP at institutional level.After which we have further discussion of the status quo and challenges facing in HRPP construction in China,especially,Peking University as an example.