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Artículo de revisión que responde al objetivo de identificar las principales consideraciones éticas que los investigadores han de contemplar en el desarrollo de una investigación etnográfica institucional. Se realizó una revisión del estado del arte, analizando 298 tesis de posgrado. Tras la aplicación de criterios de inclusión, exclusión y eliminación de duplicados, quedaron 14 documentos, los que conformaron la muestra final. Las consideraciones éticas identificadas se estructuraron en tres grupos "planificación y aspectos metodológicos", "recolección de los datos" y "análisis, presentación de los resultados y manejo de los datos tras la finalización del estudio". Los resultados identificados se asocian a la esencia distintiva de la etnografía institucional como enfoque incipiente, pues uno de los aspectos que se aprenden en dicha etnografía es el sentido de observar cómo las personas organizan las cosas, lo que está directamente asociado a la forma de recolección de los datos desarrollada por el investigador. Conclusión: se identificaron 22 consideraciones, siendo la recolección de los datos la que presentó más elementos descritos; se revela la importancia del anonimato de los informantes, terceros involucrados y de la misma institución donde se desarrolla el estudio, pues fue la principal consideración ética distintiva del enfoque incipiente.
This review article aims to identify the primary ethical considerations researchers must have in conducting institutional ethnographic research. A state-of-the-art review was conducted, analyzing 298 theses/dissertations. After applying inclusion, exclusion, and duplicate elimination criteria, 14 documents formed the final sample. The ethical considerations identified were structured into three groups: "planning and methodological aspects," "data collection," and "analysis, result presentation, and data management after study completion." The results identified are associated with the distinctive essence of institutional ethnography as an incipient approach since one of the aspects learned in such ethnography is observing how people organize things, which is directly associated with the researcher's form of data collection. Twenty-two considerations were identified, with data collection having the most elements described. Moreover, the importance of the anonymity of informants, third parties involved, and the institution where the study is a distinguishing ethical consideration of the incipient approach.
Artigo de revisão que responde ao objetivo de identificar as principais considerações éticas que os pesquisadores devem ter no desenvolvimento de uma pesquisa etnográfica institucional. Foi efetuada uma revisão do estado da arte, a partir da qual foram analisadas 298 teses de pós-graduação. Após a aplicação de critérios de inclusão e exclusão e a eliminação de duplicados, restaram 14 documentos, que constituíram a amostra final. As considerações éticas identificadas foram estruturadas em três grupos: "planejamento e aspectos metodológicos", "coleta de dados" e "análise, apresentação dos resultados e tratamento dos dados após a conclusão do estudo". Os resultados identificados estão associados à essência distintiva da etnografia institucional enquanto abordagem incipiente, uma vez que um dos aspectos apreendidos nessa etnografia é o sentido de observar como as pessoas organizam as coisas, o que está diretamente associado à forma de coleta de dados desenvolvida pelo pesquisador. Conclusões: foram identificadas 22 considerações, sendo que a coleta de dados foi a que apresentou mais elementos descritos; destaca-se a importância do anonimato dos informantes, dos terceiros envolvidos e da mesma instituição onde se desenvolveu o estudo, pois foram as principais considerações éticas distintivas da abordagem incipiente.
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OBJECTIVE To promote the standardization and integrity of the informed consent form for clinical trials of registered anti-tumor drugs， and to protect the legitimate rights and interests of the subjects. METHODS The ethical review resolutions of clinical trial projects of registered anti-tumor drugs that were initially reviewed by the Ethics Committee of our hospital from July 1st， 2020 to July 1st， 2022 were summarized to statistically analyze the problematic items according to the “Quality Analysis Form of Informed Consent” prepared by our hospital. RESULTS Of the 316 clinical trials of registered anti- tumor drugs that were initially reviewed， 257 （81.3%） had problems with the contents of informed consent form， mainly domestic multi-center trials and phase Ⅲ trials. The main problems included the vague notification of the test fee bearer （68.5%）， the incomplete notification of the test content （59.1%）， the insufficient notification of rights and interests and risks （58.4%）， the insufficient notification of personal information protection （56.0%）， and the nonstandard expression of the informed consent form （52.5%）. CONCLUSIONS There is still a gap between the informed consent form of the clinical trials of registered anti-tumor drugs in our hospital and the requirements of the new version of Good Clinical Practice for Drugs （GCP）. The parties involved in the test can take a number of measures to improve the standardization and integrity of the informed consent form， and the research team should design the informed consent form in strict accordance with the requirements of the new GCP and pay attention to the comprehensive notification about the test. The Ethics Committee can provide the sponsor and researcher with the template of informed consent form and the key points of writing， continue to strengthen the examination ability， improve the examination quality， and effectively protect the safety and interests of the subjects.
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New drug clinical trials have been considered as a positive way for treating cancer by cancer patients and doctors, and the extended dosing is a special way for patients' withdrawal from antitumor clinical trials to obtain investigational new drugs. However, neither the regulations of expanded dosing nor the detail documents for expanded dosing have been officially published in China. At present, expanded dosing of investigational drugs is still at the exploratory stage in various medical institutions, and a complete management system has not been established to meet patients' urgent needs for drug use. Based on the practical experience of extended dosing in Hunan Cancer Hospital, this paper preliminarily explored the application procedures and ethical review requirements of extended dosing for subjects in antitumor clinical trials. It is necessary to clarify the responsibilities of all patients in the procedure and establish a patient-medical institution-sponsor joint application system. In the process of ethical review, it is recommended that all parties fully consider the risks and benefits of extended dosing for patients, and then the ethics committee makes a comprehensive assessment to decide whether to approve extended dosing.
Subject(s)
Humans , China , Physicians , Antineoplastic Agents/therapeutic useABSTRACT
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.
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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.
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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.
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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.
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Due to the physiological peculiarities of pregnant women, general clinical studies exclude pregnant women. Therefore, there is a lack of evidence of precise medication for pregnant women with diseases worldwide, which poses a significant risk for them to use medication during pregnancy. Whether to include pregnant women as subjects in clinical research has always been a focus of ethical discussion. By providing a broad overview of pregnant women’s participation in clinical research from an ethical perspective, this paper explored the risks and challenges faced by pregnant women’s participation in clinical research, and provided theoretical basis and thinking paths for how to fairly and effectively include pregnant women as subjects and promoting clinical research on pregnant women.
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With the rapid development of healthcare big data and artificial intelligence technology, how to utilize the massive medical data generated based on clinical diagnosis and treatment has become an important issue to be solved in the field of clinical research. Clinical diagnosis and treatment data is an essential part of healthcare big data, and also the main field of healthcare big data research. With the continuous deepening and extensive development of informatization, hospitals have accumulated a large number of patient-centered clinical diagnosis and treatment data. Deeply mining and analyzing these data through big data technology can provide reference for precise diagnosis and treatment, and standardized prevention and control of diseases. However, conducting relevant research still faces many difficulties and blockages, such as the increased risk of data leakage or abuse, and the difficulty in implementing informed consent. To safely, legally and efficiently utilize clinical diagnosis and treatment data to conduct clinical research and fully tap into the value of these precious medical resources, a tertiary hospital in Beijing has built a research big data platform and developed relevant systems to effectively solve the problems of blockages and difficulties in the application of rich clinical resources to clinical research, and improve the service quality of medical institutions and the conversion rate of scientific research achievements. By introducing the key points and management methods in the implementation of clinical research based on the scientific research big data platform, analyzing and exploring the existing problems and improvement measures, this paper aimed to provide theoretical basis and system reference for high-quality and efficient health and medical big data clinical research, inspire and promote the continuous improvement of medical research management, and promote the development of medical and health science and technology innovation.
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From the perspective of medical institutions, this paper sorted out the contents of Article 32 of the Measures for Ethical Review of Life Sciences and Medical Research Involving Human regarding "exemption from ethical review". At the same time, combined with domestic and foreign regulations, this paper deeply considered and analyzed the applicable premise and special circumstances of the provisions from the implementation level, and then put forward suggestions from the perspective of practical operation of medical institutions, with a view to providing some practical guidance and reference for ethical practitioners of medical institutions.
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To reduce the burden of researchers, Article 32 of the Measures for Ethical Review of Life Sciences and Medical Research Involving Human issued in February 2023 proposed that the review could be exempted. Normative exemption from review can not only relieve the burden of researchers, but also reduce the work pressure of the ethics committee, and devote limited time and energy to the review and supervision of high-risk research. This paper analyzed the four criteria for exemption from review first, and then summarized the situation of exemption from ethics review in the International Ethical Guidelines for Health-related Research Involving Humans and in the United States. In view of the fact that there are no relevant regulations on exemption from ethics review, though some medical and health institutions have implemented exemption from ethics review for some studies, the ethics committee often lacks standard operating procedures, corresponding documents, and experience for exemption from ethics review, researchers lack training for exemption from ethics review, and institutions have no supporting measures for exemption from review. To effectively implement the exemption from review, this paper proposed the following suggestions:developing standard operating procedures for exemption from review, and clarifying the review process, which can be simplified to secretary reviews, with senior secretaries or office directors judging whether they meet the exemption criteria, and the chairman reviewing and signing to convey the review decision. Refining the criteria that meet the exemption from ethics review, and providing cases and explanations as necessary, which will help researchers accurately understand the connotation of each criterion, and also provide reference for researchers to make their own preliminary judgments. Strengthening the training of researchers’ exemption from review criteria. The study should obtain the project proposal first, and provide scientific demonstration opinions. To explore the implementation of continuing review, institutions should accelerate the standardized construction of biological sample banks and databases to ensure the provision of compliant sources of biological samples and information data. Exemption from ethics review should not be abused, and the relationship between reducing the burden on researchers and ensuring the quality of ethical review should be balanced.
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The right to informed consent is the basic right of subjects in drug clinical trials. International treaties and domestic laws have successively formed a basic right protection framework, while there are still some problems such as imperfect legal norms and incomplete practical operations. To meet future challenges, it is necessary to further improve legislation, standardize notification procedures, improve notification content, expand dynamic notification methods, and strengthen ethical review, so as to build a standardized and modern system for protecting the right to informed consent of subjects.
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Due to the rapid development of new medical devices and the national policy adjustment of medical device review and approval, the difficulty of clinical trial institution and ethics committee in the risk assessment of medical device clinical trials has greatly increased. By sorting out the legal norms, standards and safety evaluation materials of medical devices, this paper systematically summarized and suggested the existing risks in clinical trials of medical devices from seven aspects, including the collection and utilization of biological sample, site environment safety, information security, product production and inspection, use of device, clinical trial design, and technical capabilities, with a view to providing a reference basis for the sponsors, clinical trial institutions, and ethics committees to scientifically establish a risk assessment system for medical devices before clinical trials, thereby reducing potential risks of compliance and safety during the clinical trial process.
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Medical ethics ward rounds truly embody the behavior of respecting human nature and providing humanistic care for patients, which is conducive to the unity of medical scientific judgment and decision-making with medical ethical judgment and decision-making, and the integration of medical ethics and medical skills. Medical ethics ward rounds focus on both doctors and patients. Through reviewing medical records and medical-related documents, interviewing medical staff as well as patients, observing doctor-patient communication, the ward environment and facilities, etc., the medical ethics ward round team conducted comprehensive ethical ward rounds on the clinical departments of the hospital, and evaluated the actual situation of them in terms of patients’ informed consent, privacy protection, application of new clinical technologies, medical quality, ward environment and facilities, professional dedication of medical staff, and so on. The respect of medical staff for the rights and interests of patients is not only the respect for the basic personality of patients, but also the external embodiment of bioethics. Medical ethics ward rounds combined with the PDCA cycle can understand the pain points and difficulties in diagnosis and treatment, as well as the experience of patients in the process of medical treatment, and construct a harmonious doctor-patient relationship through the joint efforts of both doctors and patients.
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The ethical governance of science and technology has put forward higher ethical requirements for researchers. As important personnel in medical research and front-line workers in contact with patients, clinical health workers should regulate their ethical behavior during the research process and provide informed consent to patients participating in study to protect their rights and interests. At present, patients’ rights and interests are still violated due to insufficient ethical awareness of researchers in the process of clinical research. Ethical governance of science and technology is not only a standard for researchers’ behavior and protection of patients’ rights and interests, but also a new test for scientific research management and ethical review departments, as well as an important measure to enhance the trust between doctors and patients and build harmonious doctor-patient relationship.
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Under the background of scientific and technological innovation in the new era, ethical review of traditional Chinese medicine (TCM) is facing new opportunities and challenges. Focusing on how to maintain integrity and innovation in the ethical review work of TCM clinical research in TCM medical institutions, starting from the characteristics of innovation and inheritance of TCM clinical research, this paper discussed the construction of the ethical review system of TCM clinical research, key elements of attention, shortcomings and deficiencies, training and communication, etc. It is also proposed that the joint construction of a Chinese characteristic scientific and technological ethics governance system should consider the unique requirements of modern technological means for the ethical review of scientific and technological projects such as dialectical treatment, re-evaluation of prescription projects, and expansion of indications in clinical research of TCM; innovate the form of review and strengthen the process management of ethical review; scientifically, objectively and impartially evaluate the scientific nature and social value of clinical research projects in TCM; pay attention to the toxic side effects of TCM, especially compound preparations. So as to further improve the procedural norms and quality of ethical review of clinical research of TCM, protect the legitimate rights and interests and safety of subjects, and promote the development of medicine in China.
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The research on rare diseases in China started relatively late, with scattered research resources and weak data foundation in epidemiology, diagnosis and treatment, and medication, which hinders its research progress. The rare disease data system is the foundation of rare disease research, and the ethical constraint on rare disease data collection is not only the protection of rare disease population, but also the need for the safety and quality of rare disease data. By analyzing and prospecting the current status of the construction of rare disease data systems, including the data of epidemiology, clinical diagnosis and treatment, drug trials, and follow-up to provide reference for the improvement of rare disease data systems. This paper explored the ethical issues to be followed in the process of rare disease data collection from the perspectives of justice, no harm, respect, sharing, and legalization, so as to improve the standardization of rare disease data collection and the understanding of data ethical review.
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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.
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At the end of February 2023, the new Notice on the Issuance of Ethical Review Measures for Life Science and Medical Research Involving Humans was issued by the National Health Commission, the Ministry of Education, the Ministry of Science and Technology, and the State Administration of Traditional Chinese Medicine. It adheres to the basic principles and institutional framework of the Ethical Review Measures for Biomedical Research Involving Humans , and combines with the actual situation of domestic ethical work to optimize and improve the details and procedures of the review. Based on the Ethical Review Measures for Biomedical Research Involving Humans, the Ethical Review Measures for Life Science and Medical Research Involving Humans have expanded the scope of application of ethical review. Different experts in the field have discussed in detail the changes in the scope of review, and proposed review procedures that may need to be corresponding adjustments based on the changes for the readers’ reference.
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Artificial intelligence (AI) has shown a tendency to replace human brain intelligence, and its rise has led to significant social changes. AI has pioneered the historical process of human-machine co-evolution. In the embedding of AI into medicine, it can be seen that there are a wide range of medical application scenarios. Intelligent medicine based on AI technology is of great significance, achieving spatial transmutation under spatial connection and value release under data mining. Intelligent medicine occupies a "high-level position" in value evaluation. Intelligent medicine has become a risk complex due to its tendency towards de-subjectivity of doctors, questioning the effectiveness of the intelligent algorithms, increasing difficulty in protecting information security and individual privacy, and indifference to medical humanistic care. To prevent the risks of intelligent medicine, it is necessary to reasonably define the relationship between AI and doctors, effectively prevent the risks of intelligent algorithms, increase the protection efforts of patient data security and personal privacy, thickly cultivate humanistic care in AI, and promote the improvement of the scientific and technological ethical governance system through ethical review.