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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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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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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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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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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.
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At present, there are no laws and regulations, ethical standards, and regulatory requirements related to ethical review of case reports at home and abroad. Whether ethical review is required for case reports, there are different norms in different regions, countries and medical institutions, and the provisions of different journals at home and abroad are also inconsistent. Through the discussion on whether the publication of case reports needs ethical review and approval, this paper summarized the problems of privacy protection and informed consent existing in the publication of case reports, and proposed the key points of ethical review of case reports, including the scientific nature of case reports, patient privacy protection, informed consent and conflict of interest management, with a view to making case reports conform to ethical standards and promoting the development of medical science.
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With the change of medical technology from "access management" to "filing management" in China, it is necessary for medical institutions, as the main responsibility, to pass standardized ethical review and supervision. However, there are many problems at present, such as the absence of regulations and guidelines for ethical review of clinical application of medical technology, the lack law of medical technology ethical review standard operating procedures, the insufficient review capacity, the lack of standardization in the choice of ethical review methods, the elements of informed consent and its examination need to be discussed, the lack of appropriate continuing review mode, as well as the confirmation of technical team members and department qualifications is not clearly defined. In order to safeguard the safety and rights of patients, it is important to take the following measures, including carrying out the whole-process supervision of medical institutions, clarifying the supervision process, improving the multi-departmental communication and cooperation mechanism, establishing a management committee for clinical application of medical technology, standardizing the review system of the medical technology ethics committee, clarifying submit the list of materials for ethical review, implementing classified ethical review and supervision to improve efficiency, exploring the tracking review mode, ensuring the whole-process supervision, and carrying out popular and professional ethics training. In the review of ethics committee, more attention should be paid to the main points of review, such as technical scheme, informed consent, qualifications of technical team members and departments, management system, risk assessment and emergency plan, patient compensation and other materials. While ensuring the safety and rights of patients, it also helps to accelerate the healthy development of medical technology.
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As a structural barrier, the blood-brain barrier (BBB) is located at the interface between the brain parenchyma and blood, and modulates communication between the brain and blood microenvironment to maintain homeostasis. The BBB is composed of endothelial cells, basement membrane, pericytes, and astrocytic end feet. BBB impairment is a distinguishing and pathogenic factor in diabetic encephalopathy. Diabetes causes leakage of the BBB through downregulation of tight junction proteins, resulting in impaired functioning of endothelial cells, pericytes, astrocytes, microglia, nerve/glial antigen 2-glia, and oligodendrocytes. However, the temporal regulation, mechanisms of molecular and signaling pathways, and consequences of BBB impairment in diabetes are not well understood. Consequently, the efficacy of therapies diabetes targeting BBB leakage still lags behind the requirements. This review summarizes the recent research on the effects of diabetes on BBB composition and the potential roles of glial and vascular cells as therapeutic targets for BBB disruption in diabetic encephalopathy.
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The artificial intelligence products such as diagnostic expert system and medical robot are constantly applied to medical field, which improve efficiency and benefit, and reduce the amount of labor of medical personnel, but also inevitably bring many ethical issues. The ethical challenges of artificial intelligence applying in medical field include fair benefits, unemployment, patient privacy, medical safety, division of responsibilities and supervision. The reasons may include failure to comply with basic ethical principles, technical defects, lack of legislation and supervision, implicit algorithm bias, poor data quality, insufficient public literacy and so on. The solutions proposed for the reasons included the definition of human priority, fault transparency and traceability, representative samples and researchers to avoid prejudice, the whole process supervision of research and development, production and sales, regulation to clarify moral and ethical boundaries, the legislation to improve the supervision and management system, the restriction of monopoly data, and the promotion of public awareness through education, and global governance to deal with challenges. It should ensure the application of artificial intelligence products in the medical field take "serving the interests of the human being and never harming human" as principle, under the premise of alleviating the repeated labor of medical staff to improve the efficiency and reducing the misdiagnosis and missed diagnosis, effectively improve the medical service quality.
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Objective: To standardize the capacity construction of medical ethics committee,improve the quali-ty of ethical review of clinical scientific research projects,and better protect the rights and interests of subjects.Methods: This paper reviewed the literature about standardization construction of ethical review of clinical scientif-ic research projects and analyzed them comprehensively.Results: Based on the problems of regulatory system,re-view standards,education training,ethic awareness and tracking review facing in the practice of ethical review,this paper put forward some reflections and suggestions for the ethical development trend and solving strategies of clinical scientific research projects in future.Conclusion: It should standardize the construction of ethical review system of clinical scientific research projects,strengthen education and training,promote the construction capacity of medical ethics committee of our country,and promote the scientificity and standardization of the ethical review of clinical scientific research projects.
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Objective:To standardize the present situation of informed consent in China' s clinical research projects, and to better play the role of protecting the rights and interests of subjects, in order to improve the ethicality of research. Methods:According to the actual work,this paper reviewed literatures about the existing problems and solutions in the informed consent process in clinical research to carry out comprehensive analysis and discussion. Results:Combining with the problems about researchers, subjects and ethical committees faced in informed conent process in clinical research, this paper put forward thinking and suggestions on standardizing the informed consent for future medical clinical research. Conclusion:We should standardize the informed consent form and carry out the training of the subjects and researchers about medical ethics knowledge, so as to improve the status of informed consent, reflect the scientificity and ethicality of clinical research project, and to contribute to the development and progress of clinical medicine.
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Objective To establish transgenic mice model with over expression of neuritin in bone mar-row,for the further study on the function of neuritin protein in the treatment of peripheral neuropathy. Methods Two pairs of transgenic mice(loxp-stop-loxp-neuritin and lyz-Cre/+)were fed and propagated,the DNA from the mice tails extracted and the genotype of transgenic mice identified by PCR. The wild type mice with B6 were as-signed as the controls,and the immunofluorescence was used to detect the accuracy of the neuritinloxp/+ _lyz -Cre/+. Results The two trensgenetic homozygous mice had the ability to reproduce,and the hybrid offsprings were neuritinloxp/+_lyz-Cre/+,neuritinloxp/-_lyz-Cre/+,neuritinloxp/+_lyz-Cre/-,neuritinloxp/-_lyz-Cre/-. The re-sults were met with the Mendel′s law. The results of immunofluorescence showed that the expression of neuritin of neuritinloxp/+_lyz-Cre/+ mice in bone marrow was significantly higher than the wild type mice(P < 0.05). Con-clusion The PCR method is of high reliability for identification of sub pus genotype and the female neuritinloxp/+mice mating with the male lyz-Cre/+ ones is an effective way for obtaining the neuritinloxp/+_lyz-Cre/+ mice.
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Objective:To summarize the notice of informed consent about gene information detection,and to provide a reference for ethical review of informed consent in clinical research involved gene information detection.Methods:We researched domestic and foreign literatures about gene information detection involved informed consent and comprehensively analyzed them.Results:Gene information detection caused the individual,family,and social aspects of privacy issues,and the right not to know gene information detection had been widely recognized.Informed consent was adopted in informed consent,which not only was respect for personal dignity and autonomy,but also was conducive to the effective use of gene resources.It should construct reasonable procedural system in le gal protection,guarantee the voluntary and authenticity of consent,and put it into practice.Based on the establishment of the right not to know,the Chinese law should also prohibit the implementation of gene detection or provision of gene information put forward by employers and insurance companies.In addition,it is strictly prohibited to detect infant incurable disease genes.Conclusion:In the ethical review of clinical research,when the conflict arises,it is necessary to design informed consent to resolve the conflict between the individuals' rights not to know and their personal health benefits,and to establish reasonable procedures in legislation to ensure the implementation of informed consent.
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Objective:To explore the ethical review questions of CRISPR/Cas9 gene editing technology caused in clinical research,and thus to provide a reference for matters needing attention of the ethical review involved in this technology in clinical.Methods:This paper summarized the ethical problems of CRISPR/Cas9 gene editing technology at home and abroad,analyzed the reasons and put forward some suggestions for the application of new technology in line with China's national conditions.Results:It should allow CRISPR/Cas9 gene editing technology to be applied in somatic cell gene therapy,forbidden for genital gene therapy and not considered to enhance.Since CRISPR/Cas9 lack clear subject of responsibility ethics,it brings security,conflict of rights and social equality issues.The measures that need to be taken include the strengthening of cultural communication,the formation of ethic forms of gene editing technology,the establishment of independent ethical review body at national's level,the improvement of legal norms,the formulating of technical standards and ethical principles and the major support to gene editing research field at the national level.Conclusion:In view of the potential clinical application of CRISPR/Cas9,our country should progressively restrictively develop the embryonic gene editing techniques from the prohibition.The ethics committee is responsible for the ethical review and supervision of clinical research.Members of the ethics committee and ethical staff should strengthen the study of new knowledge,strictly docking policies and regulations from accepting the clinical research projects involving CRISPR / Cas9 to ethical review,and thus to ensure the effectively review the ethical problems of genetic editing technology project.
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Objective:To summarize the existing problems and countermeasures of informed consent when children,one of the vulnerable groups in China,participate in clinical research,and further to provide reference for ethical review.Methods:We reviewed and comprehensively analyzed the domestic literatures that involved children and required informed consent.Results:Aiming at the unique physiological and psychological cognitive characteristics of children,this paper expounded the rationality of children's participation in clinical research and the timing of choice.It emphasized the existing problems in the process of informed consent such as inadequate informing,verbal acknowledgement,too long or too short time informed by the doctor-in-charge,as well as overspecialization of informed consent,inductive language,not describing potential risks and other incomplete information disclosure.According to these problems,the paper put forward some countermeasures.Conclusions:Informed consent of children's participation in clinical research should follow the general principles,consider children's characteristics,respect their willingness,and avoid unnecessary harm.
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Objective:To summarize the opportunities,challenges and countermeasures that China Food and Drug Administration (CFDA) joining ICH-GCP will bring to the construction of ethics committee,so as to provide reference for the standardization construction and review ability of ethical committee in China.Methods:We reviewed and comprehensively analyzed the domestic literatures about the requirement for ethics committee after CF-DA join ICH-GCP.Results:CFDA joining ICH-GCP was conducive to speeding up the construction of Chinese ethics committee.Aiming at the challenge of the standardization construction of ethics committee,it could use the revised policy regulations and guidelines to integrate with ICH-GCP,establish ethics certification system in line with the national condition,clear the composition of members,standardize operational procedures,and establish regional ethics committee and leader the review of the unit system;to improve the review ability,it could strengthen reviewing requirement from the aspects of sponsor responsibilities,researchers qualification,research protocols,informed consent,researcher brochures and documents management.Conclusion:CFDA joining ICH-GCP brings a rapid development opportunity for the ethics committee as well as challenges.We can solve problems from standardization construction and the improvement of review ability,to speed up the construction of ethics committee that meets the requirements of ICH-GCP.
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AIM To inVestigate the positiVe transcription elongation factor b(P-TEFb)expressjon and the effect of berberine on diabetic retina of the rat.METHODS Type 2 diabetes mellitus rat models were diabetic control rats(group A)that neither received STZ nor the high-carbohydrate/high-fat diet;16-wk diabetic rats without any drug treatment(group B);diabetic rats treated with berberine at a dose of 75,150 or staining and P-TEFb(cyclin-dependent kinases 9(CDK9)and cyclin T1)protein expression was detected by immunohistochemjstry.RESULTS The retinas of control group were thicker than those of other 6 groups.After thickness but no difference in retinal structure among all groups.Middle-.high-dose berberine and rosiglitazone fenofibrate showed no effect on CDK9 and cyclin T1 expression.CONCLUSION Berberine modulating P-TEFb level in diabetic retina may probably be one of the mechanisms to ameliorate retinopatby induced by STZ and the high-carbohydrate/high-fat diet.
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Objective To investigate the expression of peroxisome proliferator-activated receptors (PPARs) α/δ/γ protein and the effect of berberine on them in diabetic rat kidney.Methods Type 2 diabetic rats were induced by injection (ip) with streptozotocin 35 mg·kg1 and feeding with a high-carbohydrate/high-fat diet for 16 weeks.From week 17 to 32, diabetic rats were given low, middle, high-dose berberine 75, 150, 300 mg×kg-1, fenofibrate 100 mg×kg1 and rosiglitazone 4 mg×kg-1, respectively.The expression of PPARα/δ/γ protein in kidney were detected by immunohistochemistry.Results The expression of PPARα and PPARδ protein in the kidney of diabetic rat, which were significantly higher than that of the control one (P＜0.01), while PPARγ expression was obviously lower than that of the control one (P＜0.01).The expression of PPARα and PPARδ in in diabetic kidney were increased notably after middle-dose, high-dose berberine and fenofibrate treatment (P＜0.01);middle-dose, high-dose berberine and rosiglitazone treatment significantly reduced PPARγ expression (P＜0.01).Conclusion Berberine can restore the disturbed PPARα/δ/γ protein expression in diabetic rat kidney.
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AIM To investigate cyclin dependent kinase 9(Cdk9) and cyclin T1 protein expressions in diabetic rat kidney and the effect of berberine on them. METHODS Type 2 diabetes mellitus (T2DM) rats were induced by injection (ip) with diet for 16 weeks. From week 17 to 32, diabetic rats were given berberine 75, respectively. The kidney tissue structure was observed with hematoxylin/eosin (HE) staining, kidney to body weight ratio was calculated, and Cdk9 and cyclin T1 expressions were examined by immunohistochemistry. RESULTS Compared with control rats, the volume of diabetic model rat glomerulus accreted, some intercapillary cells proliferated and mesangial region expanded, both glomerular basement membrane and renal tubular basement membrane thickened. Treatment with diabetic nephropathy symptom. The diabetic kidney to body weight ratio protein expressions in diabetic kidney to near control level. CONCLUSION Berberine regulates Cdk9 and cyclin T1 protein expressions in diabetic kidney which may partly contribute to ameliorate nephropathy complication induced by STZ and the high-carbohydrate/high-fat diet.