ABSTRACT
Significant advancements have been made in the establishment of ethics committees within medical institu-tions.However,in order to achieve a high-quality development it is imperative to focus on such critical points as distinguishment between biomedical research and the clinical application of medical technologies,steadfast adherence to the fundamental princi-ples of ethical review,establishment of an ethics committee with independent administrative authority,establishing independent ethics review committees in large medical institutions based on specialty,and strengthening of ethical training for medical person-nel and biomedical researchers.
ABSTRACT
Disease animal model is an indispensable part of studying the pathogenesis and treatment of diseases.Review of the ethics and welfare is the necessary measure to ensure the quality of scientific research and promote the scientific and rational use of laboratory animals.In the review practice,it is found that most applicants are difficult to accurately understand the items listed in the application form and ethical principles related to items.Therefore,a practical and feasible set of ethical guidelines for animal experiments is necessary.This review focuses on the legal and ethical basis of developing oral disease animal models,and divides the methods of establishing oral disease animal models into physical methods,chemical methods,biological methods,and combined methods.It also elaborates on the ethical and welfare review points of different modeling methods and model evaluation methods.Hopefully,ethical censors and project applicants may get more understanding of ethical review for disease animal models,and ultimately improve the standardization and applicability of animal models.
ABSTRACT
The release of Guidelines to Strengthen the Governance over Ethics in Science and Technology marked that China's ethical governance system of science and technology has entered a new stage.The research and practice on ethics in science and technology in China are carried out along two approaches.One approach is to derive the rules of specific science and practice from the principles of general ethics.The other is to gradually form ethical governance principles and consensus for a specific type of phenomenon or problem in the process of science and technology,starting from scientific research problems and scientific and technological events and cases.Medical ethics research has also formed the tradition of medical ethics and modern bioethics in this way.In the practice of ethical governance,medical ethics is at the forefront of scientific and technological ethics,forming a"pilot area"for the research and development of scientific and technological ethics,an"explorer"for the institutionalization of ethical review,and a"demonstration area"for scientific and technological ethical governance.The release of ethical governance opinions is not the end of research on medical ethics governance,and medical ethics needs to have new achievements.Firstly,rethinking the theoretical basis and methodology of medical ethics and adhering to the guidance of Marxist theory.Secondly,a rethinking of the two research paths and how they can balance development and support each other.Thirdly,rethinking the relationship between ethics and the rule of law,and continuously improving the level of legalization of ethical governance.
ABSTRACT
Economic development drives the increase of endogenous demand,and Internet medicine integrates regional medical resources,expanding the fairness of the public's access to medical and health services.However,it is also accompanied an ethical crisis with the development of technology,which requires continuous standardization and practice.Starting from the principle of medical fairness,this paper sorted out the main advantaged characteristics of the development of Internet medicine from the aspects of data fairness,cost equity,opportunity equity,and educational equity.The existing ethical problems of Internet medicine were explored including unfair protection of ethical review mechanisms,unfair data collection of scientific and technological subjects,unfair distribution of benefits and risks,and unfair utilization of Internet medical resources.It also proposed the governance paths of compacting the subject responsibility,perfecting review and supervision,improving the sharing mechanism,bridging the digital divide,strengthening risk prevention,protecting the citizens'rights and interests,strengthening education and guidance,and increasing grassroots investment.
ABSTRACT
From the biological point of view,genes are the key to being human.With the continuous advancement of human gene technology,gene therapy has become a frontier topic with great vitality and controversy in the field of life science:it has brought more hope for the cure of diseases to human beings,but it has also triggered many ethical debates.This paper sorts out the ethical questions faced by gene therapy,extracts the challenges faced by individual rights,social justice,natural order and so on,and responds one by one,which shows that the development of gene therapy does not violate these ethical values in principle.However,the occurrence of gene editing events has sounded the alarm for us:where should the implementation boundary of gene therapy be?Through the comparative analysis of the gene editing incident and the Berlin patient case,the article points out that the study of technical safety is the key to safe application of gene therapy in clinical applications.
ABSTRACT
In-utero pediatrics is a fetal general medicine for perinatal medicine redevelopment,with the main purpose of preventing and treating fetal diseases,which studies the early prevention,screening,diagnosis,and treatment of diseases from gametes,fertilized eggs,and embryos sequential to children,adolescents,adolescence,and even the entire life cycle.Medical ethics provides strong support for the normative development of this discipline.This paper summarized the formation and development of in-utero pediatrics,analyzed the vulnerability of service subjects within in-utero pediatrics,and sorted out their ethical issues in the prevention and control of birth defects,fetal intrauterine diagnosis and treatment,as well as multidisciplinary collaborative diagnosis and treatment.It was proposed that in-utero pediatrics should follow the medical principle of maternal and fetal interests first,the principle of respect,and the principle of no harm.Finally,suggestions for ethical review of clinical and research projects on in-utero pediatrics were proposed,including strengthening the advisory service role of the ethics committee in clinical practice,timely launching the guidelines of ethical review for clinical research,and enhancing the ethical awareness of medical staff.
ABSTRACT
The medical artificial intelligence(AI)social experiment aims to more comprehensively understand the comprehensive impact of medical AI technologies and products on society,with the characteristics of wide application scenarios,complex research types and methods,multi-dimensional evaluation indicators,cross-disciplinary,and diverse subjects.To ensure the quality of ethical review in medical AI social experiment,it is urgent for relevant parties such as government authorities,research initiators,medical and health institutions,universities,scientific research institutions,enterprises,and research teams to shoulder their respective responsibilities,establish a technology product access mechanism for medical AI social experiments,improve the ethical review ability of the ethical review committee,and construct a whole cycle regulatory system.
ABSTRACT
Under the premise that the relevant laws and regulations in China do not specify the review subject of compassionate drug use,it is controversial who should bear the responsibility for the review and approval.This paper summarized and elaborated on the characteristics of compassionate drug use,and discussed the responsibilities,professionalism,and necessity of review of the ethics committee.It is believed that the ethics committee should serve as the review subject of compassionate drug use,and focus on doctor qualifications,risk-benefit ratio,informed consent forms,and conflicts of interest.
ABSTRACT
With the progress of society,the global development of scientific and technical research activities,and the increasing number of medical Institutional Review Board(IRB)review projects,the construction and management of electronic informatization have become extremely important.In the process of electronic information construction in institutional ethics review,it is necessary to take into account the new policy of ethical governance of science and technology,consider the system and standard operating procedures of IRB,and develop reasonable processes based on practical work,simplify manual operation,improve the accuracy of project management,achieve refined management,and facilitate communication among researchers,ethics committee secretaries,and members.
ABSTRACT
Stem cell clinical research is a hot frontier research. The ethical review of stem cell clinical research is full of challenges. Currently, clinical researches lack specific operational guidelines. Considered the related laws and regulations, and the operability of practical work, experts from the field of stem cells, such as law, ethics and management, will form a consensus on the basis of full discussion and continuous revision. It will provide reference for the operation of the ethics committee of corresponding institutions, and lay a certain foundation for the establishment of national expert consensus in the future, so as to promote the effective guidance of ethical review practice and quality evaluation of stem cell research.
ABSTRACT
Based on the sampling survey data of 11 164 medical researchers in China, this paper analyzed the understanding, attitude and compliance of medical researchers on scientific research ethics in China. The survey found that although most medical researchers claim to have more understanding of scientific research ethics, the level of understanding of scientific research ethics is not optimistic; the channels to scientific research ethics knowledge are diversified, but the standardized training channels are insufficient; most researchers held the positive attitude toward following the ethical norms, but those male, youth under 35, with senior professional titles, or from northeast China held negative attitude relatively; more than half of the researchers claimed that the supervision of research ethics in China was basically in place, but some people said that the violation of scientific research ethics was common, and some researchers reported that there was a phenomenon of "direct seal consent and reply" in ethical review. Compared with medical institutions, enterprises and universities are the weak links of scientific research ethics training, education and review. Based on the above actuality, it puts forward policy suggestions to strengthen the scientific research ethics training and ethics review requirements.
ABSTRACT
Based on the data of a national sampling survey, this paper described and analyzed the understanding, attitude, behavior, and their differences and influencing factors of Chinese medical researchers on ethical review of biomedical research involving human subject. The survey found that researchers with master’s degree or below, working in scientific research institutes or universities, no overseas experience, living in the central region and not serving as committee members have relatively poor acquaintance of "ethical review" ; researchers with the characteristics of male, the younger age, living in the western region, knowing less about "ethical review" , agree more with the view that "ethical review consumes too much time and energy" ; researchers who serve as members of the ethics committee are more likely to participate in scientific research projects that have not passed the ethical review process. Therefore, recommendations are put forward: comprehensively popularizing the training of ethical review, focusing on strengthening the vulnerable groups and regions, strictly implementing ethical review laws and regulations, and strengthening evaluation and supervision, so as to improve the service quality and efficiency of ethical review in multiple directions.
ABSTRACT
Informed consent is one of the key elements to protect the rights and welfare of the patients or research subjects. With the development of electronic information technology, the diversity and convenience brought by the electronization makes the electronic informed consent (E-Consent) come into being. European and American countries have begun to apply E-Consent in the field of clinical trials, established a relatively perfect E-Consent platform and software system, and initially formed the guiding principles and recommendations of E-Consent. However, the implementation of E-Consent is still less in China, and there is no targeted legal basis and guidelines for ethical review. Therefore, this paper explored the implementation potential of E-Consent domestically by analyzing the application scenarios, advantages and disadvantages, and feasibility of E-Consent, and tried to establish the practical ethic review points of E-Consent based on the basic principles of ethical principles, to ensure that clinical trials have an appropriate E-Consent process.
ABSTRACT
In order to speed up the review and approval of new drugs of Traditional Chinese Medicine (TCM) in China, it is accelerating the construction of TCM registration review evidence system, which combines the theory of TCM, human experience and clinical trials, and optimizing the technical requirements for the review of and approval of new drugs of TCM based on ancient classic prescriptions, famous old Chinese medicine prescriptions, and medical institution preparations. The United States has strict requirements on the application for the marketing of herbal medicines. According to the characteristics of herbal medicines and combined with human experience, the European Union has classified registration management, reflecting the regulatory concept of inheritance and innovation. TCM has a long history of human use experience in China, its application has a scope of application, basic requirements, and it is necessary to classify and exempt the declaration materials according to the evidence grading evaluation standards. When the ethics committee reviews the research scheme of human experience of TCM, it should pay attention to the review points such as scientific basis for new drugs or prescriptions of TCM, clinical positioning, applicable population, effectiveness and safety information, research design, sample size, conflict of interest management and informed consent. Finally, Human experience is helpful to formulate the research scheme of new drugs of TCM, which can not only improve the success rate of research and development, but also reduces the cost of research and development, accelerate the marketing of new drugs of TCM, and can benefit more patients.
ABSTRACT
To ensure the rights and safety of the subjects and improve the quality of clinical trials, the author analyzed and discussed the deviation type and typical cases from 184 cases of protocol violation reviewed by the ethics committee in 56 clinical trials in a tertiary hospital in 2020. Among the 184 cases of violating the protocol, there were 29 major protocol violation cases and its proportion is 16%; 99 cases (54%) violated the GCP principle; 56 cases of other violations of the protocol that require to be reported, accounting for 30%. Through the case analysis of the researcher gave the wrong doses to subjects without following the protocol and drug administration did not conform to the rules, analyzed and discussed from the five perspectives of the research protocol design, the researcher, the clinical trial institution, the sponsor and the ethics committee, and put forward solutions and suggestions, so as to provide reference to improve the compliance of clinical trial protocol, reduce the risk of subjects and protect their rights and safety and ensure the successful progress of clinical trials.
ABSTRACT
It is the responsibility of a clinical research institution to protect the rights and interests of research subjects. For the full process supervision of clinical research projects, the construction of a Human Research Protection Program (HRPP) which is suitable to the hospital’s situation can gradually improve the ethical review quality, and provide comprehensive protection measures for participants and potential participants throughout the entire clinical research process. Combined with the characteristics of clinical research and ethical review of Traditional Chinese Medicine(TCM), this paper introduced the construction of an HRPP system that highlights TCM characteristics. At the same time, this paper systematically analyzed the division of responsibilities, communication and cooperation of different committees and departments within the HRPP system to ensure the effective operation of the entire HRPP system, improve the quality of TCM clinical research and the protection level of the HRPP system, in order to achieve the goal of promote the healthy, orderly and scientific development of clinical research.
ABSTRACT
In the process of exploring standardized and efficient ethical review models for multi-center drug clinical trials, the ethical review alliance emerged as the times require. Compared with mature ethics committees, higher requirements have been put forward for the "young" ethics committees. By analyzing problems existing in review work of "young" ethics committees in the ethics review alliance, this paper discussed the measures to improve the review quality of "young" ethics committees and promote the standardized and efficient operation of the alliance, and put forward countermeasures and suggestions for improving the homogenization of ethics review and accelerating the clinical research process of innovative drugs.
ABSTRACT
For multi-center clinical research, how to ensure the quality of ethical review and improve the efficiency of ethical review through cooperation among centers is an important direction for clinical research management departments and research parties to explore. By combing and analyzing the existing pattern of multi-center ethical review at home and abroad, combining the current situation of the ethical review and management development in China, taking cancer clinical research as the breakthrough point, it was advocated to establish a cooperative review led by professional institute in domestic, on the basis of extensive and in-depth training exchanges and effective communication on the same platform, collaborative review, ensure quality and efficiency, so as to promote and implement the "mutual recognition" of ethical review. Then, this paper further put forward the concept of "whole-process linkage" in the ethical management process of multi-center clinical research, and pointed out that all research parties should clarify their responsibilities, enhance their awareness and ability, and jointly and comprehensively implement the protection of subjects among clinical researchers.
ABSTRACT
The ethics committee of organ transplantation technology and clinical application in a hospital has encountered some difficulties and typical cases in its review work and practice for many years. Sometimes, it is difficult to make a decision in these dilemmas. Based on the previous experience of the hospital in the ethical review of organ donation and transplantation, combined with two typical cases, this paper discussed and analyzed two review points of whether the voluntary unpaid donation and the principle of informed consent were met, and whether the risk-benefit ratio was reasonable, and put forward relevant ethical and legal countermeasure for further research by institutional ethics committees and other parties, in order to provide reference for discussing the practical problems and ethical confusion of ethical review of organ donation and transplantation.
ABSTRACT
In order to understand the status quo of ethical review of clinical research on the defecation function of patients with rectal cancer after sphincter-preserving surgery, analyze its causes and put forward corresponding suggestions, to arouse researchers’ attention to ethical review in subsequent relevant clinical studies. The ethical review of literatures related to the defecation function of patients with rectal cancer after sphincter-preserving surgery published on CNKI in recent 10 years was sorted out and summarized. The results showed that the ethical review of clinical research papers on defecation function of patients with rectal cancer after sphincter-preserving surgery was not optimistic. We should strengthen the ethical training of researchers, improve the ethical awareness of researchers, strictly implement the ethical norms of paper publication, strengthen the ethical requirements of manuscript contracts, perfect the ethical review system, and pay attention to the examination and supervision of informed consent, so as to promote the construction of ethical examination and approval norms of clinical research documents.