Looking at the problems exposed by medical ethics through the event of "gene editing baby"

On Monday, 26th of this month, a news about "AIDS immune gene editor baby" triggered a big discussion in the pharmaceutical industry Soon, the circle of friends was constantly swiped by the news, "he Jiankui", "gene editor", "Putian Department", "Hemei" and other key words were quickly pushed to the forefront of the storm People were waiting for the official level by level reports after discussion Avenue I believe that the relevant departments will give the true answers to the context of the event Here, I would like to say that it is more important for every medical worker to rationally understand the current knowledge and connotation of medical ethics in China through the event! What is medical ethics today, we know that how to make medical research activities better serve human beings, we must consider science and ethics at the same time The task of science is to solve "can" or "cannot", while the task of ethics is to solve "should" or "should not" Ethics, also known as moral philosophy, is a science with morality as its research object Medical ethics is the study of moral issues in medical practice It is the theory and theoretical system of medical morality As early as 1803, Thomas Percival of England first proposed the term "medical ethics", that is to say, the application of general ethical principles in the field of medicine is to use the theory, methods and moral principles of general ethics to solve the moral problems of the relationship between human and human, human and society, and human and nature in medical practice and the development of medical science At the beginning of the 20th century, some scholars in China translated the code of medical ethics of American Medical Association, which is the first translation of Western medical ethics theory In 1933, the first systematic medical ethics monograph in China, medical ethics, was published; In 1941, the inscription of Yan'an Medical University "saving the dying and helping the wounded, carrying out the revolutionary humanitarianism" embodied the medical ethics idea in the new revolutionary period; in the 1980s, the medical ethics circle began to pay attention to the construction of the medical ethics system, and the curriculum, exchange and monograph of medical ethics increased day by day; In 1981, the first National Symposium on medical ethics was held in Shanghai The former Ministry of Health issued the code of hospital staff and medical ethics in the same year From the end of 1980s to the beginning of 1990s, the research on medical ethics gradually deepened, and hospice hospitals were successively established in various regions; Since the 1990s, the emergence of reproductive technology, gene technology and other new technologies has promoted the development of Chinese medical ethics to bioethics In 1998, China's relevant regulations and policies, the former Ministry of health formulated the measures for ethical review of biomedical research involving human body (Trial), which is the first time that China's health administrative departments put forward the requirements of establishing an ethics committee in the form of laws and regulations In 1999, the State Food and Drug Administration issued the code for the administration of clinical trials of drugs, Article 9 of which clearly stipulates that "in order to ensure the rights and interests of the subjects in clinical trials and provide public guarantee for them, an ethics committee shall be established in the medical institutions participating in clinical trials" In 2000, the former Ministry of Health informed the establishment of the "medical ethics Expert Committee of the Ministry of health" to review the ethical issues in medical research, and began work in 2001 Chapter III of GCP revised in 2003 "protection of subjects' rights and interests" clearly states: "ethics committee and informed consent are the main measures to protect the rights and interests of subjects; in order to ensure the rights and interests of subjects in clinical trials, an independent ethics committee must be established" In 2007, the former Ministry of Health issued the measures for ethical review of biomedical research involving human beings (for Trial Implementation), which provided clear guidance for regulating the ethical review of biomedical research involving human beings in China The guiding principles for ethical review of drug clinical trials promulgated in 2010 standardized the ethical review of drug clinical trials In 2016, the avant-garde Family Planning Commission promulgated the measures for ethical review of biomedical research involving human beings, reaffirming the establishment of an ethical committee in national medical institutions, which will conduct ethical review of medical research projects involving human subjects Two months later, CFDA issued the code for quality management of drug clinical trials (Revised Draft) for comments The ethics committee was divided into a single chapter, which detailed the responsibilities, composition and operation of the ethics committee, review work procedures and work records, more standardized the composition and operation of the ethics committee, reflecting the importance of the role of the ethics committee in protecting the rights and interests of subjects 。 In 2017, CFDA issued the opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical and medical devices, which proposed that: ① regional ethics committees can be set up in different regions according to the needs; ② for multi center clinical trials conducted in China, after the ethical review of the leader unit, other member units should recognize the review conclusions of the leader unit and no longer repeat the review; ③ Change the previous problems of emphasizing examination and approval but neglecting ethics, and advance the ethical examination gate to before the clinical trial application; ④ before the registration applicant puts forward the clinical trial application, submit the clinical trial scheme to the ethics committee of the clinical trial institution for examination and approval Problems existing in ethical review through a number of policy implementation and reform, although China's medical ethics has issued an organizational framework and administrative approval is gradually refined, there are still many problems, otherwise, today's events may be strangled in the cradle At present, there is no special supervision institution for ethical review of clinical scientific research projects in China, especially in the relevant laws and regulations The projects of verification are all registration tests for drugs and medical devices, which will not involve clinical research projects basically, and there is no professional and strategic guidance for the review of the ethics committee, resulting in the lack of authoritative assessment and evaluation of the ethical review work The review standards are not standardized At present, the country is still in the stage of continuous exploration in the ethical review standards and norms of clinical research projects It basically copies the ethical review standards of clinical trials of drugs and medical devices, and there is no targeted ethical review standards and rules and regulations The results of different ethics committees may be different, and the same clinical research project may be approved in one unit ethics committee but not in another unit In the specific project review, the quality of ethical review of different provinces and units is uneven Insufficient training for members Most of the members of the ethics committee are experts in medicine and pharmacy, but they are lack of experts with basic knowledge and rich experience in the evaluation and analysis of ethical issues The proportion of education background is out of balance, coupled with the uneven professional quality, which results in a certain degree of randomness and subjectivity in the review of clinical scientific research projects, which inevitably leads to the phenomenon of Moral Behavior Anomie and the professional ethics review Sex and authority are questioned Members lack systematic study and training on bioethics, behaviorism, law and other related knowledge Some researchers are indifferent to the ethical awareness of clinical medical treatment, which is the most onerous business work of major hospitals As researchers of scientific research projects, clinicians have limited energy and time, and their clinical research tasks do have many factors that are difficult to guarantee Especially for the clinical research projects in the hospital, due to their small subjects and small funds, researchers' attention and enthusiasm are obviously insufficient What's more, some researchers don't pay enough attention to the ethical awareness of biomedical clinical research projects A survey shows that nearly half of the scientific research staff in China have not received the training of ethical knowledge, they lack a comprehensive understanding of the medical ethical review system, and they lack a spontaneous sense of responsibility to protect the subjects Ignore follow-up review Clinical research projects usually only focus on the initial review, and pay more attention to the scientificity, feasibility of the research program and whether the informed consent meets the ethical requirements However, most of the ethics committees do not pay attention to the revision of the research program, informed consent and other documents, the occurrence of adverse events and violations of the program in the research process, and the results after the completion of the project Conduct timely follow-up review Due to the lack of external supervision, some ethics committees did not require the clinical scientific research projects to be followed up and reviewed, and any situation in the course of the project development could not be grasped, which weakened the scientific and normative nature, and the legitimate rights and interests of the subjects could not be effectively protected The author feels that there are a series of reasons for the occurrence of any event, which is not the responsibility of one party For example, the seal fetus incident in that year was also a historical drug damage event caused by the comprehensive factors such as the incompleteness of drug developers, the laxity of drug audit departments, and the relative lag of scientific development However, since then, the development of pharmacy has made great progress The FDA of the United States has established its authority in the world, and pharmaceutical companies have done more in-depth research on drugs In general, the disadvantages and advantages can always be balanced No matter what the outcome of this incident is, there is no doubt that there are serious ethical problems In this way, if we can further improve the relevant work, we will certainly reduce some losses caused by the incident After all, an ethical approval is still valuable