Explanation from a professional perspective,Gene editing refers to obtaining new functions、New phenotypes even create new species for the purpose,Delete the target gene、Replace、Insert operation。The magic of this technology lies in,It can be through unique and accurate editing function,Change the genetic,So as to improve the tract of animals and plants,Prevention and treatment of malignant diseases,can even strengthen human beings、"Reappear" extinction species, etc.。This sounds very attractive,It's like gardener with a gardening knife,Any target object,until it meets what I want。But,The ethical risk of gene editing also comes from this。
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As a neutral technology,Gene editing is nothing and non -。But there is a major defect in this technology,is its off -target effect,This is the "editing" target that failed to reach the pre -set、Phenomenon of offset。The risk of off target lies not only in the failure of the target gene editing,The greater risk is that it may trigger the potentially unpredictable serious consequences。The function of gene editing is powerful,With an inestimable scientific research value,and huge commercial value,All of this determines,If you do not arrange a "doorkeeper",Then the master of technology may be under the temptation of interests,Violation of ethics and morality and even operate illegal crimes。Therefore,Ethical review of gene editing operations is the basic principle of general compliance with countries。
If the object of gene editing is human gene,bet365 best casino games The risk caused by off -targets will cause the edited individual and even the entire humans to fall into a dangerous situation。As early as 1999,An American boy died unfortunately due to a fierce immune response due to genetic treatment.。The editing operation of human reproductive genes will threaten the entire human gene library due to genetic effects。Therefore,The ethical risks of human gene editing are greater。Can we edit human genes, especially reproductive genes and use it for clinical,It is the most intense topic in the ethical controversy of gene editing。February 2017,The National Academy of Sciences and the School of Medicine jointly released the entitled "Human Gene Edit: Science、Ethics and Supervision "Research Report,Pointing out,If the human reproductive gene editing is applied to clinical,Healed patients,Need to go through very rigorous ethical censorship。Ethics review is equivalent to the "doorkeeper" of gene editing,It ensures that scientific workers strictly adhere to the bottom line of life ethics and scientific morals,Prevention and resisting gene editing operations are used to "do evil",Guide this technology to solve the real and necessary scientific problems,"Flowers" with goodness。
What to restrain the ethical committee?
The "He Jiankui Incident" that has a sensation a few days ago,Obviously it has passed the bottom line of ethics,It is even suspected of violating the "law"。my country does not have the laws and regulations of gene editing,At present, the legal regulations of this field mainly depend on the normative documents and departmental regulations issued by the Ministry of Health and the Ministry of Science and Technology。Some of them involve the ethical review of gene editing,Bet365 app download For example, stipulates in the "Measures for the Administration of Human Affairs and Reproductives",Application of human assisted reproductive technology,It should meet the principles of ethics; medical institutions that apply for human assisted reproductive technology should have a medical ethics committee; implementing human auxiliary reproductive technology involving ethical issues,Should be submitted to the Medical Ethics Committee for discussion。The direct specifications of the ethical review of human gene editing are "Principles of Ethical Guidance for Human Embryo Stem Cells", "Human Auxiliary Reproductive Technology and Human Sperm Rubu Ethics Principles", and "Ethical Research Ethical Review Measures involved in human biomedical research"。
From the perspective of existing specifications,Ethical review of human gene editing in my country can be made as follows: first,my country adheres to the principles of ethical review and supervision,Biomedical research involving human beings must be based on ethical review; second,The Ethics Committee is the main body of the implementation of ethical review and supervision,Medical and health institutions involved in biomedical research involved in people should set up an ethical committee,Ethics Council to carry out ethical review work independently,But needs to be managed and supervised by the medical and health institutions where their medical and health institutions are located,and accept the supervision and management of relevant regulatory authorities; third,The Ethics Committee mainly assumes three responsibilities,Protecting the subjects and promoting standards to carry out research,The whole process of ethical review and supervision of the research project,bet365 live casino games Carry out related training; fourth,The selection of members of the Ethics Commission takes the principle of diversification,In addition to professionals in the field of biomedicine,It should also have ethics、experts such as law and other fields, as well as social persons outside the agency。other,The existing specifications also stipulate the relevant legal responsibility,Aquate to the Ethics Committee。
That is to say,Ethical review of human gene editing operations such as He Jiankui,my country has "law" to follow。However, the problem is,The current standardized legal level is too low,The effect of making its deterrence and prevention of illegal behavior is greatly reduced。In the entire regulatory system of human gene editing operations,The Ethics Committee assumes a vital responsibility,But for human gene editing operations that do not comply with existing standards,The Ethics Committee does not seem to be very effective practical punishment means。In our country,Ethics review is carried out by the ethics committee of the medical institution where the medical institution is located,However, can the Ethics Commission adhere to the principle of independence to conduct review and supervision,Can its own model comply with relevant regulations,It is also facing a huge test in practice。In fact,This situation is not optimistic,This "He Jiankui Incident" is by no means alone。According to the industry authoritative person,,my country's Ethics Commission currently exists in uniform management,Admission、Lack of certification standards and regulatory mechanisms,Any small hospital can set up an ethical committee,Some ethical committees are loose,Just do superficial articles。Under the condition of bet365 live casino games incomplete legal system,Of course, it is difficult to control the red line of scientific workers to step on ethics and law。
The "cage" of the "gatekeeper" power into the rule of law
In "A Brief History of the Future",The author wrote: "Biotechnology and information technology brings strong new forces to humans,This problem also becomes urgent。There are these forces on your hand,How to use it? "Technology is the weapon of the country",But the weapon of human gene editing technology,Never allow "to do whatever you want",Must act "in accordance with the rules"。"Gatekeeper" as a gene editing operation,Ethics review and supervision rights owned by the Ethics Committee,It must be included in the rule of law mechanism for constraint。
The "cage" of the "gatekeeper" power into the rule of law,First of all, you need to solve the existing standard of legal levels too low、Problems with insufficient deterrence。Some countries have introduced laws on life ethics and human embryo research as early as the 20th century。For example, France issued the "Life Ethics Law" in 1988,Among them, the third part is the management regulations of the Ethical Committee。Scholar Jiang Li has proposed that my country should formulate a special "Human Gene Editing Law" suggestion。After the incident,,Some scholars have proposed to strengthen the medical ethics review system within the current legal framework。From reality,,Although it may not be able to formulate law at one time,But human gene editing and ethical censorship are related to the future of all humanity,Such a major adjustment object,Its legal level should never be just departmental rules or normative documents,This "cage" is obviously not strong enough。As a transition,You can consider formulating regulations on the basis of existing specifications。
Bet365 app download Next,Make necessary reforms in response to the ethical review system。Effectiveness of ethical review,To a large extent depends on whether the Ethics Commission can maintain independence。French "Life Ethics Law" regulations,Ethics Committee is absolutely independent when fulfilling its duties,and be given a legal person for。We can establish an appropriate isolation mechanism between the ethics committee and the affiliate,Independence of enhanced its duties。Another,Human gene editing operation is important,The power of the review and supervision of such research projects should be given a high -level ethical committee。Depart from the level of the existing ethics committee in my country,It is better to give this power to the committee of the health administrative department at or above the provincial level.,For particularly major scientific research projects,Ethical review can be performed by the highest level committee。
Last,The independence of the Ethics Committee does not mean that it can exempt supervision。On the contrary,The ethical review of human gene editing must be the most stringent regulatory。This incident highlights the regulatory loopholes of my country's ethical review。Strengthening supervision is the common appeal after the public reflection on this incident。This reinforcement includes self -supervision、Enhancement of government supervision and social supervision。Self -supervision is an ethical committee for self -management and supervision。Government supervision is an ethical review supervision led by the national health administrative department。The authoritative report of human gene editing mentioned earlier,The editor of human embryo genes should be performed under the supervision bet365 best casino games of the government。otherwise,It should also be encouraged to supervise,Provide the public with channels and means to supervise ethical censorship,If necessary, it can even give it the right to vote for scientific research projects。
(Author Unit: China Law Strategy Research Center of East China University of Political Science and Law)
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