Status quo of Bioethics in China

    Chinese Scholars on Ethical Lessons from Anti-Human and

    Anti-Humane Experimentation by Japanese 731 Troops

    A Panel Discussion on Ethical Lessons from Anti-Human and Anti-Humane Experimentation by Japanese 731 Troops was held at the Beijing International Conference on Bioethics on January 5, 2004. In this discussion Professor Shen Mingxian from Shanghai and Professor Du Zhizhneg from Dalian made following remarks on this topic:

    Shen maintained that the anti-human and anti-human experimentation conducted by Japanese scientists and physicians and American cover-up is a typical case in which the anti-humane activities or crimes were covered up with the name of science. He asked: When there is a conflict between humanity and science, can science override everything? He pointed out that science in general should have promoted the welfare of human beings, life science and medicine in particular should have improved the human health and their quality of life, so they are a humanistic endeavor full with humanistic concerns, and are called the Art of Humaneness/Humanness. He argued that these Japanese and US scientists/physicians are the victims of technology infatuated syndrome which led their mind to be unfeeling to, and exclude humanity. The second question Shen raised is when there is a conflict between humanity and politics, can politics override humanity? He concluded that basic ethical values and norms must be respected. Respect for persons, treat person as the end itself, this is well received categorical imperative in the world, and also a paramount ethical principle.

    Du Zhizhneg held that there are four lessons that could be drawn from the anti-human and anti-humane experimentation conducted by Japanese 731 Troops.

    1. Adhering informed consent is the most fundamental requirement which must be complied with in research involving human beings.

    2. It is common mission for the peoples all over world to adhere informed consent and respect human dignity. Any national selfishness is harmful.

    3. The spirit of Nuremberg Code is universal and absolute, any double standard will lead to  no end of trouble in the future.

    4. Research involving human beings must serve the medical purpose, physicians should properly treat all non-medical research involving human beings with their own conscience.

    Du concluded that today the human experimentation with a purpose of direct killing such as that conducted by 731 Troops would no longer take place, however, it does not meant that there will be no other human experimentation against human interests, such as those human experimentation with some political purpose or need. Furthermore, under the pressure of commercialization is it the case that human experimentation which is subordinated to commercial interest is taking place somewhere today?

    中国学者谈日本731部队反人类实验的教训

    2004年1月5日北京国际生命伦理学学术会议有一次专门讨论731部队的反人类实验的伦理教训会议的专家讨论会。会上来自上海的沈铭贤教授和来自大连的杜治政教授就此话题发表了如下看法：

    沈铭贤认为，日本科学家/医生在731部队的所作所为和美国的掩盖，是典型的以科学的名义从事反人道的活动、掩盖反人道罪行的案例。于是他问道：当人道与科学发生矛盾时，科学能高于一切吗？他指出，本来，科学是为增进人类的福祉服务的。特别是生命科学和医学，更应该致力于提高人们的健康水平和生命质量，是一项充满人性关怀的人道主义事业，正如先贤所说医乃仁术。而这些日本和美国的科学家/医生，正如萨顿指出，在一定程度上是他们自己的'技术迷恋症'的受害者，他们对技术的专注以及由此而来的麻木不仁和无知无觉达到那样一种程度，致使他们的精神对人性已完全排斥，他们的心灵对仁慈已毫无感觉。沈铭贤提出的第二个问题是，当人道与政治发生矛盾时，政治能不顾人道吗？最后，他主张一定要尊重伦理的基本价值和规范，尊重人，把人当成目的，这就是举世公认的道德的绝对命令或至上命令，也是道德的最高原则。

    杜治政认为，从731部队反人类的实验中可总结如下教训：1、坚持知情同意，是任何人体试验必须遵守的最基本的要求；2、坚持知情同意，维护人类的尊严，是全世界人民共同任务，任何民族自私和狭隘的态度都是有害的；3、纽伦堡精神是普遍的和绝对的，任何双重标准后患无穷；4、人体试验必须服务医学的目的，医学家应以自己的良心对待非医学目的一切人体试验。杜治政最后指出，在今天，像731部队那种直接以杀人为目的的人体试验，也许不大可能再出现了，但是其他某些背离人类利益的人体试验，是不是不会再有了呢？当然不能这样说。在今天，出于某种政治目的的人体试验，借口某种政治需要人体试验，在一些国家，仍有可能发生。这里要特别指出的是，当今日面临商业利益铺天盖地而来之时，屈服于商业利益的人体试验，在种种商业利益诱骗之下的人体试验，不是正在或彼或此地发生了吗？

    Chinese Scholar Criticized an Article that Distorts

    Chinese Reality Published in Bioethics

    In her presentation titled Updating Statute and Idea after Technology -Advance in Organ Transplantation in China Professor Cao Nanyan from Tsinghua University pointed out that:

    We have regrettably seen that few abroad deliberately fabricated so-called facts and attacked China on the issue of organ transplantation. For example, American University published an article on illegal organ trade of prisoners with capital punishment in China. In 1998 Carl Becker attacked China with distorted facts at a section of International Congress on Bioethics in Tokyo and his claims were refuted by Chinese scholars. However, in Bioethics vol. 13, no. 3/4, 1999 Carl Becker's article titledMoney Talks, Money Kills? - The Economics of Transplantation in Japan and China was published. In this article the author attacked China to increase the number of the prisoners with capital punishment for the purpose to use their organ in transplantation and to make money. Carl Becker has never been in China and groundlessly related the number of the prisoners with capital punishment with the use of their organ after execution. Cao claimed that Bioethics is a journal of International Association of Bioethics and the elementary requirement to publish an article should be evidence-based and reliable, and it should be prudential to the article with prejudices. As the editor of the Network knew that the article had been sent to Professor Gerheld Becker, Hong Kong Baptist University to review and Professor Gerheld Becker rejected this article as problematic. However, the editor of Bioethics persisted to publish it regardless of the article review procedure. We don't know why? What is the intention in the editor's mind?

    中国学者批评Bioethics上发表的歪曲中国现实的文章

    清华大学教授曹南燕在2004年1月6日北京国际生命伦理学学术会议一次全体会议上作题为技术之后是法规和观念的更新--中国器官移植的重大进展发言中，在概述中国有关器官移植方面立法进展后，指出：我们很遗憾地看到，国外有个别人在器官移植问题上捏造事实，恶意反华。例如，2001年American University发表中国对死刑犯的非法人体器官交易文章。1998年Carl Becker在东京国际生命伦理学大会分组会上发表反华谬论，遭到中国学者的反驳，但Bioethics 1999年7月第13卷第3/4期第227页上又发表了Carl Becker题为Money Talks, Money Kills? - The Economics of Transplantation in Japan and China的文章，攻击中国为利用死刑犯尸体进行器官移植，而使死刑人数剧增。Carl Becker本人从来没有到过中国，却毫无根据地把两者联系起来。曹南燕认为，Bioethics是国际生命伦理学学会的学术期刊，刊登的文章最起码要证据确凿、可靠，对于那些有偏见的猜测，应该要采取慎重的态度。据编者了解，此文曾交香港浸会大学Gerheld Becker教授审阅，Becker教授这篇文章有问题，建议拒绝发表，但该杂志全然不顾文章审查程序，执意发表，不知是何居心？

    Ministry of Science and Technology & Ministry of Health

    Jointly Promulgated the Ethical Guidance on Human Embryonic Stem Cell Research

    Health Newspaper, January 14, 2004

    On January 14, 2004 Health Newspaper was published the Ethical Guidance on Human Embryonic Stem Cell Research. In view of that the official English version has not been published,  some major articles will be excerpted here.

    Article 1: In order for the human embryonic stem cell research in the field of biomedicine in China to comply with bioethical norms, to assure the international bioethical guidelines and Chinese regulations concerned being respected and observed, and to promote the healthy development of human embryonic stem cell research this guidance was developed.

    Article 4: Any research for human reproductive cloning shall be prohibited.

    Article 5: The human embryonic stem cell used for research can be derived only by: (1) spared gamete or blastula after IVF; (2) fetal cells after natural or voluntarily selective abortion; (3) blastula or monosexual split blastula by somatic cell nucleus transfer technique; and (4) germ cells voluntarily donated.

    Article 6: The conduct of human embryonic stem cell research must comply with the following norms: (1) when a blastula is obtained by IVF, somatic cell nucleus transfer technique, monosexual reproduction technique or genetic modification, the culture period in vitro cannot be more than 14 days since fertilization or nucleus transfer; (2) the implantation of the human blastula which has been used for research into human or other animal's reproductive system is prohibited; (3) the hybrid between human germ cells and germ cells of other species is prohibited.

    Article 7: Buying and selling human gamete, fertilized egg, embryo and fetal tissue are prohibited.

    Article 8: The principle of informed consent and informed choice, the signing of informed consent form and protection of subject's privacy must be adhered in the conduct of human embryonic stem cell research.

    Article 9: The institute which is engaged in human embryonic stem cell research should establish ethics committee which consists of professionals in the fields of biology, medicine, law or sociology and regulatory officials, the function of this committee is to conduct the scientific and ethical review, counseling and surveillance for human embryonic stem cell research.

    Comments:

    1. This ethical guidance is an ethical guideline for the research in a specific field which was promulgated by the departments of the Government that administer the research after the Minister of Health promulgated The Guidance for Ethical Review in Medical Research in 1998 and the State Drug Administration promulgated Regulatory Norms for Drug Clinical Trials in 1999. This document first points out the consistency between compliance with ethical norms and international & national ethical guidelines on the one hand and smooth development of scientific research on the other, explicitly stipulates the prohibition of human reproductive cloning, the prohibition of the human embryonic research in vitro no more than 14 days, the prohibition of implanting human embryo used for research into human or other animal's reproductive system, the prohibition of hybrid between human germ cells and germ cells of other species, the prohibition of selling and buying human gamete, fertilized egg, embryo and fetal tissue, and emphasizes to adhere the principle of informed consent and informed choice, to protect subject's privacy, and to establish ethics committee etc. All these are very important and should be given positive evaluation.

    2. There are some problems existing in this Ethical Guidance. The definition of terminologies should be given in such a document. For example, what is the difference between blastula and monosexual split blastula? Is the blastula obtained by the somatic cell nucleus transfer technique a monosexual split one? Why are used two terms? What do they refer to respectively? In the same vein, what is the difference between the somatic cell nucleus transfer technique and monosexual reproduction technique? The definition should be given to these terms. Secondly, there are some inconsistencies in this document. For example, in Article 5 the sources of human embryonic stem cell are listed, but the techniques such as monosexual reproduction and genetic modification are not mentioned. However, in Article 6 there are listed these two techniques. Thirdly, there is no punishment in this document. If somebody violates this document, e.g. stubbornly to do human reproductive cloning, how to deal with him/her? Last but not the least, there are many times to mention ethics ethical in this document, and establishing ethics committee is required, but for the make-up of such committee the inclusion of professional in ethics is not mentioned. So the ethics committee will be the one without ethicist. What is not known that it is a negligence from the decision-maker or he/she really thinks ethics is not a discipline, anybody who is not trained could be qualified as an ethicist. Indeed, we have seen some responsible men of an ethics committee, who have not been trained ethically but only attended some workshop abroad, as a result they did not know at all how to understand and apply major ethical theories and basic ethical principles to ethical review practice, they held a double standard in ethical review of protocols, and violated international and national ethical guidelines. Furthermore, there are some ethics committees that only conducted scientific review and never ever conducted ethical review, it left only the name to these ethics committees and the reality is nothing to do with ethics. This situation should not be continued. The capacity building should be enhanced.

    中华人民共和国科技部和卫生部

    人胚胎干细胞研究伦理指导原则

                                2004年1月14日《健康报》

    第一条 为了使我国生物医学领域人胚胎干细胞研究符合生命伦理规范,保证国际公认的生命伦理准则和我国相关规定得到尊重和遵守，促进人胚胎干细胞研究的健康发展,制定本指导原则。

    第二条 本指导原则所称人胚胎干细胞包括人胚胎来源的干细胞，生殖细胞起源的干细胞和通过核移植所获得的干细胞。

    第三条 凡在中华人民共和国境内从事涉及人胚胎干细胞的研究活动,必须遵守本指导原则。

    第四条 禁止进行生殖性克隆人的任何研究。

    第五条 用于研究的人胚胎干细胞只能通过下列方式获得：（一）体外受精时多余的配子或囊胚；（二）自然或自愿选择流产的胎儿细胞；（三）体细胞核移植技术所获得的囊胚和单性分裂囊胚；（四）自愿捐献的生殖细胞。

    第六条 进行人胚胎干细胞研究，必须遵守以下行为规范：（一）利用体外受精、体细胞核移植技术、单性复制技术或遗传修饰获得的囊胚，其体外培养期限自受精或核移植开始不得超过14天；（二）不得将前款中获得的已用于研究的人囊胚植入人或任何其他动物的生殖系统；（三）不得将人的生殖细胞与其他物种的生殖细胞结合。

    第七条 禁止买卖人类配子、受精卵、胚胎和胎儿组织。

    第八条 进行人胚胎干细胞研究，必须认真贯彻知情同意与知情选择原则，签署知情同意书，保护受试者的隐私。

    前款所指的知情同意和知情选择是指研究人员应当在实验前，用准确、清晰、通俗的语言向受试者如实告知有关实验的预期目的和可能产生的后果和风险，获得他们的同意并签署知情同意书。

    第九条 从事人胚胎干细胞研究单位应成立包括生物学、医学、法律或社会学等有关方面的研究和管理人员组成的伦理委员会，其职责是对人胚胎干细胞研究的伦理学及科学性进行综合审查、咨询和监督。

    第十条 从事人胚胎干细胞研究的单位应根据本指导原则制定本单位相应的实施细则或管理规程。

    第十一条 本指导原则由国务院科学技术行政主管部门、卫生行政主管部门负责解释。

    第十二条 本指导原则自发布之日起施行。

    对《人胚胎干细胞研究伦理指导原则》的评论：

    1、这是继1998年卫生部颁布医学研究伦理审查指导，1999年国家药品监督管理局颁布药品临床试验管理规范后，国家有关主管科研部门颁布的一个专项伦理指导原则。该文件首先指出了遵守伦理规范和国际国内的伦理准则与科学研究的顺利发展的一致性，明确禁止人的生殖性克隆，禁止人胚胎的研究超过14天，禁止将研究用胚胎植入人和其他动物生殖系统，禁止人的生殖细胞与其他物种生殖细胞的结合，禁止买卖人类配子、受精卵、胚胎和胎儿组织，强调贯彻知情同意和知情选择原则，保护隐私以及要求成立伦理委员会，这些都是非常重要的，应该加以肯定。

    2、但这个伦理指导原则也存在一些问题。这样一种文件需要有术语的定义，例如囊胚和单性分裂囊胚有什么不同，难道通过体细胞核转移技术获得的囊胚不是单性分裂的吗？为什么用这两个术语，它们分别指称什么？同样，体细胞核移植技术和单性复制技术有什么不同？对这样一些术语应该界定。其次，条文之间有不一致之处。例如第五条列举了人胚胎干细胞的来源，未提单性复制技术和遗传修饰，但在第六条加上了单性复制技术和遗传修饰。第三，文件没有罚则，如果违反这个文件的规定，例如有人执意要克隆人，对他应作如何处置。最后，文件虽然多次提到伦理，也要求成立伦理委员会，但人员组成未提伦理学方面的研究人员。因此这将是一个没有伦理学家的伦理委员会。不知道这是文件的制定者一时疏忽，还是就是认为伦理学不是一门专业，任何人未经专门训练，都有资格成为是伦理学家。我们确也遇到一些伦理委员会的负责人，他们未经伦理学专门训练，在国外突击培训，结果未能领会也不会应用伦理学的理论和原则，搞什么内外有别，违反了国际公认的伦理准则和国内有关规定。还有些伦理委员会根本不作伦理审查，仅作科学审查，这类伦理委员会名存实亡。这种情况不应该再继续下去了。应该加强研究伦理的能力建设。