The Oxford Uehiro Centre for Practical Ethics
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CONTENT
EVENTS
Hosting the 2006 World Congress of Bioethics in Beijing Approved by IAB
At the meeting of the Board of Directors, IAB on November 11, 2004 during the 2004 World Congress of Bioethics in Sydney, the Board members unanimously approved that the 2006 World Congress of Bioethics will be held in Beijing after the representatives of Chinese delegation delivered presentation to them. The President of IAB, Dr. Florencia Luna announced the decision at the Closing Ceremony on November 12 afternoon, and on behalf of Chinese delegation Dr. Zhai Xiaomei made a presentation to all participants to describe the scenario of the 2006 World Congress of Bioethics in Beijing. All participants applauded this decision, and many of them expressed they are very willing to go to Beijing in 2006.
First Preparatory Meeting for the 8th World Congress of Bioethics 2006 be Held in Beijing
First Preparatory Meeting for the 8th World Congress of Bioethics which is scheduled to be held in Beijing in 2006 was held in the meeting room of Chinese Medical Association building. Professor Qiu Renzong made a report on the bidding at the meeting of the Board of Directors, IAB and the closing ceremony of the 7th World Congress of Bioethics in Sydney, and suggested the theme and main topics of the 2006 8th World Congress. Participants highly evaluated the significance of hosting the 8th World Congress in Beijing, approved the theme and main topics Professor Qiu had suggested and offered a range of important suggestions on how to do the best to organize the 2006 World Congress including the dates and composition of working committees.
Dates of the 8th World Congress of Bioethics 2006 in Beijing Decided
Dates of the 8th World Congress of Bioethics 2006 in Beijing will be August 17-20 (with August 16 as Registration Day), 2006, not November 2-6, 2006. The reasons are: (1) Avoid the time conflict with the annual conference of American Association of Bioethics; (2) These dates are still in summer vacation, more colleagues would come without need to ask for leave; and (3) The average temperature then is not too hot, and the evening is good for social events.
Proposed Theme and Main Topics of the 8th World Congress of Bioethics 2006 in Beijing
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Theme: A Healthier and Just World
Topic 1: Ethical Issues in Public Health
Topic 2: Market and Medicine: Conflict of Interest in Medical Services and Research
Topic 3: Protecting Human Subjects: Ethics, Regulations and Laws
Topic 4: Genomics and Ethics
Topic 5: Cultural Dimensions of Bioethics
Proposed Associated Congress, Conference, Symposia and Satellite Meetings
Global Summit Meeting of National Bioethics Advisory Bodies
FAB Congress
The 7th Asian Bioethics Conference
International Research Ethics: Capacity Building
ELSIs in Biobanks
Ethical and Policy Issues in HIV/AIDS
Ethical Issues in Long-term Care
Culture, Religion and Bioethics
Confucianism and Bioethics
Ethical Issues in Health Education and Promotion
Ethical Issue in Animal and Plant Biotechnology
Bioethics in Great China
Post-Congress Hong Kong Bioethics Conference
More symposia and meetings are in consideration, such as ethical framework of public health, ethical issues in SARS, ethical issues in rural health, bioethics and human rights, IRB: status quo and problems, the role of companies in bioethics etc.
Messages from IAB and ABA
Joint Statement by
President of International Association of Bioethics (IAB) and President of Asian Bioethics Association
We the undersigned met in Cape Town on 20 March to discuss the recent open correspondence between us as Presidents of our respective associations. We reviewed the issues that led up to that correspondence and agreed to move forward rather than to reflect on any shortcomings of these organizations or on their communications with each other. We had no difficulty in agreeing to the following:
1. Bioethics is an important and highly valued endeavor within countries/regions and globally.
2. All of us who work in Bioethics through national bodies and international organizations have similar aspirations for improving human life and relationships.
3. While we may have different perspectives on many issues we also have much in common and we could all benefit from mutually respectful collegial interactions
4. The current constitution of the IAB is intended to allow for representation from all regions in the world and the constitution of the ABA allows for representation from all regions in Asia. These constitutions should be mutually respected and, if necessary, changed through appropriate processes.
5. Controversies between different regions or different bioethics associations on specific issues should be resolved through dialogue and negotiation that seeks common ground while preserving independence and diversity.
6. Over the past decade successful IAB World Congresses on Bioethics have been held in Amsterdam, Buenos Aires, San Francisco, Japan, London and Brasilia. The 7th World Congress on Bioethics is scheduled to be held in the Sydney in the Pacific region. The ABA has also held many very successful Congresses in China, Japan and Korea.
7. Ongoing efforts should be made to support the work of both the Asian Bioethics Association and the International Association of Bioethics and to arrange jointly sponsored meetings in locations that promote our international aspirations for bioethics.
8. We look forward to close co-operation in taking forward the bioethics endeavor at international and global levels.
Solomon R Benatar Ren-Zong Qiu
President International Association of Bioethics President Asian Bioethics Association
Presidential Message
Qiu Renzong
(2002-2004)
Since our Conference in Seoul in November 2002, more than one year elapsed. In the case of celebrating the Chinese New Year of the Monkey, I congratulate all achievements our Asian colleagues obtained in the past year!
My colleagues and me just organized a bioethics conference, Beijing International Conference on Bioethics. Apart from Chinese participants including those from mainland, Hong Kong, Taiwan and Macao, many came from Asia as well as from Europe, America and Oceania. The conference focused the ethical issues in biomedical and health research, in HIV/AIDS, in gemonics and biotechnology with panel discussions on the informed consent in non-western cultural context, ethical lessons from 731, ethical and policy issues in HIV/AIDS prevention and treatment, and the social responsibilities of geneticists/scientists. Asian bioethicists played crucial role in this successful conference.
As I pointed out at the Inaugural Congress of IAB in Amsterdam in 1993, the development of bioethics not only depends upon the introduction and application of science and technology, but also upon economic increase, social change and political progress. Asia is a one of the regions where economy has been rapidly increasing, the social structure has been tremendously transformed, and the development and application of science and technology are catching up with advanced countries. Together with these positive development bioethics has been made great progress in Asia, whether in North Asia or South Asia, in East Asia or West Asia since the founding of our Association. On the other, the development of bioethics in Asia is uneven. In the least developed countries or regions bioethics is still within sight but beyond reach. We have to make greater efforts in the bioethics of Asia.
The prospect of bioethics in Asia can be looked forward as follows:
The 21st Century will be the one of life science and technology. The development and application of life science and biotechnology will unavoidably bring in a variety of bioethical issues. Especially, during the globalization relying on domestic resources and international cooperation, genomics and biotechnology will be widely studied and applied in the 21st century¡¯s Asia. In these activities bioethicists in Asia will take the responsibilities for protecting human health and life, respecting human dignity, safeguarding human rights, and kindly treating other species and protecting eco-environment.
Asia has huge population and she is rich with human, animal and plant genetic resources. And one of the biggest markets is being formed in Asia. So Asia will become an ideal place attracting many genetic institutes or pharmaceutical companies to come to develop and conduct biomedical and health research involving human subjects. In the research human subjects are in a vulnerable position. The protection of their health, welfare and rights is an obligation of scientists and physicians who conduct the research, sponsors who support the research as well as bioethicists who review and monitor the research.
The epidemic of HIV, SARS and avian influenza in Asia formed other center of ethical concern. The epidemic of these diseases involves ethical issues in the field of public health which may be different from those in clinical or research context. While SARS is a typical public health issue, but HIV is special in dealing with which conventional public health measures are not valid sometimes, because people living with HIV are used to be stigmatized and discriminated and the successful prevention of HIV is related with proper treatment of those social groups in the marginalized position, such as homosexuals, drug users and sex workers. So ethical issues in HIV are more closely related with human right issue.
The protection of patients¡¯ or human subjects¡¯ health, welfare and rights needs to be institutionalized through governmental regulations and legislature¡¯s laws. Developing such regulations and laws and implementing them are urgent issue facing Asia. What is pity is that in some cases few bioethicists are involved in developing and implementing these regulations and laws, and in other cases although there are much ethical debates on protecting patients and human subjects but there is no regulation or law on how to protect them in Asia. Developing these regulations or laws is a multi-disciplinary endeavor, however, the role of bioethicists in it is indispensable.
However, if we do a good job in all these activities mentioned above, we have to build our own capacity. The help and assistance from non-Asian colleagues are important, but we have to be independent and self-reliance. For example in China there are already more than 200 IRBs/ECs, among them some worked well, but some didn¡¯t. Even in some governmental regulation it is not required that an ethical review committee should have a bioethicist as its member. Its members or even its chair don¡¯t know its function, and as a result they only did scientific review and did not do ethical review. The editor and members of the editorial board of a journal didn¡¯t know the role of the journal in protecting human subjects. And even medical ethics teaching staff in medical schools didn¡¯t know the situation in the research involving human subjects and did not have the expertise of ethical review. So the training of PIs, members of IRBs/ECs, medical ethics teaching staff and editors of journals is an urgent work as a part of capacity-building. And the first training activity has been rescheduled in February 2004 because of SARS. As a PI of this first training project I have to stay in China to organize it and won¡¯t be able to attend Tsukuba conference. These activities of capacity-building have been done in India and Thailand. I am looking forward to seeing such projects that would be more often done in Asia. .
When Asian bioethicists participated in the global dialogue, we found we share important values with non-Asian colleagues. You can find the values or principles such as do no harm, beneficence, respect and justice in Confucianism or Islamism as they are in western culture. However, these values or principles are rooted in Asian culture or philosophy. The philosophical foundation of these values or principles are different from western counterpart, and the application of them are also different. For example, in many Asian countries or regions, the ties between individual and her/his family or the community he/she belongs to are much closer than those in western countries. Hence, in the process of implementing the principle of informed consent the role of family and community cannot be neglected. This is what Chinese philosophers called ¡°harmony does not mean identical¡± or ¡°there are differences in similarities¡±. In view of that we feel difficult to accept such an overarching universal ethics or global bioethics. However, it does not mean that there is no value which we share with people from other cultures, or that it is impossible to form a common ground for a common action. It is what Chinese philosophers called ¡°there are similarities in differences¡±. And I believe with the more communications between Asia and other continents shared values and common ground will increase or enlarge. But the moral diversity exists not only in the world, but also within Asia or within each continent. It can be shown in the book titled ¡°Bioethics: Asian Perspectives¡± edited by me and published by the Kluwer Academic Publisher as the 80th volume in the Book Series ¡°Philosophy and Medicine¡±. Its contributions are all non-western bioethicists. The moral diversity will benefit the development of bioethics in a global scale as well as in Asia. I am looking forward to seeing more work that will be done by Asian bioethicists in the field of cultural dimension of bioethics.
I wish success of the conference in Tsukuba.
I wish all of you enjoy the conference.
Country Report: China
Zhai Xioamei
Associate Professor
Executive Chairperson; Department of Social Science and Humanities
Peking Union Medical College
Executive Director, Research Center for Bioethics
Chinese Academy of Medical Sciences & Peking Union Medical College
Vice-President, Asian Bioethics Association
1. A Brief History of Bioethics in China
Although the morality of traditional medicine has long history of thousands years, the bioethics began in modern China with a series of events during 1970s-1980s.
In December 1979 a Conference on Philosophy of Medicine was held in Guangzhou at which a major report was focused on ethical issues raised by advanced biomedical technologies, such as life-sustaining technology, assisted reproductive technology and organ transplantation technology etc. In 1980 the journal Medicine and Philosophy was started to be published with the responsible editorship of Du Zhizheng, and in its first issue there was an article on brain death and euthanasia. In 1986 there was a workshop on bioethics for training young teaching staff in medical schools in Nanjing City organized by Southeast University and Railway School of Medicine, many of them later became the backbone of bioethics in China. In 1987 the book Bioethics (Qiu Renzong, Shanghai People¡¯s Press) was published, the book was one of the most popular books in China, 50 thousands copies were sold out soon.
Among the most important events we have to mention two conferences in 1988 and two legal cases. In July 1988 the first National Conference on ELSI Issues in Euthanasia was held in Shanghai, the conference was concluded with a statement on the right of terminally ill to choice the way of dying, except two all participants agreed. The other was the National Conference on ELSI Issues in Human Reproduction which was held in Yueyang, Hunan Province), this conference was ended with a policy recommendation on the regulation on artificial insemination and sperm banks to the Ministry of Health and the State Commission on Family Planning. In 1986 and 1987 there were two legal cases respectively on euthanasia and artificial insemination by donor that were publicized in mass media and caused the debate in professionals and the public. The case on euthanasia took place in Hanzhong City, Shanxi Province. A patient¡¯s two daughters sued the doctor to the court for he had done active euthanasia to their dying mother upon the request of the patient¡¯s another daughter and son. The courts finally sentenced that according to China¡¯s Criminal Law the doctor was guilty, but in view of the crime being insignificant he could be treated as non-guilty. The other case was in Shanghai City where a wife whose husband was infertile gave birth to a baby boy with AID, but the husband¡¯s parents refused to accept the boy because the boy did not come from the husband¡¯s blood line.
Since then almost each year there was a national conference on bioethics in addition to local conferences. Every two years one national conference was organized by the Chinese Society for Medical Ethics with the presidentship of Du Zhizheng and Li Benfu successively and the other was done by the Committee on Philosophy of Medicine (with the chairship of Peng Ruicong who is Chair of the Ethics Committee, the Ministry of Health now) affiliated with Chinese Society for Philosophy of Nature, Science and Technology. These national conferences covered almost all topics in bioethics. Academic exchanges between mainland, Hong Kong, Taiwan and Macao were getting more and more frequently. Apart from these, there were also bilateral or international conferences between China and other countries, such as Sino-Japan, Sino-US or Sino-German Conferences and Conference on Bioethics in East Asia (1995). The results of Sino-German Conference are two volumes of medical ethics: Responsibility for Health and Healthcare Policy and Medical Ethics: International Perspective (edited by H-M Sass, DP Shi and RZ Qiu, 1995) and the result of the Conference on Bioethics in East Asia is to establish the East Asian Association of Bioethics, later it was outgrown into Asian Bioethics Association.
Feminist approaches to bioethics were also promoted at the Symposium on Feminist Thought and Chinese Women (1994), in the Project of Reproductive Health and Ethics (1993-1999), in the project of Feminist Philosophy and Public Policy (1996-1999) and at the Symposium on Feminist Approaches to Bioethics (2002).
After the publicity of the sheep Dolly bioethics began to be institutionalized in mainland and became a focus not only from academics but also from the government and legislature, from the public and mass media. The regulations or laws which have been promulgated since 1998 include:
Ministry of Health (MOH): Interim Guidance on Ethical Review of Biomedical Research Involving Human Subject (1998)
Ministry of Science and Technology (MOST) and MOH: Interim Measures for the Administration of Human Genetic Resources (1998)
National People¡¯s Congress (NPA): Law on Practicing Doctors (1999)
State Food and Drug Administration (SFDA): Drug Clinical Trial Guidelines (2000)
MOH: Regulations on Human Assisted Reproductive Technologies (2001)
MOH: Regulations on Compulsory Labeling on GMO (2002)
MOH: Ethical Principles of Human Assisted Reproductive Technologies (2003)
MOH: Guidelines on Human Assisted Reproductive Technologies (2003)
MOST & MOH: Ethical Guidance on Human Embryonic Stem Cell Research (2004)
In drafting and discussing these guidelines or regulations bioethicists and other professionals have been involved and participated.
2. Human Genetics and Genomics: Ethical, Regulatory and Legal Issues
Chinese scientists participated in HGP and finished 1% of its work. They also participated in HGDP the result of which showed that Chinese came from Africa. Now many centers are focusing on the relationships between genes and diseases, the main centers include Chinese National Human Genome Research Center (Northern) and Chinese National Human Genome Research Center (Southern), Chinese Academy of Science, Chinese Academy of Medical Sciences/Peking Union Medical College, Peking University, Fudan University, Shanghai Second Medical University, Central South University, etc. Chinese scientists also participated in the International Hap Map Project.
In 1994 a controversial law was promulgated by the Parliament (NPC): Law on Maternal and Infant Health Care. In Article 10 it is stipulated that if a couple is diagnosed with certain genetic disease of a serious nature which is considered to be inappropriate for child-bearing from a medical point of view after premarital medical examination, they may get married only after consenting to take long-term contraceptive measures of performance of ligation operations. This article is regarded as the discrimination on the basis of genome by critics. In August 1998 representatives of NPC/MOH accepted suggestions made by geneticists/bioethicists who proposed that informed consent/choice should be made a principle which must be adhered in any place at any time, and promised that some articles of the law will be revised in some way at appropriate time. At the 18th International Congress of Genetics (Beijing, 1998) participants reached the following consensus:
* Countries share many ethical principles based on the will to do good and not harm. These principles can be applied in many different ways.
* New genetic technology should be used to provide individuals with reliable information on which to base personal reproductive choices, not as a tool of coercive public policy.
* Informed choice should be the basis for all genetic counseling and advice on reproductive decisions.
* Genetic counseling should be for the benefit of the couple and their family: it has minimal effect on the incidence of deleterious alleles in the population.
* The term ¡°eugenics¡± is used in so many different ways as to make it no longer suitable for use in scientific literature.
* In formulating policy on genetic aspects of health, international and interdisciplinary communication should be carried out at all levels.
* It is the responsibility of policy makers concerned with genetic aspects of human health to seek sound scientific advice.
* It is the responsibility of geneticists to educate physicians, decision-makers and the general public in genetics and its consequences to health.
In August 2003 the Government promulgated Regulation on Marriage Registry in which it is stipulated that marriage applicants only need to bring ID card and ¡°registered permanent residence¡±, premarital medical examination is voluntary, but not compulsory. However, marriage between homosexuals and cohabitation still not be protected by law.
On December 2, 2000 ELSI Committee, HGP China issued a four points statement:
* The research on human genome and its application should be focused on the treatment and prevention of diseases, but never on eugenics;
* In the research on human genome and its application, the principle of informed consent or informed choice should be adhered persistently;
* In the research on human genome and its application, the privacy of individual genome should be protected, and the discrimination on the basis of genome should be combated; and
* In the research on human genome and its application, efforts should be made to promote the equality between persons, harmony between ethnic groups, and peace between countries.
On June 10, 1998 "Interim Measures for the Administration of Human Genetic Resources" promulgated by The Ministry of Science and Technology and The Ministry of Health and enforced, in which Article 13 (6) stipulates that ¡°No approval for the application in which no evidence to confirm the informed consent being obtained from the donor of human genetic sample and her/his family member.¡±
In November 2001 Ethics Committee, MOH submitted a proposal of Ethical Principles and Regulation on Human Embryonic Stem Cell Research to MOH, the major points include:
* Prohibit human reproductive cloning and permit human therapeutic/research cloning.
* Ethical principles include: Respect, Informed consent, Safety and Efficacy, Non-commercialization.
* Sources: first choice is to derive totipotent stem cells for research from aborted fetal primordial germ cells or the spared human embryo after the success of IVF. The use of nucleus transfer to create embryo to derive stem cells is permissive in special condition, but should be subject to strict regulation.
* Prohibit: Re-implant the embryo for stem cell research into human or animal uterus;
Mix human and animal gamete or embryo to make chimera;
Use the embryo more than 14 days;
Add any external gene into embryo, or replace the nucleus of the embryo with any other human or animal nucleus;
Coerce or induce donor to be pregnant and undergo abortion or manipulate the method and time of abortion;
Selling and buying human gamete, embryo or fetal tissue.
* Ethical review, monitoring, inspection, ethics training are required.
There has been much debate on ethical issues in human genome research, human cloning, stem cell research, gene therapy, xenotransplantation, GMO, gene patenting etc. A project on these issues under the directorship of Dr. Zhai Xiaomei was completed at the beginning of 2003. This project was sponsored Beijing Municipal Government. Some of the findings have been incorporated into the proposal of Ethical Principles and Regulation on Human Embryonic Stem Cell Research made by Ethics Committee, MOH. The next step is to draft an act on one or other specific issue such as GMO and submit it to Beijing Legislature.
In January 2004 An Ethical Guidance on Human Embryonic Stem Cell was promulgated jointly by MOST & MOH, the major points of which include:
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 the function of which is to conduct the scientific and ethical review, counseling and surveillance for human embryonic stem cell research.
3. Ethical Issues in Biomedical and Health Research in China
China is a country which has long medical history with almost thousands years but without the tradition of human experimentation. There are epistemological and ethical reasons to argue against human experimentation. However, Chinese are the main victims of anti-human and anti-humane human experimentation conducted by the Japanese 731 Troops during the Japanese occupation, and they still bear the consequences of Japanese germ warfare. Since the policy of reform and openness scientists within and without mainland China found that China is rich with human, animal and plant genetic resources and pharmaceutical companies found that China would be one of the biggest markets in the world. So the research involving human subjects would be developed in China with an unimaginable pace and scope.
In 1998 MOH promulgated ¡°Interim Guidance for Ethical Review of Biomedical Research Involving Human Subject¡± which emphasizes ¡°this regulation is for safeguarding human dignity, protecting human life and health and observe basic ethical principles¡± and include chapters on informed consent, responsibilities of the investigators, rights of human subjects and IRBs.
On September 1, 1999 the State Food and Drug Administration (SFDA) promulgated ¡°Drug Clinical Trial Guidelines¡± in which it is emphasized that: ¡°All researches involving human subjects must comply to ethical principles elaborated in Helsinki Declaration and in CIOMS¡¯ International Ethical Guidelines on Biomedical Research Involving Human Subjects, i.e. justice, respect, maximum benefits to human subjects, and avoidance of harms as far as possible¡± (Article 4) and ¡°In the process of drug clinical trials the individual rights and interests of human subjects must be safeguarded, and the research must be scientific and reliable as well. Ethics Committee and informed consent are major measures to guarantee human subjects¡¯ rights and interests.¡± (Article 8) Now 165 IRBs have been set up since 1999.
In the Law on Practicing Doctors, promulgated by National People's Congress and enforced on May 1, 1999 it is stipulated in Chapter: Legal Accountabilities that if a doctor conducts experimental clinical treatment without the consent from the patient or her/his family member (Article 8) and discloses patient¡¯s privacy and cause serious consequences (Article 9), he/shi has to bear the legal accountabilities. .
Many IRBs did work very well, but many did not. Many members of IRBs/ECs and PIs are not ethically well trained, they don¡¯t know what is the function of IRBs/ECs and how to fulfill it. Some IRBs/ECs actually only did scientific review, not ethical review. There is no inspection to these 165 IRBs affiliated with SFDA, and the enforcement of regulations is very weak in MOH: some ECs only review the protocols in cooperation with foreign colleagues. So capacity-building for bioethics and research ethics is an urgent need in China. As a symbol with the publishing of the books An Introduction to Bioethics (2003) and Biomedical Research Ethics (2003), the training in bioethics and research ethics will be strengthened in coming years since 2004 on. The first training project is sponsored by CMB (Chinese Medical Board) and the training workshop will be held in February 2004. The Ministry of Education authorized PUMC Research Center for Bioethics to organize a workshop to train bioethics teaching staff for the course ¡°Ethics in Biomedical and Health Research¡± in the middle schools in this summer. Following these training activities there will be other training projects include that under the sponsorship of NIH.
In complying with international ethical guidelines on biomedical and health research involving human participants the cultural characteristics emerged in China. As well as in clinical context in research context the elements of disclosure of information and comprehension of it were affected by the factors of scientific illiteracy and culturally different discourse. For example, how to disclose the information framed in scientific language to human participants who may only know the language of yin-yang and five agents and how to help them to understand the information disclosed. As for the element of consent, in Chinese cultural context individual is in closer relationship with family and community he/she belongs to than his/her western counterpart, how to deal with the relationship between individual¡¯s consent and family/community¡¯s permission when a research project will be conducted with human participants who are living with other members of her/his family/community?
4. Ethical and Policy Issues in HIV and SARS
Ethical, policy and legal issues related to HIV prevention and treatment have been debating for a long time. In 1993 and 1996 Ethical Principles and Action Recommendations on STD/HIV and Action Recommendations on HIV and Prostitution have been submitted to the government and legislature respectively. In 2000 an action recommendations including an ethical framework for evaluation of action in HIV under the sponsorship by the Chinese Academy of Science was finished and sent the government, and the government accepted all recommendations except the suggestion of revising the law on prohibiting prostitution and drug use. In 2002 a report on law reform related to HIV was finished by a consultant team under the sponsorship of UNDP and sent to the government and legislature. The report addressed the issues such as: Why is it necessary to carry out law reform in the prevention and care of AIDS? What kind of laws do we need: Punitive or protective? Why are the conventional public health measures ineffective for AIDS? Why the prevention of AIDS should not be tied up with the solution of social problems? Is it necessary to re-evaluate the current policies on drug use and prostitution? Why it is impossible to escape the issue of human rights? Why NGOs are indispensable in prevention and treatment of HIV/AIDS? Do we have the political determination to carry out legal reform? The report contains the specified suggestions of how to revise the current laws related to HIV. And Chinese legislature has started to consider this law reform. (The English version of this report is available in the office of UNDP). Now in Suzhou City, Jiangsu Province, a regulation on HIV was promulgated in 2003 with the focus on combating discrimination against people living with HIV. In Shanghai City the current regulation on HIV would be revised soon.
The epidemic SARS in China in 2003 highlighted the weakness of public health system, the shortcomings of health care reform and the inadequacy of resources allocated to health care, and public health in particular. The health care needs of rural people including those who are working in urban areas became a focus of decision-makers¡¯, professionals¡¯ and public concern. Health information transparency and health literacy are also concerned.
5. Assisted Reproductive Technologies
The infertile rate in newly married couple is increasing for unknown reason in China. However, the Confucian value on having offspring still remains. What Mencius said still affects Chinese mind: ¡°Among three sins which violate filial piety the largest is without offspring.¡± Infertility has been regarded as a punishment for the misbehavior did by infertile people¡¯s ancestor or in his/her previous life. So infertile people experiences psychological and social pressure. The need or demand for the assistance from reproductive technologies is so great that ART became so popular and a money-making business. In the first National Conference on Reproductive Technologies participants worried about the social and ethical issues in artificial insemination and suggested MOH and the State Commission on Family Planning to regulate them. But the response was that these two ministries thought it was not the proper time to regulate them. In 1999 at the Fragrant Hill Science Conference on the 21st Dilemmas of Bioethics in Kunming City participants raised the regulation issue again. This time MOH accepted the suggestion and set up an expert team to draft the regulation.
On August 1, 2001 Regulation on Human Assisted Reproductive Technologies was promulgated by MOH and enforced. In it there is Article 22: Prohibit ¨C
* Selling or/and buying human gamete, zygote or embryo;
* Surrogate motherhood;
* Unauthorized sex selection;
In July 2003 MOH promulgated Ethical Principles of Human Assisted Reproductive Technologies in which the following principles are specified: benefit to patient, informed consent, protecting children, social good, privacy and confidentiality and non-commercialization. At the same time MOH promulgated ¡°Guidelines on Human Assisted Reproductive Technology¡± in which it is stipulated that
-- Must strictly observe the voluntary principle of informed consent or informed choice;
-- Must respect the patient¡¯s privacy;
-- Prohibit sex selection without medical indications;
-- Prohibit surrogate motherhood technology;
-- Prohibit the hybrid between human gamete and gamete from of other species; prohibit to implant gamete, zygote and embryo of other species into human body, and prohibit to implant human gamete, zygote or embryo into the body of other species;
-- Prohibit the coagulation between sperm and egg of close relatives;
-- Prohibit to transfer the gamete, zygote or embryo to other people or to do research without the patient informed and free consent;
-- Prohibit to do the study on human chimera embryo;
-- Prohibit human reproductive cloning.
6. Brain Death and Organ Transplantation
Human organ transplantation began in 1972 when Sun Yat-sen Medical College did first kidney transplantation between family members, but the patient only survived more than one year. In 1981 the number of the cases have been underdone all over mainland China is kidney transplantation 800, liver 54, heard 3, lung 2. During the recent decade organ transplantation has been developed rapidly. In 2001 the number of kidney transplantation reached to 5561, only next to USA. The advances of organ transplantation technology caused the social needs. The provision of organs has been far much less than the demand. One reason is that Chinese have not accepted the concept of brain death yet, so China is only a major country in the world which brain death has not been legalized. The other reason is the influence of traditional cultural tradition which requires a person to keep his/her body intact before to cremation. According to rough estimate each year the number of patients who need to undergo organ transplantation reach to 100 or 150 millions, however, only 130 thousands undergo the operation.
In 1996 108 members of the National Political Consultation Conference (NPCC, China¡¯s Senate) presented an act on the legislation on corpse organ donation in Beijing, Tianjin and Shanghai cities. Since then almost every year there were members of NPC or NPCC provided the similar act. On December 15, 2000 Shanghai Municipal People¡¯s Congress promulgated ¡°Regulation on Corpse Organ Donation¡± which was enforced on March 1, 2001. On August 22, 2003 Shenzhen Municipal People¡¯s Congress promulgated Regulation on Human Organ Donation and Transplantation in the Special Economic Zone of Shenzhen. Human Province¡¯s Regulation on Human Organ Donation and Transplantation will be promulgated in 2004. In recent years MOH initiated to develop the Regulation on the Determination of Brain Death, Criteria for Determining Brain Death, and draft the Regulation on Human Organ Transplantation. All these regulations emphasize the principle of voluntary consent and non-commercialization, organ selling and buying are prohibited.
In the case of the demand far much more than the provision the controversial practice of using organ of prisoners who were sentenced to capital punishment after the execution has done in mainland China. Some bioethicists (e.g. Qiu Renzong) has argued that this practice relying on organ of prisoners who were sentenced to capital punishment after the execution is ethically unjustifiable. And this practice will be ended with changing the way of execution (shooting replaced by injecting drug).
Chinese bioethicists 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 titled ¡°Money 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. Bioethics is a journal of International Association of Bioethics and the elementary requirement to publish an article should be evidence-based and reliable, and the article with prejudices should be carefully reviewed. As we 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?
7. Euthanasia
Euthanasia is the first bioethical issue that Chinese are interested in. There were a number of legal cases about euthanasia, however, the conception of euthanasia in the public as well as in professionals is confused. For example, Hitler¡¯s ¡°euthanasia¡± is not euthanasia, passive euthanasia is not euthanasia too. Questionnaires showed that about 80% in the public favor euthanasia, while 20% against. In medical professionals there is conflicting attitudes towards euthanasia. However, the majority of ethicists favor euthanasia. But according to the interpretation of the Criminal Law euthanasia should be regarded as a kind of murder because of two elements: the actor has the intention to kill someone and someone¡¯s death is caused by the action. Nevertheless, even though euthanasia is treated as murder, but the sentence is always only three years prison for the offender, but in the case of murder the offender is usually sentenced to life prison if not to capital punishment. This shows that there is difference between euthanasia and murder.
Secondly there is some problem in the arguments for euthanasia. In Chinese literature there are some articles in which the argument for euthanasia is for relieving the burden from family or society, but more bioethicists argue that the justification for euthanasia is the beneficence to the terminally ill and for the respect for her/his autonomy or self-determination.
The third issue is whether euthanasia should be legalized. Almost in each session of NPC there are acts to request euthanasia legalized. But some bioethicists argued that it is not the time now to legalize euthanasia in mainland China. In view of that the fiduciary relationship between physician and patient is getting worsen and the turn to market is eroding the sense of filial piety in the public, the legalization of euthanasia would lead to many unexpected negative consequences. What we need, they argued, is non-criminalization of euthanasia, that is to set a series of strict conditions which is to be met if euthanasia is not treated as murder, while the interpretation of euthanasia as murder will be no change.
In 2003 a book titled as Dying with Dignity (Zhai Xiaomei) was published in Beijing. The book answered all ethical questions and discussed all arguments around euthanasia raised in mainland China.
8. Recent Development
In addition to those mentioned above, the developments that should be mentioned include:
Center for Bioethics has been set up in universities or medical schools such as in Chinese Academy of Medical Sciences/Peking Union Medical College (PUMC), Huazhong University of Science and Technology/ Tongji School of Medicine, Wuhan University.
Some representative books on bioethics were published in 2003, such as An Introduction to Bioethics (Qiu Renzong and Zhai Xiaomei, PUMC Press), Biomedical Research Ethics (Chen Yuanfang and Qiu Renzong, PUMC Press), Bioethics (Xu Zongliang, Shanghai People¡¯s Press) and Bioethics (Shen Mingxian, Higher Education Press).
Last but not the least is the Beijing International Conference on Bioethics. Organized by the Research Center for Bioethics, Chinese Academy of Medical Sciences/Peking Union Medical College (CAMS/PUMC), Philosophy Summer School in China: China Britain Australia and the Committee on Bioethics, Beijing Society for Bio-engineering, the Beijing International Conference on Bioethics which had been postponed because of the SARS epidemic was rescheduled and held on January 5-7, 2004. There were about 120 bioethicists who participated in the conference, apart from those coming from mainland, Hong Kong, Taiwan and Macao, there were also those coming from Korea, Japan, the Philippines, Australia, New Zealand, South Africa, Britain, the Netherlands and USA, among them many are world famous bioethicists. Main topics of the conference are Ethics in Biomedical and Health Research, HIV/AIDS and Ethics, and Ethics and Genomics/Biotechnology. There were four panel discussions: Informed Consent in the Context of Non-Western Cultures, Ethical Lessons from Japanese 731 Troops, Ethical and Policy Issues in HIV Prevention and Treatment, and Social Responsibility of Geneticists/Scientists.
And Chinese bioethicists is also considering to host the 2006 IAB Congress.
Events
February 10-20, 2004, Biomedical and Health Research Ethics Workshop was held in Hangzhou under the sponsorship of Chinese Medical Board (CMB) and organized by the Health Science Center, Peking University. Lecturers include US Professors Robert Levine from Yale, Mark Siegler from Chicago, Bernard Lo from State University of California-San Francisco and Jeffrey Kahn from University of Minnesota, and Chinese Professors or Drs. Qiu Renzong, Peng Ruicong, Chen Yuanfang, Li Benfu, Du Zhizheng, Zhai Xiaomei, Zhang Daqing, and Wang Yanguang.
February 11-19, 2004, US Professors Robert Levine from Yale, Mark Siegler from Chicago, Bernard Lo from State University of California-San Francisco and Jeffrey Kahn from University of Minnesota were invited by the Research Center for Bioethics, PUMC to give lectures on research ethics.
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 Zhizheng 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 Zhizheng 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?
Chinese Scholar Criticized an Article that Distorts Chinese Reality Published in Bioethics
In her presentation titled ¡°Updating Statute and Idea after Technology ¨CAdvance 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 titled¡°Money 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?
Workshops
Expert Workshop on ELSI of Sex Ratio at Birth (0-4) in Mainland China
Expert Workshop on ELSI of Sex Ratio at Birth (0-4) in Mainland China was held in Beijing on June 27-28, 2004. The Workshop was organized by the Project of Reproductive Health & Ethics, Chinese Academy of Social Sciences and Research Center of Bioethics, Chinese Academy of Medical Sciences/Peking Union Medical College, sponsored by the Ford Foundation and UN Population Fund. About 60 experts from disciplines of medicine, pubic health, demography, sociology, ethics, law, women studies, family planning programmers etc. participated in the workshop, experts from Taiwan, Korea, Japan and India as well as experts from international organizations were invited to attend the Workshop too. The Workshop focused on the topics such as status quo of sex ratio at birth in mainland China, factors causing sex ratio imbalance, policy and legal factors affecting on sex ratio, international and regional experiences, and action recommendations. At the Opening Ceremony Professor Sun Jing, on behalf of Institute 1of Philosophy, Chinese Academy of Social Sciences, Mrs. Eve W-J Lee, the Program Officer of the Ford Foundation, and Mrs. Siri Tellier, the Representative of the UN Population Fund delivers speeches.
Workshops
Sino-UK Workshop on Bioethics in Beijing
On October 19-20, 2004 Sino-UK Workshop on Bioethics was held at the Great Wall Sheraton Hotel. The Workshop was jointly organized by Cultural and Education Section, British Embassy and Research Center for Bioethics, Chinese Academy of Medical Sciences(CAMS)/Peking Union Medical College(PUMC). At the Opening Ceremony, Mr. Neil Webb, the Vice Chief of the Section, and Dr. Zhai Xiaomei, the Executive Director of the Research Center for Bioethics, Representative of Academician, Professor Liu Depei, the President of CAMS/PUMC made welcome speeches. About 30 Chinese and British bioethicists participated in the meeting. The speakers include:
David Archard, Professor and Director, Institute of Environment, Philosophy and Public Policy, Lancaster University
Informed Consent
Zhai Xiaomei, Dr. and Executive Director, Research Center for Bioethics, CAMS/PUMC
Informed Consent in China¡¯s Clinical Research Context
Mairi Levitt, Dr. and Vice Director, Center for Economic and Social Aspects of Genomics, Lancaster University
Ethical Issues in Biobanks
Garath Williams, Dr. Lancaster University
Informed Consent and Human Biobanks
Zhang Xinqing, Lecturer and CDr., Research Center for Bioethics, CAMS/PUMC
Ethical Issues in Gene Therapy
Michael Parker, Dr. and Reader, Oxford University
Ethical Issues in Genetic Testing
Lei Ruipeng, Lecturer and CDr., Center for Bioethics, Huazhong University of Science & Technology(HUST)
Ethical Issues in Xerotransplantation
Sue Weldon, Dr. Lancaster University
Communication between Scientists and the Public in Biotechnology
Qiu Renzong, Professor, Institute of Philosophy, Chinese Academy of Social Sciences (CASS)
Bioethics in China: Status quo and Issues
Before and after the Workshop British bioethicists gave lectures at Peking Union Medical College (PUMC), Health Science Center/Peking University(HSC/PU), and the Graduate School/Chinese Academy of Science. They also went to Chongqing and Chengdu to give lectures. And on October 21 evening Sue Weldon, Zhai Xiaomei, Michael Parker and Qiu Renzong participated in the Caf¨¦ Scientifique to talk with about 200 participants on the topic: Should we play god in gene manipulation?
Bioethics Capacity Building in Ascendant
Up to October 31, 2004 five training workshops on bioethics/research ethics have been held in China:
|
Time |
Place |
Organizers |
Sponsor |
|
February 2004 |
Hangzhou |
HSC/PU |
CMB* |
|
August 2004 |
Shanghai |
HSPH** SMC/FU*** |
FIC/NIH**** |
|
August 2004 |
Hefei, Anhui Province |
AMU***** PUMC |
MOH****** |
|
October 2004 |
Shenzhen |
Municipal Bureau for Health |
Municipal Bureau for Health |
|
October 2004 |
Beijing |
CMIHC/CDC******* PUMC |
|
*CMB=Chinese Medical Board
**HSPH=Harvard School of Public Health
***SMC/FU=Shanghai Medical College/Fudan University
****FIC/NIH=Forgaty International Center/National Institute of Health
*****AMU=Anhui Medical University
******MOH=Ministry of Health, this workshop is the first of the Research Ethics Project of National Continuing Medical Education.
*******MIHC/CDC=Center for Maternal and Infant Health Care/Center for Disease Prevention and Control
The topics of training includes: history lessons, basic ethical principles, international and national ethical guidelines, ethical issues in research design, informed consent and confidentiality, IRB and ethical review, conflict of interest, ethical issues in human reproductive health or assisted reproduction research, ethical issues in human genetic research, ethical issues in HIV/AIDS research, ethical issues in clinical trials, ethical issues in research with vulnerable groups, ethical issues in stem cell research, ethical issues in preimplantation genetic diagnosis, ethical issue in organ transplantation, ethical issues in prenatal diagnosis/genetic counseling, and scientific integrity and misconduct in science etc.
Participants in those workshops included: PIs who engage in biomedical research or clinical trials, chairs or members of IRB, managers/administrators for scientific research in health administrations, hospitals or institutes, mentors or supervisors of Ph.D. students, chairs of departments at medical schools or hospitals, deans of medical schools, directors of institutes, vice-chief of municipal bureau for health, faculty members of medical schools and hospitals, and graduate students etc., altogether 300 or so.
The future workshops:
|
Time |
Place |
Organizers |
Sponsor |
|
November 2004 |
Chengdu, Sichuan Province |
HSC/PU |
CMB |
|
March 2005 |
Beijing |
HSPH PUMC |
FIC/NIH |
|
May 2004 |
Wuhan, Hubei Province |
HSPH HUST |
FIC/NIH |
|
Not decided |
Xian, Shannxi Province |
HSC/PU |
CMB |
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