中国生命伦理学网
The Oxford Uehiro Centre for Practical Ethics
Content
Regulation on Ethical Review of Biomedical Research Involving Human Subjects, MOH（new)
Regulation on Clinical Application of Human Organ Transplantation Technologies（new)
Regulation on Misconduct in Scientific Research, MOST（new)
Regulation on AIDS Prevention and Treatment（new)
The Debate on Compulsory Marital Examination
l The Brain Surgery for Treating Drug Addiction was Prohibited by MOH
l Action Recommendations on Correcting the Birth Sex Ratio Imbalance
l Develop a National Specific Law
l Establish or Enhance the Sex Reporting System for Hospitals and Family Planning Institutions
l Seriously Treat the Cases of Discriminating and Abusing Female Infants and Girls
l Review and Revise the Laws, Regulations and Practices with Gender Inequality
l Spread the “Action of Care for Girls” to All over the Country
l The Preferential Policy to the Family with Only One Girl or Two Girls Should be Widened
l Education of Gender Equality to all Professions
l Play the Role of NGO and Enhance the International Collaboration
l Laws and Regulations related with Bioethics in China (1)n Chapter 1: General Provisions
n Chapter 4: Obligations of Researchers
n Chapter 5: Interests and Rights of Human Subjects
n Chapter 8 Article 25: Prohibit
l Law on Practising Doctors, promulgated by National People's Congress and enforced on May 1, 1999.
n Chapter: Legal Accountabilities
n Chapter 1: General Provisions
n Chapter 2: Preparation before Clinical Trial and Necessary Conditions
n Chapter 3: Guarantee the Rights and Interests of Human Subjects
l Regulation on Marriage Registry promulgated by the State Council in August 2003
l Guidelines on Human Assisted Reproductive Technologies (Ministry of Health, July 2003)
n III. Guidelines for Practitioners
l Comments
n Ethical Guiding Principles on Human Embryonic Stem Cell Research
Regulation on Ethical Review of Biomedical Research Involving Human Subjects, MOH
On 11 January 2007 the Ministry of Health (MOH) promulgated Regulation on Ethical Review of Biomedical Research Involving Human Subjects. The regulation includes 5 chapters. In the General Provision it is pointed out that to develop the regulation is for normalising the biomedical research involving human subjects and the application of technologies concerned to protect human life and health, safeguard human dignity, and protect legitimate rights and interests of human subjects. Ethical review should be conducted according to law and regulation, and accepted bioethical principles. Ethical committees are established at ministry, provincial and institutional levels. To manage and oversee the ethical review of biomedical research involving human subjects should be include into the work of scientific research administration of health care department at all levels.
Ethical Committee at the level of Ministry of Health consists of 17 members, Qi Guoming (President, CMA), Qiu Renzong (Vice-President, CASS), Chen Yanqing (NPC), Chen Junshi (CDC), Liu Gengtao (CAMS), Chen Yude (Peking University), Li Benfu (Peking University), Yu Mengsun (Centre for Biomedical Technologies), Li Xunwei (PUMC Hospital), Yuanzhong (CAMS/PUMC), Chen Chunming (CDC), Zhai Xiaomei (CAMS/PUMC) , Hu Qingli (Shanghai Jiaotong University), Guo Zhaojiang (University of Military Medicine), Wang Ruotao (CDC), Dong Yuzhneg (Guangzhou), Fan Mingsheng (Shanghai University of Traditional Medicine).
Regulation on Clinical Application of Human Organ Transplantation Technologies
MOH promulgated Regulation on Clinical Application of Human Organ Transplantation Technologies which came into effect on 1 July 2006. The regulation includes general provision, registry, management of clinical application, oversight etc. The regulation requires that the institution which plans to develop organ transplantation should register and get permission, meet qualifications in the scientific and ethical dimensions, and establish ethics committee. Before transplantation the case should be submitted to ethics committee to review and approve. The process of informed consent must be conducted and written informed consent form must be obtained from donor and recipient. Organ trading is prohibited and the donor has right to refuse to donate before transplantation even he/she agreed before. The government is making efforts to draft a more comprehensive regulation on organ transplantation.
Regulation on Misconduct in Scientific Research, MOST
On 9 November 2007 the Ministry of Science and technology promulgated Regulation on Misconduct in Scientific Research. The misconduct is defined as:
Provide faked information on title, resume and research background;
Plagiarise scientific findings as own;
Fabricate or juggle data;
Violate informed consent and confidentiality;
Violate the norms of protecting experimental animals;
Other misconducts.
MOST is responsible for investigating and dealing with the major cases of misconduct, and establish the office of scientific integrity for it. The penalties for misconduct include: warning; criticism publicised; regular review; prohibiting to participating in scientific research; recording wrongdoings into file; demotion; dismiss.
Regulation on AIDS Prevention and Treatment
Regulation on AIDS Prevention and Treatment adopted at the 122nd Executive Meeting of the State Council on 18 January 2006 is thereby promulgated and was effective as of 1 March 2006.
Article 3 Any unit and person must not discriminate HIV infected, AID patient and her/his family members. The rights and interests of HIV infected, AID patient and her/his family members to marriage, employment, medical care, schooling shall be protected by law.
Article 7 The government at various levels shall take measures…to provide behaviour intervention for the groups who are susceptible to HIV infection with their high risk behaviour and provide care and assistance.
Article 23 The state endorses HIV voluntary counselling and voluntary testing.
Article 29 The managers of public sites shall lay condoms or install facilities for distributing or selling condoms.
Article 38 HIV positive and AIDS patient shall assume the following obligations:
Accept epidemiological investigation and guidance by CDC;
Timely inform her/his sex partners about her/his facts of infection and illness;
Faithfully inform doctor about her/his facts of infection and illness when seeking medical care;
Take necessary precautions against infecting others.
HIV positive and AIDS patient shall not intentionally transmit HIV in any way.
Article 39 Without the consent by the self or the guardian any unit and person must not disclose the name, address, work unit, image, medical record and any information of HIV infected, AID patient and her/his family members which can be inferred to her/his identity.
Chapter IV Treatment and Assistance
Article 41 Medical institution
shall provide HIV counselling, diagnosis and treatment services
to
HIV infected and AID patient.
Medical institution must not refuse to
treat her/his other disease for the patient is HIV infected or AID patient.
Article 42 Health care providers
shall disclose the fact of infection or illness to the confirmed HIV infected or
AID patient; when he/she is incompetent, disclose to her/his guardian.
Article 43 Health care institution shall provide HIV testing and counselling to pregnant women, and provide counselling, prenatal guidance, prevention, treatment, follow-up after delivery and testing to HIV infected pregnant women and infants to block the vertical transmission.
Article 44 The government above county level shall take the following measures of care and assistance:
Provide medicines for anti-HIV treatment free of charge to AIDS patients in rural areas and poor AIDS patients in urban areas;
Reduce or exempt the costs for treating opportunity infection from HIV infected and AIDS patients in rural areas and those who are poor in urban areas;
Provide counselling and primary screening to counsellee and testee free of charge;
Provide treatment and counselling to HIV infected pregnant women and women in maternity for preventing vertical transmission free of charge.
Article 45 The costs of those students who are orphans of poor AIDS patients shall be exempted or reduced.
Article 46 The government above county level shall give living assistance to poor HIV infected, AIDS patients and their family members.
Article 47 The government above county level shall create conditions to support HIV infected, AIDS patients who still can work to engage in production and work he/she be able to do.
Some provinces, such as Yunnan and Shadong promulgated similar regulations.
All there regulations, though inadequate in some aspects, provide a framework to safeguard human rights related to HIV/AIDS in China.
The Debate on Compulsory Marital Examination
Should the compulsory marital examination be resumed after the 2004 Regulation on Marriage Register in which compulsory marital examination has been cancelled? It became a topic of the hot debate in mass media in China. Recently, Provincial People’s Congress, Heilongjiang Province promulgated its revised Regulation on Maternal and Infant Health Care on June 24, 2005 in which the marital examination is compulsory for the applicants for marriage. But the Provincial Bureau for Civil Affairs declared that the regulation won’t be implemented because it runs counter the State Council (Central Government)’s Regulation on Marriage Register in which marital examination is voluntary. The mass media reported that one official from State Commission on Population and Family Planning said “we are neutral from the perspective of family planning”. And the Minister of Civil Affairs Mr. Li said that it is misunderstanding that the voluntary marital examination led to the increase in newborn defects, before and after canceling of compulsory marital examination the rate of newborn defects is within the normal range, and there is no direct and necessary link between marital examination and newborn defects. He said marital examination only examines the basic state of physical health, and is not able to detect the newborn defects.
The Brain Surgery for Treating Drug Addiction was Prohibited by MOH
In November 2004 Mr. Qi Guoming, the Chief of the Bureau for Science and Education, the Ministry of Health (MOH) announced that the Ministry prohibited the practice of treating drug addiction with brain surgery. This surgery was performed in more than 20 hospitals in mainland China. Earlier the surgery was hailed as the candidate of Nobel Prize in the weekly Southern Weekend. In August 2004 the Ministry of Health convened an expert meeting to evaluate the surgery. The typical comment on this surgery was the one presented jointly by Qiu Renzong and Zhai Xiaomei at the meeting as follows:
1. In ethical evaluation of the brain surgery to treat drug addiction we first should consider the ratio of risk-benefit. It requires us to identify the nature of risks, estimate the size of risks, and evaluate the impact of these risks to the patients, and then compare with benefits to determine if the ratio of risk/benefit is acceptable. If the ratio is unacceptable, we should not continue the treatment.
2. Now the positive effect of this surgery has not been verified scientifically yet. In treatment or research the indicators of efficacy were not established scientifically. Current indicators used in treatment or research and the data obtained cannot confirm its efficacy, because many of physicians or investigators did not use RCT. They announced the efficacy confirmed only with reported individual cases. This conclusion is doubtful.
3. The part of the brain destroyed in this surgery would result in great harms and these harms are irreversible. The serious risks of changes in the patients’ psychology, emotion, mentality and personality after the surgery were not assessed scientifically now. So on basis of 2 and 3, the ratio of risk/benefit is unacceptable.
4. Obtaining informed consent from patients/subjects is absolutely necessary. Informed consent requires us to inform patients/subjects that this is an experiment which remains to be confirmed, there are many uncertain factors, possible risks and benefits may happen to them, and the mainstream of treating drug addiction is with drug. Not providing adequate information and without trying to test their understanding of the information, the consent obtained is invalid.
5. If this is a research project, the payment by the patients is not right. The high payment paid by the patients now indicated that to perform this surgery is for the purpose to pursue for high profit and conflict of interest existed. This did serious harms to the interests of the patients/subjects and also to the scientific integrity.
6. On the basis of the points above we suggested to prohibit the practice. But the Ministry can keep one or two institutions to do systematic research on it with scientific rigor, and suggest the Ministry to draft an interim regulation on this research, and stipulate the items including standards of licensing, informed consent, protecting subjects, inclusion and exclusion criteria, scientific and ethical review, technical standards, prohibition and penalty etc.
Action Recommendations on Correcting the Birth Sex Ratio Imbalance
Expert Workshop on Ethical, Legal and Social Issues
of Birth Sex Ratio Imbalance in Mainland China
June 27-28, 2004
Organized by the Institute of Philosophy, Chinese Academy of Social Sciences
Co-Organized by the Research Center for Bioethics, Peking Union Medical College
Sponsored by the Ford Foundation
Co-Sponsored by United Nation Population Fund
1. Develop a National Specific Law
On the basis of Law on Maternal and Infant Health Care and Law on Population and Family Planning with the reference of experiences in main China develop a national specific law on illegally identifying fetus sex and artificially terminating pregnancy with the non-medical purpose of sex selection, establish and enhance the mechanism of monitoring and regulating, set up an exposure system, and prescribe the rules of penalty. The law should include limiting and regulating the production and sale of ultrasound B device and other apparatus that can be used for sex determination. Special institutions should be established, special budget be allocated, responsible persons be appointed. The leadership of national and provincial/municipal commission on population and family planning should be personally responsible for the work.
2. Criminal Liability Should Be Investigated for Those Who Illegally Identify Fetus Sex and Terminate Pregnancy for the Purpose of Sex Selection
Redefine the subject “those who do not get the license” as “those who do not get license and do medical practice beyond permissive scope” in the Article 336 on illegal medical practice and illegal performance of family planning operation of Criminal Law so as to investigate the criminal liability of those persons or institutions which possess license but illegally identify fetus sex and terminate pregnancy for sex selection. In addition , in the interpretations of Criminal Law and other laws concerned provisions on penalty to those who illegally identify fetus sex and terminate pregnancy for sex selection should be added. For “If the crime is constituted, he shall be investigated for criminal liability in accordance with law”, it should be defined that under which condition the crime is constituted, and how to investigate him for criminal liability in the interpretation.
3. Limiting the Production of Ultrasound B Device and Other Apparatus That Can Be Used to Identify Sex with Quotas and Regulate Their Sale
According to medical need limit the production of ultrasound B device and other apparatus that can be used to identify sex with quotas and regulate their sale, i.e. the sale only permissive to medical institutions which possess the license issued by health administration, and the sale to any individual or any institution which do not possess the license is prohibited. For those sellers who violate this item their license will be cancelled, heavy fine be imposed or/and they be put in prison. Heavy fine will be imposed on the buyers too.
4. Establish or Enhance the Sex Reporting System for Hospitals and Family Planning Institutions
All hospitals and family planning institutions are required to report the numbers of boy and girl newborns delivered, the numbers of boy and girl fetus aborted by artificially termination of pregnancy, the numbers of pregnant women and fetus sex tested with ultrasound B or other techniques (e.g. amniocentesis).
5. Seriously Treat the Cases of Discriminating and Abusing Female Infants and Girls
According to the law of Protecting Minors (Article 8 “Must not discriminate against female and disabled minors; prohibit drowning and abandoning of infant”) and the Law on Protecting Women’s Rights (Article 35 “Prohibiting drowning and abandoning of infant”) and Criminal Law (Chapter 4 Violating Citizen’s Personal Rights) exposure system should be established and enhanced, the cases of discriminating and abusing female infants and girls be seriously treated, the criminal liability of those offenders be investigated, the register, investigation and penalty of these cases be enhanced.
6. Review and Revise the Laws, Regulations and Practices with Gender Inequality
A team should be set up to review current laws, regulations and practices, and revise those which promote gender inequality, for example, the retirement policy for male 60 years old and for female 55 years old, the distribution of land for family only to male in rural areas. Data indicate that in the areas of one child policy the sex ratio is 115.7, but in the areas of 1.5 child policy the sex ratio 124.7, however, in the areas of two or more than two children policy the sex ratio is normal, so the 1.5 child policy (a family which only has a girl is permissive to have another child) has the implication of gender inequality, and thus should be changed. Efforts should be made for laws, regulations and policies to be gender-sensitive, to provide equal opportunity in all social areas for male and female, to treat equally male and female, to improve women’s social, economic, political and cultural status and to promote the equality between men and women.
7. Spread the “Action of Care for Girls” to All over the Country
“Action of Care for Girls” has got positive results, this Action should be spread to all over the country, and to rural areas in particular. Party and administrative leaders and popular persons in culture, sports and music come out to support this Action. Education on promoting gender equality and criticizing the prejudice of sexism and gender discrimination should be carried in all schools, including primary schools, high schools and universities. Mass media should report more about the contributions made by girls and women, unremittingly criticize the prejudice of sexism and son preference and prevent any images of gender prejudice and discrimination from media, and make contributions to promoting gender equality.
8. The Preferential Policy to the Family with Only One Girl or Two Girls Should be Widened
The enforcement of the preferential policy to the family with only one girl or two girls should be reviewed in all provinces and municipalities. And it is necessary to study how to widen this policy.
9. Education of Gender Equality to all Professions
Education of gender equality should be carried out to all professions, first, to party schools, administrative schools, teachers and journalists. The editors in chief of mass media should stop to make fuss of birth sex ratio which was reduced to an issue of hundred millions bachelors in media, and what they did not see is that the birth sex ratio first is an issue of great harms suffered by girls and women.
10. Play the Role of NGO and Enhance the International Collaboration
It is not only the governmental responsibility but also societal responsibility to correct the imbalance of birth sex ratio. The education, monitoring and advocacy role of NGO should be enhanced. It is very important for NGO to monitor the conduct of hospitals and family planning institutions and their medical professionals, monitor the conduct of enforcement agents and monitor the possible cases of girl abuse in community in the enforcement of laws and regulations concerning birth sex ratio. Meanwhile, birth sex ratio imbalance also takes place in other countries, it is also important to strengthen the international collaboration, get support from international community, and exchange experiences with those countries that have same issue.
Laws and Regulations related with Bioethics in China (1)
[Excerpts or Major Points, unofficial translations]
(1998-2003)
Interim Regulations for Ethical Review of Biomedical Research Involving Human Subject was promulgated by the Ministry of Health in 1998:
Chapter 1: General Provisions
Article 1: The guidelines are stipulated for protecting human dignity, life and health, for abiding basic ethical principles and for promoting the development of biomedicine, molecular biology and genetic engineering.
Chapter 3: Informed Consent
Article 8: All biomedical research involving human subjects must obtain written informed consent from human subjects in advance. For incompetent, guardian's consent or proxy consent must be obtained.
Article 9: In research involving children researcher must confirm:
Children shall not participate in the same research as adults;
The purpose of the research is to obtain the knowledge that is necessary for their health;
Researcher must obtain the written consent from parent or guardian of each child;
The child's denial to participate in research must be respected;
The possible harm or risk to children shall be reduced to the minimum;
In therapeutic research the efficacy shall not be lower than existing therapy.
Article 10: In research involving mental patients researcher must confirm:
For incompetent, researcher must obtain the written consent from guardian;
In therapeutic research the efficacy shall not be lower than existing therapy;
The purpose of the research is for obtaining the knowledge necessary for health need of mental patients;
Researcher shall obtain the consent from patients according to their competency. The patient's denial to participate in research must be respected;
The possible harm or risk to patients shall be reduced to the minimum.
Article 11: Biomedical research involving population
The research shall be relevant to the health need of the population;
Necessary measures must be taken to guarantee complete understanding of the research by the individuals in the population;
Protocol must be reviewed and approved by Ethics Committee, and reported to the local health administration for review and approval;
In the case that it is impossible to get the consent from individuals of the population, Ethics Committee shall review whether the research can be conducted, and whether the research has taken measures to protect the safety
of the population and individual privacy;
The researcher must not take undue measures to force or influence those who are not willing to participate in the research;
The researcher must obtain the written consent from individuals in the population. For those who are incompetent, the researcher must obtain the written consent from the guardian or legal proxy.
Chapter 4: Obligations of Researchers
Article 12: Researcher must provide human subject the following information before obtaining consent from them:
Purpose of the research and its method;
Time of participation for human subject;
Its possible benefits to human subject or other groups;
Possible harms or discomfort to human subject;
Whether there is other similar or better alternatives;
How to keep confidentiality of her/his records;
Scope of researcher’s responsibility for providing health care;
Providing free medical treatment for the injury relevant to the research;
Compensation to human subject or her/his family members when disability or death is caused by the research;
Human subject can deny to participate in research or withdraw at any stage of research, researcher cannot use it as an excuse to infringe upon her/her rights and interests.
Article 13: The researcher shall respect human subjects. Sufficient time shall be given to human subjects to ask questions and give answers; must not use cheating, threat and other undue means to human subjects; must provide adequate and relevant information and knowledge to human subjects, and give them adequate time to consider, and then ask them to make decision of whether to consent to participate in the research; only when the informed consent signed by human subject is obtained, it can be judged that the human subject consents to participate in the research; when the procedure or condition of the research is changed, the change must be explained to human subjects in details, and the consent must be obtained again from them.
Article 14: Biomedical research involving pregnant and lactating women.
In principle, pregnant and lactating women cannot be human subjects of biomedical research, except the research for protecting and promoting the health of pregnant and lactating women, fetuses or newborns. All researches must not do harm to fetuses or newborns.
Chapter 5: Interests and Rights of Human Subjects
Article 15: Researcher shall commit to give certain compensation or free medical services to human subjects, but the amount or services shall not constitute an inducement to human subjects. Providing compensation or free medical services to human subjects must be approved by the Ethics Committee.
Article 16: Keeping confidentiality and protecting privacy. Perfect confidential measures must be taken to the research materials. The researcher must not disclose anything involving the privacy of human subjects to media. The researcher shall disclose human subjects the use of future materials prior to the research, and report to the Ethics Committee.
Article 17: Financial compensation
Those human subjects who get temporary or permanent injury owing to participating in the research shall get treatment and financial compensation; if the death of human subject is caused, her/his family shall get compensation. Any research, any institution or any individual must not deprive this right from human subjects.
Chapter 8 Article 25: Prohibit
• Any scientific experiment related with human asexual reproduction;
• Any research using human embryo and aborted fetus;
• Exchange of aborted fetus and organ with any body abroad;
• Selling or/and buying human cell, tissue and organ.
Interim Regulations on the Administration of Human Genetic Resources promulgated by The Ministry of Science and Technology and The Ministry of Health and enforced on June 10, 1998:
Article 13: In the following cases the application for international cooperation research genetic program shall not be approved:
(6) No evidence to confirm the informed consent being obtained from the donor of human genetic resources material and her/his family member.
Law on Practising Doctors, promulgated by National People's Congress and enforced on May 1, 1999.
Chapter: Legal Accountabilities
Article 8: Conduct experimental clinical treatment without the consent from the patient or her/his family member.
Article 9: Disclosure of patient’s privacy and cause serious consequences.
Drug Clinical Trial Regulations promulgated by Mr. Zheng Xiaoyu, the Director of State Food and Drug Administration (SFDA) on September 1, 1999
Chapter 1: General Provisions
Article 1: In order to guarantee the standardization of drug clinical trials, to make the results scientific and reliable, and to protect the rights and interests of human subjects and safeguard their safety, stipulated the Regulations according to the Law of Drug Regulation of the People’s Republic of China and with reference to international accepted principles.
Chapter 2: Preparation before Clinical Trial and Necessary Conditions
Article 4: All researches involving human subjects must comply to ethical principles in Helsinki Declaration and 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.
Chapter 3: Guarantee the Rights and Interests of Human Subjects
Article 8: 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 9: In order to guarantee human subjects’ rights and interests Ethics Committee shall be set up in the medical institutions conducting clinical trials. Ethics Committee shall have its members from non-medical profession, law and other institutions. The number of members is five at least with different genders. The composition and work of Ethics Committee shall be relatively independent from and not be intervened by any researcher.
Article 10: Before the clinical trials the protocol shall be reviewed, and approved by Ethics Committee with signatures, and then it can be conducted. In the period of trial any change of the protocol shall be approved by Ethics Committee, and then it can be conducted. Any serious adverse event in the trial shall be reported to Ethics Committee.
Article 12: Ethics Committee shall strictly review the following points of the protocol from the perspectives of safeguarding the rights and interests of human subjects:
(1) Qualifications and experiences of researchers, whether they have sufficient time to conduct clinical trial in question, whether the personnel and equipments conform to the requirements.
(2) Whether the protocol is appropriate, including purpose, possible harm/risks and benefits to human subjects and others, and whether the design of trial is scientific.
(3) Whether the procedure of human subjects’ enrollment is appropriate, the procedure of providing information to human subjects or her/his family member, or her/his guardian or legal proxy is complete and understandable, and the procedure of obtaining her/his written informed consent is appropriate.
(4) Providing treatment and giving compensation when human subjects are injured or died because of their participation in the trial.
(5) The acceptability of the revision of the protocol.
(6) Regularly review the risks to human subjects during the process of clinical trials.
Article 14: Researcher or her/his designated representative must explain the relevant information on clinical trial to human subjects:
(1) The participation of human subject in clinical trial is voluntary, and at any stage of trial, human subject has right to withdraw without discrimination or retaliation, her/his medical treatment and rights/interests shall not be affected.
(2) Must make human subject understand her/his individual materials about her/his participation, and obtained in the trial are confidential. Ethics Committee, Drug Regulation Administration and researchers can get access to these materials when necessary according to the regulations.
(3) Purpose, process and period of the trial, procedures of examination, expected possible harm/risks, inconveniences and benefits to human subject, and the possibility of her/his assigned to different groups in the trial.
(4) Human subject can get access to the relevant information at any time. Must give sufficient time to human subject to consider her/himself whether to participate in the trial. For incompetent human subject, information shall be provided to her/his legal proxy. In the process of informed consent shall be used the language and words that are understandable to human subject.
(5) When there is injury relevant to the trial, treatment and appropriate compensation shall be provided to human subject.
Article 15: The written informed consent form shall be obtained after complete and detailed explanation of the trial.
(1) The written informed consent form shall be signed and dated by human subject or her/his legal proxy, and by the researcher or her/his representative too.
(2) In the case that the human subject or her/his legal proxy is illiterate, there shall be one witness who is present in the all process of informed consent. After detailed explanation of the written informed consent form, human subject or her/his legal proxy expresses the consent orally, it shall be signed and dated by the witness.
(3) If Ethics Committee agrees in principle with researcher who judges that the participation of incompetent human subjects in the trial will be in their interests, these patients are permitted to enter into the trial, and the informed consent form shall be signed and dated by their legal proxy.
(4) If the informed consent is not obtained from human subject, witness or guardian, researcher must record this situation and the detailed reasons of why the consent is not obtained in the file and sign on it.
If new important materials relevant to drug in trial are found, the informed consent form must be revised and submitted to Ethics Committee for approval, and be got consent from human subject again.
Regulation on Genetically Modified Food, promulgated by the Ministry of Health on April 8, 2002 and enforced on July 1, 2002
Article 4 GMF shall be accord to Law on Food Health and other regulations concerned, and shall not cause acute, chronic or other potential health hazard to human beings.
Article 5 The safety and nutrition of GMF shall not be below the corresponding original food.
Article 9 The Minister of Health shall establish a GMF Expert Committee which is responsible for the evaluation of GMF’s safety and the quality of nutrition.
Article 16 Any food products which contain GMO and its expressed products shall be labeled as “GM XX food” or “raw material from GM XX food”. If GM XX food comes from potentially allergy inducing food, the GMF shall be also labeled as “warning to those who are allergic to XX food”.
The label of GMF shall be true, objective, and shall not contain the following contents as:
1. Explicitly or implicitly indicate it can treat some disease;
2. Make fraud of or exaggerate the function of GMF;
3. Other contents which the Ministry of Health’s regulations prohibit to label.
Regulation on Marriage Registry promulgated by the State Council in August 2003
Major points:
Marriage applicants only need to bring ID card and “registered permanent residence”
Premarital medical examination is voluntary, but not compulsory.
Marriage between homosexuals and co habitation still not protected by law.
Regulations on Human Assisted Reproductive Technologies promulgated by the Ministry of Health and enforced on August 1, 2001.
Article 22: Prohibit –
• Selling or/and buying human gamete, zygote or embryo;
• Surrogate motherhood;
• Unauthorized sex selection;
Guidelines on Human Assisted Reproductive Technologies (Ministry of Health, July 2003)
III. Guidelines for Practitioners
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 donation of human embryo; Prohibit the human egg plasma and nucleus transfer technology for the purpose of reproduction; Prohibit the hybrid between human gamete and gamete from of 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 manipulation the gene in human gamete, zygote or embryo for the purpose of
reproduction; Prohibit the coagulation between sperm and egg of close relatives;
In the same period of treatment the gamete or zygote must be derived from same male and female;
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.
Ethical Principles of Human Assisted Reproductive Technologies (Ministry of Health, July 2003):
• Benefit to patient
• Informed consent
• Protecting children
• Social good
• Privacy and confidentiality
• Non-commercialization
• Ethical review and surveillance
Ethical Guidelines for Research on Human Embryonic Stem Cells (2003)
(Promulgated by the Ministry of Science and Technology and the Ministry of Health, People’s Republic of China on December 24, 2003)
[An unauthorized translation]
1. The Ethical Guidelines for Research on Human Embryonic Stem Cell (hereinafter referred to as the Guiding Principle) are formulated for the purpose of bringing human embryonic stem cell research in biomedical domains conducted in our country to accord with bioethical norms, to ensure internationally recognized bioethical guidelines and related regulations promulgated in our country to be respected and complied with, and to promote a healthy development of human embryonic stem cell research.
2. The human embryonic stem cells described in the Guidelines include stem cells derived from donated human embryos, those originated from germ cells and those obtained from somatic cell nuclear transfer.
3. Any research activity involving human embryonic stem cells conducted by in the territory of the People’s Republic of China shall abide by the Guiding Principle.
4. Any research aiming at human reproductive cloning shall be prohibited.
5. Human embryonic stem cells used for research purpose can only be derived from the following means:
1) Spared gamete or blastocyst after in vitro fertilization);
2) Fetal cells from accidental spontaneous or voluntarily selected abortions;
3) Blastocyst or parthenogenetic split blastocyst obtained by somatic cell nuclear transfer technology; and
4) Germ cells voluntarily donated.
6. All research activities involving human embryonic stem cells shall comply with the following norms:
1) Blastocyst obtained from IVF, human somatic cell nuclear transfer, parthenogenesis or genetic modification techniques, its in vitro culture period shall not exceed 14 days starting from the day when fertilization or nuclear transfer is performed.
2) It shall be prohibited to implant embryos created by means described above into the womb of human beings or any other species.
3) It shall be prohibited to hybridize human germ cells with germ cells of any other species.
7. It shall be prohibited to buy or sell human gametes, fertilized eggs, embryos and fetal tissues.
8. The principle of informed consent and informed choice shall be complied with , the form of informed consent shall be signed, and subjects’ privacy shall be protected in all research activities involving human embryonic stem cells.
The informed consent and informed choice mentioned above refer to that the researchers shall use an accurate, clear and popular language to tell the subjects the expected aim of the experiment as well as the potential consequences and risks and to obtain their consent by signing on a form of informed consent.
9. Research institutions engaged in research involving human embryonic stem cell shall establish an ethical committee which consists of research and administrative staff from biology, medicine, law and sociology with the responsibilities for providing scientific and ethical review , consultation and supervision of the research activities involving human embryonic stem cells.
10. Research institutions engaged in research involving human embryonic stem cells shall formulate corresponding detailed measures and regulatory rules in compliance with the Guiding Principle.
11. The Ministry of Science and Technology and the Ministry of Health of China shall be responsible for the interpretation of the Guiding Principle.
12. The Guidelines shall go into effect as of the date of its promulgation.
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? 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.
Ethical Guiding Principles on Human Embryonic Stem Cell Research
(2003-460)
(Promulgated by the Ministry of Science and Technology and the Ministry of Health, People’s Republic of China on December 24, 2003)
Authorized translation
The Ethical Guiding Principles for Research on Human Embryonic Stem Cell (hereinafter referred to as the Guiding Principle) are formulated for the purpose of bringing human embryonic stem cell research in biomedical domains conducted in the People’s Republic of China to accord with bioethical norms, to ensure internationally recognized bioethical guidelines and domestic related regulations to be respected and complied with, and to promote a healthy development of human embryonic stem cell research.
Human embryonic stem cells described in the Guiding Principles include stem cells derived from donated human embryos, those originated from germ cells and those obtained from somatic cell nuclear transfer technology.
Any research activity related to human embryonic stem cells conducted in the territory of the People’s Republic of China shall abide by the Guiding Principle.
Any research aiming at human reproductive cloning shall be prohibited.
Human embryonic stem cells used for research purpose can only be derived from the following means with voluntary agreement:
Spared gamete or embryos after in vitro fertilization (IVF);
Fetal cells from accidental spontaneous or voluntarily selected abortions;
Embryos obtained by somatic cell nuclear transfer technology or parthenogenetic split embryos; and
Germ cells voluntarily donated.
All research activities related to human embryonic stem cells shall comply with the following norms:
Embryos obtained from IVF, human somatic cell nuclear transfer, parthenogenesis or genetic modification techniques, its in vitro culture period shall not exceed 14 days starting from the day when fertilization or nuclear transfer is performed.
It shall be prohibited to implant embryos created by means described above into the genital organ of human beings or any other species.
It shall be prohibited to hybridize human germ cells with germ cells of any other species.
It shall be prohibited to buy or sell human gametes, fertilized eggs, embryos and fetal tissues.
The principle of informed consent and informed choice shall be complied with , the form of informed consent shall be signed, and subjects’ privacy shall be protected in all research activities related to human embryonic stem cells.
The informed consent and informed choice mentioned above refer to that the researchers shall use accurate, clear and popular expressions to tell the subjects the expected aim of the experiment as well as the potential consequences and risks and to obtain their consent by signing on a form of informed consent.
Research institutions engaged in human embryonic stem cell shall establish an ethical committee, which consists of research and administrative expert in biology, medicine, law and sociology with the responsibilities for providing scientific and ethical review, consultation and supervision of the research activities related to human embryonic stem cells.
Research institutions engaged in research related to human embryonic stem cells shall formulate corresponding detailed measures and regulatory rules in compliance with the Guiding Principles.
The Ministry of Science & Technology and the Ministry of Health of the People’s Republic of China shall be responsible for the interpretation of the Guiding Principles.
12. The Guiding Principles shall go into effect as of the date of its promulgation.