Informed Consent in the Non-Western Cultural Context and the Implementation of Universal Declaration of Bioethics and Human Rights

5 Informed Consent in the Non-Western Cultural Context and the Implementation of Universal Declaration of Bioethics and Human Rights 1 Z H A I X I A O M E I The requirement of informed consent is crucially important in UNESCO’s Universal Declaration on Bioethics and Human Rights. In Article 6, consent is required that: 1. Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be express and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice. 2. Scientific research should only be carried out with the prior, free, express and informed consent of the person concerned. The information should be adequate, provided in a comprehensible form and should include modalities for withdrawal of consent. In China informed consent is required in many laws/regulations. In 1987 the term “informed consent” was translated into Chinese as “知情同意” (zhiqing tongyi) in the book Bioethics published in China.2 In 1990s and 2000s informed consent became a regulatory or legal requirement in a number of laws and regulations, such as Regulations for the Governance of Medical Institutions (State of Council, 1 September 1994), Law on Practicing Doctors (National People’s Congress, June 1998), Rules for Protecting Human Genetic Resources (MOST and MOH, 1998), Administrative Norms for Drug Clinical Trials (SFDA, 1999), Rules for Human Assisted Reproductive Technologies (MOH, 2001), Law on Population and Asian Bioethics Review March 2009 Volume 1, Issue 1 5–16 I n f o r m e d C o n s e n t i n t h e N o n - We s t e r n C u l t u r a l C o n t e x t Z h a i X i a o m e i A s i a n B i o e t h i c s R e v i e w M a r c h 2 0 0 9 Vo l u m e 1 , I s s u e 1 6 Family Planning (National People’s Congress, December 2001), Ethical Principles and Technical Norms for Human Assisted Reproductive Technologies (MOH, 2001, revised 2003), Ethical Guiding Principles for Human Embryonic Stem Cell Research (MOST/MOH, December 2003), Rules for Clinical Application of Human Organ Transplantation Technologies (MOH, 1 July 2006), Regulations for Prevention and Treatment of HIV/AIDS (State Council, 2006), Rules for Ethical Review of Biomedical Research Involving Human Subjects (January 2007, MOH), and Regulations for Human Organ Transplantation (State Council, 1 May 2007).3 In the Regulations for the Governance of Medical Institutions, the first official document in which informed consent is legally required, it is stipulated that: When a surgical operation, special examination or special treatment is performed, informed consent must be obtained from the patient him/herself and from his/her family member or relative with his/her signature; in the case that it is impossible to obtain the patient’s opinion and there is no family member or relative present, it can be performed after the treatment protocol is proposed by the physician and approved by the responsible person of the institution or by an authorized person. In the Rules for Ethical Review of Biomedical Research Involving Human Subjects, detailed prescription of informed consent is in its Articles 14, 16 and 17: Article 14: Respect and ensure the rights of subjects to autonomously decide to participate or not participate in research, strictly observe the procedure of informed consent, and must not use undue means such as deception, inducement and coercion, and permit subjects to withdraw at any stage of research; … Article 16: Principal investigator must obtain the written consent of voluntary informed consent before the conduct of research. When it is impossible to obtain written informed consent, the oral informed consent should be obtained in advance and the document to prove the obtaining of oral informed consent should be submitted too. For those subjects who are incompetent and not able to make decision by her/himself, the written informed consent must be obtained from...