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2.1. Informed consent in medical research involving human subjects in China

- Xiaomei ZHAI
Research Center for Bioethics, 
Chinese Academy of Medical Science & Peking Union Medical College
Dong dan san tiao No.5, Beijing 100005, China

My topic for today is about informed consent issues in medical research involving human subjects in China. Actually, this is some experience from the pilot study of my project, which is supported by the research ethics program of Harvard School of Public health/ NIH of U.S. Two of the main aims for the project are to empirically identify 1) investigators' perception toward informed consent; 2) investigators' attitudes (preferences) to the models of obtaining consent in their clinical research. This project will proceed by combining an empirical survey and analysis. The project will achieve the goals though a survey in two main academic cities. One of the selected cities is in Beijing, the Capital, and the center of culture, economy, academy, information circulation of the country, a modern city located in the north part of China. The other selected city is in Nanjing, which is an important academic and culture center in south part of China. The survey, based on a self-administered questionnaire, is designed to gather information on the current perception of informed consent and how the people to practice in their clinical research involving human subjects. The sample will come from the selected research institutes and hospitals in both cities. Completing this survey is anonymous. The demographic variables (e.g. age, gender, education, occupation status etc.) in the questionnaire will only be used to provide information about the group of people who took part in this study, and also to conduct group-level comparisons of the responses. Completing this survey is voluntary. Participants' response will be kept private and confidential. Participants may refuse to answer any questions, and could end the survey at any time. Upon request, the results will be made available to participants after completion of data collection and analysis. The reliability, validity of the questionnaire will be tested in a pilot phase. The coded data will be entered into the SPSS (8.0 version) program for analysis. This is a base line survey and we just finished the pilot study in Beijing. I would like to share some findings and experience with all of you here.

Informed consent is a legal doctrine that has been developed by the courts over a number of years in western European and North American. The doctrine of informed consent requires that doctors obtain the individual's voluntary informed consent of the subject prior to conducting medical experimentation. Informed consent is more than simply getting a subject to sign a written consent form. It is a process of communication. Informed consent is based on two fundamental ethical principles: 1) non-maleficence--protecting subjects and; 2) Respect for persons-- allowing potential subjects freedom of choice (respect their autonomy). The concept of "informed consent" is addressed in detail by the World Medical Association Declaration of Helsinki in 1964. The core of the 2000 version of the Declaration with respect to informed consent is its Article 22: "In any research on human beings, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail. The subject should be informed of the right to abstain from participation in the study or to withdraw consent to participate at any time without reprisal".

Nowadays 'Informed Consent' is an essential and indispensable moral and legal prerequisite in medical research and treatment. Although obtaining informed consent of patients and research subjects is now an expected part of medical practice and research in China, "informed consent" and "human subject protection" is still a relatively new ideal in China. Chinese cultural have profound differences with western nations. Chinese people may not share many of the assumptions implicit in a Western autonomy-based approach to bioethical deliberation. Chinese people traditionally take a duty-based rather than rights-based approach to ethical decision-making. This centuries old tradition also shares a belief in emphasis on the value of a holistic view of the person that affirms the importance of the community, society and family. In traditional Chinese culture, greater moral meaning and values rests in the interdependence of family, which transcend self-determination. One of the distinguished characteristic of Chinese culture is that they are often less individualistic than in those in Western Europe and South America. Therefore obtaining informed consent from the spouse or family member instead of merely from patients themselves is a conventional procedure in the medical practice in China. It was once to be supposed that the main reason might be on the financial aspect. The families need to afford the cost. So the consent from the families is required (Some studies showed that).

However from my pilot study, all interviewees expressed that it was and should be required absolutely to obtain the family's consent in research. This is not for the financial reasons but for the reason of respecting the culture and tradition. All of them agree that respecting the culture is one of the implications of the fundamental principle of respecting for persons. So the consent should not to be seen a purely individual matter. It is associated with wider obligations to family. The consensus is that the consent from the family not merely from the individuals is more humane and suitable to the situation of China. Also the participants would like to take time to discuss it with the family before they make the final decision.

Besides the issue of individual informed consent vs. community-assisted informed consent, there are some other issues that need to be considered which are related to the cultural background. For example proxy consent. In medical research involving human subjects, we often need to obtain the informed permission from the head of the village or the head of the unit. This is also a conventional practice and also to be seen as a special way of community-assisted consent. But we need to distinguish between "permission" and "consent". Permission of the head is not individual's consent. Consent shouldn't be replaced by permission. Because we just finished the pilot study, I hope I could share more experience in the final results with all of you soon.

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