Key Words:

ethics committees, bioethics, Japan, patients' rights, high-tech medicine.

INTRODUCTION

__In Japan, principally because of its traditional Confucian ethos, medical paternalism has been unquestioned until quite recently. Medical practice was regarded as the "Art of Jin" (the loving-kindness of Confucian teaching) for more than one thousand years (Kimura, 1986). It reflects the benevolent action of physicians on which all patients tend to depend.
__The authoritative and fiduciary relationship between medical professionals (physicians, nurses, and allied health personnel) and patients and their families has been so common that even today patients are not expected to raise questions concerning their own bodies and health care when they are ill. Of course, this situation is gradually changing due to the effect of various socio-cultural values of the younger generation, which views traditional medical values (particularly medicine's paternalistic practices) rather negatively. However, for many Japanese, even though "persons' rights to health" are provided for in Japan's Constitution - and all Japanese nationals are covered by the Health and Social Security Insurance instituted in 1961 - the "rights"-oriented approach in medical settings is not so common. In comparison with other social developments, the "patients' rights" and "consumers' rights" movements are quite small in Japan. For example, medical malpractice suits are relatively very few in number due to out-of-court resolution mechanisms called "Jidan", "Chotei", and "Wakai" (Kawashima, 1963; Kimura, 1988b, pp. 180-181).
__In addition to the social ethos which permits "medical paternalism" to go unquestioned in Japan, there is a very strong research-oriented mentality among many Japanese medical experts who often treat patients as interesting medical cases rather than as persons deserving of respect (Sunahara, 1988, pp. 8-20).
__But clearly, persons ought to be fully respected, for it is they who make moral choices in this age of secular pluralism. Further, the dignity and rights of persons should not be disregarded simply because of cultural differences. Thus, in turning our attention to bioethics committees in Japan, we should evaluate the extent to which such committees protect patients' rights, the cultural heritage of many nations in the world, as expressed in "The Universal Declaration of Human Rights," well as in various bioethical statements and guidelines such as the Helsinki Declaration of the World Health Organization (Kimura, 1988a).

THE FIRST ETHICS COMMITTEE IN JAPAN AND ITS POSITIVE PUBLIC IMAGE

__There are no regulatory bodies established to control any of the bioethics committees in Japan.¹ In December 1982, the first Japanese ethics committee was established at the Medical School of Tokushima University, because its faculty members expressed serious concern about the ethics of in vitro fertilization (IVF). Dr. Takao Saito was one of the key persons who formed this Committee; he had previously participated in the "Ethics Committee for the Protection of Human Subjects" at the University of California at San Francisco's Medical School (Saito, 1985, p. 7). This first ethics committee was composed of eight members. Six of them were faculty members in the medical school: the dean (a pediatrician), the hospital director (a dermatologist), an enzyme chemist, a physiologist, an anesthesiologist, and a medical radiologist; and two were non-medical persons - a philosopher from the Faculty of Arts and Sciences, and a lawyer from another institution. The research protocol was presented to the Committee on IVF Issues on December 1982. After eight meetings the committee had heard testimony from various experts concerning the socio-cultural and ethico-religious matters that bear on IVF procedures. Those who testified included a Buddhist scholar, a legal expert on malpractice cases, experts on animal IVF experiments, journalists, an expert on hereditary malformations, an expert on women's issues, a child psychologist, a Catholic physician, and the present author as a bioethicist. After two additional meetings the Committee announced the result of its deliberations: it approved IVF research and practice, but with several restricting conditions. This committee process caught the attention of the mass media, which noted the symbolic change in Japanese medical paternalism and the new openness to a wide variety of opinions concerning the research work which was ongoing at the Medical School.
__The first IVF baby was born not at Tokushima University Hospital but Tohoku University Hospital, where there had not been any previous effort to carry out bioethical analysis of these techniques by careful committee review. The chief of the Tohoku medical team, Dr. Suzuki, stated that his colleagues were seriously concerned about the ethical issues that related to IVF. Nevertheless, the announcement of the IVF guidelines at Tohoku University was made on the same date that its team publicly confirmed the successful implantation of a human fertilized egg (Suzuki, 1983, p. 50).
__The contrast in the two universities' approaches to research involving IVF has led to a more positive public image of Tokushima University's medical school and its ethics committee. Since then, there have been further efforts to establish similar types of ethics committees, like the one at Tokushima University, in order to provide for the ethical review of other "high-tech" biomedical advances. Even though there are not at present codified regulations governing ethics committees in Japan, as of July 1987 there were 41 ethics committees at the 42 government-supported medical universities, and three ethics committees at the eight local government-supported medical universities. Twenty ethics committees have been established among the 29 private medical universities. Thus, among the 79 medical universities in Japan, 64 (81%) now have ethics committees (Ministry of Education, Science, Sports and Culture, 1987).
__Because of growing public concern over the complexities of new biomedical technologies and their social, ethical, and legal implications, the idea that ethics committees will discuss, evaluate, and approve or disapprove a proposed medical protocol has generated a very positive public image of biomedical scientists, physicians, and ethics committees in Japan (Sunahara, 1988, pp. 195-198). Due to the absence of a common standard, however, the image of ethics committees that review clinical protocols remains varied.²

THE ROLE OF "HIGH TECH" BIOMEDICAL ETHICS COMMITTEES IN JAPAN

__Some may view the role of ethics committees merely as a public relations mechanism for the medical "insider" to show the "outsider" that ethical problems are being considered seriously. The committees' role becomes even more important for the Japanese medical researcher as he or she prepares to submit papers to international medical journals, which usually require prior clearance by an ethics committee where the faculty members are conducting "high tech" research work (Yokoyama, 1985, p. 5). In short, some citizens continue to distrust medical experts whom they believe not to be serious when claiming to protect patients' rights and dignity.
__It should be mentioned that in 1968, when Dr. Wada and his medical team at Sapporo Medical University performed the first heart transplant surgery in Japan, the recipient lived for 83 days following the transplant operation. Since there had been no confirmed record of the brain death of the donor, and no ethical review had been conducted prior to performing the heart transplant, public support for the transplant has not been forthcoming. In fact, the district attorney's office considered prosecuting Dr. Wada, but decided not to bring this case before the court due to the difficulty of verifying the issues "on camera" (Ishigaki, 1970, pp. 260-286). At the Tokyo meeting where the public accusation against Dr. Wada was made, a statement on patients' rights and the dignity of human life was read (Ishigaki, 1970, pp. 263-265). The Japanese are still experiencing the aftereffects of the Wada Case; this is one of the reasons why Japan has not yet established any official brain-death criteria. This situation might change rapidly if Japanese medical experts shifted from their long-standing paternalistic stance to a more open, egalitarian, and cooperative approach to other professions and patients.
__The growing number of ethics committees may one day be viewed as a positive sign of the changing Japanese medical context. However, it has been suggested that Japanese-style ethics committees are only camouflage to distract the public's gaze (Sunahara, 1988, pp. 188-190). In order to determine how ethics committees in Japan actually function, the Japan Federation of Bar Associations (JFBA) recently undertook a comprehensive survey.

A Survey Report on Ethics Committees by JFBA In May of 1986, the JFBA conducted a survey on ethics committees in Japan. Some results of this survey are as follows (Japan Federation of Bar Associations, 1986, pp. 56-78): __1.__The committee's responsibilities include guideline development and the review of each protocol (70%). __2.__The average number of committee members is ten, the most frequent number is eight. __3.__The Dean of the Medical School and/or Hospital Director is a member of the committee (88%). __4.__The average number of non-university affiliated members is 1.7 members. __5.__The committee is comprised of male members only (78%). __6.__The committee is comprised of medical faculty members only (20%) or of medical faculty members plus other faculty in the same university (50%). __7.__Unanimous agreement by the attending members of the committee is required (71%). __8.__There is no appeal from committee decision (71%). __9.__Committees impose no penalties on investigators if investigators disregard the final decisions of the committees (78%). _10.__Committees take no responsibility for research-related injuries to subjects (54%). _11.__Committee meetings are open to the public (0%); open with stipulations (29%); or closed (59%). _12.__There is disclosure of the deliberation process and results in the case of decisions with conditions attached (71%). _13.__No guidelines have been developed for organ transplantation (80%). _14.__The duration of the review process is from one to seven months. _15.__The number of meetings required for making a final decision on a protocol ranges from one to eleven.

__These key elements of the findings show the individuality of various Japanese ethics committees. Note that no committee has lay community members on it. This survey also reveal that ethics committees in Japan tend to be male dominated, professionally dominated, and closed mechanisms that defend medical experts' supremacy in conducting their research work in a paternalistic setting.

CONCLUDING REMARKS

__The democratization of Japan's Constitution was initiated by the U.S. Supreme Commander in Chief during the occupation of Japan following World War II. However, the democratization of Japan's traditional values is still in process; because of the nation's cultural ethos, reflected in the Japanese mind, this process will take more time to be realized. Japan's cultural heritage stresses the importance of mutual interdependence, respect for the aged, and professional and bureaucratic authority given over to the sacred Emperor (now a mere symbol for the unity of Japan). For a thousand years, the word "Ko " (public) was interpreted in Japan as "on the side of the Emperor", which, of course, has nothing at all to do with the people's power (demokratos) (Yasunaga, 1976, pp. 11-82).
__In conclusion, the Japanese need to emphasize their concern about bioethical questions through coherent and just policies formulated in a democratic social context (Kimura, 1987). In Japan, bioethics should not be merely the analysis of various ethical and religious theories and principles irrelevant to the human situation. Indeed, the notion of bioethics as civic action remains a challenge to all Japanese citizens.

NOTES

¹ The "Seimei to Rinri nikansuru Kondankai" (Round-Table Conference on Life and Ethics) was established by Mr. Hayashi, Minister of Welfare and Health, in April 1983. This conference met eighteen times and published its report in 1985. This was the first committee of its kind at the government level; it was officially attached to the minister and was composed of eleven members. The issues covered by the Conference included organ transplantation, brain death criteria, the artificial prolongation of life, terminal care for cancer patients, in vitro fertilization, and genetic diseases; the report also discussed various aspects of life, religion, nature, and ethics. The Conference concluded its work after the resignation of Minister Hayashi. The duration of the Conference was just over two years. In June 1986, the Japan Medical Association initiated its "Seimei Rinri Kondankai" (Bioethics Council). The Council has been investigating bioethical problems at a national level and has issued reports on "Sex Pre-Selection" (1986) and "Brain Death and Organ Transplantation" (1988).
² A meeting of a preparatory committee for the establishment of a National Liaison Council for Ethics Committees at Medical Schools in Japan was held at Tokyo University on December 15, 1988 and the Council was inaugurated on Feb. 13, 1989 in Kyoto. This meeting shows the great concern for setting up a national network to exchange information and encourage public debate among ethics committees. The president of this council, Prof. K. Hoshino M.D. of Kyoto University, urged that the council should be a private organization which would not force member organizations to accept council recommendations or decisions.

REFERENCES

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