- Yasuko Shirai
Section Chief, Socio-Cultural Studies Section
Socio-Cultural Environmental Research Division
National Institute of Mental Health, NCNP,
1-7-3 Kohnodai, Ichikawa, Chiba 272-0827, JAPAN

Email:

E-mail: shirai@ncnp-k.go.jp

Eubios Journal of Asian and International Bioethics 13 (2003), 130-134.

The rapid advances in the Human Genome Project have increased knowledge about genetic factors in disease as has the progress of technology in molecular genetics. With the sequencing of the human genome, vast amounts of information on the molecular pathogenesis of diseases will become available. This has inspired huge numbers of genomic studies involving human subjects in the post-sequence era, such as the so-called "Millennium Project" planned by the Japanese government in December, 1999. The outcome of human genome research in molecular genetics may lead to huge advances in personalized medicine and evidence-based medicine, however, such progress will open the door to ethical, legal, and social problems due to the special nature of genetic information of individuals.

In March 2001, "Ethics Guidelines for Human Genome/Gene Analysis Research" was issued as jointly prepared ethics guidelines by three Ministries (the Ministry of Education, Sports, Science and Technology, the Ministry of Health, Labor and Welfare, and the Ministry of Economy, Trade and Industry). This was followed, in June 2002, by the issue of "Ethics Guidelines for Epidemiological Studies" jointly presented by the Ministry of Education, Sports, Science and Technology, and the Ministry of Health, Labor and Welfare. According to these ethics guidelines, every research institute and hospital which intended to conduct genomic research involving human subjects was required to establish an ethics review committee for reviewing and monitoring the appropriateness of conducting a research protocol from ethical and scientific viewpoints. When these ethics guidelines were issued, it was implicitly premised on condition that research institutes and hospitals had set up their own ethics review committees and these committees could fulfill their rolls properly. However, there is presently no full account of information concerning the state of Japanese ethics review committees.

Our project conducted a nationwide survey on ethics committees supported by the Health Research Grant of the Ministry of Health, Labor and Welfare1)2)3). This paper reports the current status of Japanese ethics committees, presenting some results of the survey.

2. Survey on the Status of Ethics Committees in Japan

2.1 Methods

As listed in Table 1, the targeted institutions of this survey were medical schools, medical research institutes and hospitals, and a total of 2,248 institutions were selected as respondents by an assigned sampling method. The survey was carried out between March and April, 2002, and 2,248 questionnaires were distributed by mail. As presented in Table 2, a total of 538 responses were received (a response rate of 24%); the total valid answers were 527. The main issues of the survey were the composition and operation of ethics committees, yearly budget, means and contents of public release, monitoring and on-site investigation of the process of authorized research, problems and claims for operating ethics committees, and other relevant issues.

2-2. Characteristics of Respondent Institutions

Table 3 lists the characteristics of respondent institutions. As shown in Table 3, we used 7 categories of institutions for analyzing survey results to indicate the particular situation of the ethics (review) committee in each category of institution.

2-3. State of Establishment of Ethics Committees

Table 4 presents the state of the establishment of an ethics committee. Among the respondent institutions, 32% set up one ethics committee, 15% had two or more ethics committees with different roles, and 7.1% were preparing to set up an ethics committee. However, 46.6% of respondent institutions had not established any ethics committees, and had no plan to do so. Approximately 90% of small-scale hospitals and 54% of middle-scale hospitals had not established ethics committee at the time of this survey.

As shown in Table 4, 76 institutions had two or more ethics committees with different roles. Table 5 presents the configurations of the ethics committees within 76 institutions. A total of 37% institutions set up two or more ethics committees as a nested structure, and 57% placed them on the same level. This suggests that when several ethics committees with different roles were set up within the same institution, they were more often placed on the same level. When several committees were established as a nested structure, about 57% tried to adjust reviewing standards relative to each other. However, when several committees were placed on the same level, about 43% tried to adjust reviewing standards relative to the other committee.

2-4. Composition and Operation of Ethics committees

Table 6 presents the composition and mode of operation of single-type ethics committees. In the case of single-type ethics committees, they might hold a meeting once or twice per year, and at each meeting they reviewed approximately 5 applications within two or three hours. As a whole, single-type ethics committees were composed of approximately fifteen members and one-fifth of them might be external individuals.

Table 7 shows the background of external members of single-type ethics committees. In the case of medical schools, not only scientists, lawyers and law professors but also bioethicists and experts in social science and liberal arts were nominated as external committee members. While in the case of hospitals, lawyers and unspecified experts were intended to nominate as external committee members. As a whole, patients' representatives and journalists were seldom nominated as external committee members.

2-5. Budget for Operating Ethics Committees

Table 8 presents the yearly budget for operating singled-type ethics committees. More than half of all medical schools and medical research institutes prepared a budget for operating ethics committees. While in the case of hospitals, 41% of large-scale hospitals with 500 beds or more and 28% of middle-scale hospitals with 200-499 beds prepared a yearly budget for operating committees. Respondents suggested that a significant portion of the budget was devoted to remuneration for the external committee members.

2-6. Means and Contents of Public Release

Table 9 presents the means of public release of proceedings and other relevant materials of ethics committees. A total of 28% of medical institutes with a hospital and 20% of small-scale hospitals with 199 beds or less released such information by written documents, and they allowed reading of the materials and making photocopies of them. In the case of medical schools, 29% used their own webpage for public release. Approximately 47% of middle-scale hospitals and large-scale hospitals did not prepare any means of public release concerning the information on ethics committees' activities. As a whole, the content for public release consisted of the title of the research protocol, the name of researcher and a summary of the proceedings of the committees' meeting.

2-7. Monitoring the Progress of Researches

Table 10 presents the state of implementation of monitoring the progress of research in each institution. Among the respondent institutions, only 22% kept track of the progress of an approved research by, for example, receipt of a research progress report on a regular basis, at least annually. A total of 78% had no experience of monitoring the progress of research. Concerning on-site investigations only medical schools and medical research institutes indicated that they implemented it using qualified external persons.

2-8. Problems and Claims on Operating Ethics Committees

Table 11 lists some issues that more than half of the respondent institutes of a certain category considered as serious problems related to the operation of the ethics committee. One serious problem in operating ethics committee was the absence /insufficiency of administrative staff in charge. It was also difficult to nominate qualified external persons as committee members. In small-scale hospitals and middle-scale hospitals, they were worried that ethics committee members might not be fully aware of their specific roles for reviewing genomic research involving human subjects. Concerning the monitoring issues, most institutions worried about a lack of standardized procedures for monitoring the progress of research and on-site investigations. In addition, middle-scale hospitals and large-scale hospitals were concerned that they had no time to implement monitoring and on-site investigations.

3. Discussion and Conclusions

Based on the results of the present survey, the following points are suggested:

(1) At the time of this survey, 54% of respondent institutions had not established an ethics committee. Approximately 90% of small-scale hospitals have not set up any kind of ethics committee.

(2) The respondent institutions that had set up ethics committees were concerned about several problems for operating ethics committees:

a) Insufficient awareness of ethics committee members concerning their functions/ roles of reviewing the system for genomic research

b) Absence/insufficiency of administrative staff in charge of the operating ethics committees

c) Shortage/ lack of a budget for operating the ethics committees

d) Increase in the administrative burden of the internal committee members

e) Difficulties in nominating qualified external persons as ethics committee members

f) Absence of standardized procedures for monitoring and on-site-investigations for the progress of authorized research

Delayed preparation of infrastructures of ethics committees might be induced by the lack of awareness of the principal idea of "research governance by society" and systematic policies for protecting human subjects within medical research.

In conclusion, it is suggested that a systematic investigation of social policies for protecting human subjects and the dissemination of the idea of the research governance system are urgent tasks for safeguarding the dignity, rights, safety, and well-being of all actual or potential subjects of biomedical research in Japan.

References
1) Shirai Project: "Short report: A survey on Japanese Ethics Committees concerned with reviewing and monitoring Human Genome/Gene Analysis Research." November, 2002.
2) Tsuchiya, T: "Ethics Committees in Japan", presented at "the 8th International Tsukuba Bioethics Roundtable", held on February 17, 2003, Tsukuba University, JAPAN.
3)Shirai, Y, Maruyama, E, Tokunaga, K et al: "A Study of Functions and Roles of Japanese Ethics Review Committees concerned with Reviewing and Monitoring Advanced Medical Researches on Human Genome/Gene Analysis Research and Tissue Engineering" (Principal Researcher: Yasuko Shirai), supported by the Health Research Grant of the Ministry of Health, Labour and Welfare, 2003(H14 Life Science 002).
This paper was presented at "what are the Common Grounds: An American and Japanese Dialogue on Genetic Disease Linked to Racial and Ethnic Groups" held on 8-9 May, Tokyo, JAPAN