The Status of Ethics Committees in Japan

- 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.


1. Introduction

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


Table 1 Assignment of Respondent Institutions

. The total number of Medical Schools, Medical Research Institutions and National Hospitals

248

(1) Members of the Liaison Association of Medical Schools' Ethics Committees

86

(2) National institutes in medicine governed by the three ministries ( MECSST, MHLW, METI ) public research institutions, etc.

68

(3) Adjunct institutes of national universities, adjunct institutes of private universities, and Inter-Universities research institutes

26

(4) National hospitals without their branches

68

. Hospitals (without adjunct hospitals of national medical institutes, national hospitals and sanatoriums, adjunct hospitals of medical schools, and general clinics with 19 beds or less)

2,000 / 8,951

(1) Hospitals with 20-99 beds 3,815

(1) Hospitals with 20 - 99 beds 3,815

 

(2) Hospitals with 100 - 199 beds 2,590

823 (1-3)

(3) Hospitals with 200 - 299 beds 1,189

 

(4) Hospitals with 300-399 beds 691

(4) Hospitals with 300 - 399 beds 691 822

822 (4-5)

(5) Hospitals with 400 - 499 beds 311

 

(6) Hospitals with 500 beds or more 355

355

 

Table 2: Total Number of Delivered Questionnaires, Received Responses and Valid Answers  [N (%)]

Category of Institution

Delivered

Returned

Received

Valid Answers

Medical Schools and Medical Institutes

248

3

118 (48.2) *

103

Hospitals with 20 - 199 beds

823

16

142 (17.6)

146

Hospitals with 200 - 499 beds

822

3

169 (20.6)

168

Hospitals with 500 beds or more

355

0

109 (30.7)

107

Subtotal

2,248

22

538 (24.2)

524

Unknown

 

 

 

3

Total

2,248

22

538 (24.2)

527

 

Table 3 Characteristics of Respondent Institution [N (%)]

Category of Respondent Institutions

 

 

Mode of Foundation

 

 

Medical Schools within a university

31

( 5.9) *

National

58

11.7

Medical College

25

4.8

Public

142

28.7

Medical Institutes

28

5.3

Private

191

38.6

Medical Institutes with Hospital

19

3.6

Others

104

21.0)

Hospitals

421

80.4

 

 

 

With 20 - 199 beds

146

27.9

 

 

 

With 200 - 499 beds

168

32.1

 

 

 

With 500 beds or more

107

20.4

 

 

 

Region of Japan

 

 

Respondent

 

 

Hokkaido

38

7.6

Chairperson of EC

146

(30.0)

Tohoku

43

8.6

Member of EC

35

( 7.2)

Kanto & Ko-Shin-Etsu

143

28.5

Administrator of EC

43

( 8.8)

Tokai & Hokuriku

68

13.5

Others

263

(54.0)

Kinki

63

12.5

 

 

 

Chugoku & Shikoku

78

15.5

 

 

 

Kyushu & Okinawa

69

13.8

 

 

 

 

Table 4 State of Establishment of Ethics Committees [N (%)]

 

Single- type EC

Two or more EC with different roles

 Others

Preparing establishment of EC

No plan to establish EC

 Total

Medical Schools

8 (25.8)*

23 (74.2)

 ―

 ―

 ―

31 (100.0)

Medical Colleges

5 (20.0)

20 (80.0)

 ―

 ―

 ―

25 (100.0)

Medical Institutes

12 (42.9)

3 (10.7)

 ―

4 (14.3)

9 (32.1)

28 (100.0)

Inst. with Hospital

12 (63.2)

5 (26.3)

1 (5.3)

 ―

1 ( 5.3)

19 (100.0)

Hosp. with 20 - 199 beds

5 ( 3.4)

 ―

 ―

9( 6.2)

132 (90.4)

146 (100.0)

Hosp. with 200 - 499 beds

54 (32.1)

  4 ( 2.4)

 ―

19 (11.3)

91 (54.2)

168 (100.0)

Hosp. with 500 beds or more

72 (67.3)

21 (19.6)

 ―

5 ( 4.7)

9 ( 8.4)

107 (100.0)

Total

168 (32.1)

76 (14.5)

1 (2.0)

37 ( 7.1)

242 (46.2)

524 (100.0)

 


Table 5 Configuration of Ethics Committees within 76 Institutions [N (%)]

 

Nested Structure

Placed on the Same Level

Others

Total

Medical Schools

8 ( 36.4)*

12 ( 54.5)

2 ( 9.1)

22 (100.0)

Medical Colleges

6 ( 30.0)

12 ( 60.0)

2 (10.0)

20 (100.0)

Medical Institutes

3 (100.0)

3 (100.0)

Inst. with Hospitals

1 ( 20.0)

4 ( 80.0)

5 (100.0)

Hosp. with 20 - 199 beds

 

Hosp. with 200 - 499 beds

3 ( 75.0)

1 ( 25.0)

4 (100.0)

Hosp. with 500 beds or more

7 ( 33.3)

14 ( 66.7)

21 (100.0)

Total

28 ( 37.3)

43 ( 57.3)

4 ( 5.3)

75 (100.0)

 

Table 6 Composition and Operation of Single-type Ethics Committees [N (%)]

 

 

Frequencies of Meeting/ Year

 Required Time/ Meeting

 Amount of Reviewing Applications/ Meeting

 Internal

 Members

External

Members

 

 

 

 

 

(hr)

 

Total

nominated by title

Total

Male

Female

Medical Schools

Mode

4.0

3.0

20.0

6

0

2

3

1

n=5

Min

4.0

2.0

6.5

6

0

2

1

1

.

Max

12.0

4.0

20.0

7

1

7

6

2

Medical Colleges

Mo

2.0

2.0

1.0

8

2

2

2

1

n=4

Min

2.0

2.0

1.0

8

0

1

0

0

 

Max

12.0

4.0

9.0

15

2

4

3

1

Medical Institutes

Mo

3.0

2.0

0.0

4

0

4

4

2

n=5

Min

1.0

2.0

0.0

2

0

3

1

0

 

Max

6.0

3.0

15.0

7

3

6

4

2

Inst. with Hospitals

Mo

2.0

2.0

3.0

4

4

3

2

1

n=9

Min

1.0

1.0

2.0

0

0

2

2

0

 

Max

12.0

4.0

30.0

14

8

12

11

2

Hosp. with

Mo

1.0

0.5

0.2

3

3

1

1

0

20 - 199 beds

Min

1.0

0.5

0.2

3

0

0

0

0

n=3

Max

12.0

1.5

2.0

11

4

2

1

1

Hosp. with

Mo

2.0

2.0

1.0

6

5

2

1

0

200 - 499 beds

Min

1.0

0.5

0.2

5

0

0

0

0

n=37

Max

10.0

3.0

3.0

12

11

10

8

2

Hosp. with

Mo

2.0

2.0

1.0

9

5

2

1

0

500 beds or more

Min

1.0

0.2

1.0

5

0

0

0

0

n=44

Max

12.0

3.0

4.0

21

19

5

3

2

 

Table 7 Background of External Members of Single-type Ethics Committees [N (%)]

 

Scientist

Law Professor

Lawyer

Bioethicist

Experts in Social Science/ Liberal Arts

Patients' Rep.

Journalist

Others

Medical Schools

2 (25.0)*

4 (50.0)

3 (37.5)

4 (50.0)

2 (25.0)

0 ( 0.0)

0 (0.0)

4 (50.0)

Medical Colleges

1 (20.0)

1 (20.0)

2 (40.0)

2 (40.0)

1 (20.0)

0 ( 0.0)

0 (0.0)

2 (40.0)

Medical Institutes

5 (41.7)

4 (33.3)

1 ( 8.3)

2 (16.7)

2 (16.7)

0 ( 0.0)

1 (8.3)

3 (25.0)

Inst. with Hospitals

6 (50.0)

4 (33.3)

6 (50.0)

3 (25.0)

5 (41.7)

2 (16.7)

1 (8.3)

0 ( 0.0)

Hosp. with 20 - 199 beds

1 (20.0)

0 ( 0.0)

1 (20.0)

1 (20.0)

0 ( 0.0)

1 (20.0)

0 (0.0)

0 ( 0.0)

Hosp. with 200 - 499 beds

10 (18.5)

2 ( 3.7)

10 (18.5)

4 ( 7.4)

5 ( 9.3)

3 ( 5.6)

1 (1.9)

14 (25.9)

Hosp. with 500 beds or more

8 (11.1)

6 ( 8.3)

21 (29.2)

4 ( 5.6)

6 ( 8.3)

1 ( 1.4)

0 (0.0)

19 (26.4)

 

Table 8 Budget for Operating Single-type Ethics Committees [N (%)]

 

 

Budget Prepared

Budget not prepared

Total Amount of Budget / Year ( Yen ) Mode

Min

Max

Medical Schools

(n= 5)

3 (60.0)*

2 ( 40.0)

100,000

100,000

330,000

Medical Colleges

(n= 4)

2 (50.0)

2 ( 50.0)

500,000

500,000

500,000

Medical Institutes

(n= 5)

3 (60.0)

2 ( 40.0)

150,000

150,000

3,000,000

Inst. with Hospitals

(n= 7)

6 (85.7)

1 ( 14.3)

40,000

40,000

1,500,000

Hosp. with 20 - 199 beds

(n= 3)

0 ( 0.0)

3 (100.0)

-

-

-

Hosp. with 200 - 499 beds

(n=29)

8 (27.6)

21 ( 72.4)

26,000

26,000

200,000

Hosp. with 500 beds or more

(n=39)

16 (41.0)

23 ( 59.0)

0

1,200,000

 


Table 9 Means of Public Release [N (%)]

 

by written documents, allowed reading/copying

by written documents, allowed reading

on a webpage

others

no release

Medical Schools

2 ( 6.5)*

0 ( 0.0)

9 (29.0)

16 (51.6)

7 (22.6)

Medical Colleges

2 ( 8.0)

1 ( 4.0)

4 (16.0)

13 (52.0)

6 (24.0)

Medical Institutes

1 ( 6.7)

1 ( 6.7)

2 (13.3)

6 (40.0)

4 (26.7)

Inst. with Hospitals

5 (27.8)

2 (11.1)

0 ( 0.0)

6 (33.3)

4 (22.2)

Hosp. with 20 - 199 beds

1 (20.0)

0 ( 0.0)

1 (20.0)

1 (20.2)

1 (20.0)

Hosp. with 200 - 499 beds

4 ( 6.9)

5 ( 8.6)

0 ( 0.0)

12 (20.7)

27 (46.6)

Hosp. with 500 beds or more

10 (10.8)

3 ( 3.2)

1 ( 1.1)

30 (32.3)

44 (47.3)

 

Table 10 State of Implementation of Monitoring the Progress of Researches [N (%)]

 

 

implementation

no implementation

Total

 

Medical Schools

14 (46.7)*

16 ( 53.3)

30100.0

 

Medical Colleges

9 (36.0)

16 ( 64.0)

25100.0

 

Medical Institutes

3 (25.0)

9 ( 75.0)

12100.0

 

Inst. with Hospitals

4 (23.5)

13 ( 76.5)

17100.0

 

Hosp. with 20 - 199 beds

-

4 (100.0)

4100.0

 

Hosp. with 200 - 499 beds

8 (15.4)

44 ( 84.6)

52100.0

 

Hosp. with 500 beds or more

11 (12.6)

76 ( 87.4)

87100.0

 

Total

49 (21.6)

178( 78.4)

227100.0

 

Table 11 Problems and Claims on Operating Ethics Committees [N (%)]

 

Medical Schools

Medical Colleges

Medical Institutes

Inst.with Hospital

Hosp. With 20-199 beds

Hosp. With 200-499 beds

Hosp. With 500 beds or more

Procedural burdens

23 (85.2)

16 (64.0)

5 (41.7)

11 (61.1)

2 (50.0)

22 (43.1)

27 (34.2)

Absence/insufficiency of administrative staff

20 (74.1)

13 (52.0)

7 (53.8)

11 (61.1)

2 (50.0)

28 (53.8)

26 (32.5)

Shortage of budget

16 (59.3)

2 ( 8.0)

6 (46.2)

6 (35.3)

1 (25.0)

10 (19.6)

9 (11.7)

Surplus of applications for review

16 (57.1)

6 (24.0)

1 ( 9.1)

6 (35.3)

0 ( 0.0)

0 ( 0.0)

13 (16.7)

Shortage of knowledge for reviewing among committee members

8 (28.6)

3 (12.0)

3 (25.0)

8 (44.4)

3 (75.0)

30 (58.8)

34 (42.0)

Nominating qualified external members

15 (53.6)

11(44.0)

6 (54.5)

8 (44.4)

2 (66.7)

30 (57.7)

39 (48.8)

Submission of insufficient protocol by researchers

22 (78.6)

14 (56.0)

3(27.3)

6 (33.3)

1 (25.0)

12 (24.5)

23 (28.8)

Absence of standardized monitoring procedure

13 (52.0)

15 (65.2)

5 (41.7)

9 (50.0)

2 (66.7)

31 (60.8)

45 (58.4)

Having limited time for monitoring

13 (52.0)

11 (47.8)

3 (27.3)

6 (37.5)

1 (33.3)

30 (58.8)

44 (56.4)


 


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