From medical schools, 80 instruments were returned in 1995 (response rate 100%) and 62 were returned in 2002 (response rate 77.5%). From hospitals, 743 instruments were returned in 1996 (response rate 51.0%) and 464 instruments were returned in 2002 (response rate 31.1%). The results of the 1996 survey of general hospital ECs were partly presented previously in Japanese .
Respondent attributes (table 1) and ratio of established ECs (table 2)
Table 1 and Table 2 report the attributes of the respondents. In 1995, all medical schools (n = 80) had an established ECs. Conversely, only 181 (24.4%) of general hospitals in this study responded that they had established an EC in 1996 (result from reference 15), which increased significantly to 270 (58.2%) by 2002 (Figure 1: Number of Ethics Committees Established at General Hospitals in Japan).
Structure of ethics committees at medical schools (table 3) and hospitals (table 4)
and Table 4
each report the structure of ECs at responding institutions. All data was collected during the initial surveys. The overall ratio of male to female committee members was 94:6 among medical school ECs and 87:13 among hospital ECs. Medical school ECs consisted of an average of more than one member from outside of the medical school, yet within the same college/university, as well as from altogether outside of the college/university. Hospital ECs also consisted of an average of more than one member who was unaffiliated with the facility. In general, the discipline of EC members varied. Medical doctors and healthcare professionals comprised the majority, but medical school ECs included approximately one legal adviser. Professionals of ethics and other humanities were also included.
Process of ethics committees
Findings indicated an increase in workload among ECs. Medical school ECs met an average of 3.6 (SD:3.6) times in the year prior to the survey in 1995 and 7.7 (SD:4.6) times in the year prior to the survey in 2002. Hospital ECs met an average of 2.4 (SD:3.2) times in the year prior to the survey in 1996 and 3.1 (SD: 3.3) times in the year prior to the survey in 2002. In both cases, the frequency of meetings per year showed a significant increase (p
Activities of ethics committees at medical schools (table 5) and hospitals (table 6)
The activities of medical school and hospital ethics committees are reported in Tables 5
. Answers were multiple-choice. An average of 85.0% of medical school ECs responded that their everyday activities consisted of reviews of protocols for patient-targeted clinical research, regardless of whether they were related to medical treatment. Over 80% of medical school ECs were also involved in policy making, defined here as the establishing of regulations and guidelines for a certain treatment or research subject. Conversely, hospital ECs were primarily involved in the ethical review of protocols for patient-targeted clinical research directly related to medical treatment (70.6%). Compared to medical school ECs, fewer hospital ECs were involved in the review of protocols for patient-targeted clinical research unrelated to medical treatment (28.9%). Hospital ECs were also considerably involved in policy making (55.5%). A comparison of medical school and hospital ECs found that medical school ECs were more involved in the issuing of certificates intended for the editorial board of an academic journal than hospital ECs (33.8%:10.6%), and that hospitals ECs were more involved in ethics consultation (17.5%:32.2%).
Use of ethical guidelines
Instruments included a question on whether ECs had implemented an ethical guideline on the refusal of blood transfusion based on religious reasons (Jehovah's Witnesses). Among medical schools ECs in 1995, 31 (38.8%) responded yes to this question; 29 (36.3%) replied no; 13 (16.3%) responded that they were still considering it; five (6.3%) replied other and two (2.5%) did not reply. Conversely, in 2002, 35 (56.5%) medical schools replied yes to this question; 16 (25.8%) replied no; six (9.7%) replied that they were still considering it; three (4.8%) replied other and two (3.2%) did not reply. A significant increase was found in the use of an ethical guideline among medical school ECs (χ2 = 4.6, p χ2 = 35.5, p
Awareness of binding power and legal liability
Instruments targeted to medical school ECs included a question on how much binding power and legal liability they considered their decisions to carry. A total of 51 (63.8%) ECs in 1995 compared to 20 (32.3%) in 2002 believed that, "Since decisions are mere advice and have no binding power, ECs cannot take disciplinary action and have no legal liability." Seventeen (21.3%) ECs in 1995 compared to 28 (45.2%) in 2002 believed that, "Although decisions carry binding power and ECs can take disciplinary action, it is the university or university hospital, not the EC itself, that has legal liability." Three (3.8%) ECs in 1995 compared to 7 (11.3%) in 2002 believed that, "Since decisions carry binding power and ECs can take disciplinary action, the EC has legal co-liability with the university or university hospital." Nine (11.3%) ECs in 1995 and 7 (11.3%) in 2002 answered "don't know or other." These results show a significant increase in awareness of decision binding power and legal liability among medical school ECs (χ2 = 15.8, p
Instruments targeted to medical school ECs in 2002 also included a question on whether the topic of reviews had diversified in recent years. Forty (64.5%) ECs replied "much more diversified" and 19 (30.6%) answered "slightly more diversified." Only 2 (3.2%) replied "no change"; 1 (1.6%) answered "slightly less diversified," and none replied "much less diversified." In regards to an additional question that asked whether responsibilities have increased in recent years, 40 (64.5%) ECs replied "much more" and 18 (29.0%) answered "slightly more." Four (6.5%) ECs replied "no change" and none answered "much less" or "slightly less."