The goal of this study was to gain an overview of the characteristics and developments of ECs established at medical schools and general hospitals in Japan with a series of four national surveys conducted over a period of eight years. The descriptive results intimate a gradual growth in number of ECs, an increase in frequency of annual meetings and number of reviews, an increase in the use of ethical guidelines, and a greater recognized degree of responsibilities for Japanese ECs.
According to reports by the Ministry of Health, Welfare and Labor, the number of ECs (rinri-iinkai) in general hospitals with over 300 beds increased from 24.6% in 1996 to 52.0% in 2002 [21,22]. One possible factor related to this increase in number of ECs among general hospitals in Japan is the recent introduction of a system of evaluation . In fact, it was in 1998 when the Japan Council for Quality Healthcare (JCQH), a non-governmental agency that evaluates hospitals, added the category of EC in their evaluation instrument. Again, yet another factor related to this increase is the recent succession of governmental ethical guidelines. Around the turn of the century, a series of statutory guidelines, in all seven guidelines, strongly "recommended" that institutions establish an EC . For instance, the Ethical Guideline for Human Genome and Gene Analysis Research and the Ethical Guideline for Epidemiological Research mandated that all related-research need to undergo EC review. Accordingly, this change in policy may also have had an impact on the increase of ECs and on their increase in responsibility and number of reviews. This study was carried out before and after the addition of the evaluative category of ECs by the JCQH in 1998, as well as before and after the succession of governmental ethical guidelines around 2000. Study findings thus reflect the impact of these events.
The system of ECs in Japan has two unique and noteworthy characteristics: (1) medical schools and the majority of hospitals have established their EC voluntarily without any governmental regulation, and (2) ECs play the roles of both IRB and HEC, as defined in the US. Now even though medical schools and hospitals voluntarily set up their EC, their structure is largely similar. They all include members who are external, of both sexes, and from other fields than medicine. This standardization may largely be a product of the Liaison Society for Ethics Committees of Medical Schools , an association set up in 1988 among all medical school ECs to exchange information and communicate. Presently, the association meets two times a year to discuss relevant issues to the further development and needs of ECs. To our knowledge, no other nation has such an association that functions as a national alliance of medical school ECs. Incidentally, another factor related to the apparent homogeneity in structure among ECs may be the succession of ethical guidelines issued by the government around the turn of the century.
A second significant characteristic of ECs in Japan is that they are not only involved with review of research protocols, like IRBs in the US, but are also in charge of policy making, education, and consultation, similar to HEC in the US context. The reason for this double-role playing among Japanese ECs is because the GCP originally assigned all drug clinical trials to clinical trial review committees (chiken-shinsa-iinkai), and left the remaining responsibilities to ECs (rinri-iinkai). Today, the primary role for medical school and hospital ECs is research protocol review and policy making.
Study findings also showed a significant increase in the use of ethical guidelines among both medical school and hospital ECs. However, we also found a difference between medical school and hospital ECs. In 1995–6, 38.5% of medical school ECs compared to 19.1% of hospital ECs used an ethical guideline for blood transfusion by Jehovah's Witnesses. Again this difference was seen in 2002 with 56.5% of medical schools ECs using an ethical guideline compared to 34.3% of hospital ECs. We surmise that this difference is because medical school ECs tend to be more active than hospital ECs in developing policy. One possible explanation for this disparity is that medical school ECs generally function as a leader in developing ethical policy in Japan. Looking deeper, this may be related to the hierarchy of Japan's medical world in which universities hold the mainstay of power.
Overall findings showed a greater degree of responsibilities and an increase workload for Japanese ECs. The vast majority of ECs indicated that their responsibilities have increased "much more" in recent years. This is related to several factors: ECs having to function both as IRB and HEC, the rush of ethical guidelines, and an overall rise in social awareness regarding bioethical issues . Whether a standard of quality is being maintained among Japanese ECs given the increase in workload and responsibilities is a topic of future study and discussion. To ensure a consistent standard of quality of review and function among ECs in Japan, researchers and policy makers need to consider the possibilities of a central IRB, the introduction of a system of registration for ECs, increased legal binding power for committee decisions and the further development of ethics consultation.