Ethics committees (EC) and the system of research protocol peer-review began in the United States (US) [1,2]. The Declaration of Helsinki requires that all biomedical research involving human participants, including research on identifiable human material or data, should be approved by an ethical review committee [3,4]. Today, ECs and their systems of peer-review for research protocol are used worldwide [5-16].
Nowadays ECs in many countries review and consider ethical issues pertaining to clinical care and institutional policy. In fact, clinical ECs often function independently from research ethics committees [17,18]. For instance, in the United Kingdom (UK), clinical ECs largely function for ethics support and advice for healthcare providers [17-20]. In the US, institutional or hospital ECs (HECs) carry out ethics consultation and other clinically relevant activities [1].
Japanese ECs differ in system, however, from those in the US and UK. The first medical school in Japan to establish an EC was Tokushima University School of Medicine in 1982. Ten years later, in 1992, all 80 medical schools in Japan had voluntarily established an EC without any governmental regulation. This same trend emerged among general hospitals as well. The percentage of hospitals with over 300 beds that maintained an EC increased from 24.6% in 1996 to 52.0% in 2002 according to the Ministry of Health, Labour and Welfare [21,22].
In Japan, the term for ethics committees (rinri-iinkai) is often translated as an IRB, but this is quite misleading. At medical schools and the majority of general hospitals, there are actually two types of ECs [23]: an EC that reviews and monitors drug clinical trials called a chiken-shinsa-iinkai (clinical trial review committee), and an EC that reviews protocols from researchers affiliated with the institution called a rinri-iinkai (ethics committee). Clinical trial review committees are regulated by the Ministry of Health, Labor and Welfare and function in accordance with the Pharmaceutical Law and the Guidelines for Good Clinical Practice (GCP)[23]. Accordingly, their structure and management are strictly regulated. Hospitals and universities involved with clinical trials for commercial products (i.e., pharmaceuticals) are thus required by the GCP to maintain a clinical trial review committee. Conversely, ECs not involved with clinical trials for commercial products are primarily self-governing bodies established by each institution and are not government regulated. In general, medical school ECs are more involved with research protocol review than their counterpart in hospitals; they also play a larger role as a leader in policy making when compared to hospital ECs.
Today, concerns over the quality and function of ECs are increasing worldwide. Numerous studies have examined the activities and quality of ethical review of ECs among Westernized countries included Australia, Belgium, Canada, Israel, Italy, France, Germany, Netherlands, New Zealand, Spain, Sweden, Switzerland, the UK and the US [5-8,11-14,16-18]. Many of these studies have provided descriptive data on EC functions and structure [9-12,16]. Yet, despite the wealth of literature from Westernized countries, there persists a limited amount of research from Asia [10,15]. The purpose of this survey study was to describe the characteristics and developments of ECs established at medical schools and general hospitals in Japan. In general, medical school and hospital ECs are combined ethics committees taking on the roles of both clinical and research ethics committees. Japanese ECs are regulated independently by each facility as opposed to the British system in which ECs are established based on area (LREC: local research ethics committee), and accredited according to the rules formulated by the UK Ethics Committee Authority [24]. We excluded clinical trial review committees from our sample given their differences in structure, function and regulations when compared to regular ECs. This study included four national surveys conducted twice over a period of eight years.
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