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P115: A Comparative Investigation of the AAHRRP Accreditation and Clinical Research Core Hospital System in Japan

Poster Presenter

Miho Kataoka

Clinical Research and Medical Innovation Center
Hokkaido University Hospital
Japan

Objectives

We identified the differences between the Association for the Accreditation of Human Research Protection Programs (AAHRPP) standards as an international standard and the requirements of the Clinical Research Core Hospital (CRCH) in Japan to enhance activities for HRPPs.

Method

The CRCH is accredited as per the Medical Care Act in Japan. We reviewed the accreditation process and requirements by comparing the AAHRPP standards and the steps in accreditation to analyze the redundancies and differences between the systems. Coauthors: Watanabe Y, Sasaki Y, Hashimoto A, Sato N.

Results

Of the 65 standards in AAHRPP accreditation, 55 (85%) elements were identified in the CRCH requirements. In the AAHRPP domain 1 organization standards (28 elements), 23 similarities are present in the CRCH system. The areas not included in the CRCH requirements are community involvement; preparation and response plan to maintain the HRPP in the event of a disaster or public health emergency, such as COVID-19; procedures for handling international research; system for researchers to refer to concerns and suggestions; and procedures for the notification of the safety results after the completion of the study. In the AAHRPP-domain 2:26 standards regarding IRB or EC, the CRCH requirements have 24 elements in common. The detailed structure, composition, and functions of the IRB or EC were determined according to the CRCH requirements. The written policies and procedures for determining the exemption of the IRB or EC and addressing the protection of participants in research that is exempt from applicable laws and regulations were absent from the CRCH requirements. Regarding AAHRPP-domain 3: researcher and research staff (11 standards), CRCH requirements include nine elements similar to AAHRPP standards. The understanding and basic practices of human research protection programs are included in the CRCH system to fulfill the laws, regulations, and guidelines for conducting clinical research. No requirements were identified regarding the procedures for determining the resources necessary to protect participants before starting the clinical research and recruiting participants in a fair and equitable manner. Although the process of being accredited consists of document review, site visits, and interviews in both systems, the equivalent evaluation and audit are annually executed in the CRCH system under the Medical Care Act.

Conclusion

This study aimed to demonstrate that substantial redundancies exist between the two systems. However, some identified elements need to be addressed beyond the CRCH requirements to better meet the international standards. CRCH in Japan plays a central role in meeting the international standards to promote high-quality clinical research and trials to develop innovative pharmaceuticals, medical devices, and medical technologies. The hospital is accredited by the Japanese Ministry of Health, Labour and Welfare under the Medical Care Act, and around such 14 institutions exist at present. The requirements consist of the following elements: facility (number of specialties and inpatient beds, certified laboratory); performance (number of clinical research and trials, supporting other institutions to conduct studies, and educational activities); organization (governance to conduct clinical research with written policies, procedures, and practice; IRBs, including a certified review board; regulatory compliance; quality assurance; intellectual property management; public relations; public and patient consultation); and staff (the number of physicians, pharmacists, and nurses at an academic research organization, clinical research coordinators, data managers, biostatisticians, personnel with work experience at the regulation body, staff qualifications). The CRCH is also required to support other institutions in conducting clinical research. Of the elements that are not clearly defined in the CRCH system, most aspects were covered at our institute on some levels, except for the preparation and response plan in the event of a disaster or public health emergency, the written policies and procedures for determining the exemption of the IRB or EC and addressing the protection of participants in such research, and procedures for researchers to determine the resources necessary to protect participants before starting the clinical research.