Purpose：To consolidate a system for the batch review of multicenter non-interventional research and promote improvements in the efficiency and quality of their practical review by using the guidelines created by the 2018 Central Clinical Trial Review Committee/Central Ethics Review Committee Infrastructure Development Project (hereinafter “Non-interventional guidelines”).
Necessity and Features：In 2016, Tohoku University Hospital was involved in the project to create the “Guidelines related to Centralizing Ethical Review in Multicenter Research,” as well as devise non-interventional guidelines and coordinate public awareness activities in 2018. As part of its work in 2019, the hospital will create an operating manual for the non-interventional guidelines and verify its use in practice.
One special feature of the Tohoku University Hospital is its focus on conducting a centralized batch review of non-interventional research for the Initiative on Rare and Undiagnosed Diseases (IRUD) project, which began in 2016, and has already conducted a centralized batch review of all 34 sites. The hospital is currently consulting with IRUD to increase the number of research institutions and expects to demonstrate a synergistic effect with the IRUD project. As part of this project, we will solicit the opinions of institutions contracted from IRUD sites and new facilities and confirm the effectiveness of workflows in which the “Agreement,” which was previously the most significant barrier, is non-essential, as well as the effectiveness of the Institutional Requirement Confirmation, which was significantly revised. In addition, we will also conduct verification related to review cases entrusted to our care from outside of Tohoku University, such as those concerning schizophrenia, esophageal cancer, etc.
Building on the work of the prior year, we will conduct investigations over time on the progress of the mandatory single IRB review and SMART IRB associated with the revision of the US Common Rule.
We will also examine responses to the “Ethical guidelines related to human genome / genetic analysis research.”
To ensure our exposure to a wide variety of opinions, we will host regular Opinion Exchange Meetings every three months, and collaborate with other task-adopting institutions to confirm the non-interventional guidelines and generate case studies.
This project entails multiple tasks related to verification through its inclusion of multiple collaborators, including Osaka University and Nagoya University, which, like this hospital, adopted the standard model construction project in the first year, as well as Tokyo Medical and Dental University, which was involved in the 2016 project, and Kanazawa University and Fujita Health University, which are situated outside of the core hospitals conducting clinical research. The diversity of the collaborating entities thus enables the input of various opinions.

We will proceed with the following items (1) to (7).
(1) Preparation to create the operating manual for the non-interventional guidelines (We will extract issues to present a template of the procedures and application manual of the Central Ethics Review Committee to use the non-interventional guidelines. We will consider the items used for the IRUD project at Tohoku University Hospital as a starting point.)
(2) Investigation towards the creation of batch review guidelines for non-interventional research
①Domestic investigation
We will gather input on the non-interventional guidelines from all large-scale facilities, medium/small-scale hospitals, and organizations outside of academia that cooperated on the investigation items used in the 2018 project. We will also gather their opinions on the Q&A created for the same project. At the same time, we will also listen to their opinions on the portions of the current medical guidelines requiring revision to promote centralized batch review in non-interventional research.
②U.S. investigation
In the U.S., the revised Common Rules came into full effect in 2019 after a one-year postponement period, and we will conduct a continuous investigation on its implementation status in the U.S., since it is extremely important to share the contents of discussions held during that period.
In particular, we will gather information on SMART IRB.
(3) Verifying countermeasures for each problem
Considered the most important objective of the project, Tohoku University Hospital will verify reviews at new facilities implementing IRUD using the non-interventional guidelines. Osaka University, Tokyo Medical and Dental University, and Nagoya University will each verify this process by conducting a batch review of the research conducted in their medical field of specialty. They will also provide administrative support towards conducting centralized batch reviews at Fujita Health University.
(4) Creation of the operating manual for the non-interventional guidelines (draft) and the Japanese version of SMART IRB Agreement (draft)
The operating manual (draft) will be created following the execution of (1) and (2), and in parallel with (3). We will also create a Japanese version of the SMART IRB Agreement (draft) for the accreditation committee of the “AMED Ethics Review Committee Accreditation Project.”
(5) Creation of guidelines and case studies premised on the disclosure of ethical reviews of non-interventional research in Japan
We will revise the non-interventional guidelines based on (1) to (4). We will create case studies (draft) in a format that reinforces/develops the Q&A created in 2019. Furthermore, the efforts towards non-interventional research guidelines for “Ethical guidelines related to human genome / genetic analysis research” will be investigated with Dr. Yoshida acting as supervisor.
(6) Collaboration with related academic societies
Whenever appropriate, we will listen to opinions from companies and sponsors, as well as individuals from academia, and incorporate them into the creation of guidelines (draft) for non-intervention studies. We will collaborate with other task-adopting institutions (2 institutions) to confirm the non-interventional guidelines and edit the case studies (draft).
(7) Public awareness activities regarding the guidelines (draft) created through this project
We will host open, periodic Opinion Exchange Meetings every 3 months to ensure our exposure to a wide variety of opinions, and fine-tune the non-interventional guidelines and operating manual (draft).

Non-interventional research guidelines and infrastructure development of central ethics review board in Japan

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