Program

PO2-8-26

Research ethics consultation: an attempt and five-year experience in a Japanese University Hospital

[Speaker] Hiroaki Yanagawa:1
[Co-author] Rumi Katashima:1, Chiho Sato:1, Kenshi Takechi:1, Hiroshi Nokihara:1, Chikako Kane:1, Yuki Aoe:1, Yoshihiro Okayama:1, Masayuki Chuma:1, Yasutaka Sato:1
1:Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital, Japan

(Background) Attention to research ethics is a key element of biomedical research, including clinical trials. Research ethics consultation is a different activity than ethics committee and is considered as an advisory activity regarding an ethical question related to any aspect of planning, conducting, interpreting, or disseminating results of research available throughout the lifecycle of a study. In the United States, the attention to research ethics consultation was promoted by the Clinical and Translational Science Award Program initiated by the National Center for Research Resources in 2005, since request for applications noted the importance of institutional commitments to supporting ethics. In contrast, its role has not been widely known in Japan as yet.
(Methods) We started research ethics consultation in 2012 by members of clinical trial support section based on the experience of serving general consultation on issues of clinical trials in Tokushima University Hospital, an academic hospital in a rural area of Japan. We analyzed five-years' (2012-2016) records of our research ethics consultation in the present study. Essentially, inquiry relating simple procedure and application documents of ethics committee or consultation from ethics committee members is not included in our research ethics consultation.
(Results) In five years, 125 research ethics consultation were served and 115 (91%) was served before starting studies. All requests except one were from investigators of Tokushima University. The main issue was consultation of compatibility to guidance and regulations (74, 67.2%), and only 6 (4.8%) requests were consultation of issues on research ethics that investigators face in their research.
(Conclusions) It is necessary to expand the consultation function about the issues on research ethics that investigators face in their research. To promote quality of consultation providers by exchanging experiences with providers in other facilities seems to be an appropriate way at present, and nationwide and multinational organization and data sharing with the standardization of consultation should be considered.

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