Background: The research ethics consultation service (RECS) is an advisory service in which bioethicists evaluate research and development projects and assist in making sure that ethical principles are upheld within the projects. It has been implemented in several clinical research institutions and programs in Japan. However, the specific demand for this service has not yet been investigated. Objective: To identify the needs for RECS and its related factors among parties involved in clinical research. Design: An anonymous self-administered questionnaire survey delivered on site or by post. Participants: The questionnaire was administered to 144 ethics committee members and clinical research coordinators (CRC) from 78 institutions who participated in four research ethics seminars that we held in Kyoto,Tokyo and Osaka from December 2012 to January 2014. Survey period: December 2013 to February 2014. Measurements: Questionnaire with 11 multiple-choice questions. Results: 119 of 144 participants responded (return rate 82.6%). Of the respondents, 64.7% were research ethics committee members and officials, and 26.9% were CRCs. 54.6% were affiliated with universities and colleges. Irrespective of their roles and institutions, more than 90% answered that they themselves would like to use the RECS. While 37.0% preferred an institution-based service, 22.7% favored either a district-based service or service specialized for specific type or area of research. Limitations: The results obtained in this study may not be generalizable to the needs of all clinical research communities. Conclusions: We propose that public RECSs should be developed at 15 or more core research institutes in Japan to provide consultations in ethics to both ethics committees and CRCs across the country.
In April 2012, the Chiken (clinical study for drug application) Promotion Committee of Osaka Pharmaceutical Manufacturers Association (OPMA) and Osaka Clinical Research Collaborative Network (OCRCN) organized three Working Groups (WG) composed of clinical research coordinators (CRCs) and clinical research associates (CRAs) to discuss the improvement of the efficiency of Chiken execution. Each group had regular monthly meetings for one and a half years. The first WG focused on the current understanding and treatment of “source data/document”. It is revealed that a so-called “work sheet” is widely used to record clinical data/comments in Chiken; data/comments are directly recorded on Case Report Forms (CRFs) only in around 50% of the cases. The second WG focused on the method to develop a more intelligible protocol in order to avoid misunderstanding of a protocol by clinical trial sites. It is agreed that a protocol should be developed that further reflects the actual work process of Chiken in a clinical site, and that more detailed explanations of the execution process in a protocol should be helpful. The third WG focused on “standardization of checklist for both clinical sites and study sponsors”, covering the selection of clinical trial sites and execution of clinical trial agreements. It is also recognized that the checklist, apart from the original purpose of increasing the efficiency of the execution of clinical trials, is expected to be used as a training tool for beginners. After completing all tasks, a survey was made to assess this activity. Most of the members expressed positive opinions on this project, and the activity to develop a standardized checklist is on-going.