Full text loading...
薬理と治療
Abstract
Background Since revision of the Japanese Ethical Guidelines for Clinical Studies(EGCS)in 2008, researchers are required to perform their clinical studies in accordance with the EGCS. The staff of the Ethical Review Board is asked various questions from researchers. Objectives To enhance the support system and enable clinical studies to be promptly and properly carried out, we analyzed the researcher’s questions. Methods We investigated the questions and consultations in regards to the time taken to answer the questions, the inquiry method and the content of each question collected from July to September 2012. Results The number of questions and consultations were on average 100 per month. Researchers were asking the Ethical Review Board EGCS related questions, as well as, the method of application, protocol design, procedure for obtaining informed consent, conflict of interests, insurance, etc... Conclusions In order for researchers to implement high quality research, we will reflect the analyzed questions as part of the researcher’s training, and will change the application form to facilitate filling it out correctly. Furthermore, we think that it is necessary to cooperate closely with persons in charge relevant to implementation of research.
Data & Media loading...