Description of the Research
Background Efficient Protocol review is one of the key components in the IRB management. A Bioethics Research Center in a Medical and Dental University in Japan supports this process in our institute. Though, extensive mutual discussion among protocol reviewers help to standardize the level of reviewing, the comments and questions from reviewers to a protocol are often quite heterogeneous and sometime fluctuated. To establish more efficient, adequate, and consistent review of IRB protocol, we created an excel-VBA-based questioner sheet and utilized in our protocol review process.
First, this VBA-based system was reviewer-friendly and thus significantly shortened our average turnover period of pre-review. This enables us to promote effective use of time of IRB work. Moreover, since our comments to each protocol were stored based on designated categories, we were able to analyze what is the most frequent comments / categories in review reports. Included in the the top 10 most frequent comments from reviewers are: data keeping process (84comments), de-identification procedure (33 comments), and reuse of samples (20 comments). It is also frequently asked about the relevancy between one’s role in the research proposal and his/her research experience (11 comments).
VBA-based questioner system is useful to facilitate IRB review work. It is also powerful tool to uncover the points or areas that researchers may suffer and help us improve the quality of IRB protocol review.