- Translated the entire book into English.
- Changed preface partially (added that it was originally published in Japanese, and deleted the last paragraph of the Japanese version due to space limitation).
- Moved Acknowledgements to p26 due to space limitation, which was on p2 in the Japanese version．
- Added details as Note where Japanese laws and systems are mentioned.
- Added references, corrected numbers as appropriate, these for due to the above changes.
- Moved the following three items from the beginning of the guidebook to the end as supplementary information: the process of developing the guidebook, reasons for the selection of External Review Board members, and methods of COI management.
- Corrected the numbering of references.
- Added web URL for COI management policy and public comments in annotations.
- Corrected minor typographical errors.
- Changed some coloring in the text.
- A draft released for public comment