Drug Evaluation Committee 2014-20 Revisions to Subject Information Documents during the Consent Process
Related classification: Obtaining consent
Date of initial release: September 2014
Question
If revisions are made to the explanation document between the time of the initial consent explanation (explanation only without obtaining consent) and the subject's next visit, it would be appropriate to obtain initial consent at the next visit using the explanation document and consent form used at the initial explanation, and re-explain additional or changed information using the next version of the explanation document on the same day, and obtain consent again. What do you think? Is it also possible to obtain consent for the first time using the next version (without obtaining consent for the previous version)?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Subjects need to be provided with the latest information to obtain consent. If a revised version of the instruction manual has already been approved by the investigational review committee and the head of the site, there is no need to obtain consent with the initial version of the instruction manual, and consent should be obtained after explaining the revised version.
The important point is whether or not the subject fully understood the explanatory document and consented. If the history of the subject's consent is to be retained, there should be no problem if the explanation is given in the explanatory document prior to the revision and the revised version is recorded on the date of consent.