Drug Evaluation Committee 2016-48 Timing of obtaining re-consent (Part 2)
Related classification: Obtaining consent
Date of first publication: February 2017
Question
The explanatory document for subjects has been revised, and it is now necessary to obtain the subject's re-consent.
The sponsor pointed out that the timing of oral and written consent should be at the earliest of all visits by the subject to the implementing medical institution. However, there are also visits to other departments and visits for tests only.
Even if the sponsor bears the cost of a substitute visit and the subject has to wait for a long time, is it necessary to re-consent at that point in time? What is the earliest timing of the visit that we need to obtain consent?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
When information is obtained that may influence the subject's decision to continue participation in a clinical trial, the investigator must promptly communicate this information to the subject and confirm the subject's decision to continue participation in the clinical trial (GCP Article 54, Paragraph 1, Guidance 1).
Therefore, basically, oral explanation should be given at the next visit of the subject to the clinical trial after the investigator obtains the information to confirm the subject's willingness to continue the clinical trial. Also, the revised explanation should be given at the next clinical trial visit after the revision of the explanatory document has been approved by the investigational review committee, and re-consent should be obtained. We believe that the investigator should decide whether it is necessary to meet the subject off schedule just to confirm the subject's willingness to continue the trial or to obtain re-consent, based on the importance and urgency of the information to be conveyed to the subject.