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 re-consent from subjects.
The sponsor pointed out that the timing of oral and written consent should be at the earliest of all visits by subjects to the site. 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?
JPMA's Opinion
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 version of the explanatory document should be provided at the next clinical trial visit after the revision of the explanatory document is approved by the investigational review committee, and re-consent should be obtained. Whether or not it is necessary to interview subjects off schedule just to confirm their willingness to continue the trial or to obtain their re-consent should be determined by the investigator based on the importance and urgency of the information to be conveyed to the subjects.