Drug Evaluation Committee 2011-32 Confirmation of Intention to Continue a Clinical Trial with Revision of Explanatory Documents for Subjects (Part 4)
Related classification: Obtaining consent
First published: December 2011
Revised publication date: December 2016
Question
Due to the retirement of the principal investigator, the current investigator will become the successor principal investigator.
- Date of retirement of the current investigator and termination of the investigator's duties: November 30 (tentative)
- IRB: Scheduled on November 8
- Date of conclusion of clinical trial change agreement* and start of successor investigator's duties: Scheduled for December 1.
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As of December 2023The reason for setting the contract conclusion date as December 1 is to avoid having to make multiple change agreements, since the successor investigator is scheduled to change from the deputy director to the director on December 1.
The consent document needs to be revised due to the change of investigator, but the only part to be changed is the name of the investigator. Regarding the necessity of re-consent for patients participating in a clinical trial, some sponsors deem it necessary, while others deem it unnecessary. As a medical institution, we believe that this information does not fall under the category of information that influences the subject's will under Article 54 of the GCP, and that it would be sufficient if the investigator explained the change to the patient participating in the clinical trial and kept a record of the explanation in the patient's medical record. I would like to know your opinion on the necessity of re-consent in this case.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The necessity of re-consent in writing should be determined based on the reason for revising the explanatory document. In other words, if the reason for the revision corresponds to "information that is deemed to influence the subject's decision as to whether or not to continue participating in the clinical trial," as stipulated in Article 54, Paragraph 1 of the GCP, as per the guidance in Paragraphs 2 and 3, the revised explanation document should be used to explain again and the subject's continued participation in the clinical trial should be obtained in writing. The subject's consent must be obtained in writing.
It is not possible to determine in general whether or not a change in the investigator will affect the subject's willingness to participate. For example, if the previous investigator is the subject's attending physician, the change is considered to have a significant impact on the subject's will. On the other hand, there are cases in which the investigator is the subject's attending physician and has never met either the old or new investigator, and the relationship between the investigator and the subject differs from case to case. Therefore, we believe that the need for re-consent in writing should be determined by the successor investigator, taking into consideration the relationship with the subject and the degree of influence on the subject's will, and the best method should be adopted.
Since the change of investigator is an important change in the clinical trial implementation system, it is important to promptly inform the subject of the change regardless of whether or not written re-consent is required. Even if the investigator decides that re-consent is not necessary, it is necessary to be able to explain the rationale in writing. It is important to organize the relationship between the investigator and the subject and the reasons for judging that re-consent is not necessary, and to keep a record of the basis for judging that it will not affect the subject's will.
Reason for revision of opinion
We have reviewed Article 54 of GCP again regarding "information that may influence the subject's intention," and have come to the conclusion that a change of investigator is an important change in the clinical trial implementation system and may influence the subject's intention to continue the trial, and have therefore revised our opinion entirely.