Drug Evaluation Committee 2014-46 Timing for obtaining re-consent
Related classification: Obtaining consent
First published: Apr 2015
Revised publication date: Mar 2021
Question
I am currently in charge of a clinical trial for a global company. In that clinical trial, the explanatory document for subjects was revised due to a change in the symbol of the trial component, the number of subjects, the number of medical institutions participating in the trial, the period of participation in the trial, the addition of a concomitantly banned drug, and the sponsor of the trial in Japan. After approval by the Clinical Trial Review Committee, we had to explain the revised contents to the trial participants and obtain their oral consent until a bound version of the explanatory document was delivered to the hospital. However, the sponsor, for its part, is said to consider this action to be a deviation because it requires signatures on a typed copy of the approved document if a bound copy has not been received after the approval by the Trial Review Committee.
In my opinion, I have been promptly informing the subject of the revised explanatory document deemed necessary by the investigator and obtaining oral consent, but does this constitute a deviation?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
GCP Article 54, Paragraphs 2 and 3, Guidance 1 states that "When new important information that may be relevant to the subject's consent is obtained, the investigator shall promptly revise the explanatory document based on the said information and obtain approval from the investigational review committee in advance. In addition, the investigator shall promptly inform the subject who is already participating in the clinical trial of such information, confirm the subject's willingness to continue participating in the clinical trial or not, and explain the subject again using the revised explanatory document approved by the investigational review committee, in order to obtain the subject's free-will consent to continue participating in the clinical trial. The subject's free and voluntary consent to continue participating in the clinical trial must be obtained in writing.
In this regard, if the investigator determines that there is new important information that could be relevant to the consent of the subject who has already participated in the study, the investigator shall promptly provide the subject with such information, confirm the subject's intention, record it in the medical record, and obtain written consent again by providing another explanation in a revised explanation document at a later date. In such a case, a bound copy of the document should be completed.
In this case, please ensure that the delay in the completion of the bound version will not cause a significant delay or missed opportunity for written re-consent.
This commentary describes the concept of obtaining re-consent, which requires prompt provision of information to subjects who have already participated in a clinical trial, and does not provide an explanation of initial consent.
It is recommended that the revised explanatory document be used for the initial consent.
Reason for revision of opinion
With the issuance of the GCP Guidance (No. 0831-15 issued on August 31, 2020 by the Pharmaceutical Affairs Agency of Japan), minor changes have been made to the descriptions.