Drug Evaluation Committee 2010-06 Confirmation of Intention to Continue Clinical Trial Following Revision of Consent Declaration (Part 1)
Related classification: Obtaining consent
Date of first publication: June 2010
Question
I have a question about oral consent. We have revised the explanatory document in accordance with changes in the clinical trial protocol. The revised items include changes to the name of the investigational drug, changes to the conditions for participation, etc. The sponsor gave us a proposal for the oral consent to be written in the medical record, but I understood that the timing for oral consent was to be given when the patient comes to the hospital to conduct the trial, between the approval of the revision of the protocol and the explanatory document by the IRB and when the actual explanatory document is in hand. However, the sponsor is of the opinion that oral consent should be given to subjects who come to the hospital after the change in the study protocol has been decided internally and the revised part of the explanatory document has been finalized with the Clinical Trial Management Office of our hospital and based on that, a draft chart entry regarding oral consent is prepared, but before the revised explanatory document is received.
If that is the case, we will be taking oral consent for items that have not been approved by the IRB, is that a problem?
JPMA's Opinion
GCP Article 54, Paragraph 1 states, "When a clinical investigator obtains information that is deemed to influence the subject's decision to continue participating in a clinical trial, the investigator must immediately provide the subject with that information, record it in writing, and confirm whether the subject will continue to participate in the clinical trial. The regulations stipulate that the following is required Paragraph 2 of the same article also stipulates that "the information shall be provided to the subject immediately and recorded in writing. Paragraph 2 of the same article stipulates that "In the case of the preceding paragraph, if the investigator finds it necessary to revise the explanatory document, the investigator shall promptly revise the explanatory document. The same guidance states, "The investigator shall explain the trial again using the revised explanatory document and obtain free will consent in writing from the subject or the surrogate to continue participation in the clinical trial. This time, the revised explanatory document will be used.
Since the explanatory document is to be revised this time, after explaining to the subject using the revised explanatory document that has been approved by the Clinical Trial Review Committee, the subject will be asked to give his/her written consent to continue participating in the clinical trial. On the other hand, since there will be a certain amount of time before the approval by the Trial Review Committee, it is necessary to first confirm the subject's willingness to continue the trial by immediately providing the subject with the new information that is to be revised, and to record in writing that the subject has been informed of this information.