Drug Evaluation Committee 2015-39 Permissibility of continuation of a clinical trial in a subject who lost the ability to consent during the course of the clinical trial
Related classification: Obtaining consent
Date of first publication: February 2016
Question
In a brain tumor clinical trial in which consent is obtained from the subject himself/herself, what should be done if the subject temporarily or permanently loses the ability to obtain consent due to cognitive decline during the course of the trial?
Is it possible to respect the subject's original intent to consent and continue the trial if there are no changes in the explanatory documents and other information from the situation in which the subject obtained consent? Also, under such circumstances, if the explanatory documents are revised during the continuation of the trial and consent is required again, will the trial be terminated? I don't think it would be acceptable to suddenly allow the trial to continue in the middle of a clinical trial with the consent of a surrogate.
If a subject temporarily or permanently loses the ability to obtain consent due to a traffic accident or the like in a clinical trial for diabetes or the like, could you please tell me if the same response would apply as above?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If a subject becomes incapable of giving sufficient consent, it would be considered a serious adverse event. As in the case of a normal adverse event, we will consider the seriousness of the adverse event when there is no problem in ensuring safety and when the benefits and disadvantages expected to accrue to the subject are comprehensively taken into consideration.
It is important for the investigator to first determine whether or not to continue the clinical trial.
If the investigator decides that it is appropriate to continue the clinical trial, he/she should confirm the intention of the surrogate (person who has parental authority over the subject, spouse, guardian, or other person equivalent thereto) to continue participation in the clinical trial, regardless of whether or not the "explanation document has been revised," that is, regardless of whether or not "new information affecting the subject's intention to participate in the clinical trial" exists, and if the subject wishes to continue participation in the clinical trial, he/she should obtain the surrogate's consent. In the case of continued participation, it is necessary to obtain consent from the surrogate. In addition,
This should be reviewed by the Clinical Trial Review Committee.
After obtaining consent from the surrogate, it is desirable to obtain consent for continuation of the clinical trial from the subject himself/herself again when the subject regains his/her capacity to consent.
These measures do not vary depending on the subject disease of the clinical trial, etc., and should be taken in the same manner based on the judgment that the measures considered best for the subject's treatment should be taken.