Drug Evaluation Committee 2018-52 Timing of obtaining re-consent (Part 4)
Related classification: Obtaining consent
First published: Mar 2019
Question
Background
Oral consent was obtained from Subject A for changes to the explanatory document for the subject due to updated adverse drug reaction information, and this was recorded (the above explanatory document is hereinafter referred to as the "ICF revised version"). Subsequently, since the revised ICF was approved by the Clinical Trial Review Committee, when Subject A visited the site, the investigator or subinvestigator (hereinafter referred to as "investigator, etc.") attempted to obtain consent again using the revised ICF. However, Subject A needed to be hospitalized urgently and was not in a physical condition to sign the document by himself. As a result, the subject A was able to sign the document, and about one month after the hospitalization, he obtained the consent again using the ICF revised version.
Question
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(1)I think Article 54 of the GCP does not specify the timing for obtaining written re-consent, but does delay in obtaining written consent due to temporary difficulty in signing constitute a violation of the GCP?
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(2)
In the above situation where written re-consent cannot be obtained, which of the following interpretations (i)-(iii) would be correct when conducting tests for a clinical trial (tests specified in the study protocol) beyond the scope of normal medical care? The "investigational tests (tests specified in the protocol)" here refers to tests within the scope of consent obtained prior to the start of the clinical trial, and this revision of the explanatory document does not include changes resulting from changes in the protocol.
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i)
Inspections in the clinical trial can be conducted even if written consent is not obtained using the revised ICF.
Reason: Verbal consent has been obtained for the revised ICF, and the changes are not relevant to the investigational test. In addition, consent for the investigational test to be conducted has already been obtained at the initial ICF when Subject A decided to participate in the clinical trial.
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ii)
Under no circumstances should the investigational test be performed unless written consent is obtained again using the revised ICF.
Reason: Because written consent must have been obtained using the latest version of the ICF (revised ICF) at the time the investigational test is performed. The fact that oral consent for the revised ICF was obtained prior to admission or that subject A consented to the test at the first ICF when he/she decided to participate in the clinical trial is only a "guarantee of intent" at a point in time in the past.
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iii)Other than the above
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Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Answer 1
In the case in question, the delay in obtaining re-consent in writing was unavoidable because he was not in a condition to sign the document himself. What is important is not to set a uniform deadline for obtaining re-consent, but to obtain re-consent at an appropriate time so as not to disadvantage the subject.
We recommend that a record be prepared so that the reason for the delay in obtaining written re-consent can be explained to a third party.
Answer 2
In the case of your question, since the tests to be performed are within the scope for which consent has already been obtained from the subject, we believe that, in principle, there should be no problem with the operation described in i). However, as a precondition for this, the investigator must carefully determine whether to conduct the test (or continue the clinical trial) after considering the subject's condition, based on the fact that "the protection of the subject's human rights, maintenance of safety and improvement of welfare are of utmost importance" (GCP Article 1 Guidance 2 (3)).
Please refer to our previous opinion (2015-39) regarding the measures to be taken if a subject loses the ability to consent during the course of a clinical trial.