Drug Evaluation Committee 2007-23 Period during which re-consent must be obtained
Related classification: Obtaining consent
Date of first publication: Jan. 2008
Question
We are writing to you to ask for your opinion on a point that is unclear at the time of obtaining re-consent.
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1.If oral consent only is obtained, is written consent necessary?
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2.If only oral consent is obtained, is written consent required at the next and final visit?
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3.Is written consent required during the post-observation period?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Assuming that the case in question falls under Article 54 of the GCP (when information that influences the subject's intention is obtained), I would like to state my opinion as follows.
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 the information, record it in writing, and confirm whether the subject will continue to participate in the clinical trial (GCP Article 54, Paragraph 1). (GCP Article 54, Paragraph 1). In this case, the subject's signature is not required under GCP, but depending on the importance of the information, it may be necessary to consider obtaining the subject's signature. In addition, if the investigator deems it necessary to revise the explanatory document, the investigator must promptly revise the document and obtain the subject's consent for continued participation in the trial (GCP Article 54, Paragraphs 2 and 3). There is no definition of the terms "oral consent" and "written consent" in GCP, but I assume that the "oral consent" in your question refers to the procedure specified in GCP Article 54, Paragraph 1, and the "written consent" refers to the procedure specified in GCP Article 54, Paragraphs 2 and 3.
- 1.
- If the subject was provided with the information at the time it was obtained and the subject confirmed orally (or in writing, depending on the importance of the information) whether or not to continue participating in the clinical trial, and if the clinical trial had already ended when the revised explanatory document was approved by the investigational review committee and the head of the institution, then the revised document should be used to obtain another consent. If the clinical trial has already ended when the revised Explanatory Document is approved by the Clinical Trial Review Committee and the head of the institution, there is no need to obtain another consent using the revised Explanatory Document.
- 2.
- If a revised version of the explanatory document has been approved by the Investigational Review Committee and the head of the site at the time of the last visit (last observation), then it is necessary to obtain another consent with the revised document.
- 3.
- Although it is difficult to make a general statement because it depends on the information obtained, in general, since there are still post-observations as stipulated in the protocol and the subject will continue the trial, it would be necessary to obtain another consent with the revised explanatory document.