Drug Evaluation Committee 2017-51 Delivery of Original Signed Consent Document to Subjects
Related classification: Obtaining consent
Initial release date: December 2017
Revised publication date: March 2021
Question
This question is related to Question No. 2007-21, "Use of Consent Documents Prepared by Medical Institutions.
After approval by the Clinical Trial Review Committee, the consent document was printed and used at the site until the bound version was completed. However, three copies of the consent document were printed, each signed by a physician, an explanatory assistant, and a subject, and each (investigator, secretariat, and subject) kept a copy. In other words, the subjects were also provided with the original, not a copy of the consent document.
Article 53 of the GCP states, "A copy of the consent document must be provided to the subject." However, would it be a violation of GCP to make three copies of the original and have the subject retain the original? If it is a violation of GCP, what would be the problem?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 53 of the GCP states that a copy of the signed consent document must be given to the subject. The purpose of this provision seems to be to allow the subjects themselves to check the contents of their consent at any time.
Therefore, in cases such as the case in question, where the consent document cannot be bound in time and it is unavoidable, there is no problem in delivering the consent document signed or stamped directly to the subject instead of a copy, as it does not violate the purpose of this provision. However, the consent document kept by the investigator, the clinical trial office, and the subject must be identical, including the date of entry. It should also be noted that the consent document should include the number of versions of the explanatory document to which the subject was given an explanation, so that it is clear what the subject's consent was for.
Reason for revision of opinion
The name and seal were deleted in accordance with the partial revision of the GCP ordinance (December 25, 2020).