Drug Evaluation Committee 2017-34 Order of Signature on Consent Document
Related classification: Obtaining consent
Initial release date: December 2017
Revised publication date: March 2024
Question
Are there any regulations regarding the order of signatures on the consent document by the physician (investigator or subinvestigator), investigational collaborator, and subject?
(1) The physician explains the clinical trial and the physician signs the consent document.
(2) The investigator explains the clinical trial and the collaborator signs the consent document.
(3) The subject agrees to participate, and the subject signs the consent document.
（The order (1) to (3) is the usual flow of obtaining consent at the site.
Would it be considered a violation of GCP Article 52, "The subject must not be coerced by the investigator, etc., or have his/her judgment improperly influenced" if the physician's or collaborator's signature appears before the subject signs the consent document?
- We have heard that the order of signatures on the consent document has been pointed out in some cases during FDA and EMA inspections. Is there a problem with the order of signatures on the consent document from (1) to (3)?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
There are no regulations in GCP regarding the order of signatures on the consent document, and even if the order is the order in question, it is not necessarily considered a violation of GCP Article 52, Paragraph 2 (Consent of the subject must not be forced by the investigator or unduly influenced by the judgment of the investigator).
On the other hand, GCP Article 52, Paragraph 1, Guidance 1 states, "The consent document must be signed and dated by the investigator who provided the explanation and the person who is to be the subject or the surrogate, respectively, stating that they fully understand the contents of the explanation document and agree to participate in the clinical trial. If a cooperating investigator provides supplementary explanations, the cooperating investigator must also sign and date the document. The following is an explanation of the form.
Therefore, when the investigator and, if necessary, the cooperator provide sufficient explanation and the subject agrees of his/her own free will to participate in the clinical trial, the date and signature of the investigator and the subject should be entered in the consent document as a record of their confirmation of the subject's consent. If consent has not been obtained in the above manner, as in the order of your question, it would be desirable for the investigator, etc. to confirm that the subject has signed the consent document of his/her own free will and to record that fact.
In addition, some overseas regulatory authorities may judge that there is a possibility of influencing the subject's free will (silent pressure) if the investigator, etc. signs the consent document before the subject. In light of this, we believe it is important to appropriately record the process of explaining to the subject and obtaining consent so that it can be confirmed from the consent document or medical record, etc., so that it is clear that consent is obtained of the subject's own free will.
Reason for revision of opinion
The partial revision of the GCP Ministerial Ordinance (December 25, 2020) removed the requirement to affix a name and seal.
Some descriptions have been changed to more accurately express the purpose of the opinion.