Drug Evaluation Committee 2010-07 Obtaining Consent for Candidate Subjects with Potential Conflicts with Selection/Exclusion Criteria

Related classification: Obtaining consent

Initial release date: June 2010
Revised publication date: December 2021

Question

A patient has been identified as a potential subject through medical record screening, but based on the patient's previous observations and test results, there is a possibility that certain exclusion criteria may be violated. Testing and observation to determine if the exclusion criteria are violated will be done after consent is obtained. The patient's previous examinations and observations may not be definitive, but rather may be based on test values, pain level, or other factors that, with time, may no longer be in conflict with the criteria.

Is it possible to obtain consent at this stage? Is it possible to obtain informal consent? In my personal perception, obtaining consent is something that is taken on the assumption that the selection criteria are met and that the exclusion criteria are not violated. We also believe that the same is true with respect to informal consent.

However, the monitor told me that I could give my consent and that if I had explained in advance, he only wanted me to sign in the space for the explainer. Naturally, I protested, but they countered that it was not a violation of the GCP.

I feel that if I had to give informal consent and explanation of consent to all soon-to-be-entrants, there would be no point in a consent document (unless, I think, the test values are so subtle that they cannot be determined without screening). Is there a clear set of rules and regulations for consent explanations and prior informal consent?

Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)

I would like to express my opinion based on the assumption that your question, "waiting for a time for test values, pain level, etc., will not conflict with the criteria," will not be detrimental to the treatment of the patient in question.

There is no term or definition of "informal consent" in GCP with respect to obtaining consent to participate in a clinical trial. It is necessary to obtain consent in writing and to provide an explanation using an explanatory document prepared by the investigator and approved by the investigational review committee (GCP Article 50, Paragraph 1). When obtaining consent, the investigator must sign a consent document stating that he or she agrees to participate in the clinical trial after fully understanding the contents of the explanatory document (GCP Article 52, Paragraph 1).

However, if the request for participation in a clinical trial is based on the premise that the patient is at a stage where there is a possibility of violating the exclusion criteria, such as test values and pain level, and this is fully explained in the explanation document, then there is no problem with allowing the patient to participate in the clinical trial. If this is fully explained in the explanatory document, there is no problem in allowing the patient to participate in the clinical trial, and written consent should be obtained at this point. However, the investigational drug must be administered only after screening tests have shown that the patient does not violate the exclusion criteria.

Reason for revision of opinion

In accordance with the issuance of the GCP Guidance (July 30, 2021, Pharmaceutical Affairs Bureau of Japan, No. 0730-3), the opinion text has been partially changed.

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