Drug Evaluation Committee 2019-58 Obtaining Consent for Continued Participation in Clinical Trials by Telephone and Mail

Related classification: Obtaining consent

Initial release date: May 2020

Question

Oral and written consent will be obtained for additional safety information. In some cases, it takes more than one month to obtain written consent after the approval by the Clinical Trial Review Committee. Therefore, we received instructions to obtain oral consent by telephone and written consent by mail.

We recognize that oral consent by telephone is necessary because there is an interval between visits and it may be detrimental to the subject to continue the investigational drug without providing safety-related information. However, although there is no clear violation of GCP regarding written consent by mail, I have some questions and would like to discuss them with you.

When to provide written consent by mail

  1. 1) Number of reports and countries from which data was obtained
    Should the explanation be given by telephone again after the document has arrived?
  2. 2)
    When exactly will the date of consent, the date of explanation and the date of delivery be?
  3. 3)
    Is it assumed that the written explanation is to be returned by the subject? Or will only the signed consent document be returned?
  4. 4)
    GCP states that there is no problem with consent by mail, but is there a problem from a medical or medicolegal standpoint?
  5. 5)
    If a subject requests an explanation in person, can't the sponsor be asked to pay for the cost-sharing reduction?

Please be aware that the subjects in this case are not from far away, but are within the range of those who generally visit our hospital. I am consulting with you because I feel that there is a discrepancy with the Japanese medical practice.

Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)

As stated in Clinical Trial 119 Past Opinions 2018-16, " Informed Consent for Consenting Consenters by Telephone," we believe that informed consent should be given face-to-face at the site of the clinical trial. The need to obtain consent for continued participation in a clinical trial should not be simply and uniformly carried out by mail, but should be determined based on the importance, urgency, and complexity of the information to be provided to the subject, such as whether the next visit to the hospital is sufficient or whether an urgent meeting with the subject is necessary (past opinion). 2016-53, "Timing of Obtaining Re-consent (Part 3)" ). In addition, even in cases where the explanatory and consent documents are mailed, we believe that methods such as obtaining consent without verbal explanation in person or by telephone are problematic.

We present our opinion based on the assumption that the case in question is conducted by both telephone and mail, but there is no general method for such a case, so please discuss the details with the sponsor.

  1. 1) Number of reports and countries from which data was obtained
    As with face-to-face meetings, both parties must have the written explanation in hand and the explanation must be given orally.
  2. 2)
    The date of explanation, the date of consent, and the date of delivery are, respectively, the date of explanation to the subject by the investigator, the date when the subject and the investigator sign the consent document, and the date when the signed copy of the consent document is sent to the subject or handed to the subject. The date when the subject and investigator actually signed the consent document must be indicated on the consent document. Since the explanation is not given in person, there may be differences between the two dates, so the informed consent process should be recorded in detail in the medical record.
  3. 3)
    I do not see a problem with the subject signing the form and returning it to you.
  4. 4)
    If you are concerned about the lack of face-to-face contact, I believe that the Medical Care Act only stipulates the principle of face-to-face treatment, but not the explanation for obtaining consent. If you can tell us specifically which provision you are concerned about the possibility of a violation, we will consider it again.
  5. 5)
    As for the criteria for the payment of subject burden reduction expenses, each company has its own view, so Clinical Trial 119 refrains from answering this question.

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