Drug Evaluation Committee 2018-16 Informed Consent for Alternate Consenters by Telephone
Related classification: Obtaining consent
Initial publication date: 08/2018
Revised publication date: Mar 2021
Question
Please tell us whether the following methods of obtaining consent are problematic under GCP and, if so, why. If the above methods are not problematic, please tell us if there are any points to be noted in their operation.
The surrogate (a person with parental authority over the subject) lives far away and is unable to come to the site of the study. Therefore, an explanatory document for consent is mailed to the surrogate consentor, and the investigator and the study collaborator explain the consent to the surrogate consentor over the phone while the surrogate consents to the study. The explanation will be given in sufficient time, and any questions or doubts will be answered by telephone or e-mail. If the surrogate agrees to participate in the clinical trial, he/she signs the consent form and the form is mailed to the site.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
A surrogate is considered to be a person who has the best interests of the subject in mind (GCP Article 2 Guidance 14). Therefore, when consenting to participation in a clinical trial, it is important that the subject fully understands not only the content of the explanatory document but also the subject's current condition. Therefore, we believe that it is a prerequisite that explanations are provided to the surrogate consenting party in person at the site.
However, if it is unavoidable to explain to the proxy by telephone or through an online conference system, it is necessary to provide sufficient explanation using the explanatory document, to give the subject the opportunity to ask questions and sufficient time to decide whether or not to participate in the clinical trial after consultation between the subject and the proxy, and to provide a method for the proxy to answer all questions to the satisfaction of the subject. After ensuring that all questions can be answered to the satisfaction of the subject and the surrogate, it would be one idea to ask the Clinical Trial Review Committee for its opinion on obtaining consent by this method.
Reason for revision of opinion
With the issuance of the GCP Guidance (No. 0831-15 issued by the Pharmaceutical Affairs Agency on August 31, 2020), minor changes have been made to the description.