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 consentor (a person with parental authority over the subject) lives far away from the Investigator Site and is unable to visit the Investigator Site. Therefore, an explanatory document for consent is mailed to the surrogate and the investigator and collaborator explain the consent to the surrogate over the phone while the surrogate reads the explanatory document. 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 Investigator Site.
JPMA's Opinion
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, it is assumed that the explanation to the surrogate is given in person at the Investigator 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, it is also a good idea to ask the investigational review committee for its opinion on obtaining consent by this method.
Reason for revision
With the issuance of the GCP Guidance (No. 0831-15 issued on August 31, 2020 by the Pharmaceutical Affairs Agency), minor changes were made to the description.