Drug Evaluation Committee 2016-53 Timing of obtaining re-consent (Part 3)
Related classification: Obtaining consent
Date of first publication: February 2017
Question
In the study for which I am currently in charge, a telephone contact occurs every week. If the consent document is revised (only the responsible physician is changed), is it acceptable for the CRC to confirm the subject's intention to continue the clinical trial during the telephone contact, rather than explaining it when the subject comes to the hospital? (GCP states that the subject must be provided with the relevant information immediately.)
Also, when updating the safety information, I understand that it may be difficult to convey this information over the phone, but in that case, do we still have to explain it during the phone contact and confirm the subject's willingness to continue the clinical trial? We would appreciate it if you could provide us with your opinion on this matter.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
When information is obtained that may influence the subject's decision to continue participation in a clinical trial, the investigator is required to promptly inform the subject of such information and confirm the subject's decision to continue participation in the clinical trial (GCP Article 54, Paragraph 1, Guidance 1). In other words, the investigator or sub-investigator must confirm the subject's willingness to continue the clinical trial, and we believe that explanation and confirmation of willingness by the cooperating researcher (CRC) alone is inappropriate.
The following questions should be considered regarding the method of explanation to subjects, confirmation of their willingness, and timing of obtaining their re-consent, such as whether the investigators should confirm their willingness to continue the trial at the time of telephone contact and obtain their re-consent using the explanation document (revised version) at the next clinical trial visit, or whether an unscheduled interview with subjects is necessary to obtain their re-consent. The investigator should make a judgment based on the importance, urgency, and complexity of the information to be communicated to the subject.
When confirming the subject's willingness to continue the clinical trial by telephone contact, it is necessary to give the subject an opportunity to ask questions, answer them sufficiently, and obtain the subject's understanding, as well as to record the circumstances of the contact.
Please refer to our previous Opinion 2011-32 regarding whether a change in investigators affects the willingness to continue a clinical trial.