Drug Evaluation Committee 2013-15 Procedure for discontinuation of a clinical trial at the time of withdrawal of consent
Related classification: Obtaining consent
First published: August 2013
Question
What is your opinion on how to handle a subject's request to withdraw his/her consent to participate in a clinical trial?
Progress and outline
The investigator obtained the subject's consent to participate in the clinical trial and administered the investigational drug. Subsequently, the subject asked the CRC in charge to withdraw the consent, and the CRC received the withdrawal of consent. The circumstances leading to the withdrawal of consent were then reported to the investigator.
Questions
GCP Article 50 states that "the investigator must obtain consent in writing. I understand that "investigators, etc." in this case refers to "principal investigators and subinvestigators" in Article 10-1 (some people in the facility think that "etc." includes "CRCs"). If the role of "investigators, etc." is to obtain consent, I think it is necessary to do the same when consent is withdrawn. I believe that when consent is withdrawn, the investigator is responsible for explaining the subsequent safety investigation and the benefits and disadvantages (including medical aspects) that may result from the withdrawal of consent.
Please tell us how to respond to this issue in accordance with GCP.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
GCP Article 51, Paragraph 1, Guidance 1 (8) states, "The subject or the subject's surrogate may refuse or withdraw the subject's participation in the clinical trial at any time. Refusal or withdrawal shall not cause the subject to be treated unfavorably or to lose any benefits that he/she would have received if he/she had not participated in the clinical trial." The provision stipulates that In this regard, when a subject withdraws consent to participate in a clinical trial, the response on the part of the implementing medical institution must be to respect the subject's wishes and promptly terminate the clinical trial for the subject in question.
Furthermore, Article 1 Guidance 2 (7) of the GCP states that "the responsibility for medical care for the subject and for medical decisions made for the subject shall always be borne by the physician or dentist. Therefore, the investigator should contact the subject promptly and 1) make appropriate efforts to confirm the reason for withdrawal of consent, while fully respecting the subject's right not to have to reveal the reason for the withdrawal, and 2) make the subject aware of the possibility of harm to the subject. In addition, it is necessary to make appropriate efforts to 1) confirm the reason for the subject's withdrawal, while fully respecting the subject's right not to have to reveal the reason for the withdrawal, 2) confirm the existence of adverse events, and 3) consult with the subject regarding the subject's disease and subsequent treatment for the adverse events.
Note that "investigators, etc." in GCP Article 50 and other provisions refer to "principal investigators and subinvestigators" (see GCP Article 10, Paragraph 1, Item 5).