Drug Evaluation Committee 2020-35 Records of Withdrawal of Consent for Participation in Clinical Trials
Related classification: Obtaining consent
Date of first publication: December 2020
Question
We have received an opinion from a clinical investigator that a "consent withdrawal document" should be prepared and signed by the investigator regarding withdrawal of consent. However, the investigator requested us to prepare a draft of the withdrawal of consent document, saying that it is necessary to preserve the subject's intention.
In this case, is it correct to say that the investigator should decide whether or not to prepare a withdrawal of consent document? I would like to ask for your opinion on whether or not to prepare the consent withdrawal document.
We also received an opinion that patients who refused to participate in a clinical trial after consent was explained to them should be asked to sign a statement that they will not participate in the trial. I told the physician that the refusal of consent can be confirmed by the screening list and that it is acceptable to record the refusal in the patient's medical record, but he seems to think that the record and the indication of the patient's intention are two different things.
As a CRC, I feel uncomfortable about whether it is necessary to ask the patient to sign the consent form if the patient refuses after having listened to the explanation of the clinical trial.
Both of the above two points may be the investigator's decision, but I would appreciate your opinion.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 51, Paragraph 1, Item 8) of the GCP stipulates that "the subject may withdraw from participation in a clinical trial at any time" and Article 51, Paragraph 9) of the GCP stipulates that "the subject will not be treated disadvantageously by not participating or withdrawing from participation in a clinical trial. It is necessary to place the highest priority on the free will of the subject or prospective subject (hereinafter referred to as "subject") to participate in a clinical trial, and it is necessary to create an environment where the subject does not feel pressured to refuse to participate in a clinical trial or to withdraw his or her consent to participate in a clinical trial once he or she has given his or her consent. GCP does not require the subject to sign a "withdrawal of consent document" or a "statement that he/she will not participate in the clinical trial," as you mentioned in your question. In addition, requiring subjects to submit such documents may put pressure on them to "decline," and we believe that introducing such documents should be carefully considered.
From the above perspective, we recommend obtaining the opinion of the Clinical Trial Review Committee when requesting the subject's signature on such a document. In addition, if the subject's signature is requested at the time of withdrawal of consent, this should be stated in the explanatory document in advance.