Drug Evaluation Committee 2020-23 Obtaining Consent through Online Clinical Trials
Related classification: Obtaining consent
Date of first publication: September 2020
Question
The following answers are provided as "Q&A on Conducting Clinical Trials of Pharmaceuticals, Medical Devices and Regenerative Medicine Products under the Influence of New Type Coronavirus Infection" (updated May 26, 2020).
Q9
In the "Guidelines for the Appropriate Implementation of Online Clinical Practice" (March 2008 (partially revised in July 2048) by the Ministry of Health, Labour and Welfare), there is a statement that "medical care should not be provided that has not undergone clinical trials or clinical studies and whose safety has not been established. According to the guideline, should clinical trials not be conducted using online medical care? （According to this statement in the guideline, should clinical trials not be conducted using online medical care?)
A9
According to the guideline, "Online medical care that is appropriately conducted in a clinical trial may be conducted. According to a confirmation with the Medical Affairs Division of the Medical Affairs Bureau of the Ministry of Health, Labour and Welfare, the description in the guideline is based on the fact that information on the patient's physical and mental condition is more limited in online medical care than in face-to-face care, from the perspective of medical safety in general online medical care, etc., and that clinical trials are not assumed to be the subject of the guideline. The guideline does not assume that clinical trials are the subject of the guideline.
We interpret the above Q&A as allowing for online treatment in clinical trials, but it does not specify whether consent can be obtained online using paper media. Is there a problem under GCP with explaining and obtaining consent online using paper media in the following manner, instead of obtaining consent electromagnetically?
- Send the explanation and consent documents to the potential subjects in advance, and arrange the date and time of the online explanation.
- When explaining the trial online, the identity of the subject should be verified in some way.
- The clinical trial will be explained and questions and answers will be answered online.
- If the subject agrees to participate in the clinical trial online, the date and signature on the consent document are confirmed through the online screen.
- The consent document is returned (or brought to the clinic).
- The investigator and others will later date and sign the consent document with the "date of online explanation" and "date when consent was confirmed.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
In this Q&A, it is generally possible to conduct online medical care in clinical trials, and Q&A 9-2 discusses the applicability of online medical care when the investigator is forced to take measures that differ from the provisions of the protocol and normal procedures under the influence of new coronavirus infection (hereafter referred to as COVID-19). The Q&A section discusses the applicability of online medical care in cases where the investigational protocol and normal procedures have to be differently applied. In addition, as stated in the Q&A, physicians are required to understand that the information on the patient's physical and mental condition that can be obtained in online care is more limited than in face-to-face care from the perspective of medical safety, etc. in online care in general. Given this, the method of obtaining consent described in your question seems to be acceptable as a method of obtaining consent for continued participation in a clinical trial under the influence of COVID-19 in a clinical trial incorporating online medical care during the course of the trial. However, whether it is appropriate to use this method for obtaining consent for participation in a clinical trial before the clinical trial under the influence of COVID-19 or in a normal clinical trial after the convergence of COVID-19 is considered to require sufficient consideration in each individual clinical trial.
In accordance with GCP Article 52, Paragraph 1, Guidance 1, the consent document must be dated and signed by the subject as well as the investigator and others (i.e., the date of signature must be noted), but other dates such as "date of online explanation" or "date of confirmation of consent" are not mandatory. Rather, it would be more important to document this informed consent process in detail in the medical record, etc.
See also previous Opinion 2019-58 (Obtaining Consent for Continued Participation in Clinical Trials by Telephone and Mail).