Drug Evaluation Committee 2017-31 Participation in Clinical Trials by Welfare Beneficiaries (Part 2)
Related classification: Other
Date of first publication: October 2017
Question
We have learned that a subject already participating in a clinical trial at our hospital has gone through the application process to receive welfare benefits. Currently, we are waiting to hear whether the application will be approved or not.
Since the explanatory document was not prepared with the welfare recipient's participation in mind, the explanatory document that we are currently receiving consent for is one that does not describe the case in which the welfare recipient participates in the study. The sponsor of the clinical trial is of the opinion that there is no problem for welfare recipients to participate in this study. We have not yet been able to speak to the welfare office representative regarding the fact that the welfare recipient is participating in the clinical trial. The investigator has not yet started to prepare an explanatory document for the welfare recipient's participation in the clinical trial, and the investigator has not yet been reviewed by the Clinical Trial Review Committee.
Please let us know if there is anything we should pay attention to when a subject participating in a clinical trial receives welfare benefits during the course of the clinical trial.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If a welfare recipient participates in a clinical trial, it may affect his/her eligibility for benefits and the burden of medical expenses during the trial, as described in past Opinions 2007-07 and 2007-09. However, the investigator should promptly inform the subject of the mutual impact of the welfare recipient's receipt of welfare benefits and participation in the clinical trial, and confirm the subject's intention regarding the treatment of the burden reduction expenses and continued participation in the clinical trial, and record the series of events that occurred. We believe that it is necessary to confirm the subject's willingness to receive welfare benefits and to continue participation in the clinical trial, and to record the series of events. Coordination with the welfare office in the subject's residential area and the subject should then be conducted in parallel with the implementation of the clinical trial.
In addition, the fact that the subject is participating in a clinical trial constitutes personal information, so when your hospital consults with the welfare office, please be sure to comply with the Personal Information Protection Law and the "Guidance for the Appropriate Handling of Personal Information by Medical and Nursing Care Professionals" (April 14, 2009 (partially amended in October 2020), Personal Information Protection Commission, Ministry of Health, Labour and Welfare). (April 14, 2009 (partially revised in October 2020), Personal Information Protection Commission, Ministry of Health, Labour and Welfare).