Drug Evaluation Committee 2023-14 Regarding IRB Circulating Review
Related Category: Institutional Review Board
Initial Publication Date: August 2023
Question
This is a question regarding IRB circulation review. Even after the COVID-19 pandemic subsides, our hospital intends to continue utilizing both in-person reviews and circulation reviews.
We would appreciate your guidance on the following questions.
Currently, when there are no new clinical trials under review at our hospital, we conduct circulation reviews via email as a special measure during the COVID-19 pandemic, in accordance with the Ministry of Health, Labor and Welfare’s administrative notice titled “Handling of Reviews by Review Committees Regarding Clinical Trials Related to COVID-19.”Given that no particular issues have arisen with our hospital’s circulation review process to date, and considering that circulation reviews were conducted even before the COVID-19 pandemic—for example, by the Ministry of Health, Labor and Welfare’s advisory councils(e.g., the 15th Meeting of the Infectious Diseases Subcommittee of the Health Science Council held on February 4, Heisei 28), we intend to conduct in-person reviews only under the conditions listed below and, in all other cases, continue to utilize the cloud-based document management system “Agatha” for circulation reviews.Unlike email, the cloud-based document management system “Agatha” assigns a unique ID to each IRB member and requires a password plus a one-time password to log in, enabling two-way communication within the IRB’s workspace on the cloud.Provided that IRB deliberations using the cloud-based document management system do not constitute a violation of GCP, we plan to seek the understanding of the clinical trial sponsor and, after obtaining the approval of the IRB members, revise our Standard Operating Procedures (SOPs).
We would appreciate your guidance on whether IRB deliberations using a cloud-based document management system constitute a violation of GCP. If they do not constitute a violation, please advise us whether they are acceptable under our hospital’s draft conditions for holding in-person IRB meetings.
Draft Conditions for Holding In-Person IRB Meetings
○ Review of new clinical trial applications
○ Ongoing review in accordance with GCP regulations (for pharmaceuticals, GCP Article 31, Paragraph 1)
Review of the appropriateness of continuing the clinical trial; meetings must be held at least once a year
○ Review of safety-related matters from the perspective of subject protection
・ First report of a serious adverse event occurring at this hospital
However, this applies only when a causal relationship with the investigational drug cannot be ruled out. For the second and subsequent reports, the IRB Chairperson will determine whether to conduct a face-to-face review.
・ Deliberation on safety information reports requiring revisions to the protocol or informed consent document
・ Deliberation on protocol or informed consent form revisions deemed by the principal investigator or Chairperson of the IRB to potentially influence a subject’s decision
○ When deemed necessary by the Chairperson of the IRB
○ When an IRB member requests an in-person review after reviewing the distributed IRB materials
Opinion of the JPMA
We believe that round-robin review via email or other means was approved solely as a special measure during the spread of COVID-19 and should not be applied as a standard procedure under normal circumstances.
Although the method presented this time reportedly allows for two-way communication via the cloud, we believe it is difficult to ensure deliberations of the same quality as those conducted in person, given that real-time exchanges are not possible and there is no guarantee that all members are participating in the discussion.Therefore, with the exception of minor amendments to ongoing clinical trials, I believe that deliberations should, in principle, be conducted in person or through methods capable of ensuring deliberations of equivalent quality.