Drug Evaluation Committee 2021-37 Review by the Institutional Review Board Regarding the Removal of a Co-Principal Investigator
Related Category: Institutional Review Board
Initial Publication Date: October 2021
Question
Regarding the removal of a collaborating investigator, the revised GCP Guidance (July 30, Reiwa 3, Pharmaceutical and Medical Products Safety and Evaluation Committee Notice No. 0730-3) explicitly states: “Furthermore, the removal of a collaborating investigator that affects the clinical trial implementation structure also requires review by the Institutional Review Board (IRB).”Regarding this interpretation, is it consistent with the statement in the JPMA’s Opinion No. 2013-13, which states: “With regard to the removal of a sub-investigator, we recommend that the necessity of IRB review be determined by taking individual circumstances into account, rather than requiring IRB review across the board”?Does this mean that IRB review is required only when the removal of a sub-investigator affects the clinical trial implementation structure, and that IRB review is not required if the removal does not affect the structure?
JPMA Opinion
IRB review for the removal of a co-investigator is not required across the board; it is necessary only when it affects the clinical trial implementation structure. This point has been clarified in the recent revision of the GCP Guidance.The impact on the clinical trial implementation structure is likely to vary depending on factors such as the duties performed by the co-investigator being removed and the number of remaining co-investigators.Therefore, regarding the removal of a co-investigator, we believe the principal investigator must carefully assess whether the clinical trial can be conducted appropriately even after the removal of the co-investigator in question, and then prudently determine whether a request for IRB review is necessary.