Chapter 39

A Change of Principal Investigator

Please note that if the current investigator has not been overseeing the study, WCG IRB will also need to know how long the PI has been gone, why the PI left, who has been overseeing the study in the PI’s absence, and if there have been any participant safety concerns during this time. The Board expects departing PIs to arrange for an orderly transition of their research to the new investigator. The Board requires written approval from the sponsor directed to WCG that the change is acceptable and has been approved per 21 CFR 312.53(a).

If you submit via ClinSphere® eReview Manager, select Modification to Research (under “Start Something New” on the home page) and then “Change in Investigator” on the following screen; submitters using IRBNet to submit, should use the offline initial review form available to you.

In most cases, WCG IRB will provide an updated consent form with the new PI’s name and contact information included. Once approved, the new PI is also authorized by WCG IRB to carry out the study as previously approved for the prior investigator (except where the Board provides alternate instructions to the new PI). This includes continued use of the previously approved study materials (recruitment materials, participant materials, and so forth). For more information about when an updated consent form is not needed, please contact us.

When changes to translated documents that were provided to WCG IRB for approval are necessary, the client (site, sponsor, CRO) is responsible for arranging those updates with their vendor and then submitting the updates to WCG IRB, including the signed translator certification statement, for processing. If changes to a translated consent form do not require a translator (for example, name, phone numbers, etc.), then the staff at the site (or the sponsor/CRO) can make those changes, and a new translation certification statement is not required. Only changes that require translation need to be done by a translator and confirmed with a new translation certification statement.