IRB Transfers
An IRB transfer happens when a study that has been approved by another IRB is transferred to WCG IRB. Transfers happen for a variety of reasons — if an investigator decides to change IRBs for some reason, if a local IRB is closing, or if the study is at an institution that has recently signed a contract with WCG IRB.
Required Documentation for an IRB Transfer Review Request
- Initial Review Submission Form (accessed via ClinSphere® eReview Manager or IRBNet) .
- Background information provided on the WCG IRBForm IRB Transfer Cover Letter Checklist & Summary.
- Any documents that the submitter has been instructed to provide based on his/her answers to the questions on the IRB Transfer Cover Letter Checklist & Summary. https://www.wcgclinical.com/irb-resources/irb-forms/ (for example, the form instructs the submitter to provide any new risk or benefit information that was not submitted to the previous IRB).
- A copy of the complete current protocol if not already on file at WCG IRB.
- A copy of the currently approved consent form (the one approved by the previous IRB).
Any documents that the submitter has been instructed to provide based on his/her answers to the questions on the IRB Transfer Cover Letter Checklist & Summary form (for example, the form instructs the submitter to provide any new risk or benefit information that was not submitted to the previous IRB).
IRB Transfers Fall Into Two Categories
“Active” – some or all participants are on active* treatment and the site may recruit more participants for the study.
“Follow-up only” – the site will not recruit any more participants, but still has participants in follow-up (participants no longer on active* treatment).
*WCG IRB acknowledges that the definition of “active” may vary, depending on the type of research being transferred. For drug studies, generally if a participant is no longer receiving any study drugs (active drug, control, placebo, etc.), but the investigator is collecting follow-up data on them, then those participants are in follow-up, not “active.”
Why the distinction between “active” sites and sites in “follow-up only?”
If a site is still enrolling and/or has active participants, WCG IRB will provide the site with an updated consent form with instructions for how participants can contact WCG IRB if they have questions about their rights as a research participant or with questions, concerns, input, or complaints about the research. Alternatively, if the site’s participants are all in “follow-up only” status, WCG IRB will review the existing consent form for completeness, and if it is compliant with the regulations, will accept the existing consent form and provide a letter for the site to give to participants notifying them of the change of IRB.
Recommended Instructions for Institutions Deactivating Their IRB or Transferring Multiple Projects to WCG IRB:
- Plan a conference call with WCG IRB to discuss preliminary steps toward transition of studies.
- Begin to assess which studies have active participants that will need to be transitioned first.
- Begin to assess continuing review schedules which may necessitate immediate transfer to keep those studies open for active participants. (Plan to keep the existing IRB functioning until all open studies have either closed or been approved by WCG IRB.)
- Notify WCG IRB of the number of studies that are to be transitioned.
- Communicate to the research community the plan to transfer active studies to WCG IRB.
- Communicate to the research sponsors the plan to transfer active research to WCG IRB – notifying them of impending change with request for payment of transfer and give the sponsor a deadline after which transfer will take place.
- Establish a date for a startup meeting with a WCG IRB representative, if necessary or desirable, depending on staff familiarity with WCG IRB forms and systems, or volume of studies.