Agreement for Transferring IRB Oversight from (insert Name of IRB) to Fred Hutch IRB
1)Identify the studies to be transferred (describe):
2)Describe how the availability and retention of pertinent records are maintained by the original IRB once transfer to the Fred Hutch IRB has occurred:
All IRB documents from the original IRB will be transferred to the Fred Hutch IRB with the initial application or continuing review report submitted to the Fred Hutch IRB. Where practicable, both electronic and paper copies of all IRB documents from the original IRB will be transferred. If the transfer of paper copies is not feasible, electronic copies of all IRB documents deemed required by the Fred Hutch IRB in its sole judgment shall be transferred in a format that is fully accessible and readable by the Fred Hutch IRB and staff within the Fred Hutch Institutional Review Office. If the transfer of paper copies along with the electronic copies is not feasible, the transferring IRB shall retain the paper copies intact and in a secure manner indefinitely and shall make all the documents available for inspection or audit after the IRB transfer to Fred Hutch’s IRB is complete. The transferring IRB agrees to deliver the paper copies of all IRB records to the Fred Hutch IRB in the event the transferring IRB’s policies and practices dictate destruction of the IRB records.
3)What is the effective date for transfer of oversight, including records for the clinical investigation(s)?
4)Who will confirm that Fred Hutch has conducted review of the transfer study(ies) before Fred Hutch accepts responsibilities for the study(ies)?
5)How will you confirm the next continuing review date once a study(ies)
6)Will consent forms be revised when the study(ies) are transferred to the Fred Hutch IRB?
7)Who will be responsible for notifying key parties of the transfer of IRB oversight and provide copies of this communication to:
Principal Investigators ______
Name/title of responsible party
Sponsors ______
Name/title of responsible party
Original IRB______
Name/title of responsible party
Fred Hutch IRB ______
Name/title of responsible party
CRO______
Name/title of responsible party
Other responsible third party______
Name/title of responsible party
DSMB______
Name/title of responsible party
8)Who will be responsible for updating IRB registration, if needed?
IRB registration of (insert name of original IRB):
______
Responsible party/name/title
Fred Hutch IRB:
:
______
Responsible party/name/title
9)The following institutional representatives acknowledge the terms of this agreement as outlined in section 1-8 above. Their signature on behalf of their respective institutions authorizes the terms of this IRB transfer agreement.
Signatory Official of Original IRBSignatory Official of IRB
Responsible for Transferred Study(ies) Review and Oversight
Printed Name:______Printed Name: ______
Title: Title:
Address: Address:
Telephone:Telephone:
Fax: Fax:
Signature:Signature:
Date: Date:
0367IRBform_TransferAgreement / Version 1.02 / 07-03-2017 / Page 1 of 3