NOTE: The turnaround times below represent the schedule for complete submissions. Incomplete submissions or submissions requiring follow-up may be delayed. IRO staff will contact the PI and/or study team within the screening window so issues may be addressed and corrected.
All turnaround times are counted in business days, unless otherwise noted.
For studies coordinated through Clinical Research Support (CRS), the processing time shown below represents the number of days allotted for IRO staff to provide approval documents to CRS. CRS posts documents on Clinical FYI within 2 days of receipt of approval documents from the IRO.
ACTIVITY/DOCUMENT TYPE / SCREENING TIME TO CHAIR OR IRB MEETING / REVIEW TIME / PROCESSING TIMEFull Committee Review / New Application, New Participating Site Application, Modification, PI Response to IRB1 / See IRB Meeting Schedule for submissions deadlines2 / Approval documents distributed 1 day following the IRB meeting3
Continuing Review Report / To IRB within 30 calendar days of expiration date / Approval documents distributed 1 day following the IRB meeting3
Continuing Review Report + Modification / To IRB within 30 calendar days of expiration date / Approval documents distributed 1 day following the IRB meeting3
Expedited Review / New Application
(New Participating Site Application, Minimal Risk, Exempt, Not Human Subjects Research Determination) / To IRB Chair (Chair) within 7 days of receipt / 2 days / Approval documents distributed 2 days following Chair signature5
Research Modification Form / To Chair within 5 days of receipt4 / 2 days / Approval documents distributed 2 days following Chair signature5
Continuing Review Report / To Chair within 30 calendar days of expiration date / 2 days / Approval documents distributed 2 days following Chair signature5
PI Response
(formal response to IRB Result Letter) / To Chair within 5 days of receipt / 2 days / Approval documents distributed 2 days following Chair signature5
Reporting Forms
Adverse Event / To Chair within 2 days of receipt / 2 days / Final documents distributed 3 days following Chair signature6
Noncompliance / To Chair within 2 days of receipt / 2 days / Final documents distributed 3 days following Chair signature6
Unanticipated Problem / To Chair within 2 days of receipt / 2 days / Final documents distributed 3 days following Chair signature6
3rd Party Safety Report (if reporting criteria are met)7 / To Chair within 2 days of receipt / 2 days / Final documents distributed 3 days following Chair signature6
Closure / To Chair within 7 days of receipt / 2 days / Final documents distributed 3 days following Chair signature
ACTIVITY / DOCUMENT TYPE / PROCESSING TIME / NOTES
Other Activities / Result Letter / Letter distributed 5 days following IRB review / If a submission is disapproved, the PI will be notified by email within 1 day of meeting.
Letter to OHRP / FDA / Letter distributed (a) 30 calendar days after the incident is reported to the IRB or (b) 10 business days following the IRB meeting, whichever is later. / If the IRB determines an event is Serious and/or Continuing Noncompliance or an Unanticipated Problem, external organizations will be notified as required
External IRB Cover Sheet – New Application / 5 days / Permission from the IRO is required before applying to an external IRB. This approval is documented on the "IRO Endorsement of External IRB Application" form.
Certification Letter / 3 days to IRO Director for signature / Certification of IRB Approval, generally provided to funding agencies upon request
Footnotes
1 - Submissions that are Disapproved will return to the same Full IRB Committee by which the item was Disapproved.2 - New Applications which require Scientific Review Committee (SRC) must obtain SRC approval before being assigned to an IRB meeting.
3 - Submissions that go to Full Committee Review and are not Approved as Submitted will be issued a formal Result Letter. See Result Letter timing under "other."
4 - If a Research Modification Form indicates the change is an "emergency," IRO staff will provide documents to Chair within 1 day of receipt.
5 - If the Expedited Reviewer determines a transaction requires Full Committee Review, it will be assigned to the next available IRB meeting
6 - If the Expedited Reviewer refers a Reporting Form to the Full Committee, IRO staff will notify the PI and IRO Contact of its agenda assignment. The PI will then be given an opportunity to provide further information for Committee consideration.
7 - Third Party Safety Reports which do not meet reporting criteria will undergo administrative review only, and will be acknowledged and returned to the PI within 7 days.
0411IRBform_TurnaroundTimesExt / Version 1.00 / 01-29-2018 / Page 1 of 1