Approval and Follow Up
APPROVAL TIMELINE
Approval time is dependent on the level of review. If all materials are included in the original submission and there are no requested revisions -
- EXEMPT proposals are reviewed by the IRB Chair and can typically be approved within 1 week.
- EXPEDITED proposals require only a single IRB member to approve. The IRB Chair can approve, but most often these proposals are sent to an IRB member with more similar disciplinary knowledge to the proposal. Given the back and forth and that most IRB members are faculty volunteers, these proposals are typically approved in 1-2 weeks.
- FULL proposals require the approval of the full board at a convened meeting. IRB members are typically provided 2 weeks to review all materials before meeting. Given the requirement to convene the board and the challenges of finding a time when all can meet, proposals under full review are typically approved in 3-4 weeks.
We strive to respond to submissions as quickly as possible, but when there is a high volume (multiple proposals for course projects), when studies require more than the Chair to review, or when proposals are incomplete or require revision, the process is delayed. We thank you for your attention to preparing complete proposals, following the guidance, and for your patience.
Once approved, the PI(s) will receive notice by email from the IRB Chair. The approval letter will outline PI responsibilities with respect to continuing review, amendments, reporting adverse effects, and closure of the protocol.聽
AMENDMENTS
After initial approval of a protocol in any category (Exempt, Expedited, and Full), if any of the following aspects of your research study have changed, please submit Form E for approval:
- Changes to research personnel
- Changes to the research protocol or instruments
- Changes to the research subjects’ identity or number recruited/enrolled
- Changes to the consent documents
- Any other substantive changes
For Exempt protocols, changes could alter the exemption status.
CONTINUING REVIEW
Annual continuing review is required for Expedited and Full Review protocols to ensure ongoing protection of human subjects. Submit Form C at least 30 days in advance of approval expiration.
ADVERSE EFFECTS
All research categories (Exempt, Expedited, and Full Review) require prompt reporting of adverse events, unanticipated problems, or breaches of confidentiality. However, these events are less likely in Exempt studies due to their minimal risk nature. Please use Form G to report such incidents within 48 hours of awareness.
NOTIFICATION OF CLOSURE
Closure must be reported when all research activities, including data analysis involving identifiable information, are complete. This applies to Expedited and Full Review studies. Exempt studies do not require formal closure. Submit Form F to notify the IRB and officially close the protocol.
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