Full Board Review Deadline and Pre-review of Full Board Studies
In an effort to better serve our research community and streamline the review process, the IRB will change its procedures for all protocol submissions that require full board review: Initial Applications, Continuing Reviews, and Amendments. Starting June 23, 2016, all submissions requiring full board review will undergo an administrative pre-review. An IRB staff member will review all documents submitted for review to ensure they adhere to all applicable federal and CU Boulder regulations. Any required revisions will be communicated through eRA. After all required revisions are complete, the protocol will be scheduled for review at the next available convened IRB meeting. If no revisions are required, the submission will be scheduled for the next available board meeting.
Why are you making this change?
Addressing administrative issues prior to the meeting will allow board members to focus on substantive issues during the board meeting, rather than things such as missing information, typographical errors, and contradictions in the submission.
What about deadlines?
There will no longer be deadlines for board meetings; however, there will be an internal agenda close date, after which no additional items may be added to the agenda. The agenda close date will be 6 business days before the meeting date. The meeting schedule can be found here.
How do I plan my timeline for the new pre-review process?
All submissions will be reviewed within 10 business days. The majority of Initial Applications will require some kind of revisions before they are board-ready, so you should plan on that. If all issues noted in the pre-review are not adequately addressed, a second response will be required; however, if you address each issue noted in the pre-review it will be scheduled for the next available Board meeting. The agenda closes 6 business days before the meeting date so you should factor that in with timing your response.
What if I don’t want to make a revision requested in the pre-review?
Protocols will not be scheduled for board review until all required changes have been addressed. If there is a justifiable reason to not make a change noted in the pre-review, the investigator should reply with the justification and the protocol will be scheduled for board review.