Submission to Approval

1. Submission to Approval What happens to my protocol once I submit it to the HIC office

2. Before Submission • Signatures of the Principal Investigator, faculty sponsor (if needed), and the Department Chairperson are required. • Other approvals-YCCI, PRC*, PPRC* or external IRB’s, etc. • Don’t use staples- use paper clips instead • Make sure you have the required number of copies of each document listed on the HRPP website

3. Electronic Submission • For new protocols be sure to upload all of the protocol documents • For reapprovals and/or amendments be sure to upload only those documents that you are revising in tracked format (along with the 5R and amendment request forms) • Each document should be named appropriately, according to type (protocol, consent, etc). • Make sure you click submit TWO TIMES ! (if you do not receive an email saying it was submitted or if the status is pending you did not click twice) • Refer to the COEUS training website for any questions (http://www.yale.edu/coeus/ )

4. The Drop Off-Submission • Protocols can be dropped off at the HIC office during business hours 8:30-5 or in the drop box outside the office door. • HIC recommends dropping off the protocol at the HIC office as campus mail has been known to be much less efficient; protocols have been known to be lost for weeks or never make it here. • Electronic protocols can be submitted any time. • Again, be sure to click submit!

5. The Drop Off-Submission • The administrative staff will stamp the HIC application with a received stamp that includes the date for your records. • The administrative staff will check for completeness, training for all study personnel, and Conflict of Interest disclosure for the Principal Investigator. They will return any protocol with missing documents, or if the PI does not have training or has not filed a COI disclosure. * • The HIC will no longer hold onto incomplete submissions for paper copies and incomplete electronic submissions will be rejected in COEUS. • The next step is Triage

6. TRIAGE • This is the where the determination between Full Committee Review and Expedited Review is made. • Every day an HIC staff member is assigned to triage and everything that comes in that day is triaged within 1-2 days. • Expedited is determined by Federal regulations, not the HIC. • Expedited Review DOES NOT mean faster review!

7. Electronic Triage • The triager is responsible for all incoming electronic submissions. • This staff member checks for completion and determines if the protocol requires Full Committee or Expedited review, just as with the paper submissions.

8. Regulatory Review • New protocols submitted to the HIC are assigned to an HIC regulatory reviewer (staff member), who will review the submission for clarity, completeness, and regulatory compliance.   • This staff member will work with the PI or research coordinator to create a version of the protocol that is ready for submission to the Full Committee or for expedited review.

9. Expedited Review • This means that the research falls into one of the federally mandated expedited review criteria. • The protocol can be reviewed by an HIC regulatory analyst, and does not have to go to full committee for review

10. Federal Regulations regarding expedited review Federal Regulations allow for expedited review when • Research presents no more than minimal risk • The research fits specified categories • The identification of subjects (or their responses) would not place them at risk of criminal or civil liability, be damaging to their financial standing or reputation, be stigmatizing (unless there are appropriate protections in place for guarding this)

11. HIC Procedures for Expedited Review • Once the protocol or amendment has been triaged as expeditable it is given to the administrative assistants to enter all of the protocol information into COEUS, the HIC tracking system. • Once a protocol is entered into COEUS it is then assigned for review

12. HIC Procedures for Expedited Review (cont’d) • When a protocol is being reviewed as “expedited”, communication between the HIC staff and protocol correspondent is usually via e-mail or phone call. • This communication will notify the correspondent as to whether the protocol is approved or requires specific minor revisions.

13. The Full Committee Packet • This packet is put together by a coordinator every Tuesday by noon. This packet contains the HIC application, reapproval forms, amendment form, consent forms, other necessary approvals, DSMB reports, sponsor protocols, etc….. • Each study is assigned reviewers for the meeting. New= primary and secondary, reapprovals and amendments= primary. • Committee members review their assigned documents prior to each meeting.

14. HIC Procedures for Full Committee Review • All HIC applications that do not meet criteria for expedited review are reviewed at a full Committee meeting. • The HIC also sends expedited protocols to full Committee meetings at times when the protocol deals with a controversial topic. • Most new applications are not approved the first time, there are generally Specific Minor Revisions (SMR) required.

15. Full Committee Meeting • Committees meet every Wednesday of the month -three evenings and one afternoon. • Each protocol is discussed and voted on. • Any revisions requested are conveyed to the PI via letter by Friday of that week.* • Approvals are also typically ready by Friday with all the appropriate documents validated.

16. Revisions • The PI or the Study Coordinator makes the revisions that the HIC requires. The revised documents are then resubmitted to the HIC for further review. • Once received by the Regulatory Analyst assigned to that protocol, the revisions are reviewed (most often within one week of receipt) and if complete, will be approved.

17. Approval • Approval letter, Approved HIC application, Approved consent forms, and other acknowledged documents are prepared for pick up. • Email is sent to the correspondent and PI that the documents have been approved.