Submission to ApprovalSubmission to Approval

What happens to my protocol once I What happens to my protocol once I submit it to the HIC officesubmit it to the HIC office

Before SubmissionBefore Submission

Signatures of the Principal Investigator, Signatures of the Principal Investigator, faculty sponsor (if needed), and the faculty sponsor (if needed), and the Department Chairperson are required. Department Chairperson are required.

Other approvals-YCCI, PRC*, PPRC* or Other approvals-YCCI, PRC*, PPRC* or external IRB’s, etc.external IRB’s, etc.

Don’t use staples- use paper clips insteadDon’t use staples- use paper clips instead

Make sure you have the required number Make sure you have the required number of copies of each document listed on the of copies of each document listed on the HRPP websiteHRPP website

Electronic SubmissionElectronic Submission For new protocols be sure to upload For new protocols be sure to upload allall of the of the

protocol documentsprotocol documents For reapprovals and/or amendments be sure to For reapprovals and/or amendments be sure to

upload only those documents that you are upload only those documents that you are revising in tracked format (along with the 5R revising in tracked format (along with the 5R and amendment request forms)and amendment request forms)

Each document should be named Each document should be named appropriately, according to type (protocol, appropriately, according to type (protocol, consent, etc). consent, etc).

Make sure you click submit TWO TIMES ! (if Make sure you click submit TWO TIMES ! (if you do not receive an email saying it was you do not receive an email saying it was submitted or if the status is pending you did not submitted or if the status is pending you did not click twice)click twice)

Refer to the COEUS training website for any Refer to the COEUS training website for any questions questions ((http://www.yale.edu/coeus/ ) )

The Drop Off-SubmissionThe Drop Off-Submission

Protocols can be dropped off at the HIC Protocols can be dropped off at the HIC office during business hours 8:30-5 or in office during business hours 8:30-5 or in the drop box outside the office door.the drop box outside the office door.

HIC recommends dropping off the protocol HIC recommends dropping off the protocol at the HIC office as campus mail has been at the HIC office as campus mail has been known to be much less efficient; protocols known to be much less efficient; protocols have been known to be lost for weeks or have been known to be lost for weeks or never make it here.never make it here.

Electronic protocols can be submitted any Electronic protocols can be submitted any time. time. Again, be sure to click submit!Again, be sure to click submit!

The Drop Off-SubmissionThe Drop Off-Submission

The administrative staff will stamp the HIC The administrative staff will stamp the HIC application with a received stamp that includes application with a received stamp that includes the date for your records. the date for your records.

The administrative staff will check for The administrative staff will check for completeness, training for all study personnel, completeness, training for all study personnel, and Conflict of Interest disclosure for the and Conflict of Interest disclosure for the Principal Investigator. They will return any Principal Investigator. They will return any protocol with missing documents, or if the PI protocol with missing documents, or if the PI does not have training or has not filed a COI does not have training or has not filed a COI disclosure. *disclosure. *

The HIC will no longer hold onto incomplete The HIC will no longer hold onto incomplete submissions for paper copies and incomplete submissions for paper copies and incomplete electronic submissions will be rejected in electronic submissions will be rejected in COEUS.COEUS.

The next step is TriageThe next step is Triage

TRIAGETRIAGE

This is the where the determination This is the where the determination between Full Committee Review and between Full Committee Review and Expedited Review is made.Expedited Review is made.

Every day an HIC staff member is Every day an HIC staff member is assigned to triage and everything assigned to triage and everything that comes in that day is triaged that comes in that day is triaged within 1-2 days.within 1-2 days.

Expedited is determined by Federal Expedited is determined by Federal regulations, not the HIC.regulations, not the HIC.

Expedited Review DOES NOT mean Expedited Review DOES NOT mean faster review!faster review!

Electronic TriageElectronic Triage

The triager is responsible for all The triager is responsible for all incoming electronic incoming electronic submissions. submissions.

This staff member checks for This staff member checks for completion and determines if the completion and determines if the protocol requires Full Committee protocol requires Full Committee or Expedited review, just as with or Expedited review, just as with the paper submissions. the paper submissions.

Regulatory ReviewRegulatory Review

New protocols submitted to the HIC New protocols submitted to the HIC are assigned to an HIC regulatory are assigned to an HIC regulatory reviewer (staff member), who will reviewer (staff member), who will review the submission for clarity, review the submission for clarity, completeness, and regulatory completeness, and regulatory compliance.  compliance.  

This staff member will work with the This staff member will work with the PI or research coordinator to create PI or research coordinator to create a version of the protocol that is ready a version of the protocol that is ready for submission to the Full Committee for submission to the Full Committee or for expedited review. or for expedited review.

This means that the research This means that the research falls into one of the federally falls into one of the federally mandated expedited review mandated expedited review criteria.criteria.

The protocol can be reviewed The protocol can be reviewed by an HIC regulatory analyst, by an HIC regulatory analyst, and does not have to go to full and does not have to go to full committee for reviewcommittee for review

Expedited ReviewExpedited Review

Federal Regulations regarding Federal Regulations regarding expedited reviewexpedited review

Federal Regulations allow for Federal Regulations allow for expedited review whenexpedited review when Research presents no more than Research presents no more than

minimal riskminimal risk The research fits specified categoriesThe research fits specified categories The identification of subjects (or their The identification of subjects (or their

responses) would not place them at risk responses) would not place them at risk of criminal or civil liability, be damaging of criminal or civil liability, be damaging to their financial standing or reputation, to their financial standing or reputation, be stigmatizing (unless there are be stigmatizing (unless there are appropriate protections in place for appropriate protections in place for guarding this)guarding this)

HIC Procedures for Expedited HIC Procedures for Expedited ReviewReview

Once the protocol or amendment Once the protocol or amendment has been triaged as expeditable it is has been triaged as expeditable it is given to the administrative assistants given to the administrative assistants to enter all of the protocol to enter all of the protocol information into COEUS, the HIC information into COEUS, the HIC tracking system. tracking system.

Once a protocol is entered into Once a protocol is entered into COEUS it is then assigned for reviewCOEUS it is then assigned for review

HIC Procedures for Expedited HIC Procedures for Expedited Review (cont’d)Review (cont’d)

When a protocol is being reviewed When a protocol is being reviewed as “expedited”, communication as “expedited”, communication between the HIC staff and protocol between the HIC staff and protocol correspondent is usually via e-mail correspondent is usually via e-mail or phone call. or phone call.

This communication will notify the This communication will notify the correspondent as to whether the correspondent as to whether the protocol is approved or requires protocol is approved or requires specific minor revisions.specific minor revisions.

The Full Committee PacketThe Full Committee Packet

This packet is put together by a coordinator This packet is put together by a coordinator every Tuesday by noon. This packet every Tuesday by noon. This packet contains the HIC application, reapproval contains the HIC application, reapproval forms, amendment form, consent forms, forms, amendment form, consent forms,

other necessary approvals, DSMB reports, other necessary approvals, DSMB reports, sponsor protocols, etc…..sponsor protocols, etc…..

Each study is assigned reviewers for the Each study is assigned reviewers for the meeting. New= primary and secondary, meeting. New= primary and secondary, reapprovals and amendments= primary. reapprovals and amendments= primary.

Committee members review their assigned Committee members review their assigned documents prior to each meeting.documents prior to each meeting.

HIC Procedures for Full HIC Procedures for Full Committee ReviewCommittee Review

All HIC applications that do not meet All HIC applications that do not meet criteria for expedited review are reviewed criteria for expedited review are reviewed at a full Committee meeting.at a full Committee meeting.

The HIC also sends expedited protocols to The HIC also sends expedited protocols to full Committee meetings at times when the full Committee meetings at times when the protocol deals with a controversial topic.protocol deals with a controversial topic.

Most new applications are not approved Most new applications are not approved the first time, there are generally Specific the first time, there are generally Specific Minor Revisions (SMR) required.Minor Revisions (SMR) required.

Full Committee MeetingFull Committee Meeting

Committees meet every Wednesday Committees meet every Wednesday of the month -three evenings and of the month -three evenings and one afternoon.one afternoon.

Each protocol is discussed and Each protocol is discussed and voted on.voted on.

Any revisions requested are Any revisions requested are conveyed to the PI via letter by conveyed to the PI via letter by Friday of that week.*Friday of that week.*

Approvals are also typically ready by Approvals are also typically ready by Friday with all the appropriate Friday with all the appropriate documents validated.documents validated.

RevisionsRevisions

The PI or the Study Coordinator The PI or the Study Coordinator makes the revisions that the HIC makes the revisions that the HIC requires. The revised documents are requires. The revised documents are then resubmitted to the HIC for then resubmitted to the HIC for further review. further review.

Once received by the Regulatory Once received by the Regulatory Analyst assigned to that protocol, the Analyst assigned to that protocol, the revisions are reviewed (most often revisions are reviewed (most often within one week of receipt) and if within one week of receipt) and if complete, will be approved.complete, will be approved.

ApprovalApproval

Approval letter, Approved HIC Approval letter, Approved HIC application, Approved consent application, Approved consent forms, and other acknowledged forms, and other acknowledged documents are prepared for pick documents are prepared for pick up.up.

Email is sent to the Email is sent to the correspondent and PI that the correspondent and PI that the documents have been documents have been approved.approved.