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

Submission to Approval
What happens to my protocol once I
submit it to the HIC office
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
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/ )
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!
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
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!
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.
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.
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
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)
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
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.
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.
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.
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.
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.
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.