Yale University Human Research Protection Program
920 PR.4 Use of Western IRB for Review and Oversight of Research
Involving Yale Investigators
Overview................................................................................................................................................ 1
Protocols Qualifying for Possible WIRB Review ................................................................................... 1
Protocol Submission Process................................................................................................................ 1
Protocol Changes and Continuing Review ............................................................................................ 2
Fees for Yale IRB review ....................................................................................................................... 2
Pl’s Ongoing Reporting Responsibility to Yale IRB ............................................................................... 2
WIRB Responsibilities and Oversight ................................................................................................... 2
Links to Relevant Forms and Policies ................................................................................................... 3
Contact Information ............................................................................................................................... 3
Overview
This procedure reviews the process for use of Western IRB (WIRB) for Institutional Review Board (IRB) review
and oversight of research involving Yale investigators. Yale maintains an Agreement for Services with WIRB
which sets forth understandings, authority and responsibilities of both institutions.
Protocols Qualifying for Possible WIRB Review
Studies that qualify for consideration for WIRB review must meet all of the following criteria:
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It must be a multi-site clinical trial that was written and designed by the sponsor (without any scientific
contribution by Yale University faculty) and that is sponsored by a for-profit entity/company;
It cannot involve planned emergency research, gene transfer, embryonic stem cells, prisoners, or Phase I
trials in healthy controls;
It does not receive federal funding or funds from another not-for-profit funding agency;
There are no imposed restrictions on approval from the Yale Cancer Center Protocol Review Committee
(PRC) or any other committee such as limitations on enrollment, etc.;
The Principal Investigator (PI) must meet the Yale University requirement to serve as a PI on a research
protocol;
The PI does not hold an IND.
Each request for WIRB submission will be reviewed internally. The Yale IRBs retain the authority to deny the
request should any concerns regarding the submission be identified.
Protocol Submission Process
Protocols qualifying for WIRB review must be first sent to the Human Investigation Committee via an email
submission with the subject of an email as ‘Request for WIRB review’. The submission needs to consist of:
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A Request to Submit a Research Protocol to WIRB,
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If applicable, PRC approval letter,
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Approval letters from other Committee’s required to review the study at Yale as applicable (e.g. the
Scientific and Safety Committee (SSC), the Yale Magnetic Resonance Research Center Protocol Review
Committee (MRRC-PRC), or Radiation Safety Committee (RSC), etc.).
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All sponsor and local documents associated with the research: sponsor protocol, Investigator’s Brochure
(IB), all consent forms containing Yale required language, recruitment materials, and any FDA
correspondences available.
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920 PR 4 – Use of Western IRB for Review and Oversight of Research Involving Yale Investigators
Upon receipt, the Yale IRB will save the documents in an electronic file and enter the protocol into the system for
tracking purposes. The Yale IRB is responsible for verification of the WIRB review eligibility criteria, verification of
the PI’s and staff’s compliance with HIPAA and Human Subject Protection training requirements, verification of
the congruency between the terms of In Case of Injury language in the consent forms and the contract with the
sponsor, and identification of any factors that may disqualify a protocol from authorization for WIRB review.
Once the protocol is approved for submission to WIRB, a signed WIRB checklist and WIRB Authorization letter
are issued and sent to the PI and the correspondent on the study. The PI is then allowed to pursue WIRB
approval. Once the approval is issued, the Yale IRB is notified by WIRB via an email. The Yale IRB will keep a
copy of WIRB approval letter in the shadow file. The Yale IRB may, at its discretion, conduct a follow-up review of
WIRB-approved consent forms and other documents for Quality Assurance purposes. Any problems identified
during this review will be communicated to the WIRB Contact for resolution.
Protocol Changes and Continuing Review
Once a new application has been referred to WIRB by the Yale IRB, any changes, amendments, or modifications
as well as continuing review should be sent directly by the principal investigator to WIRB (or to the study sponsor)
via electronic submission.
Personnel amendments must be submitted to the Yale IRB prior to WIRB submission. The Yale IRB will verify
training and COI (where applicable) compliance. Any discrepancies will be communicated with the PI and the
study correspondent. Signed amendment request will be returned to the PI/study correspondent.
The Yale IRB will be notified by WIRB via an email when the submission is approved. Documentation of WIRB
approval will be saved in the study specific electronic file.
Fees for Yale IRB review
The Yale IRB charges an initial fee for review of commercial IRB submissions. The fees are not locked during the
duration of the study and are subject to change.
Pl’s Ongoing Reporting Responsibility to Yale IRB
In addition to reporting requirements to WIRB as the IRB of record per their policies and procedures, the Yale PI
is responsible for notifying Yale IRB about any reportable events per HRPP Policy 700 ‘Noncompliance,
Suspension and Termination’.
WIRB Responsibilities and Oversight
WIRB will assume the IRB protocol oversight and perform IRB functions in compliance with federal regulations.
WIRB will review and either approve or disapprove new protocols; review and approve, disapprove or modify
consent forms; review and approve or disapprove the participation of the investigator(s); monitor adverse event
reports; and maintain required IRB records. WIRB will conduct continuing review of study protocols appropriate to
the degree of risk in such protocols, or at least an annual review of each study. WIRB will serve as HIPAA Privacy
Board for studies under its purview.
WIRB will contact the investigator or study coordinator directly to obtain additional information or necessary
documents required for initial and continuing review. The Yale IRB may assist WIRB in soliciting this information
if WIRB has difficulty obtaining such information through the normal procedures of contacting the investigator or
study coordinator.
WIRB will notify the Yale IRB of any of the following: WIRB termination or suspension of a study; adverse events
that it considers serious that were not anticipated in the WIRB-approved protocol and were found to be possibly,
probably or definitely related to the research occurring at Yale or at other sites when Yale is the managing center
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920 PR 4 – Use of Western IRB for Review and Oversight of Research Involving Yale Investigators
in a multi-center trial; any unanticipated problems involving risks to subjects or others; instances of serious or
continuing noncompliance with the federal regulations or the requirements and the determinations of WIRB, along
with WIRB’s assessment as to how such noncompliance impacted research subjects and what remedial actions it
recommends; WIRB monitoring reports and any other matter that comes to the attention of WIRB that adversely
affects Yale’s compliance with applicable regulations. WIRB will notify the Yale IRB of its decisions to approve,
disapprove, or recommend modification of research studies.
WIRB is not required to determine whether noncompliance is serious or continuing, but if it elects to do so and
finds serious or continuing noncompliance it will notify Yale and Yale will notify federal agencies as required, with
a copy to WIRB.
WIRB will review all protocol-specific conflict of interest (COI) forms pertaining to protocols referred to WIRB, and,
pursuant to Yale’s COI and other policies, WIRB will take the contents of the COI form into consideration in
reviewing and deciding upon the related protocol.
WIRB will provide upon request any documents or information in its possession relative to a protocol or
investigator, including but not limited to, protocol submission history, response time by the investigator, copies of
documents sent by the investigator to WIRB, together with any and all related documents.
Relevant Forms and Policies
WIRB Workflow
Request to Submit a Research Protocol to WIRB
Consent Required Language
IRB fee schedule
Policy 110: Institutional Review Board Review Fees
Policy 700: Noncompliance, Suspension and Termination
Contact Information
For WIRB:
Written inquiries may be addressed to:
Western Institutional Review Board
3535 Seventh Avenue SW
Olympia, WA 98502-5010
Website information: http://www.wirb.com/
Phone: (360) 252-2500 or (800) 562-4789
Yale IRB:
Website information: http://yale.edu/hrpp/
hrpp@yale.edu
Phone: (203) 785-4688
Fax: (203) 785-2847
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