University of Colorado Denver
Colorado Multiple Institutional Review Board
Standard Operating Procedures
SOP - WIRB Protocols
Version #: 001
Effective Date: 11/1/2008
Supersedes Document:
This Policy Pertains to: WIRB Protocols
Responsibility for executing this policy: Director, WIRB Coordinator
Last Reviewed on: 10/24/2008
Result:
Approval Authority: Director
Approved by: Alison Lakin, Director, COMIRB
Date:
11/1/2008
1. PURPOSE
To describe the procedures/communications required when WIRB (Western IRB) serves as the primary
IRB of record.
2. POLICY
WIRB provides Full Board Review for Particular industry sponsored protocols.
As of July 19, 2006, investigators from UCHSC and its affiliates who have already opted-in to this system
will have their industry-sponsored protocols be reviewed by WIRB (Western IRB), an independent central
IRB. This applies to industry-sponsored protocols only. Investigator-initiated, grant-supported or
expedited/exempt protocols may not be reviewed by WIRB and must be reviewed by COMIRB, as
indicated on the WIRB Eligibility Form (CF-051).
Those studies that were reviewed by WIRB during the shutdown in 2000, will remain with WIRB until they
close, using the mechanism that was put in place at that time (refer to 5.1.5 through 3.1.7 for applicable
procedures), unless they receive administrative approval to return back to COMIRB.
3. SPECIFIC POLICIES
3.1
a) In order to have a protocol reviewed by WIRB, the PI must go through the ‘opt-in’ procedure, to
be done during a specified time frame.
b) Administrative approval to ‘opt-out’ of WIRB and return to COMIRB for non-industry sponsored
protocol reviews will be done on an annual basis during a specified time frame.
3.2
The PI will submit 2 copies of the initial review packet to COMIRB, which will include both
COMIRB and WIRB required documents. If the study sites include DHHA or UCH, the clearance
letters should be included in the packet (all required documents listed on the WIRB Initial Review
Cover Letter, CF-050).
WIRB coordinator will do in-house review of the packets for eligibility. HIPAA Authorization forms
will also be reviewed/noted by WIRB coordinator. Packets that do not meet eligibility
requirements will be returned to the PI and will need to be submitted to COMIRB for full board
review. If the protocol does meet eligibility criteria, one packet will be kept in a yellow file folder at
COMIRB (per CP-017), and the other packet will be sent to WIRB.
3.3
After approval, WIRB will send both the PI and COMIRB the Approval letter, approved consent
form, and any other approved documents. COMIRB will send the PI a hard copy of the feedback
letter, noting the HIPAA Authorization form(s) and any suggested changes. If the DHHA or UCH
WIRB Protocols
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University of Colorado Denver
Colorado Multiple Institutional Review Board
Standard Operating Procedures
are study sites, COMIRB will provide the approved consent form and the HIPAA Authorization
form to the regulatory personnel.
3.4
For all updates or changes to a protocol (including amendments, advertisements, SAE’s, etc.),
the PI/study coordinator will send the documents directly to WIRB. Personnel and site changes
should be submitted to both WIRB and COMIRB. All approval letters/acknowledgements will be
sent by WIRB (including approved annual continuing reviews), to both the PI and to COMIRB.
3.5
PI will send their closure request to both WIRB and COMIRB. WIRB will send an
acknowledgement to both the PI and COMIRB.
3.6
WIRB may contact COMIRB for questions requiring contact with a PI/study coordinator regarding
a protocol. When appropriate, COMIRB acts as liaison between the PI/study coordinator and
WIRB.
3.7
WIRB will notify the COMIRB of all reportable actions regarding the protocol and COMIRB will be
the institution responsible for investigating and reporting to the appropriate federal and
institutional entities (see SOP IR-075
4. RESPONSIBILITY
The COMIRB Director and WIRB Coordinator are responsible for review and implementation of the SOP.
The COMIRB Director is responsible for day-to-day oversight of this SOP.
5. APPLICABLE REGULATIONS AND GUIDELINES
45 CFR 46. 103, 108, 109
21 CFR 56. 103, 108, 109
OHRP Guidance:
General Guidance on the Use of Another Institution’s IRB, 1991
Up-date Suitability of a Designated Institutional Review Board (IRB), 1997
Knowledge of Local Research Context, 1998 updated 2000
6. ATTACHMENTS
CF-050
WIRB Initial Review Cover Letter
CF-051
WIRB Eligibility Checklist
CP-017
Study File Folder Organization
Suspensions and Terminations: Reporting to Federal Authorities
7. PROCEDURES EMPLOYED TO IMPLEMENT THIS POLICY
Who
Director
WIRB Coordinator
Task
Oversees Opt-in/Opt-out process
In-house review of WIRB protocol packet. Determines eligibility of WIRB
protocol. Reviews and notes HIPAA Authorization forms. Sends protocol
packet to WIRB. Upkeep of WIRB files at COMIRB throughout the life of the
protocol. Acts as liaison between PI/study coordinator and WIRB when
necessary.
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