The Chesapeake Research
Review Inc. (CRRI)
Institutional Review
Board Option
at Stony Brook
University
SBU investigators wishing to conduct industry-sponsored biomedical research studies may choose between the IRB services provided locally by SBU's IRBs (CORIHSa, CORIHSb) or those provided by our associate, Chesapeake Research Review Inc. (CRRI).
Please note that investigator-initiated studies must be reviewed by
SBU's IRB and are not eligible for review by CRRI.
If you wish to use CRRI's IRB Service, you
first
need to confirm with your sponsor that the sponsor will accept direct
invoicing from CRRI and allow direct payments to CRRI. Once you have confirmed (preferably in writing) that this
billing method is acceptable to your sponsor, then you will need to:
I. Complete your CRRI application by visiting the CRRI CIRBI™ website:
The Center for IRB Intelligence (CIRBI™) is
Chesapeake IRB's web-based electronic platform, which supports the
entire IRB process, from initial submission and review to study
close-out.
All users must register prior to accessing the CIRBI system.
To register, go to
www.cirbi.net and click on
“Sign Up”. A temporary password will be sent to the e-mail account
specified at the time of registration. Users are required to change
their password when logging into CIRBI for the first time.
All study-related contacts must also be
registered in the CIRBI system prior to completion of an online protocol
application. Therefore, it
is recommended that any individual who intends to use CIRBI immediately
register in order to facilitate future research submissions.
To submit a research proposal follow the
directions/prompts found within CIRBI and the Smart Form: CIRBI uses
Smart Form technology, which directs users to complete only those
sections of the application that are directly applicable to the research
study. Users will be prompted to upload all required study documents
into the Smart Form. The Smart Form may be completed in one session or
multiple sessions by saving the form and accessing it at a later date.
First-time CIRBI users are highly encouraged
to contact our CRRI Project Coordinator,
NOTE #1:
At the time of your initial protocol submission to CRRI, please
include the Sponsor’s template Informed Consent Form.
CRRI will then convert the Sponsor’s Consent Document into the
CRRI/SBU approved ICF.
NOTE #2:
In assessing CRRI deadlines and meeting dates (available on CRRI's
website at www.chesapeakeirb.com),
the investigator must factor in 2 working days for ORC
review/processing. ORC does not assume responsibility for making a
particular CRRI review deadline.
II. After you
submit your application package electronically to CRRI, you must satisfy
SBU application requirements for CRRI studies, also now electronic:
If you are not
already registered and/or if you have not yet created a study on IRBNet,
please follow the directions available on our website at
http://www.stonybrook.edu/research/irbnet/IRBNet%20for%20SBU%20BNL%20Researchers.pdf
Create a study,
complete initial fields, and when it’s time to download, complete, and
upload documents back into your study designer, do so with the following
documents from the forms and documents library of IRBNet:
A.
SBU IRB/Institutional Fee Invoice Authorization Form
B.
SBU
Scientific Merit Review Form: The application materials must be
endorsed as scientifically meritorious by either the department chair or
departmental review committee of
all
departments impacted by the proposed activity.
C. SBU
University Hospital Form: This form is necessary to assess impact of
the proposed activity on UH patients, services and facilities.
Make sure you share, and obtain e-signatures from all appropriate
parties, as detailed in sections V and VI of the IRBNet link above.
III. Send an e-mail to
Judy.Matuk@Stonybrook.edu
with the subject heading: CRRI study submitted on CIRBI [Insert PI name
here]
IV. SBU Responsibilities re: CRRI-Reviewed Protocols
A. SBU Responsibilities Prior to Protocol Submission to CRRI
When the e-mail referenced in section III is received:
1. Eligibility to use CRRI, and proper fee authorization will be certified,
2. Departmental chair/committee scientific merit assessment will be
confirmed
3. Institutional processes
for financial disclosure/ COI management requirements, budget review and
contract negotiation will be confirmed as initiated, in process or
completed with notification to appropriate University officials for
tracking and compliance purposes.
Once 1, 2 and 3 are reviewed and determined to be satisfied, CRRI
will be notified to commence review of the submitted protocol.
Concurrent with this notification may be reminders of special
considerations for local context that should be considered during IRB
review.
B. SBU Responsibilities Concurrent with Protocol Review by CRRI
Concurrent with CRRI IRB review will be ORC’s review of local
compliance and administrative local requirements. Often, CRRI, SBU and
the sponsor will need to negotiate together to confirm compliance with
federal regulations and SBU best practices.
SBU University Policy P209, including the investigator disclosure
form process, and following thresholds for determining significant
financial interest in a pharmaceutical company are applicable to
investigators submitting to CRRI for IRB review. Where there is human
subject involvement in a sponsored activity, recommendations of the SBU
COI Committee will be forwarded to ORC, who will retain responsibility
for forwarding the management plan (as applicable) to CRRI.
C. SBU Responsibilities: Post CRRI IRB Approval
SBU's ORC retains on-site monitoring responsibility for all
studies, reviewed locally or by CRRI. Reports of site monitoring
activities which have any finding that potentially impact human subject
protections will be shared with CRRI.
Similarly, the ORC will be provided with any reports of CRRI’s
on-site monitoring activities.
V. Investigators approved through CRRI’s IRB must still report
Unanticipated Problems to the SBU Office of Research Compliance, in
addition to CRRI reporting requirements
The policy:
http://www.research.sunysb.edu/HSG/HSGsec16.html#16.E
The form to complete:
http://www.stonybrook.edu/research/forms/up-usaeform.doc
(or online in the study designer
of your IRBNet study)
VI.
Questions for CRRI?
CRRI welcomes your questions, comments and concerns at any time.
Feel free to contact the applicable individuals as follows:
www.chesapeakeirb.com
CIRBI Help Desk Information
Hours of Operation:
9:00am – 6:00pm (Eastern Standard Time)
Toll-free Phone Number:
1-866-99CIRBI (1-866-992-4724)
Email:
CIRBI@irbinfo.com
IRB Services Supervisory Team
Ms.
Executive Director of IRB Services Director of Operations
(P) 443.884.2900
(P) 443.884.2900
(F) 410.884.9190
(F) 410.884.9190
tstraut@irbinfo.com
lbuchanan@irbinfo.com
Institutional, Social & Behavioral Team
Mr.
Project Coordinator
Associate Director
(P) 443.283.1624
(P) 443.283.1577
(F) 410.884.9190 (F) 410.884.9190
rcruise@irbinfo.com
lcarlile@irbinfo.com
Subject Contact Information
Billing/Finance
IRB Management
Study Subject Adviser Mr. Jeff Wendel
Ms.
(P) 410.884.2900 (P) 443.283.1520 (P) 443.283.1546
Subjects are encouraged (F) 410.884.9190
(F) 410.884.9190
to call collect jwendel@irbinfo.com
mcdonough@irbinfo.com
- Updated 04/01/2008