IRB Reliance Agreement Request Form- non - UVA IRB as IRB of Record

IRB RELIANCE AGREEMENT REQUEST FORM
Non-UVa IRB to serve as IRB of Record
INSTRUCTIONS AND INFORMATION
The purpose of this form is to facilitate centralized review of research and encourage multi-site
collaborations and to eliminate, where possible, reviews by multiple IRBs. The request will be
considered by the IRB-HSR on a case by case basis.
 A Reliance Agreement also known as an IRB Authorization Agreement allows an institution to
rely on the IRB of another institution for review of human subject’s research.
 This form should be completed if you would like to implement an agreement to rely on a nonUVa IRB to serve as the IRB of record for a single protocol or a group of protocols. .
 See the IRB Reliance Agreement Request Form: UVa IRB to serve as IRB of Record if you
would like the UVa IRB-HSR to serve as the IRB of record.
 Complete this form and submit it along with the IRB Reliance Agreement from the IRB of
Record to [email protected]
Submission Date:
Submitted By:
Phone:
Email:
Website: http://www.virginia.edu/vpr/irb/hsr/index.html
Phone: 434-924-2620 Fax: 434-924-2932 Box 800483
Version Date: 05/30/17
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IRB RELIANCE AGREEMENT REQUEST FORM
UVa IRB-HSR to serve as IRB of Record
NOTE: The IRB-HSR may decline a request to rely on a non UVA IRB. For more information, contact the IRB-HSR.
UVa IRB for Health Sciences Research (IRB-HSR) Information
Name of Institution
FWA #
IRB-HSR Registration Number
IRB Contact Name/Phone Number
Signatory Official/Phone Number
Signatory Official Contact Address
University of Virginia
00006183
00000447
Susie Hoffman/434-924-9634
David Hudson/ 434-243-0900
Senior Associate VP for Research
University of Virginia
PO Box 400301
136 Hospital Drive
Charlottesville, Virginia 22904
UVa Information
PI of Protocol(s) at UVa
--Name
--Title
--Address
--Phone
--Email
UVa Contact
-- Name
--Contact UVa Box Number
--Contact-Phone Number
--Contact- Email
Designating the IRB of Record
Name of IRB of Record
Institution affiliation of IRB (if applicable)
FWA # ( if applicable)
IRB Registration Number
YES
NO
Do you confirm that the IRB of Record is a member of
SMART IRB and will use the SMART IRB Reliance Agreement If NO, explain reason
template and SOP’s
IRB Contact Information
--Name
--Phone number
--Email
Website: http://www.virginia.edu/vpr/irb/hsr/index.html
Phone: 434-924-2620 Fax: 434-924-2932 Box 800483
Version date: 05/30/17
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Is this agreement for a single protocol or a group of
protocols?
Does UVA have an existing IRB Reliance Agreement with
the IRB of Record that would cover this study?
If NO answer this set of questions:
Single (Protocol Title:
)
Group ( Group Name:
)
YES
NO
Do not know
Will the IRB of Record serve as the HIPAA Privacy Board?
YES
If (study is /studies are) not federally funded or not
regulated by the FDA does the IRB of Record apply the
federal regulations to all research regardless of funding
source ( e.g. “unchecked the box” on their FWA)?
(Study team will need to confirm the answer with the IRB of
Record)
NA
YES
Is the IRB of Record in the state of Virginia?
YES
NO
Do you confirm you have attached the IRB Reliance
Agreement from the IRB of Record?
If NO, explain reason for not attaching:
YES
NO
NO
NO
Research Information
Provide a brief description of the study.
Explain the roles & responsibilities of
UVA researchers.
Explain the roles & responsibilities of
non- UVA researchers if different from
UVA researchers.
NA OR Explain:
Do you confirm that a CIRB Application will be submitted through Protocol Builder for each protocol to be
covered under this IRB Reliance Agreement?
YES
NOTE: The IRB-HSR may decline a request to rely on a non-UVa IRB. For more information, contact the IRB-HSR.
Website: http://www.virginia.edu/vpr/irb/hsr/index.html
Phone: 434-924-2620 Fax: 434-924-2932 Box 800483
Version date: 05/30/17
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ACKNOWLEDGMENT OF RELYING INSTITUTIONS AGREEMENT TO CEDE IRB REVIEW &
ACKNOWLEDGMENT OF REVIEWING IRB’S AGREEMENT TO SERVE AS IRB OF RECORD
This form documents that IRB review will be:
ceded under the SMART IRB Master Common Reciprocal IRB Authorization Agreement
and that all will follow the SMART IRB SOPS.
will not be ceded under the SMART IRB Master Common Reciprocal IRB Authorization
Agreement.
1). The University of Virginia agrees to cede IRB review to the Click here to enter name of
Reviewing IRB for the study noted below:
Study Title:
Overall PI or Sponsor Name
UVA Investigator:
Attach CV
Relying Institution IRB Contact acknowledging approval to cede IRB review:
Date:
Name:
Phone:
Email:
AND
2) The Click here to enter name of Reviewing IRB agrees to serve as the Reviewing IRB (IRB of
Record) for the study and relying institution noted above.
Reviewing IRB Contact acknowledging approval to serve as IRB of Record:
Date:
Name:
Phone:
Email:
Website: http://www.virginia.edu/vpr/irb/hsr/index.html
Phone: 434-924-2620 Fax: 434-924-2932 Box 800483
Version date: 05/30/17
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A copy of the completed form will be shared with the IRB contact of the relying institution.
Website: http://www.virginia.edu/vpr/irb/hsr/index.html
Phone: 434-924-2620 Fax: 434-924-2932 Box 800483
Version date: 05/30/17
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