IRB AUTHORIZATION AGREEMENT REQUEST FORM
INSTRUCTIONS AND INFORMATION
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This form should be completed if you would like to implement an IRB Authorization Agreement (IRB
AA) with an IRB outside of UVa.
An IRB AA is a mechanism whereby one institution relies on another for IRB review and approval of all
or part of a study.
The IRB-HSRcan serve as the IRB reviewing the full protocol , the IRB relying on another
institution’sIRB to review the full protocol or may share oversight, with each IRB reviewing only the
work done at their own institution..
As the “Reviewing Institution”, an institution is responsible for IRB review and continued oversight.
As the “Relying Institution”, an Institution cedes IRB review and continuing oversight to the Reviewing
Institution’s IRB.
In a “Shared IRB Review”, each institution is only responsible for the work being done at their
institution.
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
Associate VP for Research
University of Virginia
PO Box 400301
136 Hospital Drive
Charlottesville, Virginia 22904
PI of Protocol at UVa
--Name
--Title
--Address
--Phone
--Email
Outside Institution Information
Name of Institution
FWA #
IRB Registration Number
IRB Contact Name
--Name
--Phone # and Email
Website: http://www.virginia.edu/vpr/irb/hsr/index.html
Phone: 434-924-2620 Fax: 434-924-2932 Box 800483
Version date: 02/03/14
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Signatory Official
--Name
--Title
--Address
--Phone
--Email
PI of Protocol at Outside Institution
--Name
--Title
--Address
--Phone
--Email
Protocol Information
Protocol Title
Protocol PI (must
match PI listed on
protocol)
Sponsor or Funding
Agency
IRB # of protocol
from outside
institution
IRB-HSR Protocol #
UVa Contact Name
Phone
Email
Summary of Overall
Research Activities*
*Include the purpose, hypotheses and procedures
Designating the Reviewing and Relying Institution.
1. Will UVa be the Reviewing Institution?
YES
If YES, skip to # 3.
If NO, Reviewing IRB/Ethics committee Name:
NO
Is the IRB/Ethics committee in a foreign country?
YES
NO
IF YES,
 explain your experience with the site and the personnel at the site :
 explain your experience with the local IRB/ethics committee:
 will data with any HIPAA identifiers be brought to the US?
*Federalwide Assurance and IRB Registration numbers may be obtained from the outside
institution or found at http://ohrp.cit.nih.gov/search
Website: http://www.virginia.edu/vpr/irb/hsr/index.html
Phone: 434-924-2620 Fax: 434-924-2932 Box 800483
Version date: 02/03/14
Page 2 of 3
2. Reviewing Institution’s Protocol Information
Protocol Number
OR NA
Required Documentation Attached:
Copy of IRB Application/ Protocol
Copy of IRB Approval
Do you confirm that the work being done by UVa personnel is outlined in the outside Protocol?
YES
NO
IF YES, Identify location (page or section #)
3. Will UVa be the Relying Institution?
YES
NO
IF YES, go to # 4.
IF NO, describe the work that will be done at outside institution:
*Federalwide Assurance and IRB Registration numbers may be obtained from the outside
institution or found at http://ohrp.cit.nih.gov/search
4. Has the IRB-HSR previously approved this protocol?
YES
NO
IF YES, IRB-HSR Protocol #
IF NO, complete the following:
 List the UVa personnel that will be working on this project:
 Describe the work that will be done at UVa:
5. Will human research activities, including subject recruitment, enrollment and/or study
interventions/interactions with a subject, occur on UVa property or include data/specimens
from UVa patients/subjects?
YES
NO
IF YES, explain
Note to IRB staff: Need to determine if any HIPAA Authorizations, Data Use Agreements or
Waiver of HIPAA Authorization is required. If subjects will be seen at UVa, will also need to
determine if any other ancillary approvals are required.
NOTE: The IRB-HSR may decline a request to be the Reviewing or Relying Institution. For more
information, contact the IRB-HSR Director Susie Hoffman at 434-924-9634 or srh@virginia.edu.
Submitted by:
Date:
Website: http://www.virginia.edu/vpr/irb/hsr/index.html
Phone: 434-924-2620 Fax: 434-924-2932 Box 800483
Version date: 02/03/14
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