IRB RELIANCE AGREEMENT AND IRB CEDE REQUEST FORM
UVa IRB-HSR to serve as IRB of Record
INSTRUCTIONS AND INFORMATION
IF THE RELYING INSTITUTION IS A MEMBER OF SMART IRB DO NOT COMPLETE PART A OF THIS FORM.
PROCEED TO PART B.
IF AN IRB RELIANCE AGREEMENT IS ALREADY IN PLACE FOR THE PROPOSED PROTOCOL PROCEED TO PROTOCOL BUILDER
TO SUBMIT A PROTOCOL APPLICATION TO THE IRB-HSR
INSTRUCTIONS AND INFORMATION: PART A
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 for researchers from another
institution to rely on the IRB-HSR to serve as the IRB of record for a single protocol or a group of protocols.
 See the IRB Reliance Agreement Request Form: Non-UVa IRB to serve as IRB of Record if you would like a NON
UVa IRB to serve as the IRB of record.
 Complete this form and submit it to the IRB-HSR office along with other required documents.
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: 03/01/2017
Page 1 of 9
PART A:
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 the UVa IRB-HSR. 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
Relying Site Information
Relying Site Institution Name
State any other names by which the organization
(site) is known or does business and any corporate
affiliations it has with other organizations, such as a
university or hospital network.
Do those other entities/ sites operate under their
own independent FWAs?
YES
NO
If yes, each of those entities/sites will need to complete a
separate request form.
Site FWA #
YES
NO
Has the site’s federal wide assurance been
extended to non-federally funded research?
Is the Site AHHRPP accredited?
YES
NO If Yes, latest accreditation date:
Single
Is this agreement for a single protocol or a group
Group ( Group Name:
)
of protocols?
Research Information
Provide a brief description of the study
Explain the roles & responsibilities of
UVA researchers.
Explain the roles & responsibilities of
NA OR Explain:
non- UVA researchers if different from
UVA researchers
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
Page 2 of 9
Local Context Issues
NA – all subjects to be enrolled at UVA.
1. Are there any state or local laws that need to be considered that would impact a research
protocol or informed consent document (wards of state, emancipated minors, results of
pregnancy testing)?
YES
NO
2. Are there any local, community or cultural issues that may be different for your population of
subjects that require consideration?
YES
NO
3. Do you expect a large percentage of the potential research population to speak languages
other than English or Spanish?
YES
NO
If so, what languages?
4. Does your site approve of the use of short forms for non English speaking individuals?
5.
YES
NO
If Yes, are there any limitations on the use of short forms (e. g. only minimal risk research)?
YES
NO
6. Describe any institutional policies and procedures or generally accepted ways you
operationalize obtaining assent of children for participation in research.
7. Describe any institutional policies and procedures or generally accepted ways you
operationalize obtaining surrogate consent for adult individuals with impaired decisionmaking capacity.
8. Are there any special characteristics of your institution or community of which the IRB-HSR
should be made aware?
YES
NO
If yes, describe:
9. Is there anything described in the protocol that would not fall within the policies and
practices of your institution that the IRB-HSR needs to be aware of?
YES
NO
If yes, describe:
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
Page 3 of 9
Site Specific Informed Consent Requirements
NA – all subjects to be enrolled at UVA.
1. Provide local language to include in the consent regarding compensation in the event of a
research related injury.
.
2. Will the Site use a Stand Alone HIPAA Authorization or require HIPAA language in the
research consent? Check one option below:
Stand Alone HIPAA Authorization
HIPAA Language in research consent form
If HIPAA Authorization language will be in in research consent form, include language
3. Any additional local language to be included in Header/footer of document (e.g. relying
institution study tracking #)
Oversight Mechanisms
NA – all subjects to be enrolled at UVA.
1.
Does the organization have a quality assurance/audit group responsible for overseeing
ongoing research?
YES
NO
If yes, please describe
2. Does the organization have other oversight mechanisms?
YES
NO
If yes, please describe
3. Contact information for person in charge of quality assurance/audit or other oversight
mechanism
Name
Email
Phone
4.
Provide the name of the person/office that will provide additional protections if a child is
enrolled who is a Ward of the State.
NA No children will be enrolled
NA- No subjects will be enrolled at 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
Page 4 of 9
PART B:
PROTOCOL INFORMATION
Instructions:
The UVA study team should complete this form for each new protocol that will be covered via
SMART IRB processes or by an existing IRB Reliance Agreement.
Protocol Information
Protocol Title
UVa PI (must match PI
listed on protocol)
IRB-HSR #/UVA Study
Tracking # of protocol
Research Information
Complete this section if Part A of this form was not completed.
Provide a brief description of the
study
Reason for request to rely on the
IRB-HSR.
Explain the roles & responsibilities
of UVA researchers.
Explain the roles & responsibilities
of non- UVA researchers if different
from UVA researchers
NA OR Explain:
NA OR Explain:
Relying Institution Information
Relying Institution PI
--Name
--Title
--Address
--Phone
--Email
Relying Institution Study Team Contact
--Name
--Address
--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
Page 5 of 9
Relying Institution IRB Contact Information
--Name
--Phone number
--Email
--URL for the site IRB
Do you confirm that you have attached a
Research Study Staff Log?
Subject Enrollment
Will subjects be enrolled at UVA
facilities?
Will subjects be enrolled at non- UVA
facilities?
NO
staff
YES
NO
YES
NO
YES
NA No additional research
Ancillary Reviews
Each relying site is responsible for obtaining any required local institutional ancillary reviews that
apply to the conduct of this protocol.
SUBMIT ALL APPLICABLE APPROVALS to the UVa PI who will submit them to the UVA IRB-HSR with
this form.
Subjects will not be allowed to enroll at a relying site until all required local institutional committee
approvals are submitted to UVa and the relying site has received an approved consent form for
their site.
Applicable Not Applicable Review Type
Comments
Radiation Safety/ HIRE Review
Cancer Center Protocol Review
Committee (PRC)
Pharmacy Review
Nursing Review
Biomechanical/ Clinical Engineering
Sponsor/ contract agreements
Other: specify
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
Page 6 of 9
Conflict of Interest
INSTRUCTIONS: Each site is responsible for reviewing the protocol and determining if a conflict of
interest exists in accordance with the SITE’s institutional policies. The conflict and the management
plan must be disclosed to the IRB-HSR. The IRB-HSR will have the final determination if it is
appropriate for the IRB-HSR to assume the responsibilities of the IRB of Record.
Does the protocol present any potential conflicts of interest as defined in the relying Site’s
institutional policies?
YES
NO
If Yes, describe the conflict.
Provide the language the site requires in the consent form regarding the conflict.
Do you confirm you have attached the Conflict of Interest Management Plan?
YES
NO
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
Page 7 of 9
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). Click here to enter name of Relying Institution agrees to cede IRB review to the University of
Virginia IRB for Health Sciences Research (IRB-HSR) for the study noted below:
Study Title:
Overall PI or Sponsor Name
Relying Site Investigator:
Attach CV
Relying Institution IRB Contact acknowledging approval to cede IRB review:
Date:
Name:
Phone:
Email:
AND
2) The University of Virginia IRB-HSR 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
Page 8 of 9
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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