Expanded / Continued Access Procedures for
Central IRB
PROCEDURE:
Preliminary steps:
1. Researcher must notify the IRB-HSR of the central IRB which will be utilized for
the expanded access protocol.
2. If the central IRB to be used is not already on the IRB-HSR FWA, The FWA will
need to be amended
3. Researcher obtains signatures from appropriate personnel at UVA and the central
IRB on the IRB Authorization Agreement ( see Appendix C) This form should
be kept by the PI and the central IRB. A copy should be sent to the IRB-HSR
with the application.
4. The researcher should contact the School of Medicine /Grants and Contracts
office to determine needs.
New Approval (If protocol does NOT fall under the
authority of the Cancer Center)
1. Researcher completes the central IRB Submission Form.
2. Simultaneously, a protocol information form (Appendix B) is sent to the IRBHSR. The IRB-HSR office will confirm current training and send back a training
certificate.
3. All documents are reviewed by the PI.
4. Documents are submitted to the central IRB by the study team
5. Once the central IRB has approved the protocol, the following documents will be
submitted to the IRB-HSR within 5 working days:
 Central IRB Submission Form
 Sponsor’s protocol
 Approved consent form
 UVA HIPAA Stand-alone Authorization
 IRB-HSR/Central IRB Investigator Agreement (Appendix A)
 Documentation of any local committee approvals required (e.g. Radiation
Safety Committee, Institutional Biosafety Committee, GCRC)
 Documentation of central IRB approval
 IRB Authorization Agreement ( Appendix C)
6. An administrative review by IRB-HSR staff is completed. IRB-HSR staff will
verify all documents are in order and approvals from all other applicable
committees have been received. (Appendix B)
7. Documentation of all subsequent approvals from central IRB is to be submitted to
IRB-HSR within 5 working days of receipt.
New Approval (If protocol falls under the authority of the
Cancer Center)
1. The Principal Investigator notifies the Cancer Center IRB Coordinator/Study
Coordinator of the name of the Expanded Access Trial he/she wishes to open.
2. The researcher completes the central IRB Submission Form and the consent form
using the sponsor's template
3. Simultaneously, a protocol information form (Appendix B) is sent to the IRBHSR. The IRB-HSR office will confirm current training and send back a training
certificate.
4. All documents are reviewed by the PI.
5. Documents are submitted to the central IRB by the study team
6. Once the central IRB has approved the protocol, the following documents will be
submitted to the IRB-HSR within 5 working days:
 central IRB Submission Form
 Sponsor’s protocol
 Approved consent form
 UVA HIPAA Stand-alone Authorization
 IRB-HSR/central IRB Investigator Agreement (Appendix A)
 PRC application form (Appendix C)
 Documentation of any local committee approvals required (e.g. Radiation
Safety Committee, Institutional Biosafety Committee, GCRC)
 Documentation of central IRB approval
 IRB Authorization Agreement ( Appendix C)
7. IRB-HSR staff add a IRB-HSR # to the PRC Application Form and forward it to
the PRC office.
8. An administrative review by IRB-HSR staff is completed. IRB-HSR staff verify
all documents are in order and approvals from all other applicable committees
have been received. (Appendix B)
9. Documentation of all subsequent approvals from the central IRB are to be
submitted to IRB-HSR within 5 working days of receipt.
Continuations
1. Upon receipt of a continuation approval from PI/central IRB, IRB-HSR staff
will:
 Verify training completion
 Provide PI with Training Certification
Modifications
1. Upon receipt of a modification approval from PI/central IRB, IRB-HSR staff
will:


Enter “Receipt” event in IRB-HSR IRB Online.
File documents in IRB-HSR file.
Advertisements
All advertisements will be submitted to central IRB by the study team and approved prior
to use.
1. Upon receipt of an advertisement approval from PI/central IRB, IRB-HSR
staff will:
 Enter “Receipt” event in IRB-HSR IRB Online.
 File documents in IRB-HSR file.
Protocol Violations and Deviations
The PI is responsible for submitting protocol violations and deviations to the central IRB.
Adverse Events
Adverse events are to be submitted to central IRB by the PI according to central IRB
policies.
REFERENCES:
"Continued Access to Investigational Devices During PMA Preparation and Review,"
Blue Book Memorandum, D96-1
http://www.fda.gov/cdrh/d961.html
Appendix A: Investigator Agreement for Continued Access Protocols
UNIVERSITY OF VIRGINIA
IRB FOR HEALTH SCIENCES RESEARCH
INVESTIGATOR AGREEMENT
Title of Study:
______________________________________________________________________________________
______
______________________________________________________________________________________
_____
BY SIGNING THIS DOCUMENT, THE INVESTIGATOR AGREES:
1. That no subjects will be recruited or entered under the protocol until the Investigator has received
approval from the central IRB.
2. That any materials used to recruit subjects will be approved by the central IRB prior to use.
3. That any modifications of the protocol or consent form will not be initiated without prior written approval
from the central IRB, except when necessary to eliminate immediate hazards to the subjects.
4. That any serious deviation from the protocol will be reported promptly to the central IRB in writing.
5. That adverse events will be reported to the central IRB according to their policies.
6. That the continuation status report for this protocol will be completed and returned to the central IRB
within the time limit required.
7. That all subjects will sign a copy of the most current non- expired consent form.
8. That the IRB-HSR office will be notified within 30 days of a change in the Principal Investigator or of the
closure of this study.
9. That no personnel will be allowed to work on this protocol until they have completed the IRB-HSR
Online training and the IRB-HSR has been notified.
________________________
Principal Investigator
(Name Printed)
__________________________
Principal Investigator
(Signature)
___________
Date
BY SIGNING THIS DOCUMENT, THE CHAIR AGREES:
1.
2.
3.
4.
To assume overall responsibility for the conduct of this investigator.
To work with the investigator, and with the central IRB and the IRB-HSR as needed, to maintain
compliance with this agreement.
That the Principal Investigator is qualified to perform this study.
That the protocol is scientifically relevant and sound.
_____________________________
_____________________________
Department Chair/Division Head*
Department Chair/Division Head
(Name Printed)
(Signature)
*(Cannot be Principal Investigator or Sub-investigator)
__________
Date
The Committee reserves the right to terminate this study at any time if, in its opinion, (1) the risks of further
experimentation are prohibitive, or (2) the above agreement is breached.
For Use by IRB-HSR Office
IRB-HSR # __________
Revised 112-19-06
Page 1 of 1
Appendix B: Continued Access IRB/IRB-HSR Protocol Information Form
IRB-HSR/Central IRB
Protocol Information Form
Sponsor Protocol #______________(If Applicable)
Title:__________________________________________________________________________
______
Do you/will you have a contract with an outside sponsor for this protocol?
Yes
No
If yes- name of group you will have contract
with:___________________________________________________________________
Is this protocol funded by a Grant?
Yes
No
If Yes- GHIC# for Approved Grant ______________
Does this study involve an investigational drug or use of a drug for an unapproved
indication/dose/route of administration?
Yes
No
Is this protocol part of an outside sponsored IND?
Yes
No
If Yes- IND#_____________________
Does this study involve an investigational device or use of an approved device for an
unapproved indication?
Yes
No
If Yes, Investigational Device Exemption
IDE#____________________________
Yes
No
If Yes, is this protocol part of a UVA Physician sponsored IDE?
If Yes,
School of Medicine Clinical Trials Office/DSMB approval required.
Does this study involve the use of radiation for research purposes?
Yes
No
If Yes, Radiation Safety Committee approval is required unless standard
wording from the IRB-HSR Website is used.
Will any part of this study be done in the GCRC?
Yes
No
If Yes, GCRC approval required. Attach one copy of GCRC submission.
GCRC#___________
Does this study involve the use of recombinant DNA, biological vectors or infectious agents?
Yes
No
If Yes, IBC approval required. IBC#____________
To avoid any conflict of interest are any IRB-HSR members/alternates listed on the protocol
or 1572 form?
Yes
No
If Yes, please list names below.
______________________________________
______________________________________
Will you be using any specimens from a human? Yes No
Will all collection (i.e. blood drawing) and processing (i.e. anything
that involves the specimen container to be opened) occur in a UVA
clinic/hospital or clinical lab?
Yes No
If No- attach approval from the Institutional Biosafety Committee
IBC#__________
If you need to register with the IBC go to
http://keats.admin.virginia.edu/bio/home.html
Revised 12-19-06
INVESTIGATORS
PLEASE NOTE:



If an individual is a UVA employee, please list his/her official UVA registered e-mail address. Do not list an alias e-mail
address on IRB-HSR forms. Ex: use srh@virginia.edu, not SRHoffman@virginia.edu.
ALL individuals having contact with subjects or their identifiable information for this protocol must be listed below.
All e-mails from the IRB-HSR regarding a protocol will be sent to the PI, Study Coordinator(s) , Department Contact and IRB
Departmental Coordinator (if applicable)
Principal Investigator: (First) _________________
(Last)____________________________________(Degree)____________
Phone ____________________ E-mail___________________________ Messenger Mail Address
_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Note: only 1 person may be listed as the PI by the IRB-HSR- please list others as sub-investigators. If the PI is NOT a faculty
member a faculty member must be listed as a sub-investigator. Students are not allowed to be the Principal Investigator.
Study Coordinator I: (First) ____________________
(Last)____________________________________(Degree)____________
Phone____________________ E-mail___________________________ Messenger Mail
Address__________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Study Coordinator II: (First) ____________________
(Last)____________________________________(Degree)____________
Phone____________________ E-mail___________________________ Messenger Mail
Address__________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Department Contact: (First) ___________________
(Last)___________________________________(Degree)____________
Phone___________________ E-mail_____________________________ Messenger Mail
Address_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Note: Usually a person who knows how to get in touch with the PI or Study Coordinator if they’re unavailable (i.e. PI secretary/department manager). The Department Chair
should not be listed as the Department Contact.
Departmental IRB Coordinator: (First) ___________________
(Last)___________________________________(Degree)____________
Phone___________________ E-mail_____________________________ Messenger Mail
Address_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Sponsor/Granting Agency Name:
______________________________________________________________________
Address: ________________________________________ Phone: _______________________ Fax:
_________________
City, State, Zip:
______________________________________________________________________________________
Revised 12-19-06
Page 1 of 2
Sub-investigators
List ALL individuals who will have contact with subjects or will have access to research data that has identifying information
(e.g.-subject name or medical record number)
Sub-investigator: (First)
______________________(Last)__________________________________(Degree)_______
_
Phone_______________ E-mail___________________________ Messenger Mail
Address_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Sub-investigator: (First)
______________________(Last)__________________________________(Degree)_______
_
Phone_______________ E-mail___________________________ Messenger Mail
Address_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Sub-investigator: (First)
______________________(Last)__________________________________(Degree)_______
_
Phone_______________ E-mail___________________________ Messenger Mail
Address_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Sub-investigator: (First)
______________________(Last)__________________________________(Degree)_______
_
Phone_______________ E-mail___________________________ Messenger Mail
Address_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Sub-investigator: (First)
______________________(Last)__________________________________(Degree)_______
_
Phone_______________ E-mail___________________________ Messenger Mail
Address_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Sub-investigator: (First)
______________________(Last)__________________________________(Degree)_______
_
Phone_______________ E-mail___________________________ Messenger Mail
Address_________________________
School _____________________________________________
Department___________________________________________ Division______________________________________
Are there additional sub-investigators?
Revised 12-19-06
Yes
No
If Yes, attach additional pages.
Page 2 of 2
Appendix C:
Institutional Review Board (IRB) Authorization Agreement
Name of Institution or Organization Providing IRB Review (Institution/Organization
A):
________________________________________________________________________
_____
IRB Registration #: __________ Federalwide Assurance (FWA) #, if any:
_________________
Name of Institution Relying on the Designated IRB (Institution B):
University of Virginia
FWA #: 00006183
The Officials signing below agree that the University of Virginia may rely on the
designated IRB for review and continuing oversight of its human subjects research
described below: (check one)
(___) This agreement applies to all human subjects research covered by Institution B’s
FWA.
(__X_) This agreement is limited to the following specific protocol(s):
Name of Research
Project:________________________________________________________
Name of Principal
Investigator:____________________________________________________
Sponsor or Funding Agency: ________________ Award Number, if any:
__________________
(___) Other
(describe):__________________________________________________________
The review performed by the designated IRB will meet the human subject protection requirements of
Institution B’s OHRP-approved FWA. The IRB at Institution/Organization A will follow written
procedures for reporting its findings and actions to appropriate officials at Institution B. Relevant minutes
of IRB meetings will be made available to Institution B upon request. Institution B remains responsible for
ensuring compliance with the IRB’s determinations and with the Terms of its OHRP-approved FWA. This
document must be kept on file by both parties and provided to OHRP upon request.
Signature of Signatory Official (Institution A):
________________________________________ Date: ___________
Print Full Name: ___________________________ Institutional Title:
_____________________
NOTE: The IRB of Institution A must be designated on the OHRP-approved FWA for
Institution B.
Signature of Signatory Official (Institution B):
________________________________________ Date: ___________
Print Full Name: Ariel Gomez
Institutional Title: VP for Research and
Graduate Studies)
Version Date 1-31-07