University of Pittsburgh
Institutional Biosafety Committee (IBC)
HGT RENEWAL REPORT – Clinical Trials ONLY©
Form to use as of March 1, 2013
1) Submit the renewal electronically via email attachment to: ibo@pitt.edu
2) Submit the Investigator’s NIH-style biosketch via email attachment
3) Fax a Signed copy of the Assurance page to the IBC Office -- FAX: 412 383-1769
Application instructions: Do not leave any blanks, unless instructed to do so. Incomplete applications will be returned.
Send to: ibo@pitt.edu
a. I agree to conduct this research in accordance with the compliance policies of the rDNA Office University of
Pittsburgh Institutional Biosafety Committee, including all requisite training of students, staff and other
professionals participating in this research.
b. I have consulted Section IV-B-7 of the NIH Guidelines describing the responsibilities of the Principal
Investigator and hereby agree to comply fully with all provisions of the NIH Guidelines
c. I understand I am responsible for assuring that my research facilities are in compliance with local, state and
federal environmental laws and regulations.
d. I understand that I am responsible for the proper conduct of any research by listed Co-Investigator(s) that are
directly related to this protocol application
e. I certify that there are no changes in the research protocol (including changes in the source of DNA, hostvector systems, dosage ranges, approved BSL level of laboratory facilities changes, etc.) previously
approved by the IBC
f.
I understand that changes must be reviewed via a modification, which must be prospectively approved by
the IBC
g. If funded by an extramural source, I assure that this application accurately reflects all procedures involving
recombinant or synthetic nucleic acids or other materials under the NIH Guidelines as described in the funding
grant proposal.
h. The information within this application is accurate to the best of my knowledge.
i.
I understand that yearly renewal is required for continuing approved research.
j.
By the submission and acceptance of this signed document at the IBC Office I am in agreement with the
statements a-i (above).
k. Principal Investigator’s signature:
NOTE: The IBC Office and IBC in conjunction with the Safety Office reserve
the right to conduct inspections of the research facilities at any time
SECTION 1.
IBC Human Gene Transfer Renewal Information
a. Principal Investigator name
b. Alternate contact name
c. IBC protocol number being renewed
IBC Office Use Only
date received:
Page 1 of 4; renewal
SECTION 2.
Renewal Reporting
a. Is this a NEW clinical trial proposal using recombinant or synthetic nucleic acid molecules?
Yes
 If “YES” to the question above, STOP! You must complete the standard IBC application.
Stop
 Contact the IBC Office staff for assistance 412-383-1768 or ibo@pitt.edu
b. Have there been any changes in the investigator contact information since the last IBC review Yes
interval?
 If “YES”, you must also complete Section 5 of this application
c. Have there been any changes in the alternate contact information since the last IBC review interval? Yes
 If “YES”, you must also complete Section 6 of this application
d. Have there been any changes in the location of the research facilities since the last IBC review
interval? Was the research relocated to another building or room?
 If “YES”, you must also complete Section 7 of this application
 Be aware that some facilities changes may not be acceptable on this renewal and may
require you to complete a full renewal application using the IBC APPLICATION form
e. Have there been any changes in the clinical protocol since the last IBC review interval?
 If “No”, continue on to Section 3 of this application
No
No
No
Yes
No
Yes
No
f. Describe the changes in a BRIEF summary (2-3
sentences) in the text box provided on the right
 HIGHLIGHT any changes in the protocol
 Provide a “Summary of Changes” document or
append highlighted changes in the
Investigator’s Brochure
SECTION 3.
Clinical Trial Information
a. Provide the TOTAL projected enrollment for the UPMC/Pitt study site for this clinical trial
b. Is the study currently approved by the University of Pittsburgh IRB (Institutional Review
Yes
No
Board)?
 If “Yes” skip to question 3d, below
c. Provide a brief explanation why the study does not
have IRB approval at this time
 After response, skip to question 3k
Local
Overall
d. How many study subjects have been enrolled to-date?
Local
Overall
e. How many study subjects have received intervention to-date?
Local
Overall
f. How many study subjects have withdrawn to-date?
active gene transfer intervention and active recruitment
g. Identify the status; is the study:
closed to enrollment
on hold
other; Explain:
h. Is the study currently in the Long-Term Follow-up (LTFU) phase of the trial?
Yes
No
 If “No” skip to question 3k
i. How many study subjects remain on LTFU?
J. What is the estimated time to completion of LTFU?
Yes
No
k. Is the study currently in the Analysis phase of the research?
L. Is the study only in the LTFU phase; all planned analysis has been completed?
University of Pittsburgh IBC
Renewal
Yes
No
SECTION 4.
SUMMARY of AE, SAE, Injuries, or Unexpected Exposures since last IBC review
NOTE: The NIH Guidelines requires that investigators report All Adverse Events, or any problems, such as:
exposures, injuries or other unanticipated problems to the IBC. NOTE: Human Gene Transfer Adverse Events
should be reported to the IBC as soon as possible after the event.
a. Have there been any Adverse Events (AE) or Serious Adverse Events (SAE), injuries, or unexpected
Yes No
exposures in this study since the last review interval?
 If “No”, skip to question 4e
Local
Overall
b. Provide the number of events both Local and Overall:
c. Have the local events been reported to any University of Pittsburgh offices or departments?
Yes No
 If “No”, skip to question 4e
IBC
d. If “yes” to 4a (above), indicate in the boxes to the right,
IRB
the office or department to which the problem was
FDA
reported
NIH/OBA
Department Chair
Other; Specify:
e. Has the most recent Data Safety Monitoring Board or Committee (DSMB) report been uploaded
into OSIRIS?
Yes No
 If “No”, provide the DSMB report to the IBC in addition to this renewal report or provide an
explanation why there is not a recent DSMB report on a separate document/memo
f. Was the study intervention modified in any way related to any AE/SAE or Unexpected Event (UE)s Yes No
reported?
g. If “YES” to the question above (4f), describe the
modifications to the protocol intended to mitigate any
future events:
SECTION 5.
Principal Investigator Information
NOTE: This section applies if contact information for the Principal Investigator has been changed from the
originally reviewed and approved IBC application.
 If you answered “no” to Section 2b, skip this section
Principal Investigator name
Professional title/Job Title
Degree
Department/Division
Campus address
Office telephone
Office facsimile
Office street address
Mailing zip code
E-mail address
Page 3 of 4; renewal
SECTION 6.
Alternate Contact Information
NOTE: This section applies if contact information for the Alternate Contact has changed from the originally
reviewed and approved IBC application.
 If you answered “no” to Section 2c, skip this section
Alternate contact name
Degree
Campus address
Telephone
E-mail address
SECTION 7.
Change in Research Facilities Information
NOTE: This section applies if the locations where the recombinant DNA research will be conducted have
changed from the originally reviewed and approved IBC application.
 If you answered “no” to Section 2f, skip this section
Provide all of the updated facilities information for recombinant DNA research, including the facility used for work
with human subjects (clinical areas), as applicable to your approved project.
 Provide the procedures performed in each location, for example, administration of recombinant DNA,
dressing of surgical sites, reconstitution of test materials, etc.
Room number and building
Describe procedures for this location
Location #1
Provide approved biosafety level
Location #2
Room number and building
Describe procedures for this location
Provide approved biosafety level
Location #3
Room number and building
Describe procedures for this location
Provide approved biosafety level
Page 4 of 4; renewal