Associate Provost’s Office 3/02
FOR rDNA OFFICE USE ONLY
rDNA Protocol #
 PI information
 Title
 Funding
 Procedural/BSL/Host-Vector
 Laboratory Location
IBC1/RD
IBC2/RD
Carnegie Mellon University
Institutional Biosafety Committee (Recombinant DNA)
FORM rDNA-2
MODIFICATION/CHANGE REQUEST
LABORATORY RELOCATION REQUEST
Attention: DO NOT leave any blanks. Incomplete applications may require additional information and delay processing/review.
Please submit electronically via email attachment to sshingle@andrew.cmu.edu
DATE:
PRINCIPAL INVESTIGATOR:
CURRENT TITLE OF PROJECT
IS THERE A CHANGE IN
INVESTIGATORS?:
If “YES” please fill out the New
Investigator information below:
If “NO” and the current information on
file for the Investigator has NOT changed,
skip to section 2
1. INVESTIGATOR INFORMATION:
DATE:
NEW PRINCIPAL INVESTIGATOR:
TITLE:
DEGREE:
DEPARTMENT:
OFFICE (BLDG/ROOM):
OFFICE PHONE:
OFFICE FAX:
OFFICE STREET ADDRESS
OFFICE ZIP CODE
LABORATORY (BLDG/ROOM):
LAB PHONE:
E-MAIL:
ALTERNATE CONTACT PERSON:
CONTACT PHONE:
CONTACT E-MAIL:
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Associate Provost’s Office 3/02
2. NEW TITLE: COMPLETE ONLY If different from Above
3. IF THE FUNDING SOURCE(S) CHANGED, PLEASE INDICATE BELOW:
FUNDING SOURCE:
FEDERAL FUNDING?
Yes
No
FUNDING PERIOD:
Start Date:
End Date:
4. PROJECT INFORMATION:
A. PLEASE PROVIDE THE RECOMBINANT DNA DETAILS AND PROCEDURES IN THIS PROJECT THAT YOU
ARE MODIFYING: (If no procedural or protocol changes are required at this time, please skip to 5.
Modification(s) description here
B. IS THERE ANY CHANGE TO THE BIOSAFETY LEVEL? [ ] YES [ ] NO
If YES, Explain the need to change
from the currently assigned Biosafety level. Please Note: Additional documentation may be required.
answer here
C.
DESCRIBE ANY CHANGES TO THE VECTORS OR THE HOST-VECTOR SYSTEMS:
1. Changes for the source of the clone DNA? [ ] YES [ ] NO
Provide the new source
answer here
2.
Changes in the vectors used? [ ] YES
[ ] NO
3.
Changes in the host used for the cloned DNA? [ ] YES
Provide the new vectors
answer here
[ ] NO
Provide the new host(s)
answer here
D. Will this modification result in the expression of another foreign or novel gene? [ ] YES
expressed protein and host organism of the recombinant gene:
answer here
E. Is there an anticipated change in production volume? [ ] YES
provide explanation for increase in production volume:
answer here
[ ] NO
[ ] NO
If yes, Describe the
If YES, provide the expected increase in volume and
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Associate Provost’s Office 3/02
F. Do any changes involve replication-impaired/replication-defective/replication-deficient viral vectors? [ ] YES
YES, explain these anticipated changes:
answer here
G. Do any changes involve replication competent or wild-type animal viruses? [ ] YES
anticipated changes:
answer here
[ ] NO If
[ ] NO If YES, explain these
5. RESEARCH FACILITIES:
A. Have the laboratory facilities been altered or changed, or was there a relocation to another area?
[ ] YES [ ] NO
If ‘YES’, provide the new room and building in which the work is to be performed and
corresponding Biosafety level of each procedure listed:
NEW Room and Building:
Type of work performed at this site:
Biosafety Containment for procedure:
B. Have the new facilities been inspected by EHS? [ ] YES [ ] NO
please contact EHS to arrange an inspection of the new location.
If ‘NO’,
6. CURRENT STATUS OF THIS PROTOCOL:
[ ] Continuing rDNA Experiments with changes described in this document until original expiration date
[ ] Renewal of continuing rDNA Experiments including all changes described in this document for a NEW expiration date
NOTE: rDNA Office will coordinate expiration dates to coincide with linked IACUC and/or IRB protocols.
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Associate Provost’s Office 3/02
7. CERTIFICATION
a.
I agree to conduct this project 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 project.
b.
I have consulted Section IV-B-7 of the NIH Guidelines which describes the responsibilities of the
Principal Investigator and hereby agree to comply fully with all provisions of the Guidelines. I
understand that I am responsible for assuring that my project areas are in compliance with all federal,
state, and local environmental laws and regulations.
c.
I understand that all changes in the research protocol (including changes in the source of DNA, hostvector systems, dosage ranges, laboratory room changes, etc.) or project participants must be reported
to the rDNA Office and all other university regulatory offices in connection with this protocol.
Modification requests forms are available at the Associate Provost’s Office, 412-268-4727 or email at
sshingle@andrew.cmu.edu.
d.
If funded by an extramural source, I assure that this application accurately reflects all procedures
involving Recombinant DNA as described in the grant proposal to the funding agency.
e.
The information within this application is accurate to the best of my knowledge.
f.
I understand that yearly renewal is required for continuing approved projects.
g.
I understand that notification applications and approvals must be resubmitted for committee review
after a term of three years.
h.
The electronic submission and acceptance of this document at the Associate Provost’s Office is
agreement with the statements a-g (above).
The Associate Provost’s Office and IBC in conjunction with the EHS Office reserve the right to conduct
inspections of the research facilities at any time.
Principal Investigator Name:
Signature:
Date of Application:
End of Application
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