Associate Provost’s Office 3/02
FOR rDNA OFFICE USE ONLY
rDNA Protocol #




 EHS
 Points to Address:
IBC1/ RD
IBC2/ RD
Status
IACUC
IRB
Gene Transfer
Carnegie Mellon University
Institutional Biosafety Committee (Recombinant DNA)
FORM rDNA-1
rDNA COVERSHEET
RECOMBINANT DNA RESEARCH APPLICATION
Attention: DO NOT leave any blanks. If not applicable to your research project, please indicate. Incomplete applications may
require additional information and delay processing/review.
Please submit electronically via email attachment to: sshingle@andrew.cmu.edu
1. INVESTIGATOR INFORMATION: It is the Principal Investigator’s responsibility to ensure all personnel involved in this
study are appropriately trained, and are provided the equipment necessary to perform at the designated containment level.
A.
DATE:
APPLICANT:
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:
B.
PROJECT TITLE:
C.
FUNDING SOURCE:
FEDERAL FUNDING?
Yes
No
FUNDING PERIOD:
Start Date:
End Date:
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Associate Provost’s Office 3/02
2. PROJECT INFORMATION:
A.
Describe the experimental protocol involving the recombinant DNA procedures in detail.
Provide pertinent
information for the IBC committee to evaluate the containment level as assessed by the investigator. Attach relevant portions
of the grant proposal abstract or project summary if desired. DO NOT attach the entire grant proposal.
Research description here
B. 1. DOES YOUR RESEARCH INVOLVE ANY OF THE FOLLOWING? Please Mark (“X”) all that apply:
NO
YES
a.
Use of rDNA molecules for detection purposes( ie probes)
b.
Creation or Use of c-DNA/genomic libraries
c.
Cloning and vector construction in bacteria and yeasts
d.
Cloning of toxin molecule genes
e.
Cloning genes from, or into, a Class 2, 3, 4 or restricted agent
f.
Cloning of greater than 2/3 of the genome of any eukaryotic virus
g.
Expression of rDNA products in cultured cells
h.
Propagating culture volumes exceeding 10 liters
i.
Use of vectors derived from a eukaryotic virus
j.
Transfer of rDNA molecules into humans (ie Gene Transfer Protocol)
k.
Transfer of rDNA molecules into live (intact) animals or whole plants
2. IF YOU CHECKED ‘YES’ TO ANY OF THE ABOVE, provide an explanation for each ‘YES’ answer.
Answer here for all ‘YES’ responses.
C.
BIOSAFETY LEVEL AND REFERENCES: Work is to be performed under the following biosafety levels (BSL, also
known as physical levels) of containment and work practices.
1.
Check appropriate Biosafety Level:
[ ] BSL-1
[ ] BSL-2
[ ] BSL-3
2.
Provide references from current NIH GUIDELINES to support the BSL chosen for this project:
http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html
Reference Section I: A,B,C or Section III of NIH guidelines used to determine BSL in (1) :
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Associate Provost’s Office 3/02
3.
D.
E.
F.
Provide a description of the containment practices in place for work with the recombinant DNA described, and how
they comply with the Biosafety level.
SPECIFIC VECTORS IN rDNA REAGENTS USED:
1.
From what organism is the clone DNA derived? Please give scientific name and common name of the organism.
Give the source of this DNA (ie library, PCR, synthetic oligo, etc):
answer here
2.
What genes are encoded by the cloned DNA?
answer here
3.
Describe all hosts to be used for the cloned DNA and the and the plasmid and/or viral vectors to be used for cloning.
Please describe the relevant components of all vectors except the standards (ie pUC18, pBluescript):
answer here
4.
Will this research result in the expression of a foreign or novel gene? [ ] YES
expressed protein and host organism of the recombinant gene:
answer here
5.
Could toxic products (LD50 of <100 g/Kg) be produced and released from this research? [ ] YES
If YES, Describe the toxic product(s) and containment precautions:
answer here
6.
Could an agent that is potentially infectious to mammalian hosts be produced and released from cells in the course of
this research? [ ] YES [ ] NO If YES, Describe the infectious agent and all containment precautions:
answer here
[ ] NO
If YES, Describe the
[ ] NO
Does the work involve “replication-defective” viruses? [ ] YES [ ] NO
If yes, you must provide the upper limit (in pfu) of the replication competent virus in the viral stocks and the methodology
used to determine this number:
answer here
Does the work involve replication competent or wild-type animal viruses? [ ] YES
If ‘YES’, please provide details:
answer here
[ ] NO
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Associate Provost’s Office 3/02
G.
Does the work involve pathogenic microbes? [ ] YES
If ‘YES’, please provide details:
answer here
H.
1.
Does the work involve animals?
application. If ‘NO” skip to section I.
[ ] YES
[ ] NO
If known, please enter IACUC #
2.
[ ] NO
If ‘YES’ submit an Institutional Animal Care and Use Committee (IACUC)
submittal date
protocol # here
or
If recombinant DNA is administered to live or intact animals, where is the work performed?
[ ] in the laboratory
Enter Room and building here
[ ] in the Animal Facility (provide room number and building)
[ ] rDNA is NOT administered to live animals; provide an answer for G.3, below
3.
If recombinant DNA procedures are used with animal tissues or samples, provide details regarding the
proposed experiments.
answer here
4. Will transgenic or gene targeted animals be used?
answer here
I.
[ ] YES
[ ] NO
If ‘YES’ please provide details:
1. Does work involve human subjects? If ‘YES’ submit an Institutional Review Board (IRB) committee application.
If ‘NO” skip to section J.
[ ] YES
[ ] NO
submittal date or
If known, please enter IRB #
protocol # here
2. If recombinant DNA procedures are used with human tissues or samples, provide details regarding the
proposed experiments.
answer here
3. Is this a Gene Transfer (recombinant DNA materials administered to subjects) protocol? [ ] YES
J.
[ ] NO
Does work involve any Hazardous Chemicals, biological hazards (including tissues or cells of human origin), or
toxins?
[ ] YES
[ ] NO
If ‘YES’ submit a Biohazards Committee application to the Environmental Health and Safety (EHS) Office.
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Associate Provost’s Office 3/02
3. RESEARCH FACILITIES:
A. Please list all locations (room number and building) where the project will be conducted, and describe the type of
recombinant DNA work performed at each site (e.g. transfection of cells, administration of rDNA materials to
study subjects, etc).
Room and Building:
Type of work performed at this site:
Biosafety Containment Level for each
specific procedure:
4.
PLEASE ATTACH NIH BIOSKETCH FOR PRINCIPAL INVESTIGATOR TO THIS SUBMISSION
5.
INVESTIGATOR ASSURANCE FOR PROJECTS INVOLVING RECOMBINANT DNA
a.
I agree to conduct this project in accordance with the compliance policies of the Associate Provost’s Office,
Carnegie Mellon University 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, host-vector
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
can be requested from the Associate Provost’s Office at 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 rDNA Office is agreement with the statements
a-g (above).
The rDNA 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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