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Principal Investigator

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					Recombinant DNA Research Registration
University of Florida

1) At UF ALL rDNA projects are required to be registered.
2) Your project must be approved BEFORE you begin the research.
3) This includes the construction of transgenic & knockout animals.


Registration & oversight of rDNA projects is in accordance with the NIH Guidelines for Research
Involving Recombinant DNA Molecules (NIH Guidelines) .The Guidelines define rDNA molecules as
either: “(i) molecules that are constructed outside living cells by joining natural or synthetic DNA
segments to DNA molecules that can replicate in a living cell, or (ii) molecules that result from the
replication of those described in (i) above” and classify rDNA experiments based on their potential
hazard(s) to research staff, environment, and/or public health.


Some important hyper-linked sections of the NIH Guidelines include:
Section III - Experiments covered by the NIH Guidelines (as described above)
Section IV B-7- Responsibilities of the PI
Appendix B - Classification of Human Etiologic Agents on basis of Hazard
Appendix G - Physical Containment (Biosafety Levels 1 –4)
Appendix P - Physical Containment for rDNA Plant Research
Appendix Q - Physical Containment for rDNA Research involving Animals




Project submissions are reviewed by Institutional Biosafety Committee (IBC) members; non-exempt
projects are then forwarded to the full IBC for review, comment, and approval. The IBC Committee
is composed of scientists that may not be experts in your particular field of research. Please tailor
your responses on the registration form accordingly.
We must get enough information from you to be able to make determinations about the necessary
containment level, facilities, procedures, practices, and expertise/training necessary for the safe
conduct of the project, so please be thorough. Insufficient information will delay the approval
process; the form will be returned to you for revision. Please type the form; hand written forms will
be returned.
   Please type; handwritten forms not accepted. Incomplete forms will be returned.

University of Florida
Environmental Health & Safety                                            r-DNA Document of Registration
Biological Safety Office
bso@ehs.ufl.edu                                                          #RD -
phone: (352)-392-1591
fax: (352)-392-3647

Principal Investigator:                                PI’s Title:
Department:                                            Address/Box:
Phone: Office:                   Lab:                  Email:
Project Title:
Sponsor: ________________________________________________________________________________

1. Location of Project: Building(s):                                                 Room(s):

2. Transfer of rDNA into animals on THIS project?      No                            Yes
      Species?                           Route of administration?
      Construction of Transgenics/Knockouts?           No                            Yes
      IACUC # (if not yet assigned indicate “pending”)
      Where do you plan to house your animals?
      Where do you plan to do animal procedures?

3. Will proteins or regulatory RNAs be expressed?                  No                Yes

4. Is the source of the DNA to be used from a pathogen? No ______ Yes         If yes, where will
   you obtain the agent(s)? _______________________________________________________________

5. Is the source of the DNA to be used from a biological toxin? No ______ Yes If yes, where will
   you obtain the toxin(s)? _______________________________________________________________

6. Is the source of the DNA to be cloned associated with alterations of normal mammalian cell cycle or cell
   growth (i.e. a potentially oncogenic or tumorgenic gene)?       No            Yes

Will your experiments (IF you answer YES to 7-12, be sure to explain):

7. Transfer drug, vaccine, or chemical resistance gene(s)?                  No               Yes (Explain):
   (Excluding common resistance markers in plasmid vectors or transposons used for cloning or mutagenesis)



8. Alter genes associated with an agent’s virulence?                        No               Yes (Explain):


9. Alter genes associated with an agent’s transmissibility?                 No               Yes (Explain):


10. Enable evasion of diagnostic/detection modalities?                      No               Yes (Explain):


11. Alter the host range or tropism of a pathogen?                          No               Yes (Explain):

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                                                                                                 EHS-Bio-RDNA-Reg. ver. 06/09
12. Change an organism’s normal ability to survive?                 No               Yes (Explain):


13. Will you be working with 10 or more liters of recombinant material at one time?            No            Yes

14. Will your work involve the intentional release into the environment (outside the facility or field trial) of an
    organism containing rDNA?                No              Yes

15. Project Summary/Abstract (Describe your project clearly and simply. Include background, purpose,
objectives, laboratory methods, etc. Attach additional sheets as needed.)




16. Is this transfer vector hazardous? Why or why not?



17. Is this DNA/RNA insert or transgene hazardous if someone were to get dosed with it accidentally? Why
or why not?


18. Is the disruption of a beneficial gene in the recipient or an accidental host a possibility?

    What might the consequence be?


19. NIH guidelines require that rDNA or rDNA waste be inactivated before disposal. How will you do this?


                                            -2–
                                                                                        EHS-Bio-RDNA-Reg. ver. 06_09
Detail recombinants used in this project below, one column per construct. (insert sheets as necessary see
http://www.ehs.ufl.edu/Bio/Files/AddCons.doc).
                                Construct   Construct               Construct                Construct
Source of the DNA/RNA
insert
(e.g. human, tomato, etc)
Gene name
& function


 Vector Type:
(e.g. Ad5, SV40, AAV2,
HIV-1, plasmid, etc.)
If viral vector, what % of
the viral genome is used in
the vector?
(<½ , ½ - 2/3,
> 2/3, N/A)
If viral vector, is it
replication defective?
How so?

Will you use defective
viral vector in the
presence of helper
virus?
Which?

Vector Name
provide map(s)

Expression control
elements (promoter,
enhancer, regulatory
elements, etc)


All recipient host(s)
Genus & species &
common name:

If E. coli, give strain name.

If tissue culture/cell lines
used, specify what types.



How will you introduce the
gene into this host?




Dose given (concentration
or titer & volume) to host




Is recombinant made in
your lab? If not, where?




For additional constructs, attach pages (highlight, right click, then open hyperlink): Additional Constructs.doc



                                            -3–
                                                                                      EHS-Bio-RDNA-Reg. ver. 06_09
  Please Attach Vector/Construct Maps. Electronic versions preferred (i.e. .bmp, .tif, .jpg, .pdf)


  This page can be signed then faxed, mailed, or scanned and e-mailed.

  21. The undersigned individual(s) will be involved in the experimentation described above. They are familiar
      with and agree to abide by the current NIH Guidelines. ALL PARTICIPANT SIGNATURES
      REQUIRED.

      Name (Please Type or Print)                       Signatures                                      Date




  I attest to the fact that these individuals are properly trained in the area of recombinant DNA/RNA experimentation.
  Furthermore, I agree to comply with the NIH requirements pertaining to handling, shipment, transfer, and disposal of recombinant
  DNA/RNA materials.
  I am familiar with and agree to abide by the provisions of the current NIH Guidelines and other specific NIH instructions pertaining
  to the proposed project.
  I understand that I must have EH&S or IBC approval before beginning this work.
  I understand that changes to the project described above must be reported to EH&S Biosafety in advance.
  I understand that associated IACUC or IRB approvals may be held pending EH&S or IBC approval of this work.
  The information above is accurate and complete to the best of my knowledge.


                                                            Principal Investigator                       Date


Notes (EH&S/IBC use only):




  E-mail, fax, or mail form to the Biosafety office
  bso@ehs.ufl.edu, fax: (352) 392-3647, mail: PO Box 112190


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                                                                                                        EHS-Bio-RDNA-Reg. ver. 06_09

				
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