REGISTRATION AMENDMENT

Notice of Intent to Possess or Workwith Recombinant DNA Molecules

Institutional Biosafety Committee

Georgia Institute of Technology

Submit via email to:

Office of Research Compliance March 2011

Institutional Biosafety CommitteePage 1 of 4

Voice:404.894.6949

Office of Research Compliance March 2011

Institutional Biosafety CommitteePage 1 of 4

(This form is in Word and will expand to accommodate text).

Office of Research Compliance March 2011

Institutional Biosafety CommitteePage 1 of 4

Principal Investigator / PI Title / Dept:
Telephone / Emergency Contact number: / Email:
Approved Project Title: / Approval Number (e.g. R2008-0001):
Personnel
If there are no changes from the approved protocol check here and skip to the next section
Please note: you only need to modify the information that has changed from your approved protocol.
Name all others who will be involvedin this project or have access to the rDNA. Include their titles. (If personnel are to be removed from this project, so indicate here). / Department & Telephone / Date of Completion of rDNA Training through EHS (Required for IBC approval of any rDNA use)
2 / Details of Proposed Use
If there are no changes from the approved protocol check here and skip to the next section
Please note: you only need to modify the information that has changed from your approved registrationl.
Source of Funding (If changed or new funding source has been added)
The Principal Investigator is to make an initial determination of the required levels of physical and biological containment. Is the proposed work or usage still exempt from the NIH Guidelines for Research involving Recombinant DNA Molecules?
Yes No / Give the specific NIH citation to justify your determination of exemption or other level of containment:
Level of required containment:
NIH Guidelines can be viewed at:

Brief, non-technical (lay) abstract of planned change or addition to existing protocol:
Research Materials to be used: (Indicate binomial name and strain of the recombinant DNA molecules to be used).
For each experiment, provide the following:
Source of the DNA (organisms): / Nature of the inserted sequences:
List host cells, vectors, recombinant materials: (E. coli, K-12 system, Saccharomyces system, insect cells, plasmids, cosmids, phages, etc.).
3 / If there are no changes from the approved protocol check here and skip to the next section
Are any of the following genes, viruses, factors, or conditions involved? Mark Yes or No
___ Yes ____No / Deliberate transfer of drug resistance into organisms that do not acquire them naturally? (except for approved host-vector systems that contain antibiotic resistance markers)
___ Yes ____No / Deliberate transfer of recombinant DNA into humans?
___ Yes ____No / Genes that produce vertebrate toxins with LD50 less than 100 ng/kg of body weight?
___ Yes ____No / Using human or animal pathogens as host-vector systems?
___ Yes ____No / Human or animal pathogen DNA cloned into non-pathogenic prokaryote or lower eukaryote?
___ Yes ____No / Using infectious animal or plant DNA or RNA viruses in tissue culture or using defective viruses when a helper is present?
___ Yes ____No / Altering an animal genome by recombinant DNA or testing viable rDNA-modified microorganisms in whole animals?
___ Yes ____No / Genetic engineering of plants by rDNA methods or use of plants with microorganisms or insects containing rDNA?
___ Yes ____No / Experiments involving more than 10 liters of culture?
___ Yes ____No / Deliberate release of rDNA-modified plants or animals into the environment?
4 / Location
If there are no changes from the approved protocol check here and skip to the next section
Please note: you only need to modify the information that has changed from your approved protocol.
Indicate where project will be conducted / Building / Room / Telephone
Georgia Institute of Technology
EmoryUniversity
Grady Hospital
VA MedicalCenter
Other (specify)
5 / Containment and safety equipment
If there are no changes from the approved protocol check here and skip to the next section
Please note: you only need to modify the information that has changed from your approved protocol.
Will a biological safety cabinet (BSC) be used? Yes No / Type of BSC:
Class II
A1 A2
B1 B2
Manufacturer name:
Date of last certification: / Name of certifier:
Will a horizontal or vertical laminar flow “clean bench” be used for the planned activity? Yes No
Other safety equipment to be used:
Safety pipettes
Centrifuge
Safety cups
Chemical fume hood
Others: / Method of decontamination of biological or infectious wastes:
Autoclave
Incinerator
Chemical Disinfectant (Specify)
As a result of this project, will there be any ultratoxic, shock sensitive or other chemicals which will require special handling during use, storage or disposal? Yes No
Method of disposal of chemical or biological wastes:
Have the safety precautions included in the Material Safety Data Sheets been incorporated into your procedures? Yes No
Other boards or committees that must review and approve this proposed use: / Submittal
date / Protocol number / Status
Pending / Approved
Chemical & Environmental Safety Committee
Institutional Review Board
Institutional Animal Care & Use Committee
Occupational Health & Safety Committee
Radiation Safety
You may also need to coordinate with the Biosafety Officer,
the Responsible Official, and/or Environmental Health and Safety.
6 / Previous Work Experience and Additional Information
If there are no changes from the approved protocol check here and skip to the next section
Please note: you only need to modify the information that has changed from your approved protocol.
What is the newresearch team’s previous work experience with the agent/materials specified in this application?
Please indicate any additional information or comments pertinent to the Institutional Biosafety Committee review:
7 / Certifications and Signatures
CERTIFICATION: I have read and am familiar with the standard and special microbiological practices, containment equipment, personal protective equipment, and laboratory facilities recommended for the biosafety level applicable to this project. I will ensure that all faculty, staff, and students working on this project will follow these recommendations as a condition of Institutional Biosafety Committee approval of this project.
Date: ______Principal Investigator Signature ______
SIGNATURE:
I have reviewed this rDNA registration and concur with its submission to the Institutional Biosafety Committee for review.
Date: ______Department Head Signature ______
Save this signedamendment form as a PDF file,
and email it AND A COPY OF NEW GRANT PAGES to:
.
In lieu of dept head signatures, the Office of Research Compliance willaccept an email from the dept head, sent to , in which the dept head states something like:
“I have reviewed this rDNA registration and related research plans and concur with their submission
to the Institutional Biosafety Committee for review.”

Office of Research Compliance March 2011

Institutional Biosafety CommitteePage 1 of 4