REGISTRATION AMENDMENT
Notice of Intent to Possess or Work with Recombinant DNA Molecules
or Synthetic Nucleic Acid Molecules
Institutional Biosafety Committee
Georgia Institute of Technology
Submit via email to: biosafety@gatech.edu
http://www.researchintegrity.gatech.edu
(This form is in Word and will expand to accommodate text).
Principal Investigator
PI Title
Dept:
Telephone
Emergency Contact number:
Email:
Approved Project Title:
Approval Number (e.g. R15001):
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 individuals who will be involved in this
project or have access to the materials.
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Title: Post-Doc, Graduate
Student, Undergraduate, Staff,
Other (Specify)
Date of Completion of Training through
EHS (Required)
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 (Specify sponsor name, even if funding is pending)
Project number or OSP Doc ID:
If using departmental or foundation funds, so state.
Is the proposed work or usage exempt from the NIH Guidelines for Research
involving Recombinant DNA Molecules
or Synthetic Nucleic Acid Molecules?
Yes (Exempt)
No (Non-Exempt)
Level of containment required:
In vitro:
BSL-2
In vivo:
ABSL-1
ABSL-2
Give the specific NIH citation to justify your determination of exemption or other level of containment: (e.g. Section
III-D):
NIH Guidelines can be viewed at: http://oba.od.nih.gov/rdna/nih_guidelines_oba.html
Registration approvals will be withheld unless the NIH citation is provided.
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 or synthetic DNA molecules to be
used).
For each experiment, provide the following:
Georgia Institute of Technology
Office of Research Integrity Assurance
IBC@gatech.edu
Amendment for IBC Registration: rDNA or SNA Molecules
September 2015
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Source of the DNA (organisms):
Nature of the inserted sequences:
Vector Details: Please provide/attach Vector maps for each vector you will be using. Describe below the safety
precautions for working with each vector, including whether it is self-inactivating, self-replicating, etc.
List host cells, vectors, recombinant materials: (E. coli, K-12 system, Saccharomyces system, insect cells, plasmids,
cosmids, phages, etc.).
Please list any cell lines that will be used or modified (human or animal) providing the cell line and strain:
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
Deliberate transfer of drug resistance into organisms that do not acquire them naturally? (except for
approved host-vector systems that contain antibiotic resistance markers)
Deliberate transfer of Recombinant DNA or Synthetic Nucleic Acid Molecules into humans?
Genes that produce vertebrate toxins with LD50 less than 100 ng/kg of body weight?
Using human or animal pathogens as host-vector systems?
Human or animal pathogen DNA cloned into non-pathogenic prokaryote or lower eukaryote?
Using infectious animal or plant DNA or RNA viruses in tissue culture or using defective viruses when a
helper is present?
Altering an animal genome by Recombinant DNA or Synthetic Nucleic Acid Molecules or testing viable
modified microorganisms in whole animals?
Genetic engineering of plants by Recombinant DNA or Synthetic Nucleic Acid Molecules methods or use of
plants with microorganisms or insects containing rDNA?
Experiments involving more than 10 liters of culture?
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Deliberate release of Recombinant DNA or Synthetic Nucleic Acid Molecules modified plants or animals into
the environment?
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
Emory University
Grady Hospital
VA Medical Center
Other (specify)
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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?
Georgia Institute of Technology
Office of Research Integrity Assurance
IBC@gatech.edu
Yes
No
Type of BSC:
Class II
Amendment for IBC Registration: rDNA or SNA Molecules
September 2015
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Manufacturer name:
Date of last certification:
A1
B1
A2
B2
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:
Method of decontamination of biological or infectious wastes:
Safety pipettes
Autoclave
Centrifuge
Incinerator
Safety cups
Chemical Disinfectant (Specify)
Chemical fume hood
Note: Bleach and Autoclaving may never be used in combination
Others:
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
If yes, provide details:
Describe in detail the 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
Pending
Status
Approved
Chemical & Environmental Safety Committee
Institutional Review Board
Institutional Animal Care & Use Committee
Radiation Safety
Biological Materials Safeguards Committee
You may also need to coordinate with the Biosafety Officer,
the Responsible Official, and/or Environmental Health and Safety.
Dual Use Research of Concern (DURC) Potential Assessment
 Despite its value and benefits, certain types of research conducted for legitimate purposes can be utilized for
both benevolent and harmful purposes. Such research is called Dual Use Research (DUR).
 Dual Use Research of Concern (DURC) is a subset of DUR and is defined as “life sciences research that,
based on current understanding, can be reasonably anticipated to provide knowledge, information, products,
or technologies that could be directly misapplied to pose a significant threat with broad potential
consequences to public health and safety, agricultural crops and other plants, animals, the environment,
materiel, or national security.”
 On March 29, 2012, the U. S. Government (USG) released the USG Policy for Oversight of Life Sciences
Dual Use Research of Concern to establish the requirements for the oversight of DURC by the USG. On
September 24, 2014, the USG Policy for Institutional Oversight of Life Sciences Dual Use Research of
Concern was released to establish the requirements for institutional (i.e., non-USG) oversight of DURC. The
USG considers these two policies to be complementary.
 These definitions could potentially encompass a number of life sciences research projects at Georgia Tech,
however, the current scope of the USG Policy has been limited to the following agents and toxins and
categories of experiments. Research must involve both a listed agent/toxin and category of experiment to
be deemed potential DURC.
Agent or Toxin Involved in Project (check all that apply)
Verify if this project directly involves non-attenuated forms of 1 or more of the 15 listed agents.
Georgia Institute of Technology
Office of Research Integrity Assurance
IBC@gatech.edu
Amendment for IBC Registration: rDNA or SNA Molecules
September 2015
Page 1
Avian Influenza (highly pathogenic)
Bacillus anthracis
Botulinum neurotoxin (any quantity)
Burkholderia mallei
Burkholderia pseudomallei
Ebola virus
Foot-and-mouth disease virus
Francisella tularensis
Marburg virus
Reconstructed 1918 influenza virus
Rinderpest virus
Toxin producing strains of Clostridium botulinum
Variola major virus
Variola minor virus
Yersinia pestis
NONE
Experimental Effects (check all that apply)
Indicate whether the research project indicated above produces, aims or can be reasonably anticipated to
produce any of the following experimental effects.
Enhances the harmful consequences of the agent or toxin.
Disrupts the immunity or the effectiveness of an immunization against the agent or toxin without clinical
or agricultural justification.
Confers to the agent or toxin resistance to clinically or agriculturally useful prophylactic or therapeutic
interventions against the agent or toxin or facilitates its ability to evade detection methodologies.
Alters properties of the agent or toxin in a manner that would enhance its ability to be disseminated.
Alters the host range or tropism of the agent or toxin.
Enhances the susceptibility of a host population to the agent or toxin.
Generates or reconstitutes an eradicated or extinct agent or toxin listed in Question 6.2 of this form.
NONE
If you checked any of the above experimental effects, please explain:
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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 new research 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:
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Certifications and Signatures
PI 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 _____________________(or submit via GIT email for electronic signature)
DEPARTMENT CHAIR/GTRI LABORATORY DIRECTOR SIGNATURE:
I have reviewed this DNA registration and related research plans and concur with their submission to the Institutional
Biosafety Committee for review.
Date:
Department Head Signature _____________________(or submit via GIT email for electronic signature)
Save this signed amendment form as a PDF file,
and email it AND A COPY OF NEW GRANT PAGES to:
biosafety@gatech.edu.
In lieu of dept head signatures, the Office of Research Integrity Assurance will accept an email from the dept head,
sent to biosafety@gatech.edu, in which the dept head states something like:
“I have reviewed this rDNA registration and related research plans and concur with their submission
Georgia Institute of Technology
Office of Research Integrity Assurance
IBC@gatech.edu
Amendment for IBC Registration: rDNA or SNA Molecules
September 2015
Page 1
to the Institutional Biosafety Committee for review.”
Georgia Institute of Technology
Office of Research Integrity Assurance
IBC@gatech.edu
Amendment for IBC Registration: rDNA or SNA Molecules
September 2015
Page 1