Tufts University & Tufts Medical Center
Institutional Biosafety Committee (IBC)
Tel: 617-636-4109, Fax: 617-636-8354
E-mail: ibc-office@tufts.edu
Website: http://www.tufts.edu/central/research/IBC/
FOR IBC OFFICE USE ONLY
APPROVAL DATE
EXPIRATION DATE
To submit for review, please e-mail this form to the IBC Office (ibc-office@tufts.edu)
AMENDMENT FORM
Please note that amendments may also affect other aspects of that registration, and those areas should also be reflected
in this document. Some amendments may require submission to the full Institutional Biosafety Committee. Others may
be approved administratively by a Biosafety Officer. The Biosafety Officers reserves the right to call to full Committee
review of the amendment or to require a new registration instead, if necessary. When submitting an amendment, the
Principal Investigator is required to review all of the details of the original registration to assure the IBC that all
unamended details remain identical to the original registration. Complete this form and send it electronically to ibcoffice@tufts.edu to submit for review.
Amendment to Registration #
Registration Title
Mark the checkboxes as confirmation:
I am familiar with and agree to abide by the NIH Guidelines for Recombinant and Synthetic Nucleic Acid
Molecules, CDC/NIH Biosafety Guidelines, OSHA Standards, institutional policies, and other federal, state
and local regulations relating to this project.
I attest that the information contained in the attached registration is accurate and complete.
I accept responsibility for ensuring that all personnel involved in this project will be trained regarding the
procedures approved, the potential biohazards, relevant biosafety practices, and emergency procedures.
I confirm that the relevant Exposure Response Plan(s) will be followed.
I will submit written reports to the Institutional Biosafety Committee concerning:
1. Any accident that results in a known or potential exposure to recombinant or synthetic nucleic acid
materials, infectious agents or biological toxins; or any incident resulting in the known or suspected
release into the environment of recombinant or synthetic nucleic acid materials, infectious agents or
biological toxins into the environment.
2. Any problems with physical or biological containment safety procedures or equipment, or facility
failures.
3. Any new information bearing on the safety of this work such as technical data relating to hazard and
safety procedures.
Electronic Signature of the
Principal Investigator:
Date:
By typing your name you are submitting an electronic signature that confirms your understanding and adherence to the
above statements and IBC policies. This is considered legal documentation and confirmation of your agreement to
execute all activities as approved.
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INSTRUCTIONS FOR COMPLETING THIS FORM
- Please type responses within the space/box provided. You can mark the checkboxes by double-clicking on the box.
- Submit the completed draft electronically to the IBC Office e-mail (ibc-office@tufts.edu)
- A Biosafety Officer will pre-review the form and determine if the research requires IBC Full Committee Approval or IBC
Administrative Approval. Please be aware that it is in your best interest to submit the draft to the IBC office well in
advance of the submission deadline for the IBC meeting.
I. PROPOSED MODIFICATION(S)
More than one of the Sections below may be affected by the proposed modification. Please complete each section as
necessary.
Addition/change in use of rDNA or synthetic DNA
Addition/change in use of infectious agents, human material, and biological toxins (exempt amount)
Addition/change in procedure used
Addition or relocation where agent(s) is/are used (any new space must be inspected prior to use)
II. RECOMBINANT OR SYNTHETIC DNA
A. Type of Modification
Addition of recombinant or synthetic DNA (new vectors, etc.)
Change in use of recombinant or synthetic DNA
B. Justification and Technical Details
1. Purpose of addition/change:
2. Name(s), biosafety level(s), and NIH Guidelines categorization(s) of DNA to be added
Biosafety Level
BSL-1, BSL-2, BSL-3
Name
Animal Biosafety Level
ABSL-1, ABSL-2, ABSL-3
(containment/housing)
Check all that apply below:
Section III-F: Experiments that are exempt from NIH Guidelines, but covered by local regulations.
Section III-E: Experiments that require IBC notice simultaneous with initiation.
Section III-D: Experiments that require IBC approval PRIOR TO initiation of experiments.
Section III-C: Experiments that require IBC and Institutional Review Board (IRB) approvals and Recombinant DNA
Advisory Committee (RAC) review before research participant enrollment.
Section III-B: Experiments that require NIH/OBA and IBC Approval BEFORE initiation of experiments.
Section III-A: Experiments that require IBC Approval, Recombinant DNA Advisory Committee (RAC) review, and NIH
Director Approval PRIOR TO initiation of experiments.
3. Nature and species of sequence(s) added
Name of Sequence
Source
(species name)
Nature of Insert or
Expressed Protein
Function
Promoter
4. New vectors and host cells
Name of Vector
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Source of Vector
Gene Transfer
Method
Name of Host for
Propagation or of
Packaging Cell Lines
Target Recipient of
rDNA
5. Provide additional information for sequences that code for toxins, oncoproteins, increased virulence, or other
potentially hazardous RNA/protein.
6. What is the percent of viral genome in the sequence(s)’s construct?
7. Provide restriction maps of vectors unless they are commercially available. If commercially available, please indicate
vendor.
8. What is the percent of viral genome in the vector(s)’s construct?
9. If using a lentiviral vector system, state its generation.
10. Is the vector attenuated or replication deficient?
NO
YES
11. Please describe in detail the testing that will be done to confirm attenuation or replication incompetence. Include
the location of records. See “Policy on Retroviral Replication Competency Testing” for more information.
NOTE: Insertion of oncogenes also requires testing (describe below).
12. Please confirm that results of testing will be submitted to the IBC for review.
13. Is a helper virus required for replication?
NO
YES
NO
YES
14. Describe the assay used to measure titer of replication competent virus (background) generated or helper virus.
III. ADDITION OF INFECTIOUS AGENTS, HUMAN SOURCE MATERIALS, OR BIOLOGICAL TOXINS
A. Type of Modification
Addition of infectious agent(s)
Addition of human or non-human primate (NHP) material(s)
Addition of biological toxin(s)
B. Justification and Technical Details
1. Purpose of agent addition:
2. Name, source, and biosafety level(s) of each agent to be added
Name
Source
Biosafety Level
BSL-1, BSL-2, BSL-3
Animal Biosafety Level
ABSL-1, ABSL-2, ABSL-3
(containment/housing)
3. If the agent is toxic, provide LD50:
4. If the agent is a human pathogen, what is the infectious dose?
5. The risk of exposure will be mitigated by the following:
*Check all that apply and indicate with what agent each is used and the location of use (e.g. lab room #, DLAM facility, etc.)
Personal Protective Equipment (PPE)
Agent(s) & Location of Use (N/A if not applicable)
Gloves
Lab Coat
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Disposable Lab Gown
Disposable Booties
Tyvek Suit
N-95 Respirator
Surgical Mask
PAPR (Powered Air Purifying Respirator)
Safety Glasses
Other:
Engineering Controls
Biosafety Cabinet
Other:
Date of Certification
C. Decontamination
If the amendment contains more than one agent, provide clarification for each of the answers below.
1. Please check
to confirm the information is the same as described in the original registration. If different answers
are applicable for this amendment, please describe below.
2. What chemical and/or thermal process will be used for decontamination?
3. Describe the processes involved in the decontamination and/or disposal of the following:
a. Liquid waste:
b. Contaminated solid waste:
c. Cultures, plates, stocks, etc.:
d. Animal bedding:
If handled by DLAM/LAMS, please check
the box:
Per standard ABSL-appropriate DLAM/LAMS procedures
e. Animal cages:
If handled by DLAM/LAMS, please check
the box:
Per standard ABSL-appropriate DLAM/LAMS procedures
f. Animal carcasses:
If handled by DLAM/LAMS, please check
the box:
Per standard ABSL-appropriate DLAM/LAMS procedures
D. Exposure Response Plan(s)
1. Please check
to confirm that the necessary Exposure Response Plan(s) is/are the same as described in the original
registration. If different plans apply to this amendment, please complete the questions below.
2. Please list the titles of ALL Exposure Response Plan(s) associated with this AMENDMENT ONLY. Many plans are
available for download on the IBC website.
Title of each Exposure Response Plan to be utilized
3. If a specific plan has not been developed for the agent you are proposing to work with or if you require changes to
the existing Exposure Response Plan, the Biosafety Officer will work directly with you at the time of pre-review to
develop a specific Plan, if necessary. To aid in this process, please provide the following information:
a. Are there signs and symptoms of exposure?
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b. Identify prophylactic medicines or vaccinations for this agent, if available.
c. Is there an increased risk to immunocompromised individuals exposed to this agent?
IV. ADDITION/CHANGE IN PROCEDURE
A. Procedure to Be Added/Changed
B. Justification and Technical Details
V. PROCEDURES WITH LIVE ANIMALS
Only complete this section if the biohazardous materials will be administered to live animals.
A. Administration of Agent
1. Name of species to be exposed to agent:
2. Are the animals immunosuppressed?
No
Yes
3. Agent(s) and dose(s) administered:
4. Route(s) of administration:
5. Location(s) of administration (building and lab
room #):
6. Will administration(s) be done inside a biosafety cabinet?
7. Will the biological agent or hazardous metabolite be excreted by urine, feces or wound drainage? Provide
duration, if applicable.
B. Housing/Handling Inside and Outside of Centralized Facilities
1. Will animals be removed from the centralized facilities?
Yes
No
a. If yes, will animals be returned to DLAM post administration of the agent(s)?
No
b. Please indicate location in centralized animal facility where the animals are returned:
Yes
c. Please indicate the Animal Biosafety Level necessary in the centralized facilities for the animals upon return:
ABSL-1
ABSL-2
2. Will a DLAM biohazard cage card be used to identify the agent used?
Yes
a. If no, will an alternative method be used to identify the biohazardous agent?
b. Describe alternate method, if applicable:
No
No
Yes
3. Will handling and disposal of bedding, cages, and animal carcasses be done by DLAM staff in accordance with
standard ABSL-appropriate DLAM procedures?
Yes
No
a. If no, will handling and disposal of bedding, cage, and animal carcasses be done by laboratory staff?
No
Yes
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b. Describe staff’s method, if applicable:
VI. LOCATION(S)
List ONLY NEW Laboratories/Facilities where research is to be conducted and the corresponding biosafety level. Include
cold/warm rooms, equipment rooms, and location(s) of biosafety cabinets (BSC). All new spaces must be inspected by a
Biosafety Officer prior to use. This does not apply to locations within the centralized animal facilities.
Room Purpose
Room Number for Labs
(Main Lab, Storage, Tissue Culture,
Procedure, etc.)
Biosafety Level
OTHER RELEVANT LINKS
OVPR IBC Website:
http://www.tufts.edu/central/research/IBC/index.htm
Tufts University EHS Website:
http://publicsafety.tufts.edu/ehs/
Pathogen Safety Data Sheets:
Biosafety in Microbiological and
Biomedical Laboratories (BMBL):
NIH Recombinant DNA Guidelines:
http://www.phac-aspc.gc.ca/msds-ftss/index.html#menu
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http://www.cdc.gov/biosafety/publications/bmbl5/
http://oba.od.nih.gov/rdna/nih_guidelines_oba.html