Tel: 617-636-4109, Fax: 617-636-8354
E-mail:
Website:
REGISTRATION TITLE
Mark the checkboxes as confirmation:
I am familiar with and agree to abide by the
(NIH Guidelines), 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
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Please type responses within the space/box provided and mark the checkboxes when appropriate.
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Double-click on the checkboxes to mark your selections.
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Submit the completed draft electronically to the IBC Office e-mail (ibc-office@tufts.edu) .
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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.
PRINCIPAL INVESTIGATOR
ACADEMIC POSITION/TITLE
DEGREE(S)
DEPARTMENT/DIVISION
LAB ADDRESS
DIRECT PHONE #
E-MAIL
LABORATORY CONTACT
EMERGENCY #
FAX
DEGREE(S)
DIRECT PHONE #
E-MAIL
EMERGENCY #
Will this research utilize viable organisms containing recombinant or synthetic nucleic acid molecules in culture volumes of 10 liters or greater?
NO YES
*Research utilizing volumes greater than or equal to 10 liters is defined as “Large Scale” and requires special permission. If the project involves large scale work, please contact your Biosafety Officer for additional information.
All listed personnel must complete mandatory IBC training. See “ IBC Policy on Mandatory Biosafety Training” and IBC website for information.
NAME E-MAIL PHONE #
1.
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Provide the name(s) of each agent/material to be used. For recombinant DNA (rDNA) and synthetic nucleic acids, mark the relevant Section of the NIH Guidelines under which it is described. Detailed definitions of each can be found in Appendix A of this form. Identify the appropriate Biosafety Level (BSL) required for each agent proposed according to the NIH Guidelines at http://oba.od.nih.gov/rdna/nih_guidelines_oba.html
or the CDC/NIH Biosafety
in Microbiological and Biomedical Laboratories 5th edition at http://www.cdc.gov/biosafety/publications/bmbl5/index.htm
If you have questions regarding these categorizations, the Biosafety Officer will help you during the pre-review.
A. RECOMBINANT AND/OR SYNTHETIC NUCLEIC ACID MOLECULES – List viral vectors here, if applicable.
Recombinant and synthetic nucleic acid molecules are defined as: i) molecules that a) are constructed by joining nucleic acid molecules and b) can replicate in a living cell (i.e. recombinant nucleic acids); ii) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules (i.e. synthetic nucleic acids); or iii) molecules that result from the replication of those described in (i) or (ii) above.
1. Name(s), Relevant Biosafety Level(s), and NIH Guidelines Categorization(s)
Name
Biosafety Level
BSL-1, BSL-2, BSL-3
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.
2. Is the agent attenuated or replication deficient? NO YES*
3. *If yes, please describe in detail the testing that will be done to confirm attenuation or replication incompetence. Include the location of records. Please refer to the “ Policy on Retroviral Replication
Competency Testing .”
NOTE: Insertion of oncogenes also requires testing (please describe below).
4. Please confirm that results of testing will be submitted to the IBC for review. YES NO
B. INFECTIOUS AGENT(S) – Human source materials (e.g. blood or cell lines) should be reserved for Part F.
1. Name(s), Relevant Biosafety Level(s), and Pathology Information
Name
Biosafety Level
BSL-1, BSL-2, BSL-3
Animal Biosafety Level
ABSL-1, ABSL-2, ABSL-3
Pathology of Agent
Human pathogen, Animal
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(containment/housing) pathogen, Both, Neither or
N/A
2. If a human pathogen, what is the infectious dose for a healthy human adult?
3. Is the agent attenuated or replication deficient? NO YES
4. If yes, please describe in detail the testing that will be done to confirm attenuation or replication incompetence. Include the location of records.
5. Please confirm that results of testing will be submitted to the IBC for review. YES NO
C. BIOLOGICAL TOXIN(S)
1. Name(s), Relevant Biosafety Level(s), and Toxicity Information
Name
Biosafety Level
BSL-1, BSL-2, BSL-3
Animal Biosafety Level
ABSL-1, ABSL-2, ABSL-3
(containment/housing)
2. What is the maximum quantity of toxin that will be present?
3. What is the LD50 of the toxin in humans?
4. What is the LD50 of the toxin in animal species used in this experiment?
Toxicity of Agent
To humans, To animals, To both, Neither or N/A
D. SELECT AGENT(S) OR TOXIN(S) To determine if your study falls within the Select Agent Rule, refer to http://www.selectagents.gov/Select%20Agents%20and%20Toxins.html
1. Name(s), Relevant Biosafety Level(s), and Toxicity or Pathology Information
Name
Biosafety Level
BSL-1, BSL-2, BSL-3
Animal Biosafety Level
ABSL-1, ABSL-2, ABSL-3
(containment/housing)
Pathology or Toxicity
Humans, Animals, Both,
Neither or N/A
2. If a human pathogen, what is the infectious dose for a healthy human adult?
3. If a toxin, what is the maximum quantity that will be present?
4. What is the LD50 of the toxin in humans?
5. What is the LD50 of the toxin in animal species used in this experiment?
E. GENETICALLY ENGINEERED ANIMALS
See “ Policy on Genetically Engineered Animals ” for detailed information about the IBC review of genetic mutants and which type of review is required.
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1. Species and Relevant Biosafety Level(s)
Species
Animal Biosafety Level
ABSL-1, ABSL-2, ABSL-3
(containment/housing)
F. HUMAN SOURCE MATERIAL(S)
1. Employees of TUFTS MEDICAL CENTER are NOT required to be covered by the IBC for use of human source materials. If you are a TMC employee, provide the appropriate confirmation below.
I confirm that all research with human source materials is conducted in the Tufts Medical Center facilities and that annual Bloodborne Pathogen Training as a Tufts Medical Center employee is obtained.
OR
This does not apply to this registration.
2. Employees of TUFTS UNIVERSITY MUST register human source materials with the IBC. Provide the
information below.
HUMAN/NON-HUMAN PRIMATE (NHP) BLOOD, BODY FLUIDS, TISSUE, ORGANS
Name
Biosafety Level
BSL-1, BSL-2, BSL-3
Animal Biosafety Level
ABSL-1, ABSL-2, ABSL-3
(containment/housing)
HUMAN/NON-HUMAN PRIMATE (NHP) CELL LINES
Name
Biosafety Level
BSL-1, BSL-2, BSL-3
Animal Biosafety Level
ABSL-1, ABSL-2, ABSL-3
(containment/housing)
Please check all categories that apply to the proposed work in this registration. See the “ US Government Policy for Oversight of DURC ” and NIH/OBA Educational Materials .
Enhances the harmful consequences of the agent or toxin
Disrupts immunity of 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 that agent or toxin or facilitates their ability to evade detection methodologies
Increases the stability, transmissibility, or the ability to disseminate the agent or toxin
Alters the host range or tropism of the agent or toxin
Enhances the susceptibility of a host population to the agent or toxin
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Generates or reconstitutes an eradicated or extinct agent or toxin, or involves agents or toxins with significant potential for mass casualties or devastating effects to the economy, critical infrastructure, or public confidence as listed in the “ US Government Policy for Oversight of DURC ,” Section (III.2)
None of the above applies
Provide a BRIEF description of the goal of the research and how the agents are to be used in the box below. Lay terminology must be used in place of field-specific terms and phrases.
*The blue field will expand as text is entered.
In the following space, please summarize the intent of your proposed project. Provide enough information so that the techniques and purposes of the experiments with the biohazardous agent(s) are clear. Indicate culture volumes, maximum concentrations, and other agent-specific information. Identify at what stage of the experiment the agent is inactivated. Be as concise as possible, using reasonably non-technical terms.
*The blue field will expand as text is entered.
Will the experiment(s) result in the acquisition of new characteristics such as enhanced virulence, infectivity, drug resistance, or change in host range? NO YES*
*If yes, please explain.
List ALL laboratories where research is to be conducted and the corresponding biosafety level. Include cold/warm rooms, equipment rooms, and location(s) of biosafety cabinets (BSC). For locations in the centralized animal facilities, please indicate “DLAM” (Department of Laboratory Animal Medicine) or “LAMS” (Laboratory Animal
Medicine Services)”.
Room Number for Labs
Room Purpose
(Main Lab, Storage, Tissue Culture,
Procedure, etc.)
Biosafety Level
A. Hazardous processes used with agent. Check all that apply.
Centrifuge Sharps Animal Model Sonication Pipetting Tissue harvesting
Tissue homogenization Cell sorting (flow cytometry or other method) Other: specify
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B. Exposure route of agents. Check all that apply.
Ingestion Percutaneous Mucous Membrane Inhalation Other: (specify)
C. 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 (lab room #, animal facility, etc.). If using engineering controls, provide the date of certification.
Personal Protective Equipment Agent(s) and Location of Use
Gloves
Lab Coat
Disposable Lab Gown
Disposable Booties
Tyvek Suit
N-95 Respirator
Surgical Mask
PAPR (Powered Air Purifying Respirator)
Safety Glasses
Other: (specify)
Engineering Controls Date of Certification
Biosafety Cabinet (BSC)
Other: (specify)
A. All labs working with biological agents must have an agent and lab specific exposure control plan. Please list
the titles of ALL Exposure Response Plan(s) associated with this registration. Many plans are available for download on the IBC website . If the one you need is not there, please work with your Biosafety Officer to create one.
Title of each Exposure Response Plan to be utilized
B. OR 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:
1. Are there signs and symptoms of exposure?
2. Identify prophylactic medicines or vaccinations for this agent, if available.
3. Is there an increased risk to immunocompromised individuals exposed to this agent?
A. What chemical and/or thermal processes will be used for decontamination?
B. Describe the processes involved in the decontamination and/or disposal of the following:
1. Liquid waste:
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2. Contaminated solid waste:
3. Cultures, plates, stocks, etc.:
4. Animal bedding:
If handled by DLAM/LAMS, please check the box:
5. Animal cages:
If handled by DLAM/LAMS, please check the box:
Per standard ABSL-appropriate procedures
Per standard ABSL-appropriate procedures
6. Animal carcasses:
If handled by DLAM/LAMS, please check the box: Per standard ABSL-appropriate procedures
Please answer the following questions in the space provided. Please write “N/A” for all items that do not apply.
A. SOURCE OF GENE, GENE FAMILY, INSERT, OR CLONE
1. Name the specific DNA/RNA source or probe (human, species of animal, plant, etc.)
2. What is the percent of viral genome in the construct?
3. What is the percent of synthetic DNA in the construct?
4.
What is being expressed? What effect will be seen in the cell, animal etc.?
5. Provide information on any sequences that code for toxins.
B. VECTORS AND HOST CELLS
1. Identify the cloning/expression/transfection vectors used.
2. Identify the recipient bacterial strains and recipient host cell lines (human, species of animal, plant, etc.).
Provide a restriction map of vector unless this is a commercially available vector. If commercially available, please indicate vendor.
3. Describe the location and type of promoters and other control sequences.
4.
What is the percent of viral genome in the construct?
5. If using viral vectors, indicate packaging cell lines and assay system used to measure helper virus titer or titer of replication competent virus (background) generated. Include host range of packaged viral vector (If using retroviral or lentiviral vectors, additional requirements may apply).
6.
What is the percent of synthetic DNA in the construct?
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C. USE OF RECOMBINANT OR SYNTHETIC DNA IN ANIMALS, PLANTS, OR INSECTS
For genetically engineered rodent breeding at ABSL-1, information should be provided in the IACUC form only. See
“ IBC Policy on Genetically Engineered Mutants .”
1. Please describe how recombinant or synthetic nucleic acid molecules will be used.
2. Please check the applicable box and complete the sections below for insects or plants.
Use/generation of genetically engineered INSECTS ONLY
Use/generation of genetically engineered PLANTS ONLY
3. List the insect or plant species to be used.
4. Transgene(s) Information
Transgene Name Or
Family
Transgene Function Transgene Source Vector Used Recipient Strain
5. What is the method of transformation?
6. Does the gene encode a toxin or other hazardous agent? If yes, please describe.
7. Provide location information for insects or plants. Include building and room number.
Complete this section ONLY if the biological material(s) listed on this registration will be administered to animals.
Please provide a response for all items. If a question does not apply, please write “N/A.”
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 # OR DLAM or LAMS):
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/LAMS post administration of the agent(s)? No Yes b. Please indicate the Animal Biosafety Level necessary in the centralized facilities for the animals upon return:
ABSL-1 ABSL-2
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2. Will a DLAM/LAMS biohazard cage card be used to identify the agent used? Yes No a. If no, will an alternative method be used to identify the biohazardous agent? No Yes
b. Describe alternate method, if applicable.
3. Will handling and disposal of bedding, cages, and animal carcasses be done by DLAM/LAMS 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
b. Describe lab staff’s method, if applicable.
Tufts University EHS Website
Pathogen Safety Data Sheets
Biosafety in Microbiological and
Biomedical Laboratories (BMBL)
NIH Guidelines for Recombinant and
Synthetic Nucleic Acid Molecules
Tufts OVPR IBC Website http://publicsafety.tufts.edu/ehs http://www.phac-aspc.gc.ca/lab-bio/res/psds-ftss/index-eng.php#menu http://www.cdc.gov/biosafety/publications/bmbl5/index.htm
http://oba.od.nih.gov/rdna/nih_guidelines_oba.html
http://www.tufts.edu/central/research/IBC/index.htm
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