Download Registration Form - Institutional Biosafety Committee

IBC # 00-000
MAIN REGISTRATION FORM
DIRECTIONS
The content of the IBC Application should describe all work with biohazardous materials (including rDNA)
to be conducted by a Principal Investigator (PI), and thus it may cover multiple projects as long as all
procedures involving biohazardous materials are described comprehensively on the IBC application.
 There is no limit to the number of applications a single investigator can submit, nor are there limitations as
to how often this application is updated to incorporate an increase or change in scope.
 Submit an electronic copy of the completed application to [email protected]. Retain a copy of your completed
form for your records.

SECTION 1: GENERAL INFORMATION
Protocol Title:
(This form may cover more than one project if the work - e.g., biological materials, personnel, & locations - is
similar):
Application Type:
New
Renewal of previously approved protocol (IBC #
Amendment (Date of request:
)
)
Principal Investigator:
Personal ID (PID):
Email address:
Primary work phone number:
(
)
-
Campus office address:
Lab Building(s)/room #(s):
Lab Phone:
Co-Investigator (if applicable):
Personal ID (PID):
Email address:
Primary work phone number:
(
)
-
Campus office address:
Check here if you listed additional co-investigators on a separate sheet
Laboratory Emergency Contact:
Email address:
Main Registration Form
Personal ID (PID):
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Primary work phone number
(
)
SECTION 2: FUNDING INFORMATION
This section is necessary because an institution receiving NIH funds for recombinant DNA (rDNA) research
must comply with the NIH Guidelines for all rDNA research. The NIH Guidelines state that any institution
conducting rDNA research and receiving NIH funding for that research must establish an Institutional Biosafety
Committee (IBC). The IBC is an autonomous body that is accountable to both the institution in which the
research is conducted as well as the federal funding and oversight agencies. Therefore it is the IBC’s primary
responsibility to ensure that sponsored research at the institution is compliant with the sponsoring agency’s
research guidelines. As an extension of the IBC’s oversight responsibilities, the IBC also ensures that all
internally funded research is compliant with Virginia Tech's biosafety guidelines.
A. I am initiating/renewing RESEARCH activities
1. Please list all external/sponsor-funded programs, or projects included within your program (If
applicable):
Grant Title(s):
Granting Agency(s):
Sponsor
Award # or
Fund #:
Project Period:
2. Please list all internal-fund programs, or projects included within your program (if
applicable):
Grant Title(s):
Funding Source(s)
(including start-up
funds):
Internal Award
#
or Fund #:
Project Period:
B.I am initiating/renewing TEACHING activities
Department:
Course number:
Main Registration Form
Course level:
Course title:
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Internal award #
or Fund #:
Course Period:
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SECTION 3: ABSTRACT
Provide a brief description and overview of your research goals and objectives involving biohazardous agents and/or
recombinant DNA (rDNA) material. This should be the general area under study not detailed experimental methods;
however, sufficient information must be presented for the IBC to understand the general scope of the work. Program
descriptions must be free of technical jargon (unless unavoidable- and then briefly defined) and should be readily
comprehensible by a general audience (i.e., non-scientists who will also review this submission). Try to include: overall
objectives; the source(s) of agent and/or biological material; If research involves rDNA, describe the host(s) and vector(s)
to be used; If research involves rDNA, what is the nature of the inserted DNA sequences (genetic modification); If
research involves rDNA, Will a deliberate attempt be made to express a foreign gene, and if so, indicate the protein or
transcript that will be produced; If research involves rDNA please indicate other organisms, if any, associated with the
genetically modified organisms.
a. Overall Objectives:
b. The source(s) of DNA:
c. The nature of the inserted DNA sequences (genetic modification):
d. The host(s) and vector(s) to be used:
e. Will a deliberate attempt be made to express foreign gene, and if so, indicate the protein that will be produced:
f. Other organisms, if any, associated with the genetically modified organism:
g. Provide information regarding your direct experience handling/transporting/manipulating each of the agents listed in
your protocol. Include information regarding the use of the agents with the containment practices and experimental
protocols described in this protocol. If you do not have experience with any of the listed agents and/or procedures,
please explain who will provide the training.
h. Does any of the work described in this protocol involve dual-use research of concern (DURC)?
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SECTION 4: SCOPE OF RESEARCH
Does your program, or any of the protocols encompassed within your program, include any of the following?
Please check all that apply.
1.
Transfer/shipping of biological materials including: patient/clinical specimens, cell cultures,
tissues, genetically modified organisms and/or infectious agents, toxins of biological origin or
items on dry ice.
2.
Production and/or storage of large-scale cultures with volumes greater than 10 liters at any one
time. (Complete a Large Scale Cultures Form).
3.
Acquisition, storage, generation or manipulation of naturally occurring pathogen(s) (a pathogen
that has not been altered by rDNA) which is infectious to humans, animals or plants. (Complete
a Risk Assessment Worksheet for each pathogen).
4.
Acquisition, storage, generation or manipulation of human or non-human primate cells and/or
tissue samples. (Complete a Human-NHP Risk Assessment Worksheet). Note: All work must
be conducted using BL2/BSL2/ABSL2 containment practices.
5.
Acquisition, storage, generation or manipulation of animal (other than human and non-human
primate) cells and/or tissue samples.
6.
Acquisition, storage, generation or manipulation of regulated or select agents and/or biotoxins.
7.
Acquisition, storage, generation or manipulation of recombinant DNA (rDNA). This includes
plasmids, viral vectors, creation of transgenic animals; human gene therapy, etc.
8.
rDNA molecules cloned into pathogenic organisms that are classified as RG2, RG3, RG4 or
select agents. (Complete an rDNA in Pathogens Form as well as a Risk Assessment Worksheet
for each pathogen used as a recipient of rDNA).
9.
rDNA molecules cloned from pathogenic organisms that are classified as RG2, RG3, RG4 or
select agents.
10.
Insertion of rDNA molecules into animals (vertebrates and invertebrates) or the insertion of
rDNA-containing organisms or cells/tissues into animals. (Complete an rDNA in Animals Form.
IACUC approval is required before initiating work with animals).
11.
Insertion of rDNA molecules into whole plants or the use of rDNA-containing organisms in
conjunction with whole plants. (Complete an rDNA in Plants Form).
12.
Deliberate transfer of rDNA or RNA derived from rDNA into one or more human research
participants. This would include research involving ex-vivo transduction of cells for human
application. (Contact the IBC Administrator for a Gene Therapy Form. IRB approval is also
required before initiating research).
13.
Synthetic nucleic acid molecules cloned into pathogenic organisms that are classified as RG2,
RG3, RG4 or select agents. (Complete an rDNA in Pathogens Form as well as a
Risk Assessment Worksheet for each pathogen used as a recipient of rDNA).
14.
Synthetic nucleic acid molecules cloned from pathogenic organisms that are classified as RG2,
RG3, RG4 or select agents.
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15.
Acquisition, storage, generation or manipulation of naturally occurring RG-1 organism(s) (an
RG-1 organism that has not been altered by rDNA).
SECTION 5: BIOSAFTEY CONSIDERATIONS
What is the associated risk group level(s) of the biological agent(s) and/or material(s) you will use in the
proposed research? (If you are unsure about the risk group designation of an agent and/or material please
refer to the NIH Guidelines Appendix B.)
RG-1
RG-2
RG-3
Human or non-human primate cells/tissues
What biosafety containment practices are required for the research activities covered by this protocol? (If you
are unsure about the required containment practices for your research activities refer to the BMBL or NIH links
in each category below).
BMBL
Biological Research
Standards
BMBL
Biological Research
Involving Animals
BMBL
Biological Research
Involving Arthropods
BSL-1
ABSL-1
ACL-1
BSL-2
ABSL-2
ACL-2
BSL-3
ABSL-3
ACL-3
NIH Guidelines rDNA or
synthetic nucleic acids
Physical Containment
NIH Guidelines rDNA or
synthetic nucleic acids
Research involving
Large Animals
NIH Guidelines rDNA or
synthetic nucleic acids
Research Involving
Plants
NIH Guidelines
Large-scale uses of
Organisms Containing
rDNA or synthetic
nucleic acid Molecules
BL1
BL1-N
BL1-P
BL1-LG
BL2
BL2-N
BL2-P
BL2-LG
BL3
BL3-N
BL3-P
BL3-LG
SECTION 6: NIH-REGULATED RECOMBINANT DNA (rDNA) RESEARCH
If your research does not involve rDNA, please check A, and proceed to Section 8. If your research does
involve rDNA, complete Section 7.
A. My research does not involve rDNA or synthetic nucleic acid molecules.
B. My research does involve rDNA or synthetic nucleic acid molecules. Please indicate the
categories that pertain to your research activities.
Section III-A-1: Major Actions under the NIH Guidelines (Appendix D).
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Section III-A-1-a: Deliberate transfer of a drug resistance trait to microorganisms that are
not known to acquire it naturally, if such acquisition could compromise the use of the
drug to control disease agents in human or veterinary medicine or agriculture.
Section III-B-1: Deliberate formation of rDNA containing genes for the biosynthesis of
toxin molecules lethal at an LD50 of less than 100 nanograms per kilogram body weight.
Section III-B-2: Experiments that have been approved (previously approved under
Section III-A-1-a) as Major Actions under the NIH Guidelines (Appendix D).
Section III-C-1: Experiments Involving the Deliberate Transfer of synthetic nucleic acid
molecules, rDNA, and/or DNA or RNA Derived from rDNA and/or synthetic nucleic acids,
into One or More Human Research Participants.
Section III-D-1: Experiments using human or animal pathogens (Risk Group 2, Risk
Group 3, Risk Group 4, or restricted agents) as host-vector systems.
Section III-D-2: Experiments in which DNA from human or animal pathogens (Risk
Group 2, Risk Group 3, Risk Group 4, or restricted agents) is cloned into nonpathogenic
prokaryotic or lower eukaryotic host-vector systems.
Section III-D-3: Experiments involving the use of infectious DNA or RNA viruses or
defective RNA or DNA viruses in the presence of helper virus in tissue culture systems.
Section III-D-4: Experiments involving whole animals in which the animal's genome has
been altered by stable introduction of rDNA, or RNA derived therefrom, into the germline (transgenic animals) and experiments involving viable rDNA-modified
microorganisms tested on whole animals. Note: the purchase (or transfer to your lab) of
previously created transgenic rodents is exempt from the regulations.
Section III-D-5: Experiments involving the use of exotic and/or infectious agents to
genetically engineer plants by recombinant DNA and/or synthetic nucleic acid methods,
to use such plants for other experimental purposes, to propagate such plants, or to use
plants together with microorganisms or insects containing recombinant DNA and/or
synthetic nucleic acids.
Section III-D-6: Experiments involving more than 10 liters of culture at any one time.
Section III-D-7: Experiments involving influenza virus.
Section III-E: Experiments not included in Sections III-A, III-B, III-C, III-D or III-F; and all
such experiments may be conducted at BL-1 containment.
Section III-E-1: Experiments involving the formation and use of rDNA and/or synthetic
nucleic acid molecules containing no more than two-thirds of the genome of any
eukaryotic virus, which are conducted at BL-1 in the absence of a helper virus.
Section III-E-2: Experiments involving recombinant DNA-modified whole plants, and/or
experiments involving recombinant DNA-modified organisms associated with whole
plants, except those that fall under Sections III-A, III-B, III-D, or III-F.
Section III-E-2-a: This section covers experiments involving whole plants modified by
recombinant DNA and/or synthetic nucleic acids, and/or experiments involving
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recombinant DNA/synthetic nucleic acid-modified organisms associated with whole
plants that can be performed at BL1/BSL1 and/or BL1-P. (Exceptions: experiments that
involve the use of exotic and/or infectious agents (III-D-5) and those experiments that
fall under Sections III-A, III-B, III-D, or III-F).
Section III-E-2-b: This section covers experiments involving whole plants modified by
recombinant DNA and/or synthetic nucleic acids, and/or experiments involving
recombinant DNA/synthetic nucleic acid-modified organisms associated with whole
plants that can be performed at BL2/BSL2 and/or BL2-P. (Exceptions: experiments that
involve the use of exotic and/or infectious agents (III-D-5) and those experiments that
fall under Sections III-A, III-B, III-D, or III-F).
Section III-E-3: Experiments involving the generation of new transgenic rodents. This
section covers experiments involving the generation of rodents in which the animal's
genome has been altered by stable introduction of synthetic nucleic acids, rDNA, or
DNA derived therefrom, into the germ-line of rodents. This only covers experiments
that require ABSL-1/BL1-N containment.
Section III-F: Exempt from the NIH Guidelines.
(Please fill out an Exemption Verification Form).
SECTION 7: OTHER REQUIRED INSTITUTIONAL/EXTERNAL SAFETY APPROVALS
Depending on the scope of your research activities additional approvals may be required. Does the program or
protocol within your program involve any of the following?
Does Research
involve:
Animal subjects or
tissues?
Human subjects or
tissue?
Regulated select
agents or toxins?
Approving Body &
number:
IACUC Approval #
IRB Approval #
HHS/USDA/CDC#
FDA IND #
Expiration date:
Current Status
(if other than
“approved”):
Pending
As needed
Pending
As needed
Pending
As needed
Pending
As needed
Human gene therapy?
Import/Export of
regulated agents into
or out of the US?
Pending
As needed
Interstate transport of
regulated agents?
Pending
As needed
Intentional release into
the environment?
Pending
As needed
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Please provide additional information regarding any "pending" or "as needed" approvals.
SECTION 8: PRINCIPAL INVESTIGATOR’S ACKNOWLEDGMENT OF RESPONSIBILITIES
By signing below, I certify that I have read the following statements and agree that I and all listed participants
on my IBC protocol (including all personnel added to the protocol in the future) will abide by the statements, as
well as all policies and procedures governing the use of infectious agents, recombinant DNA and other
biohazardous materials, as outlined by Virginia Tech policies and applicable federal regulations.
 I recognize that I have a responsibility for ensuring the information provided in this application is
complete, accurate and thorough by participating in the development of the IBC application and
conducting a review of the protocols.
 I recognize that I have responsibilities for ensuring that anyone who enters my laboratory practices
appropriate biosafety precautions.
 I recognize that I have responsibilities for ensuring that all listed participants conducting this work have
received or will receive appropriate training in safe laboratory practices and procedures for this
protocol before any work begins on this project. Also, I have a responsibility for ensuring that anyone
working in or having access to spaces where this project is conducted must be instructed on the
hazards associated with this project. The IBC or EHS staff may review my records documenting the
training or instruction of personnel.
 I recognize that I have a responsibility for complying with the requirements pertaining to the shipment
and transfer of biohazardous materials.
 I recognize that I have a responsibility for reporting to the Biosafety Officer immediately any spill of
biohazardous material, any containment equipment or facility failure, any permitted decontamination
of equipment, and/or any breakdown in procedures, which may result in potential exposure of
laboratory personnel and/or the public to the biohazardous material.
 I recognize that I have a responsibility for reporting to the Biosafety Officer immediately should an
employee become ill and/or exhibit symptoms and signs consistent with an infection caused by an
organism associated with my research.
 I recognize that I have a responsibility for following all the applicable guidelines as approved for this
protocol.
 I recognize that I have a responsibility for submitting in writing a request for approval from the IBC of
any significant modifications to the protocol.
 I recognize that I must not carry out the work described in this application until it has been approved by
the IBC.
 I attest that this application is accurate and complete.
By typing your name below, you agree that this is valid as your signature
Electronic signature:
Date:
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