Revised 04/18/11
Texas A&M University-Kingsville
Institutional Biosafety Committee
Biosafety Evaluation Form
Principal Investigator (Must be faculty or academic professional administrative staff.)
Name (Last name, First name MI):
Phone Number:
Mailing Address:
Pager or Cell Phone Number:
Fax:
TAMUK Employee ID:
Email:
University Department:
Occupational Position:
Faculty Staff Note: Students cannot be Principal Investigator.
The Texas A&M University-Kingsville Institutional Biosafety Committee consists of
University faculty, staff and community members. The TAMUK IBC reviews and
assesses research projects and laboratory-based courses conducted on campus or by
faculty who utilize biohazardous materials. The TAMUK IBC provides oversight and
reporting for Federal, State and local regulations that pertain to the application and use of
biohazardous materials. The IBC consists of faculty experts in animal, plant and
microbiological gene transfer. In addition, IBC members have expertise in biosafety and
regulatory issues that ensure a comprehensive review of biohazardous research at the
University and will provide adequate evaluation of the proposed research.
The TAMUK IBC reviews research projects/courses that utilize or may result in a
biosafety risk when using the following materials:




Recombinant DNA
Human tissue, blood or body fluids
Select Agents or Biotoxins
Infectious agents
The TAMUK IBC is available to assists investigators/instructors in registering their
projects as needed in order to facilitate the review process. Contact the Research
Compliance Liaison at (361) 593-3344 or email osr@tamuk.edu to make arrangements.
Revised 04/18/11
To determine which form(s) you will need to complete, refer to the following chart:
Biohazardous Material
Infectious Agents
Or
Human/Primate Tissue,
Blood, or Fluids
Recombinant
DNA
Biotoxins/Select Agents
Complete rDNA Exempt Form
Exempt:
Yes or
No?
Yes
Infectious Agent Usage,
Wasteplan and
Decontamination Forms
rDNA Exempt Form,
Wasteplan and
Decontamination Forms
N
o
Biological Toxins Usage,
Recombinant DNA
and Artificial Gene Transfer,
Wasteplan and
Decontamination Forms
Date Received by IBC:
Texas A&M University-Kingsville
Institutional Biosafety Committee
Office of Research and Sponsored Programs: (361) 593-3344 or osr@tamuk.edu
Recombinant DNA and Artificial Gene Transfer Form
Internal IBC Use Only
IBC
Approval #:
Approved
Laboratory
Biosafety
Level(s):
NIH Guidelines Experiment
Designation:
1.
Approval Date:
Animal Housing
Method of Review:
Project Identification and Signatures
1.1 Type of Application: New Protocol 3-year Renewal of IBC #
(If this is a 3-year resubmission, do not use language referring to the previous protocol or grant in this form.)
Anticipated Start Date:
1.2 Project Title: (Project title must match grant title. If different, provide grant title also)
1.3 Principal Investigator (Must be faculty or academic professional administrative staff.)
Name (Last name, First name MI):
Phone Number:
Mailing Address:
Pager or Cell Phone Number:
Fax:
TAMUK Employee ID:
Email:
University Department:
Occupational Position:
Faculty Staff Note: Students cannot be Principal Investigator.
Assurance by Principal Investigator
Electronic submission of this form from the Principal Investigator’s TAMUK e-mail address confirms his/her
agreement to perform all activities according to the NIH Guidelines for Research Involving Recombinant DNA
Molecules and use biosafety practices described in the CDC/NIH Publication Biosafety in Microbiological and
Biomedical Laboratories (BMBL), and to report any research-related accidents or incidents to the IBC as required by
the NIH Guidelines. If applicable, this application accurately and completely reflects the activities described in any grant or
contract supporting this research. Additional conditions required by the Institutional Biosafety Committee on behalf of
Texas A&M University-Kingsville will also be followed.
Principal Investigator:
Date:
3
Date Received by IBC:
1.4 Person preparing this document
Name:
Phone number:
Email:
1.5 Personnel conducting the experiments
List the personnel that will be working on this study below (including students and temporary staff). For each
individual conducting the experiments, list their degree, applicable training, relevant experience (including duration)
and their role in the project and indicate whether they should receive correspondence about the study from the IBC.
TAMUK
Employee
or Student
ID
Name
(Last Name, First
Name MI)
TAMUK
Email ID
(ex. smith001)
Role in Project
Degree/ Years of
Experience with rDNA
Activities
Date NIH-Required Training
Modules Completed*
Biological Safety
in the Lab
Receive
Mail
from
Implementation
IBC**
of the NIH
Guidelines
* Section IV-B-1-h of the NIH Guidelines requires that Principal Investigators and laboratory staff
working with rDNA complete training in laboratory safety and implementation of the NIH Guidelines.
This training requirement can be satisfied by attending TAMUK-sponsored Biosafety workshop.
.
4
Date Received by IBC:
1.6
Bloodborne and Other Pathogens Training is required if you will work with
infectious microorganisms, human blood, human body fluids, and/or human/primate
cell lines. Will you use any of these materials?
Yes
No
1.7 Source of Funding
Please do not send grant applications to the IBC.
Name
of
funding
source:
Grant:
Will be submitted.
Submitted.
Approved. The duration of approval:
5 years
Other:
This application must be written for a maximum of three years only. IBC applications
expire after 3 years, at which time a new application will be requested.
1.8 Externally Funded Projects (Complete this section if you will receive external funds
for this research)
Name of
Sponsor:
Address:
Contact
Person:
Funding decision:
pending
awarded
Agency-assigned grant number(if available):
Nature of funding source:
Federal grant.
Other grant or contract. Specify:
5
Date Received by IBC:
2.
Scientific Summary and Rationale
2.1
Please provide the committee with a brief explanation of the proposed project. Use
language that is understandable to those with a general knowledge of biology, and define
all acronyms. Do not attach grant applications.
2.2
Describe the goals/specific aims of the recombinant DNA or artificial gene transfer
activities proposed in this application. Explain how the use of recombinant DNA
technology will further the goals of this research.
3.
Gene Transfer
3.1 Gene Transfer will involve (check and describe):
Physical methods (e.g., pronuclear injection, electroporation, “gene gun”, etc)
Describe:
Host-Vector system
Vector used:
Other
Describe:
3.2 List genetic material to be transferred (e.g., genes, DNA or RNA)
Genes, DNA or RNA
Species of Origin
Function of Gene
3.3 Describe the vector(s), including any regions that increase the biological safety of the
construct.
3.4 Explain the host range of each vector (e.g., is the vector amphotropic, ecotropic, is the vector
pseudotyped?)
3.5 Provide scientific rationale for using the vector(s) proposed.
3.6
Attach a map of each vector.
6
Date Received by IBC:
4.
NIH Guidelines Experiment Designation
The IBC will designate the section(s) of the NIH Guidelines for Research Involving Recombinant
DNA Molecules under which these experiments are covered (e.g., III-D-1-a, III-E, etc).
If you would like to suggest a designation, please refer to the NIH experiment classifications
described in Section III (pages 14-20) of the NIH Guidelines*. Please note Texas A&M
University-Kingsville policy requires that all rDNA and artificial gene transfer activities
are approved by the IBC prior to initiation.
Section(s): III*The TAMUK IBC has developed a summary of the experiments covered by the NIH Guidelines.
See Appendix A.
5.
Activities involve the use of (check all that apply):
Human subjects
IRB protocol number:
Pending
If the study involves use of gene transfer to humans you must submit a detailed addendum
in which each topic of Appendix M in the NIH Guidelines is addressed.
NIH Guidelines for Research Involving Recombinant DNA Molecules
Attach Appendix M
Attach human subjects’ consent form
Attach NIH OBA Recombinant DNA Advisory Committee (RAC) letter
Whole animals; Species:
Approx number:
IACUC protocol number:
Pending
Does this project involve the creation of transgenic or knockout animals?
No
Yes
Does this project involve inoculation of animals?
No
Yes. Describe the inoculum, the amount and the route of administration:
Can the animals release exogenous DNA into the cage?
No
Yes. Indicate for how long:
Whole plants; Species:
In vitro work (cell culture):
Cells used in these experiments (check all that apply):
Human Cells
Non-human Primate Cells
Animal Cells (non-primate)
Plant Cells
Insect Cells
Other
Microorganisms; Species:
7
Date Received by IBC:
List any available information regarding antibiotic resistance associated with the
bacterial agents used in this project. If antibiotic sensitivity profiles are available,
please provide this information as an attachment
Fungi; Species:
Whole Insects; Species:
Viruses; Name:
Do activities involve formation of rDNA molecules containing greater than 2/3 of the
genome of any eukaryotic virus?
No
Yes
Do activities involve the use of infectious human, animal, insect or plant viruses?
No
Yes
Do activities involve the use of defective animal or plant viruses in the presence of helper
virus?
No
Yes
6.
Biosafety Levels
6.1 Indicate the biosafety level in the laboratory where activities will be performed.
BSL1
BSL2
BSL3
Location (room and building):
6.2 If animals are used, indicate the biosafety level in which they will be housed.
No animals
ABSL1
ABSL2
ABSL3
Location of animal housing (room and building):
7. Use of a Biosafety Cabinet
Will work be conducted in a biosafety cabinet for these activities?
No
Yes
If yes, what is the date of certification?
8. DNA Clones
Do the DNA clones contain genes for the biosynthesis of toxic molecules lethal for vertebrates?
No
Yes
If yes, provide documentation in the Biological Toxins Usage Form.
8
Date Received by IBC:
9. Volume of Culture
Do individual activities involve more than 10 liters of culture?
No
Yes
If yes, provide location (room and building):
10. Environmental Release
Do activities involve the release of an organism containing rDNA into the environment?
No
Yes
If yes, approval of the release must be requested from the state or federal regulatory
agency.
Agency:
Date filed:
Attach a copy of the permit. IBC approval cannot be granted until permit is
received.
11.
Laboratory Procedures
11.1 Experimental activities
Provide a summary or outline of the laboratory activities that will be conducted to
accomplish the goals described in Section 2 above. The summary may be provided as an
attachment.
11.2 Standard Operating Procedures
Attach detailed Standard Operating Procedures for the experimental activities
described above. The SOPs should include a description of any procedures that may
present biosafety risks (i.e., centrifugation, use of sharps, etc.), and how you will
mitigate these risks
11.3 Potential hazards
Identify potential exposure hazards during sample preparation and experimental
manipulations. Examples: aerosol generation when transferring, mixing and/or
centrifuging, use of sharps, excretion by animals, culturing, etc.
11.4 Safety procedures
Describe the safety procedures and safety equipment used to minimize risk and prevent
release of rDNA and/or infectious agents, e.g. lab coats, gloves, face shield, biological
safety cabinet, secondary containment for liquids, spill mats, secondary containment for
centrifuge samples, etc.
9
Date Received by IBC:
11.5 Waste disposal
Attach the Biological Waste Disposal Plan (available on OSR website:
http://osr.tamuk.edu/). Call the Environmental Health and Safety Office for
information about waste disposal: (361) 593-2646 or (361) 593-4131.
11.6 Decontamination and Spill Clean-up
Attach the Decontamination Plan Template (available on OSR website:
http://osr.tamuk.edu/), including the sections entitled “Lab Specific
Requirements”. The template must be customized for your laboratory.
Save an electronic copy of this completed form and submit to
osr@tamuk.edu
You will receive an electronic message from the IBC staff within 2-3
days acknowledging receipt of your submission.
You have reached the end of this form. Please make sure that you have responded to every question on
this application (even if your response is “not applicable”) and that you have filled out all of the
applicable appendices.
Submit to:
Institutional Biosafety Committee Chairperson
Email as PDF to: OSR@tamuk.edu
Fax: 593-3409
Mail Code: MSC 201
10
Date Received by IBC:
Texas A&M University-Kingsville
Institutional Biosafety Committee
Office of Research and Sponsored Programs: (361) 593-3344 or osr@tamuk.edu
rDNA EXEMPT FORM
(Once acknowledged by the IBC as Exempt, this study will remain Exempt unless there are substantial
changes to this study or the NIH Guidelines)
Name (Last name, First name MI):
Phone Number:
Mailing Address:
Pager or Cell Phone Number:
Fax:
TAMUK Employee ID:
Email:
University Department:
Occupational Position:
Faculty Staff Note: Students cannot be Principal Investigator.
1. Does the construct contain viral DNA that represents more than 1/2 of any eukaryotic viral genome or is the
viral construct from DNA of Risk Group 2, 3, 4 viruses or restricted agents?
Yes
No
Use the links below to determine relevant Risk Group:
http://oba.od.nih.gov/oba/rac/Guidelines/APPENDIX_B.htm
http://www.cdc.gov/od/sap/docs/salist.pdf
2. Does the study involve the deliberate transfer of rDNA; or DNA or RNA that is derived from rDNA into
humans, other vertebrates, invertebrates, or plants; or consist of DNA transferred from a prokaryotic or
eukaryotic host into a host that is not a closely related strain or species?
Yes
No
3. Does this study involve the use of a microorganism from a Risk Group 2, 3, 4 or select agent as a HostVector System, or cloned DNA from a Risk Group 2, 3, 4 into nonpathogenic prokaryotic or lower
eukaryotic Host-Vector System, or if using RG-2 organisms, does it involve the movement of DNA between
organisms from different Appendix A sublists?
Yes
No
Use the links below to determine relevant Risk Group, select agent, or natural exchanger
sublist of your research materials:
http://oba.od.nih.gov/oba/rac/Guidelines/APPENDIX_B.htm
http://www.cdc.gov/od/sap/docs/salist.pdf
http://oba.od.nih.gov/oba/rac/Guidelines/APPENDIX_A.htm
4. Does this study involve the generation of Toxin Molecules lethal for vertebrates at an LD50 of less than 100
µg/kg of body weight?
Yes
No
5. Does the research involve the generation of more than 10 liters of culture at one time?
Yes
No
11
Date Received by IBC:
6. Does this study involve the deliberate transfer of a drug resistance trait to microorganisms that are not
known to acquire the trait naturally and if so, could this acquisition compromise the use of the drug to
control the disease agents in humans, animals and/or plants?
Yes
No
If you answered No to all of the above questions, the study is EXEMPT. Please finish answering the
questions on this short form and submit it to the Office of Research and Sponsored Programs.
If you answered Yes to any of the above questions this study is NON-EXEMPT; STOP HERE.
Complete the Recombinant DNA and Artificial Gene Transfer Form
Signature of Principal Investigator
Submit to:
Institutional Biosafety Committee Chairperson
Email as PDF to: OSR@tamuk.edu
Date
Mail Code: MSC 201
Fax: 593-3409
12
Date Received by IBC:
Texas A&M University-Kingsville
Institutional Biosafety Committee
Office of Research and Sponsored Programs: (361) 593-3344 or osr@tamuk.edu
INFECTIOUS AGENT USAGE FORM
Internal IBC Use Only
IBC
Approval #:
Approved
Laboratory
Biosafety
Level(s):
1.
Approval Date:
Animal Housing
Method of Review:
Project Identification and Signatures
1.1 Type of Application: New Protocol 3-year Renewal of IBC #
(If this is a 3-year resubmission, do not use language referring to the previous protocol or grant in this form.)
Anticipated Start Date:
1.2 Project Title: (Project title must match grant title. If different, provide grant title also)
1.3 Principal Investigator (Must be faculty or academic professional administrative staff.)
Name (Last name, First name MI):
Phone Number:
Mailing Address:
Pager or Cell Phone Number:
Fax:
TAMUK Employee ID:
Email:
University Department:
Occupational Position:
Faculty Staff Note: Students cannot be Principal Investigator.
Assurance by Principal Investigator
Electronic submission of this form from the Principal Investigator’s TAMUK email address confirms his/her
agreement to perform all activities according to the NIH Guidelines for Research Involving Recombinant DNA
Molecules and use biosafety practices described in the CDC/NIH Publication Biosafety in Microbiological and
Biomedical Laboratories (BMBL). If applicable, this application accurately and completely reflects the activities described in
any grant or contract supporting this research. Additional conditions required by the Institutional Biosafety Committee on
behalf of Texas A&M University-Kingsville will also be followed.
Principal Investigator:
Date:
.
13
Date Received by IBC:
1.4 Person preparing this document
Name:
Phone number:
Email:
1.5 Personnel conducting the experiments
List the personnel that will be working on this study below (including students and temporary staff). For each
individual conducting the experiments, list their degree, applicable training, relevant experience (including duration)
and their role in the project and indicate whether they should receive correspondence about the study from the IBC.
Name
(Last Name, First
Name MI)
TAMUK
Employee
or
Student
ID
Role in Project
Degree/ Years of Experience with
Microbiological Activities
Date Biological
Safety
in the Lab
Training
Completed*
Receive
Mail
from
IBC**
1.6 Bloodborne and Other Pathogens Training is required if you will work with infectious
microorganisms, human blood, human body fluids, and/or human/primate cell lines. Will you use any
of these materials?
Yes
No
1.7 Source of Funding
Please do not send grant applications to the IBC.
Name of funding
source:
Grant:
Will be submitted.
Submitted.
Approved. The duration of approval:
5 years
Other:
This application must be written for a maximum of three years only. IBC applications expire after 3 years, at
which time a new application will be requested.
1.8
Externally Funded Projects (Complete this section if you will receive external funds
for this research)
Name of Sponsor:
Address:
Contact Person:
Funding decision:
pending
awarded
Agency-assigned grant number(if available):
14
Date Received by IBC:
Nature of funding source:
Federal grant.
Other grant or contract. Specify:
2.
3.
Scientific Summary and Rationale
2.3
Please provide the committee with a brief explanation of the proposed project. Use
language that is understandable to those with a general knowledge of biology, and define
all acronyms. Do not attach grant applications.
2.4
Describe the goals/specific aims of the activities involving infectious agents proposed in
this application. Explain how the use of the agent(s) will further the goals of this research.
Infectious Microorganism(s)
3.1 Describe the infectious microorganism(s) that will be used in these activities.
3.2
Does the microorganism synthesize a toxic molecule that is lethal for vertebrates?
No
Yes
If yes, describe the toxin:
3.3 Does the individual activity involve more than one liter of culture?
No
Yes
If yes, indicate location (room and building):
3.4 Is there a vaccine available and recommended for persons working with this
microorganism?
No
Yes
If yes, provide the name of the vaccine:
3.5 List any available information regarding antibiotic resistance associated with the bacterial
agents used in this project. If antibiotic sensitivity profiles are available, please provide
this information as an attachment
4.
Activities involve the use of (check all that apply):
15
Date Received by IBC:
Human subjects
IRB protocol number:
Pending
Whole animals; Species:
Approx number:
IACUC protocol number:
Pending
Does this project involve the creation of transgenic or knockout animals*?
No
Yes
*If you purchase transgenic or knockout animals from a non-University vendor, check “No”.
Does this project involve inoculation of animals?
No
Yes. Indicate the amount and route of administration:
Whole plants; Species:
In vitro work (cell culture):
Cells used in these experiments (check all that apply):
Human Cells
Non-human Primate Cells
Animal Cells (non-primate)
Plant Cells
Insect Cells
Other:
Microorganisms; Species:
Fungi; Species:
Insects; Species:
5. Microorganism Storage Location
Indicate the location where the microorganism will be stored (room and building):
6.
Biosafety Levels
6.1 Indicate the biosafety level in the laboratory where activities will be performed.
BSL1
BSL2
BSL3
Location (room and building):
6.2 If live animals are used, indicate the biosafety level in which they will be housed.
No animals
ABSL1
ABSL2
ABSL3
Location of animal housing (room and building):
16
Date Received by IBC:
7.
Use of a Biosafety Cabinet
Will work be conducted in a biosafety cabinet for these activities?
No
Yes
If yes, what is the date of certification?
8.
Laboratory Procedures
The following questions request information about SOPs that will be used for this project.
8.1 Experimental activities
Provide a summary or outline of the laboratory activities that will be conducted to
accomplish the goals described in Section 2 above.
8.2
Standard Operating Procedures
Attach detailed Standard Operating Procedures for the experimental activities
described above. The SOPs should include a description of any procedures that may
present biosafety risks (i.e., centrifugation, use of sharps, etc.), and how you will mitigate
these risks.
8.3
Potential hazards
Identify potential exposure hazards during sample preparation and experimental
manipulations. Examples: aerosol generation when transferring, mixing and/or
centrifuging, use of sharps, excretion by animals, culturing, etc.
8.4 Safety procedures
Describe the safety procedures and safety equipment used to minimize risk and prevent
release of infectious agents, e.g. lab coats, gloves, face shield, biological safety cabinet,
secondary containment for liquids, spill mats, secondary containment for centrifuge
samples, etc.
8.5
Waste disposal
Attach the Biological Waste Disposal Plan (available on OSR website:
http://osr.tamuk.edu/). Call the Environmental Health and Safety Office for
information about waste disposal: (361) 593-2646 or (361) 593-4131.
8.6
Decontamination and Spill Clean-up
Attach the Decontamination Plan Template (available on OSR website:
http://osr.tamuk.edu/), including the sections entitled “Lab Specific Requirements”.
The template must be customized for your laboratory.
17
Date Received by IBC:
Save an electronic copy of this completed form and submit to
osr@tamuk.edu.
You will receive an electronic message from the IBC staff within 2-3 days acknowledging
receipt of your submission.
You have reached the end of this form. Please make sure that you have responded to every question on this application (even if
your response is “not applicable”) .
Submit to:
Institutional Biosafety Committee Chairperson
Email as PDF to: OSR@tamuk.edu
Mail Code: MSC 201
Fax: 593-3409
18
Date Received by IBC:
Texas A&M University-Kingsville
Institutional Biosafety Committee
Office of Research and Sponsored Programs: (361) 593-3344 or osr@tamuk.edu
BIOLOGICAL TOXINS USAGE FORM
Internal IBC Use Only
IBC
Approval #:
Approved
Laboratory
Biosafety
Level(s):
1.
Approval Date:
Animal Housing
Method of Review:
Project Identification and Signatures
1.1 Type of Application: New Protocol 3-year Renewal of IBC #
(If this is a 3-year resubmission, do not use language referring to the previous protocol or grant in this form.)
Anticipated Start Date:
1.2 Project Title: (Project title must match grant title. If different, provide grant title also)
1.3 Principal Investigator (Must be faculty or academic professional administrative staff.)
Name (Last name, First name MI):
Phone Number:
Mailing Address:
Pager or Cell Phone Number:
Fax:
TAMUK ID:
Email:
University Department:
Occupational Position:
Faculty Staff Note: Students cannot be Principal Investigator.
Assurance by Principal Investigator
Electronic submission of this form from the Principal Investigator’s TAMUK e-mail address
confirms his/her agreement to perform all activities according to the NIH Guidelines for Research
Involving Recombinant DNA Molecules and use biosafety practices described in the CDC/NIH
Publication Biosafety in Microbiological and Biomedical Laboratories (BMBL), and to report any
research-related accidents or incidents to the IBC as required by the NIH Guidelines . If applicable, this
application accurately and completely reflects the activities described in any grant or contract supporting this
research. Additional conditions required by the Institutional Biosafety Committee on behalf of Texas
A&M University-Kingsville will also be followed.
Principal Investigator:
Date:
19
Date Received by IBC:
1.4 Person preparing this document
Name:
Phone number:
Email:
1.5 Personnel conducting the experiments
List the personnel that will be working on this study below (including students and temporary staff).
For each individual conducting the experiments, list their degree, applicable training, relevant
experience (including duration) and their role in the project and indicate whether they should receive
correspondence about the study from the IBC.
TAMUK
TAMUK
Name
Employe
Email ID
(Last Name, First Name
e or
(ex.
MI)
Student
smith001)
ID
Role in Project
Degree/ Years of Experience
with Toxin Activities
Date
Biological
Safety
Receive
in the
Mail
Lab
from IBC
Training
Complete
d
1.6 Bloodborne and Other Pathogens Training is required if you will work with infectious
microorganisms, human blood, human body fluids, and/or human/primate cell lines. Will
you use any of these materials?
Yes
No
1.7 Source of Funding
Name
of
funding
source:
Grant:
Will be submitted.
Submitted.
Approved. The duration of approval:
5 years
Other:
This application must be written for a maximum of three years only. IBC applications
expire after 3 years, at which time a new application will be requested.
1.8 Externally Funded Projects (Complete this section if you will receive external funds for this
research)
Name of Sponsor:
20
Date Received by IBC:
Address:
Contact Person:
Funding decision:
pending
awarded
Agency-assigned grant number (if available):
Nature of funding source:
Federal grant. Submit a copy of the grant with your IBC application.
Other grant or contract. Specify:
2.
3.
Scientific Summary and Rationale
2.5
Please provide the committee with a brief explanation of the proposed project. Use
language that is understandable to those with a general knowledge of biology, and define
all acronyms. Do not attach grant applications.
2.6
Describe the goals/specific aims of the activities involving biologically-derived toxins
proposed in this application. Explain how the use of the agent(s) will further the goals of
this research.
Description of Biological Toxin
3.1
Indicate what toxin (unfractionated mixture, purified conjugate, microbial culture capable
of producing toxin) will be used in these activities.
3.3
Describe the form of the toxin (e.g., liquid, particles):
3.3 Indicate the amount of toxin to be obtained:
3.4
Is there an antidote available for persons exposed to the toxin?
No
21
Date Received by IBC:
Yes
If yes, explain:
3.5 Provide the LD50 of the toxin, including species and route:
4.
Activities involve the use of (check all that apply):
Human subjects
IRB protocol number:
Pending
Whole animals; Species:
Approx number:
IACUC protocol number:
Pending
Does this project involve inoculation of animals?
No
Yes. Indicate the amount of toxin and route of administration:
Can the toxin be released into the environment?
No
Yes
If yes, describe how the toxin-containing materials (urine, feces, bedding,
etc.) will be inactivated:
Whole plants; Species:
In vitro work (cell culture)
Cells used in these experiments (check all that apply):
Human Cells
Non-human Primate Cells
Animal Cells (non-primate)
Plant Cells
Insect Cells
Other:
Insects; Species:
5. Location of Toxin Production, Storage and Activities
5.1
Indicate where the toxin will be produced and/or stored.
Location (room and building):
5.2
Indicate where the toxin activities will be performed.
Location (room and building):
5.3
Will the toxin be weighed?
No
Yes
If yes, indicate location (room and building):
22
Date Received by IBC:
6.
Handling of Toxin
Toxins must be handled in a chemical fume hood or biological safety cabinet. If a biological
safety cabinet is used, indicate the most recent date of certification:
7. Animal Biosafety Level
If live animals are used, indicate the biosafety level in which they will be housed.
No animals
ABSL1
ABSL2
ABSL3
Location of animal housing (room and building):
8.
Standard Operating Procedures (SOP)
The following questions request information about SOPs that will be used for this project.
8.1 Experimental activities
Provide a summary or outline of the laboratory activities that will be conducted to
accomplish the goals described in Section 2 above.
8.2
Standard Operating Procedures
Attach detailed Standard Operating Procedures for the experimental activities
described above. The SOPs should include a description of any procedures that may
present biosafety risks (i.e., centrifugation, use of sharps, etc.), and how you will mitigate
these risks.
8.3 Potential hazards
Identify potential exposure hazards during sample preparation and experimental
manipulations. Examples: aerosol generation when transferring, mixing and/or
centrifuging, use of sharps, excretion by animals, culturing, etc.
8.4 Safety procedures
Describe the safety procedures and safety equipment used to minimize risk and prevent
release of biological toxins, e.g. lab coats, gloves, face shield, biological safety cabinet,
secondary containment for liquids, spill mats, secondary containment for centrifuge
samples, etc.
23
Date Received by IBC:
8.5
Waste disposal
Attach the Biological Waste Disposal Plan (available on OSR website:
http://osr.tamuk.edu/). Call the Environmental Health and Safety Office for
information about waste disposal: (361) 593-2646 or (361) 593-4131.
8.6
Decontamination and Spill Clean-up
Attach the Decontamination Plan Template (available on OSR website:
http://osr.tamuk.edu/), including the sections entitled “Lab Specific Requirements”.
The template must be customized for your laboratory.
Save an electronic copy of this completed form and submit to
osr@tamuk.edu.
You will receive an electronic message from the IBC staff within 2-3
days acknowledging receipt of your submission.
You have reached the end of this form. Please make sure that you have responded to every question on
this application (even if your response is “not applicable”) .
Submit to:
Institutional Biosafety Committee Chairperson
Email as PDF to: OSR@tamuk.edu
Fax: 593-3409
Mail Code: MSC 201
24
Appendix A
Texas A&M University-Kingsville
Summary of Experiments Covered by the NIH Guidelines
Link to the NIH Guidelines for Research Involving Recombinant DNA Molecules:
NIH Guidelines for Research Involving Recombinant DNA Molecules
III-A-1: Major Actions under the NIH Guidelines (Require review by the NIH
Recombinant DNA Advisory Committee (RAC) prior to IBC review)
III-A-1-a: Deliberate Transfer of a drug resistance trait to microorganisms that are not
known to acquire the trait naturally if such acquisition could compromise the use
of the drug to control disease agents in humans, veterinary medicine, or
agriculture.
III-B-1: Experiments involving the cloning of toxin molecules with LD50 of less
than 100 nanograms per kilogram body weight
III-C-1: Experiments involving the deliberate transfer of rDNA, or DNA, or RNA
derived from rDNA, into one or more human research participants
(Require review by the NIH Recombinant DNA Advisory Committee
(RAC) prior to IBC review)
III-D-1: Experiments using Risk Group 2, Risk Group 3, Risk Group 4* or
Restricted Agents as Host-Vector Systems
III-D-1-a:
III-D-1-b:
III-D-1-c:
III-D-1-d:
III-D-2
Introduction of rDNA into Risk Group 2 Agents (e.g., use of adenoviral vectors)
Introduction of rDNA into Risk Group 3 Agents (e.g., use of lentiviral vectors)
Introduction of rDNA into Risk Group 4 Agents
Introduction of rDNA into restricted agents (Requires review by the NIH
Recombinant DNA Advisory Committee (RAC) prior to IBC review)
Experiments in which DNA from Risk Group 2, Risk Group 3, or Risk
Group 4*, or restricted agents is cloned into nonpathogenic prokaryotic or
lower eukaryotic host-vector systems
III-D-2-a: Transfer of DNA from Risk Group 2 or Risk Group 3 agents into nonpathogenic
prokaryotes or lower eukaryotes.
III-D-2-b: Transfer of DNA from restricted agents into non-pathogenic prokaryotes or
lower eukaryotes (Requires review by the NIH Recombinant DNA Advisory
Committee (RAC) prior to IBC review)
III-D-3: Experiments involving the use of infectious DNA or RNA viruses or
defective DNA or RNA viruses in the presence of helper virus in tissue
culture systems
III-D-3-a: Experiments involving the use of infectious or defective Risk Group 2 viruses in
the presence of helper virus
III-D-3-b: Experiments involving the use of infectious or defective Risk Group 3 viruses in
the presence of helper virus
III-D-3-c: Experiments involving the use of infectious or defective Risk Group 4 viruses in
the presence of helper virus
III-D-3-d: Experiments involving the use of infectious or defective restricted poxviruses in
the presence of helper virus(Requires review by the NIH Office of Biotechnology
Activities (OBA) prior to IBC review)
III-D-3-e: Experiments involving the use of infectious or defective viruses in the presence
*Risk group classifications can be found in Appendix B of the NIH Guidelines
**Physical containment requirements can be found in Appendix G of the NIH Guidelines
25
of helper viruses which are not covered in Sections III-D-3-a through III-D-3-d
III-D-4: Experiments Involving Whole Animals in which the animal's genome has
been altered by stable introduction of recombinant DNA, or DNA derived
therefrom, into the germ-line (transgenic animals) and experiments
involving viable recombinant DNA-modified microorganisms tested on
whole animals
III-D-4-a: Recombinant DNA, or DNA or RNA molecules derived therefrom, from any
source except for greater than two-thirds of eukaryotic viral genome may be
transferred to any non-human vertebrate or any invertebrate organism and
propagated under conditions of physical containment comparable to BL1 or
BL1-N** and appropriate to the organism under study
III-D-4-b: Experiments involving recombinant DNA, or DNA or RNA derived therefrom,
involving whole animals, including transgenic animals, and not covered by
Sections III-D-1
III-D-4-c-(1): Experiments involving the generation of transgenic rodents that require
BL1 containment** are described under Section III-E-3, Experiments
Involving Transgenic Rodents
III-D-4-c-(2): The purchase or transfer of transgenic rodents is exempt from the NIH
Guidelines under Section III-F
III-D-5: Experiments to genetically engineer plants by recombinant DNA methods,
to use such plants for other experimental purposes (e.g., response to
stress), to propagate such plants, or to use plants together with
microorganisms or insects containing recombinant DNA.
III-D-5-a: Experiments involving most exotic infectious agents with recognized potential for
serious detrimental impact on managed or natural ecosystems when
recombinant DNA techniques are associated with whole plants
III-D-5-b: Experiments involving plants containing cloned genomes of readily
transmissible exotic infectious agents with recognized potential for serious
detrimental effects on managed or natural ecosystems in which there exists the
possibility of reconstituting the complete and functional genome of the infectious
agent by genomic complementation in planta.
III-D-5-c: Experiments with a small number of readily transmissible exotic (see Section VM, Footnotes and References of Sections I-IV) infectious agents, such as the
soybean rust fungus (Phakospora pachyrhizi) and maize streak or other viruses
in the presence of their specific arthropod vectors, that have the potential of
being serious pathogens of major U.S. crops.
III-D-5-d: Experiments involving sequences encoding potent vertebrate toxins introduced
into plants or associated organisms. Experiments Involving the Cloning of Toxin
Molecules with LD50 of Less than 100 Nanograms Per Kilogram Body Weight,
require NIH/OBA approval before initiation.
III-D-5-e: Experiments with microbial pathogens of insects or small animals associated
with plants if the recombinant DNA-modified organism has a recognized
potential for serious detrimental impact on managed or natural ecosystems.
III-D-6: Experiments Involving More than 10 Liters of Culture.
III-E:
Experiments not included in Sections III-A, III-B, III-C, III-D, III-F.
III-E-1:
Experiments Involving the Formation of Recombinant DNA Molecules
Containing No More than Two-Thirds of the Genome of any Eukaryotic
Virus
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 Section III-A, III-B, III-D,
or III-F.
*Risk group classifications can be found in Appendix B of the NIH Guidelines
26
**Physical containment requirements can be found in Appendix G of the NIH Guidelines
III-E-2-a: Experiments with recombinant DNA-containing plants and plant-associated
microorganisms not covered in Section III-E-2-b or other sections of the NIH
Guidelines. (e.g., experiments involving rDNA-modified plants that are not
noxious weeds or that cannot interbreed with noxious weeds in the immediate
geographic area).
III-E-2-b-(1): Plants modified by recombinant DNA that are noxious weeds or can
interbreed with noxious weeds in the immediate geographic area
III-E-2-b-(2):Plants in which the introduced DNA represents the complete genome of a
non-exotic infectious agent
III-E-2-b-(3):Plants associated with recombinant DNA-modified non-exotic
microorganisms that have a recognized potential for serious detrimental
impact on managed or natural ecosystems
III-E-2-b-(4): Plants associated with recombinant DNA-modified exotic microorganisms
that have no recognized potential for serious detrimental impact on managed
or natural ecosystems
III-E-2-b-(5):Experiments with recombinant DNA-modified arthropods or small animals
associated with plants, or with arthropods or small animals with recombinant
DNA-modified microorganisms associated with them if the recombinant DNAmodified microorganisms have no recognized potential for serious
detrimental impact on managed or natural ecosystems
III-E-3: Experiments Involving Transgenic Rodents
III-F-1: Experiments involving rDNA molecules that are not in organisms or
viruses.
III-F-2: rDNA molecules that consist entirely of DNA segments from a single
nonchromosomal or viral DNA source, though one or more of the
segments may be a synthetic equivalent.
III-F-3: rDNA molecules that consist entirely of DNA from a prokaryotic host
including its indigenous plasmids or viruses when propagated only in that
host (or a closely related strain of the same species), or when transferred
to another host by well established physiological means.
III-F-4: rDNA molecules that consist entirely of DNA from a eukaryotic host
including its chloroplasts, mitochondria, or plasmids (but excluding
viruses) when propagated only in that host (or a closely related strain of
the same species).
III-F-5: Those that consist entirely of DNA segments from different species that
exchange DNA by known physiological processes, though one or more of
the segments may be a synthetic equivalent.
III-F-6: Those that do not present a significant risk to health or the environment
(see Section IV-C-1-b-(1)-(c), Major Actions), as determined by the NIH
Director, with the advice of the RAC.
*Risk group classifications can be found in Appendix B of the NIH Guidelines
**Physical containment requirements can be found in Appendix G of the NIH Guidelines
27