Initial Application • CampusOptics

Applicant Info

Email Address* Required

Phone Number

First Name* Required

Last Name* Required

Basic Information

Application Type

Title* Required

Principal Investigator* Required

Additional Investigators

Associated Research Labs

ADMINISTRATIVE INFORMATION AND CERTIFICATIONS

Co-PI (if applicable)

Department

a. Application Type

Location of Project (Bldg / Room #)

Project Description

b. Application Type

Course Number

Protocol Number

Materials used in this project

Vertebrate tissue or fluids

Toxins

Microbial agents and Infectious Agents

Recombinant Nucleic Acids, Synthetic Nucleic Acids and / or Transgenic Organisms

Indicate the Biosafety Level at which this project will be conducted

Indicate the Personal Protective Equipment (P.P.E) required for this protocol

Permit details – please indicate if any of the following permits are required for this study to proceed

USDA Permit

APHIS Permit

Other (Specify)

Select Agent Use – does this protocol make use of select agents or toxins

Committee Approvals – please indicate if IACUC and / or IRB approval is required for this study to proceed

IACUC

IRB

Will plants be used?

Waste Disposal and Terminal Inactivation

Disposal of Liquid and Solid Biological Waste

I agree to follow the waste disposal methods described below, where appropriate:

Chlorine bleach will be added to all liquids to a final concentration of 10% bleach and left for a minimum of 20 minutes contact time prior to disposal down the drain.

All contaminated solids will be placed in an appropriately labeled biohazard bag or sharps container, as appropriate. Bags will be placed in an appropriate biohazard waste container meeting guidelines provided by HMM. When ¾ full HMM will be notified to pick up the container(s) for proper waste disposal.Samples requiring autoclaving will be processed prior to collection by HMM.

All work surfaces will be cleaned, after use, with an appropriate disinfectant.

Disposal of Animal Waste for LARC Users

I agree to follow the waste disposal methods described below, where appropriate:

All waste vertebrate tissue will be sealed in a bag appropriate to the biosafety level and placed in a freezer / refrigerator dedicated to, and labeled for this purpose associated with each of the LARC vivaria. Waste will then be collected by HMM and processed for proper waste disposal.Contact LARC (larc@utsa.edu) for assistance with this process.

Shipping and Transformation

Will samples be shipped from UTSA to other institutions?

If transporting samples to or from UTSA or to other sites on campus please read the statement below and check the appropriate response. If you will be following different transportation procedures please give details below:

I agree that all biological samples will be transported in a sealed secondary container that can withstand leakage of contents, shocks and other conditions incident to ordinary handling and transportation in a way that contents should not leak to the outside of the shipping container, even if leakage of the primary container occurs. If the contents are biohazardous the secondary container will be clearly labeled with a biohazard label.

Certification

I certify that, to the best of my knowledge, the information provided in this application is complete and correct. I am familiar with, and agree to abide by the University’s policies for research with potentially biohazardous materials, the BMBL 6th Edition and guidelines established by the NIH, CDC that may pertain to the research project detailed in this application.

I will ensure all personnel under my supervision are provided with an initial lab orientation and any additional training, instruction, and/or supervision needed to work safely with the biological agents and materials associated with this project.

I understand that I am responsible for immediately reporting any violations of the NIH Guidelines, problems with containment, and / or any research related accidents or illnesses to the Biosafety Officer (x6101) and the IBC.

I agree to notify the IBC of changes in the project described herein and will submit an IBC amendment form to the committee for review.

Date

Toxin 1

Name

LD50 and species determined in

What form will the toxin be obtained in

Will sharps be used in procedures involving toxins?

Will you be administering the toxin to animals?

Is this a Select Agent Toxin?

Is there an additional toxin?

Toxin 2

Name

LD50 and species determined in

What form will the toxin be obtained in

Will sharps be used in procedures involving toxins?

Will you be administering the toxin to animals?

Is this a Select Agent Toxin?

Is there an additional toxin?

Toxin 3

Name

LD50 and species determined in

What form will the toxin be obtained in

Will sharps be used in procedures involving toxins?

Will you be administering the toxin to animals?

Is this a Select Agent Toxin?

Is there an additional toxin?

Toxin 4

Name

LD50 and species determined in

What form will the toxin be obtained in

Will sharps be used in procedures involving toxins?

Will you be administering the toxin to animals?

Is this a Select Agent Toxin?

Is there an additional toxin?

Toxin 5

Name

LD50 and species determined in

What form will the toxin be obtained in

Will sharps be used in procedures involving toxins?

Will you be administering the toxin to animals?

Is this a Select Agent Toxin?

Is there an additional toxin?

Tissue, Fluid, or Cell Line 1

List the tissue, fluid or cell line and the species from which it is derived

Does the tissue contain a known infectious agent?

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Tissue, Fluid, or Cell Line 2

List the tissue, fluid or cell line and the species from which it is derived

Does the tissue contain a known infectious agent?

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Tissue, Fluid, or Cell Line 3

List the tissue, fluid or cell line and the species from which it is derived

Does the tissue contain a known infectious agent?

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Tissue, Fluid, or Cell Line 4

List the tissue, fluid or cell line and the species from which it is derived

Does the tissue contain a known infectious agent?

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Tissue, Fluid, or Cell Line 5

List the tissue, fluid or cell line and the species from which it is derived

Does the tissue contain a known infectious agent?

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Tissue, Fluid, or Cell Line 6

List the tissue, fluid or cell line and the species from which it is derived

Does the tissue contain a known infectious agent?

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Tissue, Fluid, or Cell Line 7

List the tissue, fluid or cell line and the species from which it is derived

Does the tissue contain a known infectious agent?

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Tissue, Fluid, or Cell Line 8

Does the tissue contain a known infectious agent?

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Tissue, Fluid, or Cell Line 9

List the tissue, fluid or cell line and the species from which it is derived

Does the tissue contain a known infectious agent?

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Tissue, Fluid, or Cell Line 10

List the tissue, fluid or cell line and the species from which it is derived

Does the tissue contain a known infectious agent?

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PLANT PROTOCOL - SECTION B. MICROBIAL OR INFECTIOUS AGENTS

1. List all agents (including E. coli strains and viral vectors used in cloning)

2. Risk Group (note the risk group of certain agents may not be the same as the biosafety level)

3. Will the agent be grown in volumes of 10L or more (in a single vessel)

4. Are any of the agents listed classified as Select Agents?

5. Will the agent be genetically modified at UTSA or at the source? (If YES, complete Section C)

6. Will cultures be grown in volumes of 10L or more (in a single vessel)?

7. List any plant species or cells lines that will be infected with this agent?

8. Where will infected plants be housed (Bldg / Room No.)

9. Describe any special safety considerations for handling the agents, infected plants or materials associated with infected plants:

Agent 1

List agent (including E. coli strains and viral vectors used in cloning)

Risk Group (Note: the Risk Group may not always correspond to the Biosafety Level)

Will the agent be grown in volumes of 10L or more (in a single vessel)?

Are any of the agents listed classified as Select Agents?

Will the agent be modified either at UTSA or at the point of origin? (If YES, complete section D)

If the agent is a BSL-3 agent will any biological material be removed from the BSL-3 facility?

Will the agent be administered to animals? (This includes invertebrates such as Drosophila and C. elegans)

Will the agent be used to infect vertebrate tissue (cell lines)? If Yes, complete Section B

Add another agent?

Agent 2

List agent (including E. coli strains and viral vectors used in cloning)

Risk Group (Note: the Risk Group may not always correspond to the Biosafety Level)

Will the agent be grown in volumes of 10L or more (in a single vessel)?

Are any of the agents listed classified as Select Agents?

Will the agent be modified either at UTSA or at the point of origin? (If YES, complete section D)

If the agent is a BSL-3 agent will any biological material be removed from the BSL-3 facility?

Will the agent be administered to animals? (This includes invertebrates such as Drosophila and C. elegans)

Will the agent be used to infect vertebrate tissue (cell lines)? If Yes, complete Section B

Add another agent?

Agent 3

List agent (including E. coli strains and viral vectors used in cloning)

Risk Group (Note: the Risk Group may not always correspond to the Biosafety Level)

Will the agent be grown in volumes of 10L or more (in a single vessel)?

Are any of the agents listed classified as Select Agents?

Will the agent be modified either at UTSA or at the point of origin? (If YES, complete section D)

If the agent is a BSL-3 agent will any biological material be removed from the BSL-3 facility?

Will the agent be administered to animals? (This includes invertebrates such as Drosophila and C. elegans)

Will the agent be used to infect vertebrate tissue (cell lines)? If Yes, complete Section B

Add another agent?

Agent 4

List agent (including E. coli strains and viral vectors used in cloning)

Risk Group (Note: the Risk Group may not always correspond to the Biosafety Level)

Will the agent be grown in volumes of 10L or more (in a single vessel)?

Are any of the agents listed classified as Select Agents?

Will the agent be modified either at UTSA or at the point of origin? (If YES, complete section D)

If the agent is a BSL-3 agent will any biological material be removed from the BSL-3 facility?

Will the agent be administered to animals? (This includes invertebrates such as Drosophila and C. elegans)

Will the agent be used to infect vertebrate tissue (cell lines)? If Yes, complete Section B

Add another agent?

Agent 5

List agent (including E. coli strains and viral vectors used in cloning)

Risk Group (Note: the Risk Group may not always correspond to the Biosafety Level)

Will the agent be grown in volumes of 10L or more (in a single vessel)?

Are any of the agents listed classified as Select Agents?

Will the agent be modified either at UTSA or at the point of origin? (If YES, complete section D)

If the agent is a BSL-3 agent will any biological material be removed from the BSL-3 facility?

Will the agent be administered to animals? (This includes invertebrates such as Drosophila and C. elegans)

Will the agent be used to infect vertebrate tissue (cell lines)? If Yes, complete Section B

Add another agent?

Agent 6

List agent (including E. coli strains and viral vectors used in cloning)

Risk Group (Note: the Risk Group may not always correspond to the Biosafety Level)

Will the agent be grown in volumes of 10L or more (in a single vessel)?

Are any of the agents listed classified as Select Agents?

Will the agent be modified either at UTSA or at the point of origin? (If YES, complete section D)

If the agent is a BSL-3 agent will any biological material be removed from the BSL-3 facility?

Will the agent be administered to animals? (This includes invertebrates such as Drosophila and C. elegans)

Will the agent be used to infect vertebrate tissue (cell lines)? If Yes, complete Section B

Add another agent?

Agent 7

List agent (including E. coli strains and viral vectors used in cloning)

Risk Group (Note: the Risk Group may not always correspond to the Biosafety Level)

Will the agent be grown in volumes of 10L or more (in a single vessel)?

Are any of the agents listed classified as Select Agents?

Will the agent be modified either at UTSA or at the point of origin? (If YES, complete section D)

If the agent is a BSL-3 agent will any biological material be removed from the BSL-3 facility?

Will the agent be administered to animals? (This includes invertebrates such as Drosophila and C. elegans)

Will the agent be used to infect vertebrate tissue (cell lines)? If Yes, complete Section B

Add another agent?

Agent 8

List agent (including E. coli strains and viral vectors used in cloning)

Risk Group (Note: the Risk Group may not always correspond to the Biosafety Level)

Will the agent be grown in volumes of 10L or more (in a single vessel)?

Are any of the agents listed classified as Select Agents?

Will the agent be modified either at UTSA or at the point of origin? (If YES, complete section D)

If the agent is a BSL-3 agent will any biological material be removed from the BSL-3 facility?

Will the agent be administered to animals? (This includes invertebrates such as Drosophila and C. elegans)

Will the agent be used to infect vertebrate tissue (cell lines)? If Yes, complete Section B

Add another agent?

Agent 9

List agent (including E. coli strains and viral vectors used in cloning)

Risk Group (Note: the Risk Group may not always correspond to the Biosafety Level)

Will the agent be grown in volumes of 10L or more (in a single vessel)?

Are any of the agents listed classified as Select Agents?

Will the agent be modified either at UTSA or at the point of origin? (If YES, complete section D)

If the agent is a BSL-3 agent will any biological material be removed from the BSL-3 facility?

Will the agent be administered to animals? (This includes invertebrates such as Drosophila and C. elegans)

Will the agent be used to infect vertebrate tissue (cell lines)? If Yes, complete Section B

Add another agent?

Agent 10

List agent (including E. coli strains and viral vectors used in cloning)

Risk Group (Note: the Risk Group may not always correspond to the Biosafety Level)

Will the agent be grown in volumes of 10L or more (in a single vessel)?

Are any of the agents listed classified as Select Agents?

Will the agent be modified either at UTSA or at the point of origin? (If YES, complete section D)

If the agent is a BSL-3 agent will any biological material be removed from the BSL-3 facility?

Will the agent be administered to animals? (This includes invertebrates such as Drosophila and C. elegans)

Will the agent be used to infect vertebrate tissue (cell lines)? If Yes, complete Section B

Add another agent?

Agent 11

List agent (including E. coli strains and viral vectors used in cloning)

Risk Group (Note: the Risk Group may not always correspond to the Biosafety Level)

Will the agent be grown in volumes of 10L or more (in a single vessel)?

Are any of the agents listed classified as Select Agents?

Will the agent be modified either at UTSA or at the point of origin? (If YES, complete section D)

If the agent is a BSL-3 agent will any biological material be removed from the BSL-3 facility?

Will the agent be administered to animals? (This includes invertebrates such as Drosophila and C. elegans)

Will the agent be used to infect vertebrate tissue (cell lines)? If Yes, complete Section B

Add another agent?

Agent 12

List agent (including E. coli strains and viral vectors used in cloning)

Risk Group (Note: the Risk Group may not always correspond to the Biosafety Level)

Will the agent be grown in volumes of 10L or more (in a single vessel)?

Are any of the agents listed classified as Select Agents?

Will the agent be modified either at UTSA or at the point of origin? (If YES, complete section D)

If the agent is a BSL-3 agent will any biological material be removed from the BSL-3 facility?

Will the agent be administered to animals? (This includes invertebrates such as Drosophila and C. elegans)

Will the agent be used to infect vertebrate tissue (cell lines)? If Yes, complete Section B

Add another agent?

Agent 13

List agent (including E. coli strains and viral vectors used in cloning)

Risk Group (Note: the Risk Group may not always correspond to the Biosafety Level)

Will the agent be grown in volumes of 10L or more (in a single vessel)?

Are any of the agents listed classified as Select Agents?

Will the agent be modified either at UTSA or at the point of origin? (If YES, complete section D)

If the agent is a BSL-3 agent will any biological material be removed from the BSL-3 facility?

Will the agent be administered to animals? (This includes invertebrates such as Drosophila and C. elegans)

Will the agent be used to infect vertebrate tissue (cell lines)? If Yes, complete Section B

Add another agent?

Agent 14

List agent (including E. coli strains and viral vectors used in cloning)

Risk Group (Note: the Risk Group may not always correspond to the Biosafety Level)

Will the agent be grown in volumes of 10L or more (in a single vessel)?

Are any of the agents listed classified as Select Agents?

Will the agent be modified either at UTSA or at the point of origin? (If YES, complete section D)

If the agent is a BSL-3 agent will any biological material be removed from the BSL-3 facility?

Will the agent be administered to animals? (This includes invertebrates such as Drosophila and C. elegans)

Will the agent be used to infect vertebrate tissue (cell lines)? If Yes, complete Section B

Add another agent?

Agent 15

List agent (including E. coli strains and viral vectors used in cloning)

Risk Group (Note: the Risk Group may not always correspond to the Biosafety Level)

Will the agent be grown in volumes of 10L or more (in a single vessel)?

Are any of the agents listed classified as Select Agents?

If the agent is a BSL-3 agent will any biological material be removed from the BSL-3 facility?

Will the agent be administered to animals? (This includes invertebrates such as Drosophila and C. elegans)

Will the agent be used to infect vertebrate tissue (cell lines)? If Yes, complete Section B

Add another agent?

SECTION D – USE OF RECOMBINANT OR SYNTHETIC NUCLEIC ACIDS AND / OR TRANSGENIC ORGANISMS

1. Categorization of experiments according to the NIH Guidelines for research involving recombinant or synthetic acids and / or transgenic organisms: Please select the specific subsection(s) from Section III of the NIH Guidelines (e.g. III-D-3-a) under which you believe this research is covered

2. Will this project use CRISPR or related technologies?

3. Will proteins or regulatory RNA’s be expressed?

4. Is the source of nucleic acids associated with alterations of normal cell cycle or cell growth (e.g. oncogenic or tumorigenic)

5. Will the nucleic acid be replication competent or able to replicate in a living cell?

6. Will any expressed proteins be a toxin known to affect vertebrates? (If YES, complete Section A)

7. Will the recombinant nucleic acid be inserted into a vector

8. What vector system will be used?

9. Is the vector replication competent?

10. Will a packaging or helper system be used?

11. Describe the packaging / helper system to be used:

12. Description of recombinant / synthetic work:

13. Please provide any additional information regarding your target genes below, you may use this section if your target genes are unknown or their function is unknown

14. Will recombinant organisms be grown in volumes of 10L or more (in a single vessel)?

15. Will nucleic acids be introduced into animals or be used to produce transgenic animals? (Including invertebrates such as Drosophila or C. elegans)

16. Are there any further special safety considerations associated with any of the recombinant / synthetic nucleic acids, gene products, vectors or hosts used in this research project?

Gene 1

Name

Biological Source

Biological Activities of the Product

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Gene 2

Name

Biological Source

Biological Activities of the Product

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Gene 3

Name

Biological Source

Biological Activities of the Product

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Gene 4

Name

Biological Source

Biological Activities of the Product

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Gene 5

Name

Biological Source

Biological Activities of the Product

Add another gene?

Gene 6

Name

Biological Source

Biological Activities of the Product

Add another gene?

Appendix A - CRISPR

1. Which organism(s) do you plan to modify?

2. Is the work in cell culture?

3. Is the work in a whole organism?

4. What is the function of the gene(s) being modified?

5. What will be the function of the gene(s) after modification?

6. Will the gene editing technology be used for human gene transfer research?

7. Are the guide RNA gene and the Cas 9 gene physically linked on the same DNA

8. Is the guide sequence specific to animals or humans or could it affect both?

10. For CRISPR research involving viral vectors, a Genome Target Scan (GT-Scan) for off target effects by your gRNA must be completed. This is necessary to determine if there is homology to human DNA and for assessing the risk of potential exposure in the event of an unanticipated incident. An off-target database is available at http://www.rgenome.net/cas-offinder/.

11. Will the genome editing technology target embryos or germ cell lines?

12. Will the research involve the creation of a gene drive experiment (i.e., a system that greatly increases the probability that a trait will be passed on to offspring?

Safety Considerations: 1. Are any special safety considerations required to perform this study?

Safety Considerations 2. What should be done in the event of an accidental exposure (e.g. needlestick)

Person 1

Name

UTSA ID

Position

Describe project specific training

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Person 2

Name

UTSA ID

Position

Describe project specific training

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Person 3

Name

UTSA ID

Position

Describe project specific training

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Person 4

Name

UTSA ID

Position

Describe project specific training

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Person 5

Name

UTSA ID

Position

Describe project specific training

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Person 6

Name

UTSA ID

Position

Describe project specific training

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Person 7

Name

UTSA ID

Position

Describe project specific training

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Person 8

Name

UTSA ID

Position

Describe project specific training

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Person 9

Name

UTSA ID

Position

Describe project specific training

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Person 10

Name

UTSA ID

Position

Describe project specific training

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SECTION F – PROJECT SUMMARY AND SAFETY PRECAUTIONS

1. Description of the experimental goals:

2. Experimental design and procedures:

4. Assessment of biohazard potential and special safety considerations:

5. Containment conditions and procedures:

SECTION G – DUAL USE RESEARCH

1. Enhance the harmful consequences of the agent or toxin

2. Disrupt immunity or the effectiveness of an immunization against the agent or toxin without clinical or agricultural justification.

3. Confer to the agent or toxin resistance to clinically or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitate their ability to evade detection methodologies

4. Increase the stability, transmissibility, or the ability to disseminate the agent or toxin

5. Enhance the susceptibility of a host population to the agent or toxin

6. Generate or reconstitute an eradicated or extinct agent or toxin

7. Alter the host range or tropism of the agent or toxin

I agree to abide by all the measures laid out in the University of Texas at San Antonio’s Dual Use Research of Concern Policy. In the event that the project or results change in any way as to alter the DURC status the research will cease and the IBC Chair will be notified immediately.

Category 2

Introduction

A "Pathogen with pandemic potential (PPP)" is a pathogen that is likely capable of wide and uncontrollable spread in a human population and would likely cause moderate to severe disease and/or mortality in humans. Pathogens with a pandemic potential are often those with little to no pre-existing immunity in the human population.

Does your research involve, at any point, a PPP (pathogen of pandemic potential), or any pathogen that will be modified in such a way that is reasonably anticipated to result in a PPP, regardless of its progenitor agent? This includes the generation, use, reconstitution, or transfer of an eradicated, extinct, or existing PPP.

Consider the characteristics of the starting agent as well as those of the pathogen(s) anticipated to result from the proposed experiments. If an experimental outcome results in a non-PPP "that is likely capable of wide and uncontrollable spread in a human population and would likely cause moderate to severe disease and/or mortality in humans," then the research is in scope of Category 2.

Introduction:

Consider the hypothesis being tested and the likelihood that the experiments will enhance the transmissibility, virulence, and/or immune evasion of the pathogen in humans. Consider also whether the research involves transferring or using an eradicated or extinct PPP or a previously identified PEPP, regardless of whether the research is expected to modify the pathogen.

Does your research involve or result in any of the following experimental outcomes or actions?

Enhance transmissibility of the pathogen in humans;
Enhance the virulence of the pathogen in humans;
Enhance the immune evasion of the pathogen in humans such as by modifying the pathogen to disrupt the effectiveness of pre-existing immunity via immunization or natural infections; or
Generate, use, reconstitute, or transfer an eradicated or extinct PPP, or a previously identified PEPP.

Category 1

Does your research involve, at any point, one or more biological agents or toxins described in:

Any Select Agents and Toxins listed in 9 CFR 121.3-9CFR 121.4, 42 CFR 73.3-42 CFR 73.4, and 7 CFR 331.3 and regulated by USDA and/or HHS.
Any Risk Group 4pathogens listed in Appendix B of NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) - Classification of Human Etiologic Agents on the Basis of Hazard.
A subset of Risk Group 3 pathogens listed in Appendix B of the NIH Guidelines - Classification of Human etiologic Agents on the Basis of Hazard. - This subset consists of all RG# pathogens except HIV, HTLV,SIV, Mtb (including myobacterium bovis), CLade II of MPVX viruses unless containing nucleic acids coding for clade I MPVX virus virulence factors, vesicular stomatitis virus, Coccidioides immitis, C. posadasii, Histoplasma capsalatum, and H. capsalatum var. duboisii. This list may be updated in the Implementation Guidance on a periodic basis.
For biological agents affecting humans that have not been assigned a Risk Group in the NIH Guidelines, refer to the current edition of Biosafety in Microbiological and Biomedical Laboratories (BMBL). In such cases, agents affecting humans that are recommended to be handled at Biosaftey Level 3 (BSL-3) or Biosafety Level 4 (BSL-4) per the BMBL guidance are subject to this Policy.

Could your research be reasonably anticipated to result in, or does result in, in any of the following experimental outcomes or actions on a designated biological agent or toxin?

Consider the hypothesis being tested and likelihood of any of the outcomes resulting from the experiments to be conducted.

Increase transmissibility of a pathogen within or between host species;
Increase virulence of a pathogen or convey virulence to a non-pathogen;
Increase the toxicity of a known toxin or produce a novel toxin;
Increase the stability of a pathogen or toxin in the environment, or increase the ability to disseminate a pathogen or toxin;
Alter the host range or tropism of a pathogen or toxin;
Decrease the ability for a human or veterinary pathogen or toxin to be detected using standard diagnostic or analytical methods;
Increase resistance of a pathogen or toxin to clinical and/or veterinary prophylactic or therapeutic interventions;
Alter a human or veterinary pathogen or toxin to disrupt the effectiveness of preexisting immunity, via immunization or natural infection, against a pathogen or toxin; or
Enhance the susceptibility of a host population to a pathogen or toxin.

Risk Assessment

Risk Assessment - Introduction

An important aspect of this assessment is the understanding of the potential benefits of research as well as the steps necessary to mitigate the known and potential risks of the proposed research.

If requested by your IRE or Biosafety office, please include both a risk assessment and risk mitigation plan for your proposed research and the potential benefits to public health, agriculture, food security, economic security, or national security. What potential solutions to identified problems or vulnerabilities apply to scientific, public health, national security, or agricultural communities?

What is the timeline for this potential positive impact of the research (immediate, near future, years, etc.)?

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