IBC Determination Request : Division of Research : Texas State University

Name *

Email *

Department *

Is the project associated with a Material Transfer Agreement (MTA)?

Yes

No

Upload a copy of the MTA

Project Title:

Do you have a current IBC protocol? *

Yes

No

Please attach current IBC documentation here *

If you answered ‘Yes’, please answer the following. If this does not apply, please write in N/A and continue to the rest of the questionnaire.

What agents/materials have you been approved to work with by the IBC? *

Do you have any changes to location, scope of work, or personnel?

Yes

No

You indicated changes to location, scope of work, or personnel of previously approved/registered IBC activity. Please submit an amendment through the online Kuali system. Contact Research Integrity and Compliance at 512- 245-1423 or ricibc@txstate.edu if you have questions.

A. Research

Yes

No

B. Instructional/Teaching

Yes

No

Is this for demonstration purposes only?

Yes

No

C. Field work

Yes

No

Will any samples be transported to a Texas State Campus?

Yes

No

D. Other (humanitarian, professional service)

Yes

No

Provide the course/lecture number

A. Vertebrate/invertebrate tissue or fluids

Yes

No

Please describe in the abstract the source and type of vertebrate and/or invertebrate tissues, fluids, or other biological materials that will be used in your laboratory and indicate if they are known or suspected to contain infectious agents. Research involving these materials may require Institutional Biosafety Committee (IBC) oversight. As such, you may be required to submit an IBC application through the Kuali online system to ensure the activities are properly documented, registered, reviewed, and approved by the IBC.

B. Toxins/Biohazard nanoparticles

Yes

No

Is the toxin on the Federal Select Agent Program (FSAP) list?

e.g., botulinum neurotoxin, ricin, Shiga toxin, diphtheria toxin, etc.

Yes

No

What is the toxin total quantity possessed or used?

Enter "N/A" if no FSAP-listed toxin is used.

The nanoparticle engineered to target or interact with living systems

Yes

No

Does the nanoparticle pose a risk of unintended biological effects?

Answer No if no nanoparticles interact with living systems.

Yes

No

Is the nanoparticle being used as a vaccine delivery or a gene therapy vector?

Yes

No

Is the nanoparticle non-biological (e.g., inert metal oxide in cosmetics) and not carrying biohazardous material?

Yes

No

C. Microbial agents and or/ Infectious agents

Yes

No

Please provide details in the abstract regarding the biological agents, organisms, and materials that will be used in the laboratory, including their source and applicable Risk Group classification(s). Research involving these materials often requires Institutional Biosafety Committee (IBC) oversight. Accordingly, you may be required to submit an IBC application through the Kuali online system to ensure the work is properly documented, registered, reviewed, and approved by the IBC prior to initiation of the research activities.

D. Recombinant or Synthetic Nucleic Acids

Yes

No

Indicate all that apply for work involving recombinant or synthetic DNA.

recombinant or synthetic nucleic acid molecule(s) are being used, constructed, or manipulated (e.g., plasmids, cDNA, genomic DNA, RNA, gene-editing templates such as CRISPR guide RNAs)

DNA is being cloned into a vector or host-vector system

DNA is being used in a gene-editing context without a viral vector

DNA is being used to produce or modify a toxin, pathogen, or other hazardous agent

DNA is being used in human gene therapy or human gene transfer experiments

DNA is being used in gene drive modified organisms (GDMOs)

DNA is being used in whole plants requiring BSL3 or BSL4 containment

Please note: Texas State University currently does not have BSL-3 or higher facilities.

DNA is being used in experiments involving more than 10 liters of culture or viable rDNA-modified microorganisms tested on whole animals

Is the DNA being used in a manner that could be classified as “gain-of-function” research

DNA is being transferred into a host organism

Yes

No

Is it a deliberate transfer to a microorganism, cell, or human participant?

Answer "No" if no DNA is transferred into a host organism.

Yes

No

E. Biological material and associated medium

e.g., water samples, plants, dead/live animals, genetically modified organisms, arthropods, etc.

Yes

No

Please provide details in the abstract regarding the biological materials and associated medium that will be used in the laboratory, including their source. Research involving these materials often requires Institutional Biosafety Committee (IBC) oversight. Accordingly, you may be required to submit an IBC application through the Kuali online system to ensure the work is properly documented, registered, reviewed, and approved by the IBC prior to initiation of the research activities.

F. Not applicable

Yes

No

Please provide an explanation why the options provided above are not applicable for your proposed activity.

Indicate if any of the below permits are applicable to your work. *

USDA/APHIS

CDC

Other

Not applicable

Please describe all contained/field activities and procedures that involve components most relevant for review by the Institutional Biosafety Committee, such as the use of recombinant or synthetic nucleic acids, handling of hazardous materials or biological materials.

IBC Determination Request

General Information

Activity Details

Abstract(Non-technical)