IBC FAQs
ALWAYS refer to the federal guideline to verify current information
| Research involving the following require IBC approval: | Needs IBC Approval |
|
Live Infectious agents (viruses, bacteria, fungi, parasites, prions, etc.) that can cause disease in healthy humans and/or significant environmental or agricultural impacts, as covered by the Biosafety in Microbiological and biomedical laboratories (BMBL) guidelines https://www.cdc.gov/labs/BMBL.html |
Yes |
|
Human tissues (including all fluids, tissues, excretions, secretions, or cell lines) as covered by the U.S> Occupational Safety and Health Administration (OSHA) Bloodborne pathogens Standard https://www.osha.gov/SLTC/bloodbornepathogens/bloodborne_quickref.html |
Yes |
|
Genetically modified animals and whole plants as covered by NIH guidelines |
Yes |
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Nonhuman primate materials (including live animals, all fluids, tissues, excretions, secretions, or cell lines) as covered by the BMBL and OSHA Bloodborne Pathogen Standard |
Yes |
| Regulated Plant Pest of Pathogens as covered by USDA-APHIS https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/SA_Regulations | Yes |
|
Recombinant/synthetic nucleic acid molecules, as covered by NIH Guidelines (April 2019) NIH Guidelines 2019 |
Yes |
Work that Does Not Require IBC Review and Approval?
IBC makes the determination if a study does not require IBC oversight. Contact RCC for more information at ibc@tamusa.edu.
In general, activities involving in vitro use of nucleic acids (i.e., PCR) and does not involve the cloning and propagation of recombinant or synthetic nucleic acid molecules in cells, organisms or viruses.
What are recombinant DNA (rDNA) and Synthetic Nucleic Acids (SNA)?
The NIH defines rDNA/synthetic nucleic acids (SNA) as:
- molecules constructed by joining nucleic acid molecules and that can replicate in a living cell (rDNA)
- nucleic acid molecules that are chemically or by other means synthesized or amplified
- molecules that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules (SNA)
- molecules that result from the replication of those described above
- Examples include:
- Plasmids introduced into bacteria, living cells, animals, or plants
- Viral vectors introduced to bacteria, living cells, or animals
- Genetically modified microorganisms or cell lines (regardless of whether the material was modified by the researchers or already received in a modified form)
- Genetically modified plants or animals
- Nanotechnology used to deliver rDNA/SNA to living cells or animals
What are the Risk Levels
Microorganisms Risk Groups 1-4 (RG)
Organisms are classified into various risk levels depending on the harm to humans and the environment.
RG1 – Are not associated with disease in healthy adult humans or animals
RG2 – Are associated with a disease which is rarely serious and for which preventative or therapeutics is often available
RG3 – Are associated with serious or lethal human disease for which preventative or therapeutics may be available
RG4 – Are associated with lethal human disease for which preventative or therapeutics are not readily available
Microorganisms and their associate RG designation can be found at ABSA website