IBC Policy on When to Submit an IBC Approval Request Form
Approved by IBC on March 8, 2017
Any research or teaching activity involving utilization of biohazardous materials (such as, infectious agents, human body fluids or tissues, biological toxins, or recombinant/synthetic nucleic acids) at Colorado State University (CSU) is subjected to review and oversight by the Institutional Biosafety Committee (IBC). Reviews are conducted in accordance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) and the CDC/HHS Biosafety in Microbiological and Biomedical Laboratories (BMBL). This review process ensures that all activities involving these materials and the facilities used to conduct such work are in compliance with current federal guidelines and regulations, and applicable CSU policies. Anyone planning to work with these biohazardous materials must submit the proposed use of these biohazardous materials for IBC review and approval.
There are two kinds of IBC approval forms:
- Agent Approval Request Form (AARF), and
- Project Approval Request Form (PARF).
A PI must submit an Agent Approval Request Form (AARF) for each infectious agent (BSL1-BSL3) they have (or plan to have) in their possession; this applies to plant, animal, and human infectious agents. This form requests information on how the agent will be used, as well as specific containment and disposal procedures for the agent. This information is used by the IBC to make informed decisions and suggestions on mitigating real or potential risks in using that agent. A separate AARF is required for each infectious agent* (i.e., each genus species) regardless of the pathogenicity (attenuation, non-replication competent, etc.) and applies to agents being stored as well as those actively being used. AARFs for BSL1 agents may be reviewed by the BSO (or IBC Chair); all other AARFs must to be reviewed by the IBC.
A PI must submit a Project Approval Request Form (PARF) for each project that involves potentially biohazardous materials to be conducted at CSU, regardless of funding (including unsponsored, as well as sponsored projects). This form describes the overall project and intended use of the biohazardous material(s). A PARF is required for each project that involve use of
- infectious agents (regardless of BSL; AARF also required),
- human and non-human primate body fluids or tissues (including primary human cell lines**),
- certain biological toxins*** (regardless of quantity), or
- non-exempt recombinant/synthetic nucleic acid****;
- a single PARF may include several infectious agents, human samples, and/or recombinant/synthetic nucleic acids.
PARFs that involve non-exempt recombinant/synthetic nucleic acids must be reviewed by the full IBC at a convened meeting; all other PARFs may be reviewed by the BSO (or IBC Chair).
*Escherichia coli K-12 (and its derivatives) Host-Vector Systems are exempt and do not require an AARF as long as they that do not contain DNA from Risk Groups 3, 4, or restricted organisms, or involve large-scale experiments (e.g., more than 10 liters of culture in one vessel), or cloning of toxin molecule genes, or experiments described in Section III-B of the NIH Guidelines.
***Biological Toxins Requiring a PARF
- Abrin
- Botox
- Botulinum neurotoxins
- Diacetoxyscirpenol (DAS)
- Ricin
- Saxitoxin
- Staphylococcal Enterotoxins (Subtypes A, B, C, D, and E)
- Short, paralytic alpha conotoxins
- T-2 toxin
- Tetrodotoxin
**Established human and non-human primate cell lines do not require a PARF, however do fall under the BloodBorne Pathogens Standards; the IBC recommends all work with cell lines be done in a Biosafety Cabinet and require the following:
****Experiments involving the following recombinant/ synthetic nucleic acid molecules are exempt from the NIH Guidelines and therefore do not require a PARF:
i. Nucleic acids that are NOT to be contained in organisms, cells, or viruses and that have not been
modified or manipulated (e.g., encapsulated into synthetic or natural vehicles) to render them
capable of penetrating cellular membranes.
ii. Synthetic nucleic acids that:
- can neither replicate nor generate nucleic acids that can replicate in any living cell (e.g., oligonucleotides or other synthetic nucleic acids that do not contain an origin of replication or contain elements known to interact with either DNA or RNA
polymerase), and - are not designed to integrate into DNA, and
- do not produce a toxin that is lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight.
iii. Molecules that consist solely of the exact recombinant or synthetic nucleic acid sequence from a single source that exists contemporaneously in nature.
Summary of when an AARF or PARF is required
| Biohazardous Agent | AARF | PARF |
|---|---|---|
| Storage of BSL1, BSL2 BSL3 agent* | Yes | No |
| Use of BSL1, BSL2, BSL3 agent* | Yes | Yes |
| Use of human and non-human primate samples (fluids, tissues, primary cell lines)** | No | Yes |
| Storage or use of biological toxins | No | Yes |
| Use of non-exempt recombinant/synthetic nucleic acid (without a viral vector) | No | Yes |
| Use of non-exempt recombinant/synthetic nucleic acid (without a viral vector) | Yes | Yes |