Biosafety (Biohazard Compliance)

It is the policy of UNM to adhere to principles of biosafety and biosecurity in all UNM research, regardless of source of funding, so as not to endanger the health and safety of University personnel, students, visitors, the public, or the environment. The Institutional Biosafety Committee (IBC) is charged with reviewing and approving proposed research projects conducted by UNM faculty on UNM premises to ensure an assessment of associated risks has been conducted and mitigating engineering administrated, and personal protective equipment is available and will be applied in order to safely conduct the research. 

The IBC is composed of scientific, administrative, and community members.  The Committee’s composition is based on guidelines outlined in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines).  The institution prefers that scientists from each department holding significant amounts of biologically hazardous materials and agents be represented.  Memberships are rotated and each member minimally serves a three-year term.  The Biohazard Compliance administers the IBC at UNM.

The Biohazard Compliance encourages research faculty to communicate with IBC members or the Biosafety Officer when they are considering research that may require IBC review and approval before implementation.

IBC approval is necessary to ensure compliance with federal and state regulations and guidelines concerning research with biological hazards and recombinant or synthetic nucleic acid molecules. Covered biological research will be evaluated for potential adverse effects on employees, the public, and the environment. The review and approval process ensures:

1. Research with hazardous biological agents and recombinant or synthetic nucleic acid molecules are under the control of one Principal Investigator (PI). The PI is responsible to the University and is a paid faculty member of UNM. The PI takes responsibility for the use, storage, and disposition of agents while on UNM properties.
2. A peer review committee (IBC), operating on the behalf of the University Regents agrees that the proposed safety procedures mitigate the risks to an acceptable level and therefore approves the proposed work with biological hazards and/or recombinant or synthetic nucleic acid molecules on UNM premises, under the conditions set forth in the IBC application.

Obtain IBC approval before handling the following biological agents for in vitro or in vivo experiments.

1. Manipulation of nucleic acid molecules in living cells (humans, vertebrates, invertebrates & RG 2-4 microbes) in vivo and in vitro
2. Microbial pathogens of humans of Risk Group (RG) 2-4
3. Select Microbial Agents & Biotoxins that are listed as potential bioterrorism agents
4. USDA microbial pathogens of domestic animals and plant crops
5. Human Gene Transfer / Therapy Trials
6. Human Vaccine Trials
7. Administration of nucleic acid molecules or genetically modified microorganisms to animals
8. Nonexempt experiments covered under the NIH Guidelines

How to apply for IBC approval

1. Secure a copy of the most recent IBC Protocol Application posted on the webpage or by contacting Biosafety (Biohazard Compliance).
2. Fill out sections I-V of the IBC Protocol Application as instructed. If you have questions, contact a member of the Biosafety Office for help.
3. Fill out the applicable Addenda as checked in Section VI of the IBC Protocol Application.
4. Provide supporting documentation (e.g., medical surveillance, CVs/resumes, plasmid maps, publications).
5. E-mail the IBC Protocol Application and supporting documentation to IBC@salud.unm.edu.
6. Completed applications will be reviewed and voted upon at the next regularly scheduled meeting. Note the IBC meets on the third Wednesday of February, May, August, and November. Protocol submissions are due the last Wednesday of January, April, July, and October.
7. You will receive a letter within two business days of the meeting that your application was approved, approved pending modification, tabled for more information, disapproved, or considered exempt from review. Details will be supplied in the letter.
8. If the application was approved pending modification you are required to respond in writing documenting compliance with the contingency(ies) stipulated in the letter, prior to receiving full approval. If written confirmation of contingency fulfillment is not received by Biosafety (Biohazard Compliance) within two quarterly meeting cycles from the date of initial agenda item, your application will be administratively terminated, and you may not handle (use) the agent(s) at UNM.
9. Once full approval has been awarded you will receive a copy of the first page of your application with an IBC Co-Chair’s signature on it and an assigned IBC Number. This is your approval documentation. Save it and your application for reference. Please reference the assigned IBC approval number on all future correspondence. Your approval means:
   1. You may begin handling the agent under the conditions stated in your application (including contingencies applied).
   2. Your approval is applicable for 5 years from the date indicated in your ID Number (PI - year-month-submissions), at which time you must submit a new application to continue the work. Applications more than 5 years old will be administratively terminated.
   3. You are required during the 5-year period of your application approval to submit an annual review (Addendum G of the application) to keep your approval current.
   4. You are required to notify Biosafety (Biohazard Compliance) of any significant modifications to your work in real time by submitting appropriate Addenda (e.g., A, C, F) for review.
   5. You may terminate your IBC Application at any time. If you choose to keep the agents in storage, the agents must be documented in your current Biological Agent Inventory as "archive/storage." Contact Biosafety (Biohazard Compliance) to learn more about your Annual Biological Inventory.