Investigator Responsibilities

Training

Required Biological Safety Training

All faculty, students, and staff working with biohazardous or recombinant/synthetic nucleic acids must complete biosafety training within 60 days following registration and BEFORE conducting any research. The Research Biosafety: Handling Biohazardous Materials course is administered through the CITI program and must be renewed once every three (3) years.

An institution must follow the NIH Guidelines if it receives any funding from the NIH for research involving recombinant or synthetic nucleic acid molecules. Even if only one research project involving recombinant or synthetic nucleic acid molecules at an institution benefits from NIH support, all such projects conducted at or sponsored by that institution must comply with NIH Guidelines.

Shipping and Transport of Biohazardous Materials

Faculty, senior research staff, AND administrators responsible for shipping biological materials must complete Shipping and Transport of Biological Materials training to familiarize themselves with IATA/DOT shipping regulations. Renewal for this training is required every three (3) years.

Annual Inspections and Inventory

The University of Alabama adheres to the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules and follows the recommendations of the NIH Office of Science Policy (OSP). Inspections by the BSO must be performed to ensure that laboratory standards are rigorously followed (Section IV-B-3-c-(1) NIH Guidelines).

In addition to NIH Guidelines, the BSO will also evaluate:

• SOPs
• General Safety Measures
• Compliance with OSHA Standards
• Training Records
• Biomaterials Inventory
• Biosecurity
• Containment Practices

Inspections are not limited to labs working with recombinant/synthetic DNA.

BSL-2 labs are inspected annually and all NEW labs must be inspected by the BSO prior to beginning any work. Also required is the annual completion of the Lab Biosafety Self-Audit Form and the Biological Material Inventory Form. Completed forms must be submitted to bso@ua.edu.

Purchasing

Biological Materials

All purchases of biological materials follow the same review process as other items ordered from vendors not currently under contract or bid and are sent to EHS for review. Additional oversight is required for certain categories and requires review and approval by the BSO:

Biological Agents: Orders involving human or animal cell lines, bacteria, viruses at Risk Group 2 or higher, select agents, and biological toxins must be reviewed by the Biological Safety Officer (BSO, EHS). Many vendors, such as ATCC, also require certification from the BSO prior to fulfilling an order.

Synthetic Nucleic Acids: Orders for synthetic DNA or RNA (e.g., oligonucleotides and gene constructs) must comply with the NIH Policy on the Ordering or Provision of Synthetic Nucleic Acids in the IRP. Currently, sequences of concern (SOCs) must be screened when they are:

• DNA or RNA
• Single- or double-stranded
• AND 200 nucleotides or longer (including the corresponding amino acid sequence, if applicable). Effective October 13, 2026, this screening threshold will be reduced to 50 nucleotides.

When EHS reviews an order, it cross-references the request with the Institutional Biosafety (IBC) database of approved projects and materials. If the material is not associated with an approved or pending project, the Principal Investigator (PI) will be contacted for clarification. Orders requiring IBC approval will not be released until a Biological Use Authorization (BUA) is submitted.

EHS also must verify that the proposed facilities are suitable for safe use of the requested material and works with the PI to resolve any issues while the order is in transit.

Depending on the item requested (e.g., equipment, biological materials, chemicals), additional information may be required by UA Purchasing and/or EHS. This may include equipment specifications, SOPs, IBC protocol numbers, or other regulatory documentation specific to the purchase.

Regulated Chemicals

If you are purchasing a chemical located on the regulated chemical list be prepared to declare this in the BuyBama purchasing interface. You will receive a request to provide a standard operating procedure (SOP) detailing how this chemical/material will be utilized in your research.

Hazardous Waste

EHS provides proper disposal of both biologically hazardous and regulated medical wastes.

Lab Registration and Decommissioning

Lab Registration

Any time a new research or teaching lab space is started, lab registration is required. We consider a space a “NEW lab space” if:

1. A new PI or instructor, who had not previously been responsible for research or teaching at UA, is assigned to a lab space.
2. An existing lab research program moves into a newly assigned lab space, either as a result of moving to a new location or through expansion.

In order to register a new lab, please complete the Lab Registration form or contact the University Laboratory Safety Manager by email or at 205-348-5905 if you have questions or concerns.

Laboratory Decommissioning

Thorough decommissioning MUST be performed by the lab’s exiting PI, or the research group before any new laboratory personnel can move into that same space. Decommissioning pertaining to biological, chemical, and radiation hazards must be verified by EHS. For questions or concerns related to decommissioning guidelines and procedures, contact the University Laboratory Safety Manager by email or at 205-348-5905.

Additional Decommissioning Resources

Reference Links

It is the responsibility of the Principal Investigator (PI) to ensure that all responsibilities within the guidelines are met.