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Research Ethics & Compliance

Investigator Responsibilities

Training

Required Biosafety Training

All faculty, students, and staff working with biohazardous or recombinant/synthetic nucleic acids must complete biosafety training within 60 days following registration 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 the NIH Guidelines.

It’s important to note that CITI biosafety coursework and the Environmental Health & Safety (EHS) assignments through Skillsoft are distinct. You should initiate the CITI coursework with the guidance of the OREC Biological Safety Program page instructions.

Shipping and Transport of Specimens

Faculty, senior research staff, and administrators responsible for shipping biological materials must complete Shipping and Transport of Biological Materials (Renewal every two (2) years) to familiarize themselves with IATA/DOT shipping regulations.

Contact the Biological Safety Officer at (205) 348-5941 for more information on required biosafety training.

You will need to initiate the CITI coursework aided by the Biosafety CITI Training Login Instructions.

Registration and course selection process for non-UA personnel

Annual Inspections & 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 adherence to NIH Guidelines, your BSO will evaluate SOPs, general safety measures, compliance with OSHA standards, training records, biomaterials inventory, biosecurity, and containment practices.

Inspections are not limited to those labs working with recombinant/synthetic DNA. BSL-2 labs must be inspected annually, and the BSO must inspect all NEW labs (see lab registration section) prior to the start of work. Annual completion of the Lab Biosafety Self-Audit Form in addition to the Biological Material Inventory Form is required. Please submit completed forms to biosafety@ua.edu.

2024 Annual Inventory/Self Audit Campaign

The downloadable Lab Biosafety Self-Audit (fillable pdf) and Biological Material Inventory forms (fillable Word doc), can be edited using Word and Adobe. Please submit both completed documents by email to biosafety@ua.edu no later than November 29, 2024.

Purchasing Hazardous Materials (EHS)

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 from EHS to provide a standard operating procedure (SOP) detailing how this chemical/material will be utilized in your research. The Biosafety SOP and the EHS SOP are different documents and not interchangeable.

Hazardous Waste (EHS)

The office of Environmental Health & Safety (EHS) provides proper disposal of both biologically hazardous and regulated medical wastes through a contracted disposal service.

Information about the disposal of biological materials can be found on the EHS websites:

Additional information on infection control including sterilization guidance

Lab Registration & Decommissioning (EHS)

LAB REGISTRATION

‘Research’ or ‘Teaching’ lab space is considered a “NEW” space if:

  • A new PI or instructor, not previously responsible for research or teaching at UA, is assigned to a lab space
  • An existing research program is assigned new lab space, either as a result of moving to a new location or through expansion of the program.

In order to register a new lab, please complete the Lab Registration Form or contact the Lab Safety Manager at (205) 348-5905 if you have questions or concerns.

DECOMMISSIONING

Thorough decommissioning MUST be performed by the exiting Lab’s 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 both Biological Safety and EHS. For decommissioning guidelines contact Juliette Commodore-Botoklo in EHS.

Reference Links

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