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Research Compliance

BIOLOGICAL SAFETY PROGRAM

When engaging in research with biohazardous materials, safety is of key importance. The UA Biosafety program and the Office for Research Compliance are here to assist you with the necessary safeguards needed to conduct your experiments safely and in compliance with Federal regulations and guidelines. Our offices are here to work on your behalf if the unexpected occurs. Our goal is to mitigate the inherent risks associated with the laboratory setting.

Currently, the University of Alabama approves the use of Risk Group 1 & 2 biohazardous agents. Please contact the BSO for any proposed research involving Risk Group 3 organisms or biohazards. The University reserves the right to impose additional terms and conditions on investigators who conduct research on; or engage in teaching activities that involve microorganisms harmful to humans, animals, or the environment.

Please contact biosafety@ua.edu if you have any questions or comments.

Institutional Biological Safety Committee (IBC)

The University of Alabama has an institutional biological safety program established to ensure that all research, testing, and teaching activities involving the use of biohazardous materials, and the facilities used to conduct such work, remain compliant with all external regulations and applicable university policies.

The Institutional Biological Safety Committee (IBC) was established in order to conform to National Institute of Health (NIH) guidelines. The IBC is now involved in the oversight of all projects involving infectious agents and recombinant DNA (rDNA).

Responsibilities

  • to review the use of Risk Group 1 (RG1) and RG2 biohazardous agents;
  • to review and approve the use of select agents and recombinant DNA (NIH Guidelines);
  • to review the Biological Safety Program annually to determine if the program is effective and compliant with regulations;
  • to advise the Institutional Biological Safety Officer (IBSO) and support the biological safety program;
  • to assist the IBSO with enforcement of regulations and guidelines; and
  • to advise the Vice President for Research.

IBC Meetings are scheduled on the first Tuesday of the month unless otherwise arranged.

Institutional Biosafety Committee Login

Biological Use Authorization (BUA)

PROJECT REGISTRATION

It is the policy of The University of Alabama to have all work involving biological material as well as all work involving recombinant or synthetic DNA reviewed by the Institutional Biosafety Committee (IBC).  Approval must be granted before work begins. To submit a project or protocol for review, please complete a Biological Use Authorization (BUA) Form. If a protocol needs to be closed, please submit an IBC Protocol Closure Form.

BUA timeline showing the review schedule

TIMELINE

Total turnaround (barring revisions) is approximately 4-6 weeks (barring revisions):

  • PI Submits BUA – 1-2 weeks prep time
  • BSO reviews application – 1-2 weeks
  • BSO/IBC reviews pre-meeting – 1 week
  • IBC deliberations – 1 day
  • ORC document turnaround – 1-2 weeks
BUA flow chart showing the pat of review

A BUA IS REQUIRED FOR THE FOLLOWING:

  1. Projects that utilize Recombinant or Synthetic Nucleic acids.
  2. Projects utilizing potentially pathogenic materials/organisms, including those that are considered hazardous to humans, animals, agriculture, and the environment.
  3. Projects that will import biological/botanical samples internationally.
  4. Projects categorized as Risk Group 1 or 2. (BMBL 6th ed.)
  5. Projects that are currently not funded, or are categorized as ‘Start-Up’ funding, especially federally funded projects.

Frequently Asked Questions about the BUA

APPLICATION REVIEW

EACH SUBMISSION

  1. Must be received by the 15th of each month to be considered for the next IBC meeting. IBC meetings are scheduled for the first Tuesday of the month.
  2. BUA must be complete, including supporting documentation, permits, and SOPs. BUAs may accompany IRB or IACUC protocol submissions.

THE BSO REVIEWS APPLICATIONS FOR THE FOLLOWING:

  1. The title of the project must match any corresponding IRB or IACUC protocols.
  2. SOPs attached and current.
  3. The project abstract is written in plain language. It should be clear, concise, organized, and appropriate for the intended audience. (Community members sit on the IBC)
  4. Exposure Control Plan (Bloodborne Pathogens).
  5. Permits/MTAs attached

TIMELINE

Preliminary application review will take approximately 1-2 weeks.

RISK ASSESSMENT

Project risk assessment is initially performed by the PI. Following BUA submission, the BSO will perform a full Risk Assessment.

  1. Determine Category, Risk Group, and Containment level.
    • Category A: Containment level 1 based on NIH Guidelines; BMBL; and/or established guidelines plus additional project-specific considerations.
    • Category B: Containment levels 1 & 2 include proposals for recombinant or synthetic nucleic acids (r/sNA) covered by NIH Guidelines and/or other biohazards or pathogens requiring BSL-1 or BSL-2.
  2. Are additional containment practices needed?
  3. Full inspection of Lab space and equipment.
  4. Is Occupational health surveillance requested?
  5. Evaluate the experience and training of all researchers listed on BUA. (training certificates)

The BSO then utilizes the BSO/IBC review flow chart to determine what the path of review will be.

TIMELINE:

  • BSO/IBC reviews pre-meeting – 1 week
  • IBC deliberations – 1 day
  • ORC document turnaround – 1-2 weeks

MONITORING & REPORTING

POST-APPROVAL MONITORING (PI, BSO, EHS, ORC)

  1. PI is responsible for submitting an updated inventory and self-audit of the lab annually.
  2. Once the rDNA protocol is approved, the lab becomes eligible for random compliance inspections by the BSO and/or EHS.
  3. BSO performs and documents random inspections of labs with approved BUAs yearly.

REPORTING IS ONGOING FOR THE LIFE OF THE AUTHORIZATION

  1. IBC receives written results of lab inspections at regularly scheduled meetings.
  2. PI receives written notification of results of lab inspection and submits response to corrective actions.
  3. ORC submits NIH OSP notification if required.
  4. ORC submits an annual report to OSP.

Investigator Responsibilities

Guidance & Tools

The Potentially Infectious Material/Bloodborne Pathogens Program affects a variety of areas on campus. Employees and students may perform tasks that involve much more than simply working with human blood.

An employee or student is covered by this policy if they work with or are potentially exposed to any of the following materials:

  • Human blood, human blood components, and products made from human blood.
  • Human bodily fluids, including semen, vaginal secretions, cerebrospinal fluid, synovial fluid, plural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, and any body fluid visibly contaminated with blood.
  • Any unfixed tissue or organ (other than intact skin) from a human living or dead.
  • Cell, tissue, or organ cultures from humans or animals unless certified free of bloodborne pathogens.
  • Blood, organs, or other tissues from animals unless certified free of bloodborne pathogens.
  • Culture medium unless certified free of bloodborne pathogens.