Apply to use higher-risk micro-organisms

The procedure for applying to work with higher-risk micro-organisms. UABSC approval is required before undertaking any work with higher-risk organisms.

Introduction and higher-risk micro-organisms definition

  1. Researchers are responsible for identifying the risk group of the organisms that they are working with. There is no definitive list of high-risk micro-organisms, as even the risk for the same species might change according to genetic changes, use, methodology and country. The ASNZ2243.3:2022 standard provides guidance for microbial classification in Australia and New Zealand, adapting current WHO guidelines to regional requirements. Go to the Australian/New Zealand Standard 2243-3:2010: Safety in laboratories Part 3: Microbiological safety and containment standard.
  2. Any micro-organism that displays resistance to antibiotics and/or treatments used to clinically treat the microorganism in question.

Criteria for assessment are similar to HSNO decision-making but also include additional factors such as the pathogenicity of the microorganism, the expertise of the applicants, and the proposed protocols and controls.

Refer to the Classification of Risk Group guidelines. Researchers who are unsure of the risk group classification for a particular micro-organism should, in the first instance, contact the biosafety officer.

Application process – how to apply to use higher risk micro-organisms

  1. Create a new biological safety application – “Application to use higher risk microorganisms” using Ethics RM, following the steps in the Infonetica Ethics RM – Creating an application guide, noting the following:
    1. The application form is intended to provide guidance to the applicants. Applicants should supply any additional information relevant to the application.
    2. Applicants are encouraged to ensure that the descriptions of any experimental protocols are written so that they can be understood by lay members. However, there will be parts of the application that require technical detail. Where this is the case, ensure that sufficient detail is supplied so the scientific members can readily assess the proposal.
    3. Emphasis should be placed on protocols to mitigate risk when working with these organisms.
    4. Applicants should state the location where the proposed work is to be undertaken and the staff and students involved in the project.
    5. The committee encourages applicants who have limited experience with high-risk micro-organisms to consult/collaborate with a microbiologist or infectious disease specialist prior to developing their application.
  2. Submit the application following the steps in the Infonetica Ethics RM – Submitting an Application – no sign-off (Biological Safety Committee applications only) guide.
  3. The principal investigator must submit the application, as they will be agreeing to the terms and conditions of the application in the process of submission.
  4. The application must be submitted at least 10 working days before the next UABSC scheduled meeting.

Committee requests for further information

  • During the assessment of the application, the committee may decide that it needs further information prior to coming to a final decision. You will be informed formally by letter what further information the committee would like added to the application. The application is formally stalled once the request for information is sent.
  • After you have amended the application form, resubmit the form for review. Only major revisions will require full committee re-review.

Contact

Head of Research Ethics
Email: Dr Dana Wensley

Hazards and Containment Manager and Biosafety Officer
Email: Dr Francesca Casu