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Biosafety Assurance FAQs |
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What does the term “Biosafety Assurance” mean?At QUT, 'biosafety assurance' means the minimisation of risks of 1. transmission of infectious disease to QUT staff, students or the public as a result of QUT-related activities, and 2. the accidental/unauthorised release of infectious agents or genetically modified organisms (GMOs) from their appropriate levels of containment. What is the basis for achieving biosafety assurance at QUT?A process for overseeing activities involving non-genetically modified infectious agents has been developed by the QUT Institute Biosafety Committee, in consultation with key stakeholders. The essential elements of this process are:
Together, these elements form a Standard Operating Environment for the conduct of biosafety related work at QUT. Why is there a requirement for specific project approval with dealings involving GMOs, when there is no such requirement for projects involving non-genetically modified infectious agents?It is the judgement of IBC that efficient biosafety assurance is best served by a procedures-based process. The essential elements of this are risk assessed standard operating procedures (SOPs) that are approved by the IBC and accessible to the QUT community via the research ethics web site, and completed biosafety notification forms which indicate the nature of the biosafety activities carried out and SOPs used by individual research groups or teaching units. In the case of dealings with GMOs, a project based system is imposed upon QUT by the Office of the Gene Technology Regulator (OGTR). QUT’s previous experience with the OGTR in recent years has shown that the OGTR is happy to approve quite broad classes of work under single permits, particularly when the work is low risk and contained within a laboratory. Therefore, research groups involved only in contained dealings should not have to obtain large numbers of OGTR permits; a “project” may sometimes encompass all the activities of a research group. If my project requires approval through the OGTR system, does this mean I do not need to engage with the QUT SOP-based process for biosafety assurance?No it does not mean that. The OGTR have made it very clear that they expect certified facilities to maintain SOPs, especially for activities such as GMO storage, transport, waste disposal, decontamination and staff induction. The QUT SOP-based system will therefore serve as an ideal underpinning of the OGTR system. In other words, all dealings with GMOs must be covered by SOPs. This does not mean that the SOPs have to be different for GMOs as compared to non-GMOs. E.g. it may be that the procedures for disposal of GM and non-GM bacteria will be identical. Who is responsible for formulating new SOPs?The Principle Project Investigator or Unit Coordinator, because if they are going to supervise activities, they need to be actively responsible for the safety of these activities. In practice, the process of formulating a new SOP will often be facilitated by the on-line availability of all related SOPs, and the involvement of the facility manager. This involvement is obligatory to ensure that proposed SOPs are compatible with the facility infrastructure, organisational structure, and other approved SOPs. What happens if I want to change a SOP?If it is an SOP that you were responsible for formulating, and the new SOP will supersede the old, then the modified SOP will replace the original in the SOP database. If you wish to adapt an existing SOP to a new purpose, then it is a whole new SOP that will co-exist with the original. Changes must be risk assessed and approved by the IBC. Approval will be executive, flying minute, or at an IBC meeting, at the discretion of the IBC. What if I want to add another already approved SOP to my existing biosafety notification form?Notify the IBC via Research Ethics of the requested change. Approval will be executive, flying minute, or at an IBC meeting, based on the nature of the change and at the discretion of the IBC. Can other people copy and use SOPs that I have formulated?The IBC considers the SOP register to be valuable intellectual property developed within QUT. The SOPs can therefore be freely used and adapted by the QUT community. The SOP on-line database is not accessible to outside parties, and SOPs cannot be supplied to outside parties without permission of the DVC for Research and Commercialisation. What happens paperwork-wise if there is an untoward biosafety incident e.g. suspected laboratory acquired infection, or break-down of containment?Make use of the Health and Safety Section incident report proformas. For how long are SOPs and notification forms valid?After five years the IBC will ask the initiators if the SOPs are still current and correct, and may seek a new application dependant on the nature of work. I have questions on the requirements for dealings with GMOs?For information on the requirements for dealings with GMOs we recommend researchers first visit the website of the Office of the Gene Technology Regulator (OGTR), in order to gain the most up to date information on requirements. At the site you will find information on what constitutes a GMO; what dealings are considered exempt, NLRD, DNIR and DIR. Further guidance on OGTR matters can be gained by discussing with your Faculty/Iinstitute representative on the Institute Bioasfety Committee. Other useful links and resources
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