• Section 1 - Purpose
• Section 2 - Authority
• Section 3 - Scope
• Section 4 - Procedure
• Institutional Biosafety at RMIT
• Gaining Institutional Biosafety Approval at RMIT
• Institutional Biosafety Review Process
• Monitoring of Institutional Biosafety Approvals
• Suspension and/or Withdrawal of Institutional Biosafety Approval
• Certifications for Physical Containment Facilities
• Complaints
• Section 5 - Definitions

Section 1 - Purpose

(1) To ensure safe and responsible research and teaching involving gene technologies and genetically modified organisms (GMOs), consistent with institutional policy, and Australia’s Gene Technology Framework.

Section 2 - Authority

(2) Authority for this document is established by the Research Policy.

Section 3 - Scope

(3) This procedure applies to all staff, students, visiting researchers and honorary and adjunct appointees undertaking or supporting research across the RMIT Group and external research locations, and all research activities or projects involving gene technologies conducted at or reasonably considered to be the responsibility of RMIT. Gene technologies are methods and techniques used to alter, manipulate, transfer or modify genetic material in organisms, including technologies regulated under Australia's national Gene Technology legislative framework.

(4) This procedure applies to all staff, students, visiting researchers and honorary and adjunct appointees undertaking or supporting research or teaching involving gene technologies and/or GMOs at all RMIT Group and external locations, and any research or teaching RMIT is responsible for considering, reviewing, or approving to meet regulatory, funding, or governance requirements.

(5) This procedure applies to gene technologies and genetically modified organisms as defined and regulated under Australia’s Gene Technology Framework.

Section 4 - Procedure

Institutional Biosafety at RMIT

(6) The RMIT Institutional Biosafety Committee (IBC) reviews, approves and monitors all use of gene technologies and GMOs at RMIT, aligned to Australia's national Gene Technology legislative framework. Gene technologies (regardless of origin) can only be used in teaching or research with explicit IBC review, and approval or acknowledgement, as appropriate. Where required, a licence from the Office of the Gene Technology Regulator (OGTR) will be gained and maintained.

(7) RMIT University provides professional development, resources, processes and infrastructure that support researchers to know when they require institutional biosafety approval, to gain and conduct research in line with IBC approval, Australia’s Gene Technology Framework and RMIT policy.

(8) In Australia, RMIT researchers will remain compliant with Australia’s Gene Technology Regulatory Framework including the Gene Technology Act 2000, the Gene Technology Act 2001 and  the Gene Technology Regulations 2001 at all times, including when at other institutions.

(9) Outside Australia, RMIT staff members will remain compliant with Australia’s Gene Technology Regulatory Framework where possible.

Gaining Institutional Biosafety Approval at RMIT

(10) All dealings with gene technologies or GMOs will be reviewed and approved or acknowledged, as appropriate, by the IBC before any activities or dealings with these gene technologies or GMO commence. The procedures for Exempt, Notifiable Low Risk Dealings (NLRDs) and licenced dealings are set out below:

Exempt and Notifiable Low Risk Dealings (NLRDs)

(11) For activities or dealings classified as Exempt or as Notifiable Low Risk Dealings (NLRDs) (see Definitions for more information on these classifications):

1. Researchers or other RMIT staff members will apply using the Institutional Biosafety Exempt/NLRD form available through the RMIT Research Ethics Platform (REP).
2. Once all the required information has been provided the Researcher or other RMIT staff member will submit the application in REP for governance review by the Research Ethics, Integrity and Governance (REIG) Team.
3. The governance review will be completed within 5 working days. If no issues are identified, the application will be progressed by the REIG Team to the IBC for review. If issues are identified, the applicant will be notified and required to address these before the application is progressed to the IBC for review.
4. Applications will be reviewed at the first available IBC meeting.
5. The IBC reviews the applications with potential outcomes being:
   1. approved, or
   2. Revision required (minor or major), or
   3. not approved.
6. The applicant will be notified of the outcome via REP and in a timely manner, within 5 working days following the IBC meeting.
7. Once approved, exempt and NLRDs will have a maximum approval period of five years from the date of approval.
8. Exempt and NLRD cannot be amended.

Licenced Dealing

(12) Researchers or other RMIT staff members will apply using the relevant application form provided on the OGTR website.

(13) Once complete, the applicant will submit a copy of their application via email (biosafety@rmit.edu.au) to the REIG Team for governance review.

(14) The governance review will be completed within 5 working days. If no issues are identified, the application will be progressed by the REIG Team to the IBC for review. If issues are identified, the applicant will be notified and required to address these before the application is progressed to the IBC for review.

(15) The IBC reviews the application with potential outcomes being:

1. preliminary endorsement, subject to final approval and licence from the OGTR, or
2. revisions required, or
3. not endorsed.

(16) Following preliminary endorsement by the IBC, the REIG Team will submit the dealing, in consultation with the applicant, to the OGTR for final approval and licencing.

(17) Licenced dealings are subject to the approval period specified by the OGTR and any additional conditions of approval as set by the OGTR.

Animal Research

(18) Where gene technologies and GMO research involves animals, the researcher or other RMIT staff member will also:

1. clearly detail the involvement of GM animals or animals exposed to other GMOs in the IBC application form
2. gain approval from the RMIT Animal Ethics Committee (AEC), in accordance with the Animal Ethics Procedure, before starting any research
3. conduct the research in line with:
   1. AEC ethical approval.
   2. IBC approval and
   3. state and federal animal welfare legislation
   4. the Guidelines for the Generation, Breeding, Care and Use of Genetically Modified and Cloned Animals for Scientific Purposes (2007)

Multi-Centre Research

(19) Where a planned project involves researchers from RMIT University and other collaborating institutions (within Australia and/or overseas), researchers will notify the IBC and provide copies of any relevant documentation requested. A clear plan of each institution’s responsibilities will be formally documented through a formal exchange of letter/s between the institutions.

(20) Where RMIT is responsible, in part or full, for the research and where the planned project also involves researchers from other institutions (including within Australia and/or overseas) researchers will:

1. submit an application to the IBC for review and approval,
2. ensure there is a clear plan which sets out the respective responsibilities of all institutions involved, with this plan to be documented through a formal exchange of a letter/s between the institutions, and
3. notify the IBC and provide copies of any relevant documentation requested.

(21) Where the research is the sole responsibility of another institution (i.e. an external project) and the planned project also involves researchers from RMIT:

1. the IBC will not review the research provided another IBC has reviewed and approved
2. RMIT researchers will submit a copy of the application approved by the other institution’s IBC to the Coordinator and receive acknowledgement prior to any staff member working on an external project. The IBC will note any approvals from external IBCs and assess compliance with the relevant legislation and regulations, and institutional policy.

Institutional Biosafety Review Process

(22) The IBC reviews all applications for Exempt, NLRDs and Licenced dealings and applies the set of principles outlined in the Gene Technology Framework that govern the classification of dealings with GMOs, the containment of dealings with GMOs and the conduct of people whose work involves recombinant DNA or gene technology.

Maintaining Institutional Biosafety Approval
Variations to a Dealing

(23) Approvals for an exempt dealing or NLRD cannot be amended or varied. Where researchers or others need to vary a dealing, a new application must be submitted for governance and IBC review clearly detailing any new or varied elements not included in the original assessment.

(24) Licenced dealings can only be varied with the prior approval of the OGTR. Researchers will contact the REIG Team via email (biosafety@rmit.edu.au) who will liaise with the OGTR on their behalf. The IBC will review any potential variations to licenced dealings, and any comments will be notified to the researcher prior to formal submission of a variation to the OGTR.

Reporting

(25) Researchers will submit an annual report at the end of each financial year for the life of the activity or dealing.

(26) The Principal Investigator will submit a final report within six months of the end of the approval period.

(27) Reports will use the RMIT templates, available from REIG.

(28) Reports will detail how the research involving GMOs complied with the Act and Regulations over the reporting period, and detail any non-compliance and/or adverse incidents, including unintentional release or spills of GMO material.

(29) The IBC will review all annual and final reports. REIG will inform researchers if the reports have been accepted or if more information is needed.

Containment Breach

(30) Any breach of containment will be reported to REIG, and to the relevant Technical Services, as soon as it is discovered. This reporting is separate to any Health, Safety and Risk reporting.

(31) The report, sent via email (biosafety@rmit.edu.au), will detail the breach of containment and any action that has or will be taken in relation to the event and to prevent any recurrence.

(32) The report will be reviewed by the IBC at the next scheduled meeting. The IBC may require researchers to provide further information and/or carry out further actions. Where appropriate and/or as required, the IBC will notify the line manager, licence holder, and/or the OGTR.

(33) Where a breach of containment involves any real or suspected release, including spills, of genetically modified materials or organisms outside of a certified facility, the IBC will report any real or suspected unintentional release of GMOs to the OGTR as soon as reasonably practicable.

Monitoring of Institutional Biosafety Approvals

(34) The IBC monitors all dealings for research involving gene technologies and GMOs at RMIT through inspections and the review of records and reports (including annual and final reports, review of Containment Breach Report forms).

Suspension and/or Withdrawal of Institutional Biosafety Approval

(35) The IBC may suspend or withdraw approval for any project when:

1. GMO or gene technology is used in a manner inconsistent with the approved protocol. In this instance the IBC Chair or Deputy Chair may require that the activities (either the specific activity in question or the full project) cease immediately; or
2. the approved protocol is no longer consistent with the Act or Regulations; or
3. The researchers do not fulfil their reporting requirements; or
4. any other instance of non-compliance with the Act or Regulations which the IBC deems of sufficient nature to warrant suspension or withdrawal of approval for a project.

(36) Where the IBC has suspended or withdrawn approval for a project, the REIG Team will notify the line manager of the Principal Investigator, and may also notify the OGTR and other parties as appropriate.

(37) In reviewing cases of non-compliance, the IBC may refer the matter to the institution (the Designated Officer at RMIT), or the OGTR as appropriate, for consideration. Where required, the IBC will refer a matter to the institution (the Designated Officer at RMIT) for consideration in line with the Research Integrity Breach Management Procedure.

Certifications for Physical Containment Facilities

(38) All work involving gene technologies and genetically modified organisms (GMOs) must be conducted in certified physical containment (PC) facilities.

(39) All facilities seeking certification as a Physical Containment (PC) facility will meet current OGTR Guidelines for the Certification of Physical Containment Facilities (level and type). This requirement does not apply to facilities used solely for activities regulated under AS/NZS 2243.3:2010, Safety in Laboratories, Part 3: Microbiological Safety and Containment, and where no gene technologies or GMOs are involved.

(40) IBC members will conduct inspections and complete the appropriate application checklist for the PC facility type and level. The PC Facility Manager/Supervisor, or a suitable nominee, will also attend inspections. It is advisable that a researcher intending to conduct dealing(s) within the facility be present to answer questions. All issues will be resolved before the application for certification proceeds.

(41) The Facility Manager/Supervisor will collate any additional paperwork required for the certification application and forwarding to the Coordinator. The Coordinator will send completed applications to the Deputy Vice Chancellor (Research & Innovation) to be authorised prior to submission to the OGTR. Following submission, the Coordinator will liaise with the OGTR to ensure that any outstanding certification requirements are resolved.

(42) Once certification is granted by the OGTR, the REIG team will retain a copy of the certification on record and forward the certification and signage to the Facility Manager/Supervisor.

(43) The IBC will inspect OGTR certified physical containment level 2 (PC2) or higher facilities at least every 12 months. The University (through the Coordinator) will maintain inspection reports for a minimum of 5 years and provide these to the OGTR on request.

(44) Access to OGTR-certified facilities is restricted to authorised persons who have completed the relevant RMIT University training. Unauthorised persons may only enter certified facilities with the permission of the PC Facility Manager/Supervisor and will not conduct any dealings in certified facilities. Unauthorised persons may include contractors, maintenance staff and visitors.

Complaints

Complaints Regarding Research Involving GMOs

(45) Any other concerned persons may make a complaint concerning the research involving GMOs or gene technology at RMIT.

(46) Complaints will include sufficient factual information to enable an assessment of whether there has been a breach of gene technology legislative requirements, institutional policies, institutional biosafety approvals and/or licences, or responsible conduct of research standards and be notified to the Research Ethics, Integrity and Governance team via biosafety@rmit.edu.au

(47) The Research Ethics, Integrity and Governance team will acknowledge receipt of the complaint, undertake an assessment of the information provided, determine whether further review, investigation or other action is warranted, and notify the Complainant, the Chair of the IBC, and any other relevant parties of the outcome of that assessment, as appropriate.

Complaints Concerning the Use of GMOs in a Particular Research Project

(48) Any concerned persons may make a complaint concerning the use of GMOs or gene technology in an RMIT dealing.

(49) Complaints will include sufficient factual information to enable an assessment of whether there has been a breach of gene technology legislative requirements, institutional policies, institutional biosafety approvals and/or licences, or responsible conduct of research standards and be notified to the Research Ethics, Integrity and Governance team via biosafety@rmit.edu.au

(50) The Research Ethics, Integrity and Governance team will acknowledge receipt of the complaint, undertake an assessment of the information provided, determine whether further review, investigation or other action is warranted, and notify the Complainant, the Chair of the IBC, and any other relevant parties of the outcome of that assessment, as appropriate.

(51) Where there are ongoing safety issues and/or non-compliance with the Act or Regulations that present significant risk to health and safety or humans, animals or the environment, the institution will ensure researchers cease activities, and the IBC may suspend or withdraw approval where warranted.

(52) In consultation with the IBC Chair, REIG may take one or more of the following steps:

1. where the complaint relates to activities that would normally require IBC approval, the complaint will be referred to the RMIT IBC Committee to investigate in accordance with the Act and Regulations
2. where the complaint relates to activities that would normally require a licence, the complaint will be referred to the OGTR.
3. where the complaint raises a potential breach/es of research integrity, the complaint will be referred and managed in line with the Research Integrity Breach Management Procedure;
4. where the complaint raises potential misconduct that is not research related, it will be referred to the appropriate complaint management pathway within or outside RMIT, as appropriate;
5. dismiss the complaint and provide reasons for dismissal.

(53) REIG will update the complainant and other relevant parties, including the OGTR, as appropriate and in a timely manner.

Complaints Regarding a Decision of the IBC

(54) Complaints must be submitted to the Executive Director, Research Strategy and Services (EDRSS) in writing, including the grounds for the complaint and any supporting documentation, in accordance with the process established by REIG, for assessment.

(55) The ultimate decision regarding the acceptability and classification of a dealing involving GMOs lies with the IBC.

Complaints Regarding the Operation of the IBC

(56) Complaints must be submitted to the EDRSS in writing, including the grounds for the complaint and any supporting documentation, in accordance with the process established by REIG.

(57) Following receipt of a complaint, the EDRSS or nominee shall seek further information from the IBC, relevant Research Ethics, Integrity and Governance team members, and other relevant staff as necessary, to establish the veracity of the complaint, and assess whether any RMIT policies or processes have been compromised.

(58) The EDRSS or nominee will provide a report to the IBC and notify the complainant of the outcome of the assessment of the complaint, including any findings and recommendations.

(59) A summary of complaints will be included in the IBC Annual Report to the RMIT Research Committee.

Section 5 - Definitions