Research Integrity and Compliance

Institutional Biosafety Procedure

Policy Code: RS1927

Purpose

The purpose of this document is to guide researchers (including students undertaking research) and teaching staff of Federation University and Federation Training through the Institutional Biosafety Committee application process, in accordance with current Commonwealth, State and Territory legislation.

The Institutional Biosafety Committee is a Committee of the Deputy Vice-Chancellor (Research & Innovation). The Institutional Biosafety Committee (IBC) plays an important role for staff and/or students undertaking work with Genetically Modified Organisms (GMOs), by helping them to meet the requirements of current legislation.

Scope

This procedure applies to:

  • All staff, including sessional staff, employed by the University, Federation Training, or any controlled entity;
  • All persons, including Adjunct and Honorary staff, engaged in research under the auspices of the University, Federation Training, or any controlled entity;
  • All students of the University who engage in research and/or research related activities, related to their studies, while enrolled at the University.

Any teaching programs or research projects at Federation University or Federation Training that involve Genetically Modified Organisms must not commence without prior written approval from the Federation University Institutional Biosafety Committee.

Definitions

Term Definition
Application A request for approval from the IBC to carry out a research project or teaching activity.
DIR Dealing involving intentional release – A category of dealings with GMOs that take place outside of containment facilities and involve an intentional release of GMOs into the Australian environment.
DNIR Dealing not involving intentional release - A category of dealings with GMOs that take place in contained facilities, do not involve an intentional release of GMOs into the Australian environment, and do not meet the criteria for classification as Exempt Dealings or Notifiable Low Risk Dealings.
ED Exempt dealing - A category of dealings with GMOs that have been assessed over time as posing a very low risk (i.e. contained research involving very well understood organisms and processes for creating and studying GMOs). The only legislative requirement for exempt dealings is that they must not involve an intentional release of a GMO into the environment.
EDD An Emergency Dealing Determination (EDD) is a legislative instrument made under the Gene Technology Act 2000. The emergency provisions in sections 72A - 72E of the Act give the responsible Minister the power to expedite an approval of dealings with a GMO in an emergency. 
Gene Technology Act The nationally consistent legislative scheme for gene technology is comprised of the Commonwealth Gene Technology Act 2000 and Gene Technology Regulations 2001, and corresponding State and Territory legislation. Generally referred to as ‘the Act’
GM Genetically Modified
GMO Genetically Modified Organisms. In Australia, all dealings with live and viable genetically modified organisms (GMOs), including import, are illegal unless authorised under the Gene Technology Act.
GMO Register The Gene Technology Regulator may make a determination to include dealings with GMOs on the GMO Register. To be included on the GMO Register, the dealings must first have been authorised by a GMO licence. 
Dealings will not be entered onto the GMO Register until the Regulator is satisfied that the risks posed by the dealings are minimal and that it is not necessary for anyone conducting the dealings to be covered by a licence in order to protect the health and safety of people or the environment.
IBC Institutional Biosafety Committee, a Federation University committee established in accordance with the Office of Gene Technology Regulator (OGTR) for the purpose of assessing any research project involving genetically modified material.
Incident/Adverse/Unexpected event Any outcome that may have a negative impact and was not foreseen in the approved project. It is one of the standard conditions of approval that any adverse unexpected incident be formally reported to the IBC.
Monitoring The process of verifying that the conduct of research conforms to the approved proposal.
NLRD Notifiable Low Risk Dealings (NLRDs) are activities with GMOs undertaken in containment (ie: not released into the environment) that have been assessed as posing low risk to the health and safety of people and the environment provided certain risk management conditions are met.
Non-Compliance Failure or refusal by researcher/s to act in accordance with the Standard Conditions of Approval for their project, respond to the directions of the IBC, or be in breach of the Act or the Code.
OGTR Office of the Gene Technology Regulator - National Regulatory Scheme for Genetically Modified Organisms has the specific responsibility to protect the health and safety of people, and to protect the environment, by identifying risk posed by or as a result of gene technology.
PC1 Physical Containment Level 1
PC2 Physical Containment Level 2
RARMP Risk Assessment and Risk Management Plan
Terms of Reference Terms of Reference show how the scope of the Committees will be defined, developed, and verified. Generally referred to as ToR.
The Act The Gene Technology Act 2000 referred to as the act is the nationally consistent legislative scheme for gene technology, and is comprised of the Commonwealth Gene Technology Act 2000 and Gene Technology Regulations 2001, and corresponding State and Territory legislation.

Actions

Every dealing with a GMO will need to be licensed by the Gene Technology Regulator, unless the dealing is an exempt dealing, a notifiable low risk dealing (NLRD) or on the Register of GMOs.

  • Exempt dealings
  • Exempt dealings are those that pose little or no risk.
  • There will be no exemptions for any release of a GMO into the environment.
  • Exempt dealings must be conducted in accordance with Australian Standard AS/NZS 2243.3:2002 (Safety in laboratories: microbiology) for Physical Containment Level 1

Notifiable low risk dealings (NLRDs)

  • NLRDs are dealings with GMOs which are very low risk and which may proceed provided that certain conditions spelt out in the regulations are observed.
  • This will include requirements that the specified dealings be undertaken only in contained facilities (PC2).
  • NLRDs must be submitted to the IBC for assessment. A record of all NLRDs will be kept.
  • Work on the Dealing may not commence until approval by the IBC has been received.
  • The Gene Technology Act does not allow dealings which involve the intentional release of a GMO into the environment to be prescribed as a NLRD.

Licences

All dealings with GMOs (that are not exempt or NLRDs) will need to be licensed by the Regulator.  There are two forms of licences - Dealings Not Involving Intentional Release (DNIR) and Dealings Involving an Intentional Release (DIR).

The licensing system will be based on rigorous scientific risk assessment and extensive consultation with expert advisory committees, Government agencies and the public for releases of GMOs into the environment.

These must be submitted to the IBC for assessment. The IBC then transmits the "Dealing" to the OGTR for approval.

Work must not commence on these dealings until a licence has been issued by the OGTR. Approval from the OGTR may take up to 90 working days.

The following table outlines the categories of dealings and the type of approval required:

Category OGTR Licence required Containment
Exempt (ED) No, but consult IBC No intentional release to the environment
Notifiable Low Risk Dealing (NLRD) No, dealings must be assessed by IBC; notified in annual report Yes
PC1 or PC2 (usually)
Dealings Not involving Intentional Release (DNIR) Yes, applications must be reviewed by IBC; RARMP prepared and licence decision by the Regulator Yes
≥ PC2 (usually) and other conditions will apply
Dealings involving Intentional Release (DIR)
(except for limited and controlled releases)
Yes, applications must be reviewed by IBC; consultation on application, RARMP prepared, consultation on RARMP and licence decision by the Regulator Containment measures may be required, determined on a case-by-case basis, and other licence conditions will apply
Dealings involving Intentional Release (DIR)
(limited and controlled)
Yes, applications must be reviewed by IBC; RARMP prepared, consultation on RARMP and licence decision by the Regulator Containment measures will be required based on size/scope of release sought by applicant; and other licence conditions will apply
Inadvertent dealing Yes, licence decision by the Regulator only for the purposes of disposal of the GMO Containment and/or disposal measures will apply
GMO Register No, but must be previously licensed;
review of related RARMPs
Containment measures may be required
Emergency Dealings Determination (EDD) No, determination by the minister, subject to advice of threat and utility of GMO from competent authorities and risk assessment advice from the Regulator Containment and/or disposal measures may be included in EDD conditions

Application Process

Researchers should complete the following steps to gain IBC and OGTR approval:

FOR EXEMPT DEALINGS (ED): 
  ACTIVITY RESPONSIBILITY STEPS
A. Contact Ethics Officer or Secretary, IBC Principal Researcher Contact the Ethics Officer or the Secretary, IBC for advice on whether the project can be considered Exempt.
B. Complete Exempt Dealing notification form Principal Researcher Details of the project should be recorded on the Exempt Dealing application form.  This form will then be kept on record within Research Services.
C. Obtain IBC declaration

Ethics Officer

IBC Chair

The application for an Exempt Dealing should be signed off by the IBC Chair, who declares that the dealing is exempt in accordance with the Gene Technology Regulations.
FOR NOTIFIABLE LOW RISK DEALINGS (NLRD):
  ACTIVITY RESPONSIBILITY STEPS
A. Contact Ethics Officer or Secretary, IBC Principal Researcher Contact the Ethics Officer or the Secretary, IBC for advice on whether the project can be considered as an NLRD
B. Complete NLRD application form Principal Researcher Details of the project should be recorded on the NLRD application form.  Signatures of all researchers are required.
C. Submit to a meeting of the IBC Principal Researcher The application for an NLRD should be submitted to a meeting of the IBC, who will consider whether the application meets the requirements of an NLRD.  If the application is approved by the IBC, it is then signed off by the IBC Chair, who declares that the dealing is an NLRD in accordance with the Gene Technology Regulations.
D. Provide applicant with outcome of meeting Ethics Officer The Ethics Officer will inform the applicant of the outcome of the meeting.  The project will be approved unless further information is required, or the IBC have classified the project as another type of dealing.
E. Enter NLRD on record Ethics Officer The Ethics Officer will enter the details of the NLRD on record, and provide the details to the OGTR via the annual reporting process each year.
FOR DEALINGS NOT INVOLVING INTENTIONAL RELEASE (DNIR) & DEALINGS INVOLVING INTENTIONAL RELEASE (DIR):
  ACTIVITY RESPONSIBILITY STEPS
A. Contact Ethics Officer or Secretary, IBC Principal Researcher Contact the Ethics Officer or the Secretary, IBC for advice on whether the project can will be considered an DNIR or an DIR
B. Complete appropriate application form Principal Researcher

Details of the project should be recorded on the appropriate application form, which are provided online from the OGTR. http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/apps-for-gmo

Signatures of all researchers are required.

C. Submit to a meeting of the IBC Principal Researcher The application for a DNIR or DIR should be submitted to a meeting of the IBC, who will consider whether the application meets the requirements of a DNIR or a DIR. 
D. Provide applicant with outcome of meeting Ethics Officer

The Ethics Officer will inform the applicant of the outcome of the meeting.  The project will be approved unless further information is required, or the IBC have classified the project as another type of dealing.

The application should then be signed off by the IBC Chair.

Following this, authorisation should be sought from the DVC (R&I).

E. Submit complete application to the OGTR Ethics Officer The Ethics Officer will submit the complete application to the OGTR, who will acknowledge the application and assign a DNIR or DIR identification number.
F. OGTR consultation timeframes OGTR

For DNIR applications – 90 working days

For DIR applications – 150 to 255 working days

G. Decision on licence OGTR The OGTR makes a decision to issue, or refuse to issue, a licence, and the applicant will be advised.
H. Decision is recorded on the public GMO record OGTR The decision on the licence application is recorded in the GMO Record on the OGTR website.

Certification of Facilities

  ACTIVITY RESPONSIBILITY STEPS
A. Planning a new facility (laboratory, plant and animal, etc) University staff member

Certain work with GMOs must only be undertaken in facilities that are certified by the Regulator.  The legislation allows the Regulator to certify physical containment (PC) facilities to ensure that appropriate standards are met for containment of GMOs and that trained and competent staff are carrying out procedures and practices. 

Any personnel planning a new facility must contact the Ethics Officer and the Chair IBC to be guided through the OGTR’s certification process.  The Regulator has issued guidelines specifying the requirements for certification of each of each type of facility to PC containment levels 1, 2, 3 or 4, which must be met before a facility can be certified. 

B. Inspection of new facilities IBC All facilities must be inspected before certification and annually thereafter (except those certified as a PC1 facility). 
C. Certification of facilities OGTR

PC facilities are classified according to levels of stringency of measures for containing GMOs.  The classifications relate to the structural integrity of buildings and equipment uses as well as to the handling practices employed by those working in the facility.

PC level 1 (PC1) facilities are used to contain organisms posing the lowest risk to human health and the environment.

PC level 4 (PC4) facilities provide the most secure and stringent containment conditions.

Reporting and Monitoring

  ACTIVITY RESPONSIBILITY STEPS
A. Contact Ethics Officer Principal Researcher Researchers must contact the Ethics Officer immediately if any changes are intended to be made to an approved project.

Auditing of Approved Projects

  ACTIVITY RESPONSIBILITY STEPS
A. Monitoring Inspections (with prior notification)

OGTR

Licence or Certification Holders

Each year, the OGTR routinely conducts monitoring inspection to ensure that Licence and Certification holders are complying with the Gene Technology Act 2000 (the Act) and it subordinate legislation.  The OGTR will make appointments to inspect certified Physical Containment (PC) facilities and dealings conducted in those facilities including: DNIRs and NRLDs.
B. ‘Spot’ checks (unannounced)

OGTR

Licence or Certification Holders

A number of unannounced ‘spot’ checks will be conducted throughout the year to ensure that compliance is maintained at all times.

Suspension or Discontinuation of Approved Projects

  ACTIVITY RESPONSIBILITY STEPS
A. Discontinuation or Suspension of an approved research project Chair of the IBC Where the Chair of the IBC is satisfied that circumstances have arisen such that a research project is not being or cannot be conducted in accordance with the approval protocol, the IBC may withdraw approval and recommend that the research project be discontinued, suspended or that other necessary action be taken.
B. Cease research project Researchers A researcher must not continue the research if approval has been withdrawn and must comply with any special conditions required by the IBC.

Compliance

A project involving the use of GMOs cannot proceed without official written approval from the IBC and/or a licence from the OGTR.

When the application has been reviewed by the IBC, the applicants will receive notification from the IBC.

A person who deals with a GMO without a licence is guilty of an offence (punishable under Section 32 of the Act) if:

  1. the person deals with a GMO, knowing that it is a GMO
  2. the dealing with the GMO by the person is not authorised by a GMO licence, and the person knows or is reckless as to that fact
  3. the dealing with the GMO is not specified in an Emergency Dealing Determination, and the person knows or is reckless as to that fact
  4. the dealing is not a Notifiable Low Risk Dealing, and the person knows or is reckless as to that fact
  5. the dealing is not an Exempt Dealing, and the person knows or is reckless as to that fact and
  6. the dealing is not included on the GMO Register, and the person knows or is reckless as to that fact.

Non-compliance

Complaints or concerns relating to non-compliance involving the use GMOs should be directed to the Chair of the IBC (via the Ethics Officer within Research Services) in the first instance. Where complaints or grievances identify instances of non-compliance with/breaches of:

  • The National Statement on Ethical Conduct in Human Research; or
  • The Australian Code for the Care and Use of Animals for Scientific Purposes; or
  • The Australian Code for the Responsible Conduct of Research,

the following procedure will be followed:

  ACTIVITY RESPONSIBILITY STEPS
A. IBC approval suspended IBC Chair The IBC Chair will formally advise the Principal Researcher that approval for the project has been suspended.  If applicable, urgent human or animal welfare concerns will be identified and appropriate action is to be taken.
B. OGTR to be notified IBC Chair If required, the IBC Chair will contact the OGTR upon receipt of complaint.
C. Research Integrity Coordinator to be notified IBC Chair

The complaint of non-compliance will be immediately referred to the Research Integrity Coordinator and the DVC (R&I) by the IBC Chair for resolution under the provisions of the University’s Research Integrity & Misconduct Procedure.

Please note: Where complaints allege misconduct that falls outside the description of ‘research misconduct’ (as described in the Australian Code for the Responsible Conduct of Research) the complaint will be handled in accordance with institutional processes for dealing with other forms of misconduct.

D. Relevant regulatory authorities will be advised Research Integrity Coordinator If required, the relevant regulatory authorities (e.g. NHMRC or ARC) will be advised upon receipt of the complaint.

Responsibility

  • Deputy Vice-Chancellor (Research & Innovation) (as the Approval Authority) is responsible for monitoring the implementation, outcomes and scheduled review of this procedure.
  • Director – Research Services (as the Policy Sponsor) is responsible for maintaining the content of this procedure as delegated by the DVC (R&I).
  • Research Services is responsible for the administration support for the maintenance of this procedure as directed by the DVC (R&I).

Promulgation

The Institutional Biosafety Procedure will be communicated throughout the University community in the form of:

  1. an Announcement Notice via FedNews website and on the ‘Recently Approved Documents’ page on the ‘Policies, Procedures and Forms @ the University’ website to alert the University-wide community of the approved Procedure.

Implementation

The Institutional Biosafety Procedure will be implemented throughout the University via:

  1. an Announcement Notice via FedNews website and on the ‘Recently Approved Documents’ page on the ‘Policies, Procedures and Forms @ the University’ website to alert the University-wide community of the approved Procedure;
  2. Staff information sessions

Forms/Record Keeping

Document Title Location Responsible Officer Minimum Retention Period
IBC Application forms Research Services Director, Research Services 7 years
IBC Approval Notification Forms Research Services Director, Research Services Permanent
Complaints/Misconduct Report Forms Research Services Director, Research Services Permanent