GRIFFITH UNIVERSITY INSTITUTIONAL BIOSAFETY COMMITTEE
Genetically Modified Organism Project Approval Procedure
Approving Authority:
Approval Date:
Approved Document No:
Review Date:
Procedure Adviser:
Supersedes:
Institutional Biosafety Committee Ratified 02/07
01 November 2007
Agenda Document 16.0 02/07
2009
Technical Manager – Health & Safety
This procedure supersedes the Project Application Policy
6 November 2003
Description of the Procedure:
This procedure describes Griffith University Institutional Biosafety Committee’s (IBC) obligations
and commitment regarding the recommendation and review for project applications dealing with
genetically modified organisms (GMO’s) and the project application requirements for principal
researchers undertaking dealings involving GMO’s.
Related Policies, Procedures & Forms:
Gene Technology Act 2000
Gene Technology Regulations 2001
Griffith University Code of Conduct Policy
Griffith University Health & Safety Policy
Griffith University Institutional Biosafety Committee Annual Progress Report/Final Report Form
Griffith University Institutional Biosafety Committee Exempt Dealing Evaluation Report
Griffith University Institutional Biosafety Committee NLRD Project Application Form
Griffith University Institutional Biosafety Committee Potential Conflict of Interest Policy
Guidelines for Accreditation of an Organisation
Office of Gene Technology Regulator DNIR Application Form
Office of Gene Technology Regulator Guidelines for Accreditation of Organisations
[Introduction] [Scope] [Application] [Delegated Authorities]
1.0 Introduction
As a requirement under the Office of the Gene Technology Regulator (OGTR) Guidelines
for Accreditation of an Organisation the Griffith University IBC provides advice to principal
researchers on the identification and management of risks associated with dealings
involving GMO’s.
2.0 Objective of the Approval
All dealings with GMO’s must be reviewed by the Griffith University IBC for the following
reasons:
 To ensure correct GMO classification;
 To ensure all risks and hazards have been identified and are appropriately dealt
with; and
 To ensure compliance with legislation.
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GRIFFITH UNIVERSITY INSTITUTIONAL BIOSAFETY COMMITTEE
3.0 Scope
This procedure applies to members of the Griffith University IBC project review panel, any
person who may be requested or required to participate in the project recommendation
process as requested by the committee and principal researchers undertaking or proposing
to undertake dealings with GMO’s.
4.0 Approval Process
4.1.
Expedited Review Process
To expedite the project application review process IBC members will review and
recommend projects between scheduled meetings. A review panel will be
established consisting of at least five members with the collective and scientific
expertise to review and assess all matters associated with the project application.
Project applications recommended by the IBC review panel will be ratified at the
next scheduled meeting of the IBC.
4.2.
New Exempt Dealing & Notifiable Low Risk Dealing (NLRD) Project Application
Process
Prior to undertaking any GMO dealings of a kind mentioned in Schedule 2 or Part 1
or 2 of Schedule 3 of the Gene Technology Regulations 2001 a principal researcher
must obtain approval from the Griffith University IBC through the following process
(refer Attachment One):
4.2.1.
4.2.2.
4.2.3.
4.2.4.
4.2.5.
4.2.6.
4.2.7.
4.2.8.
4.2.9.
4.2.10.
4.2.11.
The principal researcher must complete the appropriate Griffith University
IBC Exempt Dealing or NLRD project application form.
The completed project application form must be submitted to the secretary
of the Griffith University IBC.
A Griffith University IBC project identifier will be assigned to the application
and logged onto the IBC project database.
The project identifier will be forwarded to the principal researcher.
The project application will be disseminated to the relevant IBC panel
members for review in accordance with section 3.1.
Project recommendations &/or requests for further information from the
panel members will be returned to the secretary of the committee within
the agreed time frame indicated with project review information.
If required, further information will be sought from the principal researcher
and responses from the researcher will be forwarded by the secretary to
the review panel members for further consideration.
A recommendation from the review panel will be forwarded to the Chair of
the committee who shall then sign the IBC declaration.
The researcher will be notified of the project approval and any associated
conditions in writing from the secretary of the committee.
Once the principal researcher has received project approval from the IBC
work can commence on the project in accordance with any conditions
specified by the IBC; with ratification at the next scheduled IBC meeting.
Project applications that are required to be notified to the OGTR will be
forwarded by the committee secretary in accordance with the respective
OGTR requirements.
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GRIFFITH UNIVERSITY INSTITUTIONAL BIOSAFETY COMMITTEE
4.3.
New Dealings Not Involving Intentional Release (DNIR) Project Application
Process
Prior to undertaking any GMO dealings of a kind mentioned in Part 3 of Schedule 3
of the Gene Technology Regulations 2001 a principal researcher must obtain
approval from the Griffith University IBC and the OGTR through the following
process (refer Attachment Two):
4.3.1.
The principal researcher must complete the appropriate OGTR DNIR
project application form.
4.3.2.
The completed project application form must be submitted to the secretary
of the Griffith University IBC.
4.3.3.
A Griffith University IBC project identifier will be assigned to the application
and logged onto the IBC project database.
4.3.4.
The project identifier will be forwarded to the principal researcher.
4.3.5.
The project application will be disseminated to the relevant IBC panel
members for review in accordance with section 3.1.
4.3.6.
Project recommendations and/or requests for further information from the
panel members will be returned to the secretary of the committee within
the agreed time frame indicated with the project review information.
4.3.7.
If required, further information will be sought from the principal researcher
and responses from the researcher will be forwarded by the secretary to
the review panel members for further consideration.
4.3.8.
A recommendation from the review panel will be forwarded to the Chair of
the committee and the Griffith University CEO delegate for signing,
currently the DVC (R).
4.3.9.
The recommended project application will be forwarded to the OGTR by
the committee secretary for final approval and licensing.
4.3.10. If further information is required by the OGTR this will be sought from the
principal researcher and responses from the researcher will be forwarded
to the OGTR for further consideration. A copy of this information is to be
sent to the IBC secretary.
4.3.11. Once the OGTR has approved the project application a licence and any
specified conditions for the dealing will be issued to the principal
researcher.
4.3.12. The IBC secretary will be notified of the project licence and any specified
conditions by the OGTR.
4.3.13. Once the principal researcher has received the licence for the GMO
dealing from the OGTR work can commence on the project in accordance
with any conditions specified by the OGTR and the IBC.
4.4.
Variations to Existing Project Applications
During the conduct of an approved project it may become necessary for the principal
researcher to modify or deviate from the original project application. The principal
researcher prior to commencing dealings involving the variation must obtain
approval from the Griffith University IBC through the following process:
4.4.1.
The principal researcher must include any variations on the original project
application form. The sections of the project application that have been
added or varied must be highlighted for easier identification.
4.4.2.
The completed updated project application and a request for variation
must be submitted to the secretary of the Griffith University IBC.
4.4.3.
A Griffith University IBC project variation identifier will be assigned to the
application and forwarded to the principal researcher.
4.4.4.
The principal researcher will be informed that the requested variations
cannot be implemented until approval has been received from the Griffith
University IBC.
4.4.5.
The project variation application will be sent to one of the IBC review panel
members for review.
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GRIFFITH UNIVERSITY INSTITUTIONAL BIOSAFETY COMMITTEE
4.4.6.
4.4.7.
4.4.8.
4.4.9.
4.4.10.
4.4.11.
If the project variation is deemed not to alter the GMO project
classification, alter the hazards or increase the risks associated with the
project or not deviate greatly from the original project application the
variation approval will be forwarded by the secretary to the Chair of the
committee for signing.
If the project variation is deemed to alter the GMO project classification,
alter the hazards or increase the risks associated with the project or
deviates greatly from the original project application then the principal
researcher will be required to submit a new project application for review
and approval by the committee.
A recommendation from the review panel member will be sent to the
committee secretary with in the agreed timeframe and then forwarded to
the Chair of the committee for signing.
Once the principal researcher has received the Exempt Dealing or NLRD
project variation approval from the IBC work can commence on the project
in accordance with any conditions specified by the IBC.
Variations to DNIR projects will be dealt with in accordance with the
respective OGTR requirements.
Project variation applications that are required to be notified to the OGTR
will be forwarded by the committee secretary in accordance with the
respective OGTR requirements.
4.5.
Extension to Existing Project Applications
During the conduct of an approved project it may become necessary for the principal
researcher to require more time to complete the original project work. The principal
researcher prior to continuing GMO dealings after the approved project completion
date must obtain approval from the Griffith University IBC through the following
process:
4.5.1.
A request for extension of an original project completion date must be
submitted to the secretary of the Griffith University IBC.
4.5.2.
A Griffith University IBC project variation identifier will be assigned to the
request and forwarded to the principal researcher.
4.5.3.
The principal researcher will be informed that the project cannot continue
after the original application completion date until approval has been
received from the Griffith University IBC.
4.5.4.
The project variation request will be sent to one of the IBC review panel
members for review.
4.5.5.
A recommendation from the review panel member will be sent to the
committee secretary with in the agreed timeframe and then forwarded to
the Chair of the committee for signing.
4.5.6.
Once the principal researcher has received project extension approval
from the IBC work can continue on the project in accordance with any
previous conditions specified by the IBC.
4.5.7.
Project extension applications that are required to be notified to the OGTR
will be forwarded by the committee secretary in accordance with the
respective OGTR requirements.
4.6.
Annual Project Progress Report/Final Report
As part of the IBC project approval process the principal researcher is required to
submit an annual progress report. This report is designed to monitor the potential
for changes or variations to GMO dealings during the approved period.
At the conclusion of the project a final report is required to be submitted by the
principal researcher to the IBC to ensure that all GMO’s have:
4.6.1.
Been destroyed;
4.6.2.
Transferred; or
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GRIFFITH UNIVERSITY INSTITUTIONAL BIOSAFETY COMMITTEE
4.6.3.
Are being appropriately stored.
4.7.
Approval Conditions
Approval of GMO project applications will be provided under the following
conditions:
4.7.1.
GMO projects will only be approved for a maximum three year period.
4.7.2.
A project application can only be extended for a maximum one year
period; if further time is required the principal researcher must complete a
new project application form.
4.7.3.
Exempt dealings must be contained within a facility and must not involve
the intentional release of the GMO into the environment.
4.7.4.
Facility and work practices must comply with facility certification
requirements at all times where applicable.
4.7.5.
Transport or transfer of any GMO’s out of the University must be notified to
the IBC prior to transport.
4.7.6.
The GMO dealing must comply with other relevant legislative requirements
where applicable.
4.8.
Potential Conflict of Interest during the project application process
If a conflict of interest is perceived the committee review panel member or principal
researcher must immediately refer to the Griffith University IBC Potential Conflict of
Interest Policy.
5.0 Responsibilities
Version
No:
V0F
5.1.
The Chairperson of the IBC is responsible for making a decision regarding the
recommendation of a project application and is the delegated signing authority for
recommended applications.
5.2.
The committee Secretary must advise the IBC Chair person of the project application
recommendation, disseminate and collate project application information, inform the
principal researcher and the OGTR if required and maintain the project database.
5.3.
IBC review panel members and any person who may be requested or required to
undertake the project recommendation process on behalf of the committee are
responsible for reviewing and providing a recommendation with respect to a submitted
project application within the agreed timeframe.
5.4.
The principal researcher is responsible for submitting applications for projects
involving GMO’s to the Griffith University IBC for review and approval, providing further
information as requested and undertake the project in accordance with any conditions
or requirements specified by either the OGTR or the Griffith University IBC.
APPROVED DOCUMENT ON INTRANET ONLY – UNCONTROLLED DOCUMENT WHEN PRINTED.
Document
Approving
Approved
Description:
Signature:
Review Date:
Custodian:
Authority:
Date:
GMO Project
Griffith University
Lynette Wilde
01/11/2007
01/11/2009
Recommendation Procedure
IBC
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GRIFFITH UNIVERSITY INSTITUTIONAL BIOSAFETY COMMITTEE
Attachment 1: Exempt Dealing & Notifiable Low Risk Dealing (NLRD) Project Approval Flow Diagram
1. OGTR Schedules and
guidelines.
2. Committee database
IBC Forms
Annual report to OGTR
and H&S Committee
Receipt of application sent to
researcher
Researcher submits project
application to IBC Secretary
* New application
*Variation/extension application
*Annual/final project report
Received & receipted
by secretary and
logged onto the
project database
system
NLRD
The secretary will
send the application
to panel members for
review (minimum of 5
members)
Project review
outcome
returned to
secretary
Project
recommended by
review panel
Yes
Researcher
informed of
recommendation
and any conditions
Project work can
commence in
accordance with
any specified
conditions
Ratified at next
committee meeting
GMO
classification
Out of session
If required
Secretary sends
facility inspection
checklist to
researcher
Exempt dealing
Bio-safety
officer
coordinates
facility works or
certification if
required
IBC files
Project Information
If required
Researcher completes
checklist and actions
local deficiencies
No
Facility Information
Researcher to provide
requested information to
secretary
Further information required
Researcher informed
by secretary
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Incorrect classification
Researcher to complete
correct classification
application
GRIFFITH UNIVERSITY INSTITUTIONAL BIOSAFETY COMMITTEE
Attachment 2: Dealings Not Involving Intentional Release (DNIR) Project Approval Flow Diagram
1. OGTR Schedules and
guidelines.
2. Committee database
IBC Forms
OGTR Forms
Project work can
commence in
accordance with any
specified condtions
Receipt of application sent to
researcher
Researcher submits project
application to IBC Secretary
* New application
*Annual/final project report
If required
Received & receipted
by secretary and
logged onto the
project database
system
Secretary sends
facility inspection
checklist to
researcher
The secretary will send
the application to panel
members for review
(minimum of 5 members)
Project review
outcomes
returned to
secretary
Researcher completes
checklist and actions
local deficiencies
Yes
Ratified at next
committee meeting
Information sent
to OGTR for
licencing
OGTR issue
licence for GMO
dealing
No
Bio-safety officer
coordinates
facility works or
certification if
required
Project information
If required
Project
recommended by
review panel
Researcher to
provide
information to
OGTR & IBC
Secretary
No
OGTR require
further information
Facility information
The OGTR requires 90 working days to process the application
Researcher to provide
requested information to
secretary
Further information required
Researcher informed by
secretary
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Incorrect classification
Researcher to complete
correct classification
application
Yes
Researcher & IBC
informed of
Licence approval
and any specified
conditions
IBC files
Annual report to H&S
Committee