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Research Ethics Office

Murdoch University Institutional Biosafety Committee

The Application Process

(Step 1) Forms

If your project is classified as exempt then use the Exempt Form on the IBC website.

If your project is an NLRD then use the NLRD form on the IBC website. This form already has parts of the information filled in.

If your project is a DNIR or DIR you can obtain the relevant forms from the OGTR website link http://www.ogtr.gov.au/pubform/forms.htm (please use the word version of the forms).

(Step 2) Deciding on the type of project.

Decide on the type of project (dealings): There are four types of dealings recognized under the legislation:

2A Projects that require approval of the IBC.

          Exempt:  These are dealings that have been assessed over time as posing negligible risk.  They do not require a license.  Exempt dealings must be contained within a facility and must not involve release of the organism into the environment.  Although the dealing is exempt you are required to notify the IBC of exempt projects. For more information see Exempt Dealings.

          Notifiable Low Risk Dealings (NLRD):  These are dealings that have been assessed over time as posing low risk.  They must be notified to the OGTR, must be contained within a certified facility within an accredited organization. For more information see the following link.

2 B Projects that cannot start until a licence is granted by the OGTR.

          Dealings Not Involving Release (DNIR): This category includes all dealings that are not exempt or NLRD and which do not involve release. These correspond to the GMAC Category A (large and small) projects.  These dealings must be licensed by the OGTR.  For more information see the handbook on regulation of Gene Technology at the OGTR website at http://www.ogtr.gov.au/pubform/handbook.htm.

          Dealings Involving Release (DIR):  All projects involving release. These dealings must be licensed by the OGTR.  For more information see the handbook on regulation of Gene Technology at the OGTR website at http://www.ogtr.gov.au/pubform/handbook.htm.

Submitting the Application

Fill in the form and submit it electronically as an email attachment to the Secretary of the
IBC, Human Resources. We must receive an electronic version so that it can be
circulated promptly to the IBC members.

You must sign a hard copy and send it to the “Secretary of the IBC, Human Resources”.
The OGTR will not accept a photocopy of the signature page. It must contain the
original signatures.

Proposals must be received at least seven working days prior to the next meeting of the
IBC, otherwise they will be held over until the following meeting.

Once the proposal has been evaluated by the IBC you will be informed of the outcome of
the evaluation by email. If further information is required, or the application form is not
properly completed, you will be asked to supply the information or complete the form.
The application cannot be submitted to the OGTG until we receive it back from you.

When can I start work on the project?

Notifiable Low Risk dealing (NLRD)
You cannot start these dealings until the IBC has evaluated your proposal and notified you that it is approved.

Dealings Not Involving Release (DNIR)
Dealings Involving Release (DIR)
You cannot start these projects until you have received a licence from the OGTR.

Timeframe for Applications

Applications  must be received by the IBC at least seven working days prior to the next meeting (see above). If they are not received by this time they will be held over until the following meeting of the IBC which will usually be four weeks later. 

The applicant will be notified of the decision following the meeting.  The IBC may recommend changes or additions to the proposal before it is sent to the OGTR.  Delays in making these will delay the process.  Once these changes have been made, a hardcopy is returned to the IBC Chair, for signing.  The proposal is the sent to be signed by the CEO (or a delegate) and dispatched to the OGTR for evaluation.

For DNIR proposals the OGTR must reach a decision within 90 working days of receipt of the proposal form.  For DIR proposals the OGTR must reach a decision within 180 working days from receipt of the proposal.

Delays to the application process

ˇ        public hearings are required (DIRs only)

ˇ        additional information is required from the applicant.

ˇ        requests for CCI are considered.

ˇ        advice is sought from the Gene Technology Ethics Committee (GTEC).

Completing the Application Form