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Human Ethics

Creating and managing your application

New applications

All research involving UOW researchers must be submitted to a UOW HREC for approval or acceptance of approval by an external HREC.  Where approval has been obtained through an external HREC the documentation must still be submitted through IRMA, the process will vary depending on whether the project is being transferred to the UOW HREC for ongoing approval, or will continue to be monitored by the external HREC. 

The application must be submitted online through IRMA

All applications should include:

  • Attachment Listing
  • The appropriate application form - if this is an HREA you will also need to include a Research Protocol
  • Participant Information Sheet/document/script
  • Consent Form/text/script
  • Scripts for any planned verbal presentations of information e.g. presentation of research to a potential participant group, debriefing
  • Copies of research instruments e.g. questionnaires, interview questions, telephone scripts
  • All advertising material
  • Any other documentation being provided to participants
  • Any approvals from other organisations that will be involved
  • Evidence of completion of Human Research Ethics training in the last five years for each investigator

Clinical trials

If you are conducting a Clinical Trial your application should also include:

  • Protocol
  • Investigator's Brochure
  • Insurance Certificate
  • Indemnity Forms
  • Study Budget
  • Details of who should be invoiced

Applications for sponsored clinical trials should include Indemnity Forms for the study and for HREC review. The forms can be downloaded from the Medicines Australia website. 

The Standard Indemnity Forms should be addressed to:
[name of site e.g. Wollongong University],

The HREC Review Indemnity Forms, addressed to:
Illawarra Shoalhaven Local Health District (ABN 13 567 011 035) acting through the University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical HREC

All documents are uploaded and submitted through the online system, IRMA. For details of this process see the .

The Illawarra Shoalhaven Local Health District (ISLHD) has made the decision to separate from the joint UOW & ISLHD Human Research Ethics Committee (HREC). To align themselves with other health organisations, ISLHD have announced its new partnership with Greater Western HREC, active from 1st July 2023.

What Does This Mean for Me?

  • If you have an approved NSW Health project in REGIS, and it is still active and current, it will be transferred to Greater Western HREC for all management and monitoring at the end of 2023.
  • If your existing project in REGIS has expired or a progress report is overdue, please submit your progress/final report by the 1st of July.  If this is not received, your project will be closed and you will be required to re-apply with Greater Western HREC if you wish to continue with your project.
  • If you are planning to submit a new application in REGIS, from the 1st of July the joint UOW & ISLHD HREC will be removed as an option and all ISLHD applications should be made to Greater Western HREC. 

Key dates 

As of 1 July 2023, the Joint UOW/ISLHD HREC will be removed as an option in the online ethics submission portal (REGIS). From this date all new, non-clinical trial applications are to be submitted to the Greater Western HREC. Further advice will be provided regarding the review of clinical trials, however staff are reassured there is a planned transition phase to prevent any disruption to research activity. 

Further Information 

If you have any questions or require further information please contact the ISLHD Research Office on 4253 4892 or email ISLHD-Research@health.nsw.gov.au. 
Alternatively, please contact UOW-humanethics@uow.edu.au and speak to the UOW ethics team.

New applications involving NSW Health should be created in and submitted through the NSW Health Research Ethics and Governance Information System (REGIS). REGIS has been partially operational for several months and will fully replace the current application process in 2019.

Basic information, including details of the transition from IRMA, can be accessed here (link to REGIS page - above). For full details, including processes for multi-site research involving other health jurisdictions, please see the NSW Health REGIS information page
Please note that all applications involving ISLHD clients must include a researcher who is a staff member of ISLHD.

Governance approval must be obtained from the relevant Local Health District. The application form for this (Site Specific Application or SSA) is automatically created in REGIS when you create the project record.

Your application should include:

  • The appropriate application form – this is created in REGIS
  • Research Protocol
  • Participant Information Sheet/document/script
  • Consent Form/text/script
  • Scripts for any planned verbal presentations of information e.g. presentation of research to a potential participant group, debriefing
  • Copies of research instruments e.g. questionnaires, interview questions, telephone scripts
  • All advertising material
  • Any other documentation being provided to participants
  • Any approvals from other organisations that will be involved
  • Evidence of completion of Human Research Ethics training in the last three years for each UOW investigator
  • Study Budget
  • Details of who should be invoiced

Clinical trials

If you are conducting a Clinical Trial your application should also include:

  • Investigator's Brochure
  • Indemnity Forms for HREC review

Applications for sponsored clinical trials should include Indemnity Forms for the study and for HREC review. The forms can be downloaded from the Medicines Australia website. 

The Standard Indemnity Forms should be addressed to:
[name of site e.g. The Wollongong Hospital],
Illawarra Shoalhaven Local Health District

The HREC Review Indemnity Forms, should be addressed to:
The University of Wollongong (ABN 61 060 567 686) of Northfields Avenue, Wollongong, NSW 2522, acting through the University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical HREC.

The UOW & ISLHD HRECs review applications for external parties if the research project falls within the expertise of one of the HRECs.

Fees apply to the review of most external research, and a Memorandum of Understanding outlining the responsibilities of all parties must be completed. Investigators are required to have completed relevant training in research ethics in the last three years.  If necessary, access to online training through UOW can be arranged.

External researchers wishing to submit their research through a UOW & ISLHD HREC should contact the Ethics & Integrity Unit, uow-humanethics@uow.edu.au, or call 4221 5014.

If you are bringing a project to UOW from another institution, you may wish to transfer the ethics approval so that the ongoing approval and monitoring is managed by a UOW HREC.  To do this you will need to submit the approved documentation, including the approval notification, through IRMA as a new application.  It is important to include a brief explanation of the reason for the transfer.  If any documentation (e.g. information sheets and consent forms) will need to change to reflect this move, please submit the revised documents with the already approved ones.  You should also notify the HREC that you are transferring from of this change. 

 

  • If you are involved in a project that has been approved by an external HREC for any reason you will need to apply to have that approval accepted by UOW. The application will receive an administrative check, to ensure that the approval is by an NHMRC certified HREC and covers the work that will involve UOW.  The ethical oversight of the project will normally remain with the approving HREC.

 

To do this you will need to submit the approved documentation, including the approval notification, through IRMA as a new application and choose the ‘request for acceptance of approval by an external HREC’ option.  The requirements for UOW researchers to have completed ethical training in the last three years will still apply.

Post Approval

Once you have obtained ethics approval you are required to submit a progress report annually and a final report on completion of your project. Physical monitoring of research records or activities may also occur. As evidence of continuing compliance, the Human Research Ethics Committee also requires that researchers immediately report:

  • Proposed changes to the protocol including changes to investigators involved
  • Serious or unexpected adverse effects on participants
  • Unforeseen events that might affect continued ethical acceptability of the project

Changes to the methods, recruitment procedures or information documents or research team need to be approved by the HREC before being implemented.
Most amendments are reviewed by the Executive Committees and can be submitted at any time. Substantial changes to projects that are more than low risk may need to be reviewed by a full committee and will need to be submitted for the appropriate agenda deadline. Please contact the Ethics Unit if you need advice on this.

Requests for changes to methods or documentation should be submitted through IRMA or REGIS (NSW Health research). Make sure you:

  • Attach copies of any revised documents with the changes highlighted or tracked, and an updated version number and date in the footer of the document.
  • If there are extensive changes please provide a clean copy as well as one showing the changes.

For UOW applications, requests for changes to investigators should be submitted using the ‘Amend Investigators’ online form in IRMA. If the amendment involves additional researchers an Investigator’s Details form and a researcher declaration for each new investigator must be completed and uploaded with the request. As of January 2020 all new investigators must have completed relevant training in the last 3 years, and evidence of the training must also be uploaded.

If any changes to documentation are required the revised documents must be included with the request.

Once you have obtained ethics approval you are required to submit a progress report annually, and a final report on completion of your project. Physical monitoring of research records or activities may also occur. 
If the study does not go ahead or is terminated prior to completion you still need to put in a report explaining what has occurred.

All reports are lodged through the online system, IRMA. Reports for ongoing and completed projects require specific forms in addition to the online questions; these forms can be accessed through IRMA or the Forms page.

HREC approval is granted for up to twelve months at a time, renewable on receipt of a progress report. Long term projects (greater than 4 years) and projects which undergo substantial modification following the initial approval may be required to submit a new application after four years.

All adverse events occurring during or as a result of participation in research should be reported to the HREC as soon as practicable. Serious events must be reported with 72 hours.

For Clinical Trials

The UOW & ISLHD HREC follows the NHMRC 2016 guideline on the monitoring of clinical trials, Safety monitoring and reporting in clinical trials involving therapeutic goods. 

Urgent safety issues requiring implementation of a safety measure should be reported to the HREC within 72 hours.

A summary of NSW Health reporting requirements can be found here. 

Any person who has a concern or complaint about the way a research project has been conducted should contact the Integrity & Ethics Manager on (02) 4221 4457 or email uow-humanethics@uow.edu.au. 

If you are moving a significant part of an approved project to another institution you should consider transferring the ethics approval to the new institution.  You should contact the Ethics Unit of the new institution to obtain advice about their processes.  Once approval has been obtained at the new institution you will need to lodge a transfer out notification in IRMA.  This will ensure that no future requests for monitoring reports are sent to you.

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