ÌìÃÀ´«Ã½app

All new applications should include the following documentation:

• Attachment Listing
• ÌìÃÀ´«Ã½app Application Form
• ReDBox Research Data Management Plan - if you are not affiliated with ÌìÃÀ´«Ã½app and wish to apply to the ÌìÃÀ´«Ã½app HREC, please contact uow-humanethics@uow.edu.au for advice.
• All advertising and recruitment materials (e.g. fliers, social media posts, invitation emails)
• Scripts for any planned verbal presentations of information, e.g. presentation of research to a potential participant group, debriefing
• Participant information sheet/document/script
• Consent form/text/script
• Copies of all research instruments e.g. questionnaires, interview questions, telephone scripts
• 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

You can find the ÌìÃÀ´«Ã½app Application Forms at our Forms, guidelines & policies page, and examples/checklists for participant information sheets and consent forms at our Examples & guides page.

Please note that all information about your project should be communicated in the ÌìÃÀ´«Ã½app Ethics Application forms.  Please do not attach entire PhD proposal documents, grant application documents, or separate protocol documents with your ethics submission; these documents will not be sent to the HREC for review and will not be considered a part of your application.  If these documents contain relevant information about your project, that information must be included in the ÌìÃÀ´«Ã½app Ethics Application forms.

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 website.

APPLICATIONS FROM EXTERNAL RESEARCHERS
The ÌìÃÀ´«Ã½app 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 (as per the fee schedule), 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 five years.  If necessary, access to online training through ÌìÃÀ´«Ã½app can be arranged.

External researchers wishing to submit their research through a ÌìÃÀ´«Ã½app HREC should contact the Human Ethics team at uow-humanethics@uow.edu.au, or call 02 4239 2080.

ALLOCATING APPLICATIONS FOR REVIEW
Applications are allocated for review by the Ethics Office, taking into account the nature and risk profile of the research, as well as the current workload of each HREC.  In light of the ÌìÃÀ´«Ã½app-ISLHD HREC separation, the Ethics Office anticipates that the majority of higher risk research (i.e. research that requires Full HREC review) relating to mental health, interactions with healthcare, health knowledge, dementia and nutrition will be allocated to the Health and Medical HREC for review.

It is recommended that researchers consult the Full HREC meeting dates and agenda deadlines well in advance of submission.

Once you have obtained ethics approval you are required to submit annual progress reports to the HREC, as well as a final report on completion of your project.  Physical monitoring of research records/activities by the Human Ethics team may also occur.  As evidence of continuing compliance, the HREC 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

AMENDMENTS
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 HREC 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 would like advice on this.

Requests for changes to methods or documentation should be submitted through IRMA. When doing so, 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 ÌìÃÀ´«Ã½app applications, requests for changes to investigators should be submitted using the ‘Amend Investigators’ online form in IRMA.  If the amendment involves additional researchers, an additional researcher declaration form for each new investigator must be completed and uploaded with the request.  All new investigators must also have completed relevant human ethics training in the last five years, and evidence of the training must also be uploaded.

PROGRESS REPORTS & MONITORING
Once you have obtained ethics approval you are required to submit annual progress reports to the HREC, as well as a final report on completion of your project.  Physical monitoring of research records/activities by the Human Ethics team may also occur.

If the study does not go ahead or is terminated prior to completion, you are still required to submit 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 are available on the Forms, guidelines & policies page.

HREC approval is granted for up to 12 months at a time, renewable on receipt of a progress report.  Long term projects (greater than four years) and projects which undergo substantial modification following the initial approval may be required to submit a new application.

ADVERSE EVENTS
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 ÌìÃÀ´«Ã½app HREC follows the NHMRC 2016 guideline on the monitoring of clinical trials, 

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

See a summary of . 

COMPLAINTS
Any person who has a concern or complaint about the way a research project has been conducted should contact the Ethics Officer on (02) 4239 2080 or email uow-humanethics@uow.edu.au.

You are eligible to apply for acceptance of an externally approved research project if you are a ÌìÃÀ´«Ã½app staff or student investigator on a research project and:

• The project has been reviewed and approved by an NHMRC registered HREC other than ÌìÃÀ´«Ã½app
• Where the research is lower risk, the project has been reviewed and approved by a non-HREC level of review, where the requirements of the National Statement section 5.1.8-5.1.14 have been met (Appendix A)
• The project has been reviewed and approved by an overseas ethics review body, where the requirements of the National Statement section 4.8.1 to 4.8.10 have been met (Appendix B)

What is an acceptance of external ethics approval?

The ÌìÃÀ´«Ã½app HREC recognises that a project has received ethics approval from an external review body in accordance with the requirements of the National Statement.

The ÌìÃÀ´«Ã½app HREC does not:

• Re-review the project documents
• Approve the project
• Monitor the ongoing conduct of the research

The following documents must be submitted with your application for acceptance of external approval:

• Initial Application documents including information sheets, consent forms, study tools etc
• All correspondence with the reviewing HREC
• Letter of Approval
• Any amendments
• Evidence that all ÌìÃÀ´«Ã½app researchers listed on the project have completed required ethics training

The documents must demonstrate:

• The approving body is an accredited ethics review body
• The approving body accepts responsibility for the project at all sites including ongoing project monitoring
• The ÌìÃÀ´«Ã½app researchers are listed as investigators
• ÌìÃÀ´«Ã½app is listed as a site where appropriate

Note: all future progress reports, amendments etc. must be approved by the external review body. The ÌìÃÀ´«Ã½app HREC must only be notified of any adverse event associated with the project, such as data or privacy breaches, physical or psychological harm.

When is acceptance of external approval not appropriate?

• There is no equivalent overseas ethics review body

A transfer-in of your project should occur where you are the chief investigator relocating the project to ÌìÃÀ´«Ã½app and the approving HREC discontinues ongoing monitoring of the project

If you are bringing a project to ÌìÃÀ´«Ã½app from another institution, you may wish to transfer the ethics approval so that the ongoing approval and monitoring is managed by a ÌìÃÀ´«Ã½app 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.

Please note that transferring an application into the ÌìÃÀ´«Ã½app HREC means that the ÌìÃÀ´«Ã½app HREC becomes the new monitoring HREC.  If you are a ÌìÃÀ´«Ã½app researcher and have had an application approved by another HREC and are seeking only to notify the ÌìÃÀ´«Ã½app HREC of this approval, please consult the information on ‘Applying for acceptance of approval by an external HREC’.

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 Office 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.