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Applications and Reporting

The University of Southern Queensland reviews all human research ethics applications in accordance with the National Statement on Ethical Conduct in Human Research. 

All ethics submissions, including new applications, amendments, exemptions, prior approvals, adverse event and milestone reports are to be made through RISE - Ethics Monitor. Please see the relevant tabs below for further information on how to submit.

The University uses RISE - Ethics Monitor for the Ethics application process.

To start a new Human Research Ethics application, please head to Ethics Monitor within RISE.

Note: Only select 'Yes' to the question, ‘Do you have approval from another Ethics Committee to conduct this project?’ in the Overview tab, if you are completing a request to have your prior approval by another HREC registered at UniSQ. All other applications should select 'No'

Refer to the Human Ethics training guide for further information on how to complete the form, or visit the Ethics Monitor SharePoint site.

The following supporting documents need to be uploaded to your HRE application:

  • relevant permissions
  • participant information sheets
  • consent forms (if required)
  • data collection tools i.e survey/interview questions
  • any additional supporting documents

If your project involves any of the following, contact the Ethics Office before completing a HRE application:

  • genetic testing
  • analysis of genetic material
  • clinical trials.

Additional information

Contact the Ethics Office

If you are involved in the conduct of research that has been approved by another Human Research Ethics Committee (HREC) then a Human Research Ethics application is required to be submitted to the UniSQ HREC. 

Complete the online HRE application, ensuring you select ‘Yes’ to the question, ‘Do you have approval from another Ethics Committee to conduct this project?’ in the 'Overview' tab.

The following supporting documents need to be attached to your HRE application:

  • HREC approval letter or notification
  • HRE application
  • information sheets
  • consent forms
  • data collection tools
  • any additional supporting documents.
Contact the Ethics Office

If you need to make changes or request an extension to your approved HRE application, the changes must be reviewed and approved by the UniSQ Human Research Ethics Committee before implementation.

Please use RISE - Ethics Monitor to create and submit your amendment request.

Please note: If your Ethics application was approved in RIMS, it has now been migrated over to RISE which means you must now use RISE to create and submit your amendment application. RIMS approved applications are referred to as 'Legacy applications' and there are slightly different steps involved when submitting an amendment to a legacy application. These steps are detailed further below.

 How to submit an amendment (RISE approved application):
  1. Log into RISE - Ethics Monitor;
  2.  Select 'My Applications';
  3.  Find the HRE approval you wish to amend and select the corresponding application ID number (not the title);
  4.  Select 'Submit an amendment' then 'Create new ethics application for amendments':
    • Please note, if you did not create the initial ethics application you may need to select 'Back', then select 'Take over this task', then 'Edit application' - the system will alert you to this.
  5.  Complete the amendment overview page and select 'Save and continue';
  6.  Make the required changes throughout the application;
  7.  Select 'Confirm' then 'Submit application':
    • (a) If you are the PI, you will be asked to confirm the declaration - Tick the confirmation box at the bottom of the screen then select "Confirm: Submit application'.
    • (b) If you are not the PI, you will be asked to delegate the application to the PI - Select the person listed as PI (if you are a student, this will be your principal supervisor). The PI will then need to open the amendment application, select 'Submit application' and follow step (a).

 

 How to submit an amendment (Legacy application):
  1.  Log into RISE - Ethics Monitor;
  2.  Enter your RIMS application ID into the 'Quick search' bar;
  3.  Select the application - it will now have a RISE approval number with the label 'Legacy'.
  4.  Select 'Submit an amendment' then 'Create new ethics application for amendments':
    • Please note, you may need to select 'Back', then select 'Take over this task', then 'Edit application' - the system will alert you to this;
  5.  Complete the Legacy amendment overview page and note the following:
    • If you are only changing investigators, requesting an extension, and/or changing the title, select 'Save and continue' and make the required changes - Submit as per step 7 above.
    • If you select 'other' you MUST select 'Save for later' and contact the Ethics Office before proceeding with making any changes. The Ethics Office will need to manually input your previous approval into the form and send it back to so you can make the required changes.

You can refer to the Human Ethics training guide for further information on how to navigate RISE - Ethics monitor, or visit the Ethics Monitor SharePoint site.

Contact the Ethics Office

It is a standard condition of Human Research Ethics approval that a milestone report is submitted annually and upon completion of the project. When you are due to report, you should receive a notification directing you to go in to the system, and complete this requirement. Unlike new HRE applications and amendment requests, anyone listed as an investigator can create and submit a milestone report.

Please use RISE - Ethics Monitor to create and submit your milestone.

Please note: If your Ethics application was approved in RIMS, it has now been migrated over to RISE - You must now use RISE to create and submit your milestone report. 

 How to submit a milestone report
  1. Click the link in your notification email (View dates here) - this will take you to the overarching project page not your ethics application;
  2. Select 'Ethics' from the right-hand side;
  3. Select your Ethics approval record - if amendments have been made this will be your most current approved amendment record.
  4. Select 'Report a milestone' then 'Report a milestone' again on the next page to confirm;
    • Please note, if you did not create the initial ethics application you may need to select 'Back', then select 'Take over this task', then 'Edit application' - the system will alert you if this is the case.
  5.  Complete the form and select 'Confirm', then 'Submit application';
  6.  Tick the declaration box and select 'Confirm: Submit application'.
 Alternate method
  1.  Log into RISE - Ethics Monitor;
  2.  Select 'My Projects';
  3.  Select the project that your Ethics approval relates to then follow steps 3 - 6 as above;

Refer to the Human Ethics training guide for further information on how to use Ethics Monitor.

Contact the Ethics Office

All ethics applications will need to go to the relevant Head of Unit/ Head of School for review and endorsement. This is a workflow step undertaken before an application comes through to the Ethics Office for review.

Heads will have a general look at the application, and pay specific attention to the following in their review:

  • Are the Aims, significance and background articulated and appropriate given the research focus of the School (or Centre) and the research team?
  • Are there benefits and risks articulated? 
  • Are there any risks specific to your School, students or courses? If yes, are these being managed appropriately?
  • Are there appropriate resources for the project?

Overview of the Steps in the System:

  1. All the project team participate in drafting the ethics application and collaborating on the design of the project (this can be done using the 'delegate this task' and 'take over the task' actions in the system)
  2. The Principal Investigator submits the ethics application through for approval - either using the 'save and continue' button on the last tab of the form or by the 'submit application' button in the ethic application overview screen. [Note: Students can not be Principal Investigators on ethics applications, the primary supervisor should be listed as the PI and will therefore submit the application]
  3. Head of School/ Head of Unit reviews and either sends back to the project team or submits it through to the ethics office. [Please note that your application is not yet with the Ethics Office until the relevant Head of Unit endorses the project].

Quality assurance or evaluation activities must be reviewed and approved by your relevant Senior Manager, Head of School or Centre Director.

Depending on what is involved with your quality assurance or evaluation activities, there are occasions where ethics approval may also be required. Please use the checklist below to determine if you will need to apply for Ethics approval.

Please review the following guidelines before commencing quality assurance or evaluation activities:

Contact the Ethics Office

If an adverse or unexpected event occurs during research or as a result of the research, please use the adverse event report form in RISE - Ethics Monitor. Anyone listed as an investigator can create and submit and adverse event report.

 How to handle unexpected events
  1. Log into RISE - Ethics Monitor;
  2. Select 'My Applications';
  3. Find the HRE approval you need to report on - select the application ID number (not the title);
  4. Select 'Report an adverse event' then 'Report an adverse event' again on the next page to confirm;
    • Please note, if you did not initiate the original ethics application you may need to select 'back' then select 'take over this task' then 'Edit application' - the system will alert you to this.
  5. Complete the form and select 'Confirm', then 'Submit application', then 'Confirm: Submit application'.

You can refer to the Human Ethics training guide for further information on how to navigate RISE - Ethics monitor, or visit the Ethics Monitor SharePoint site.

    

Contact the Ethics Office