Skip Ribbon Commands
Skip to main content
RGS
 

Add, fill out and authorise an ethics form

Other references

Researchers Training Manual (Part A)

Researchers Training Manual (Part B)

​​

​​​​​​​​​​​​In this page... 

All Project Members (including Sponsors) can add, edit and unlock the ethics forms. However, only certain project roles are allowed to force check-in, remove, mark complete, sign, authorise, unauthorise and submit an ethics form, this is to ensure the information is correct on submission.

Project Member Role for Ethics Forms:

Action

Project Member Role

  1. Add, Edit, Unlock

All Project Members

  1. Mark Complete

All Project Members, except Sponsor

  1. Remove, Force-Check-In, Unauthorise, Submit

CPI or CPI Delegate

  1. Sign

CPI and PI

  1. Authorise

CPI

RGS ethics forms

After Project Members have completed the Sites, Members and Project Details tabs, the ethics forms and supporting documents should be completed and uploaded.

Find information on which ethics and governance application forms to complete in the WA Health Research Authorisation Monitoring Form Guidelines.

The following ethics forms are available in the RGS for completion and submission to the relevant WA Health HREC(s):

  • Western Australian Specific Module (WASM)
  • WA Health Ethics Application Form (WAHEAF)

Currently the NHMRC's Human Research Ethics Application (HREA) is not available in the RGS. To facilitate its submission to WA Health HRECs, the NEAF or HREA must be completed externally and uploaded to the RGS as a supporting document.

National Mutual Acceptance (NMA) ethics forms

For NMA, the WASM must be completed in the RGS and the HREA uploaded as a supporting document. You cannot use the WAHEAF for NMA.

WA Health Lead HREC (With or Without Specialist HREC)

1. For NMA, if a WA Heath HREC is the Lead HREC, with or without an Additional WA Health HREC (Specialist), then you should complete the WASM, upload the HREA and supporting documents and submit them via the RGS.

External Lead HREC (With a WA Health Specialist HREC)

1. For NMA, if an External HREC (outside of WA Heath) is the Lead HREC and you are still submitting the ethics application to an Additional WA Health HREC (Specialist), then you should complete the WASM and upload the HREA and supporting documents and submit them via the RGS to the Specialist HREC.  At this time, you are unable to submit ethics applications using the RGS to jurisdictions other than WA Health. You must print the WASM and submit it along with your ethics application to the external HREC outside of RGS (refer to WA Health NMA Guidelines).

 NMA FD Ethics.JPG

External Lead HREC Only

1. For NMA, if an External HREC (outside of WA Heath) is the Lead HREC at this time, you are unable to submit ethics applications using the RGS to jurisdictions other than WA Health. You must complete and print the WASM and submit it along with your ethics application to the external HREC outside of RGS (refer to WA Health NMA Guidelines).

NMAExternalHREC.JPG 

2. When the External Lead HREC has approved the ethics application, the CPI or CPI Delegate, must upload to the Ethics Approval Active section, the approved HREA and supporting documents (including the ethics approval letter) and submit them with the approved WASM to the RG Office. Refer to Help Wiki: Ethics Submission, Validation and Review Assessment.

NMA Submit to RG.JPG 

Add an ethics form  ​

1. In the project's workspace, click on the Forms & Documents tab.

Forms and Docs menu.png 

2. Click on the '+' sign next to the desired phase (e.g. Applications) and category (e.g. Ethics Approval, Site Authorisation) grouping to expand that section.  To add an ethics form, you must click on the 'Applications', 'Ethics Approval' and 'Active' groupings to see the 'Forms' grid and the corresponding buttons. 

A form may be added only after the required sections of the Project Details tab have been completed and authorised.  Otherwise, you will be prompted with an error message in the Ethics Approval section of the Forms & Documents tab.   Click on the link to the Project Details tab and complete and authorise the required sections (refer to Help Wiki: Fill out and authorise Project Details).

FD message - PD ethics.png 

If the user changes anything in Project Details tab, any Active forms (i.e. unsubmitted) marked as complete must be unlocked, to ensure the updated information is populated into the forms and there are no additional questions that have to be answered or answers that should be amended.

3. Click 'Add' under the 'Forms' grid. The 'Add Selected Forms' screen will automatically launch.

FD Active Ethics Forms.png           

4. 'Select' either the WA Health Ethics Application (WAHEAF) OR WA Specific Module (WASM) and then click 'Add Selected Forms to Project'. The WASM should be selected if you are intending to use the HREA as your ethics application form. The HREA must be completed externally and uploaded to the RGS as a supporting document.

The RGS will only allow you to add either the WAHEAF or WASM. These form options will disappear from this screen once an ethics form has been added to the project.

           Add ethics form.jpg           
       

5. When the form is successfully added, you will be directed back to the Forms & Documents tab. Version 1.0 of the selected ethics form now appears under the 'Ethics Approval', 'Active' section of the Forms & Documents tab. For ethics approval, a project can have only one 'Active' form at a time. If you added the incorrect form, you must remove the existing form by selecting it and clicking 'Remove' before adding the correct one.

Remove WAHEAF.jpg

6. All Project Members can click on the embedded link in the form name to open it, allowing for viewing or editing. 

Forms and Docs active form waheaf.png 

​Following submission, if the Ethics Executive Officer (EEO) requires revisions to a form and has marked it as 'Additional Information Required' (AIR) in the 'Submitted' grid, a new version of the form will automatically be created under the 'Active' grid.  You must implement the required changes to this version, which will then be submitted to the EEO for their review (refer to Help Wiki: Ethics Submission, Validation and Review Assessment).

Fill out an ethics form

1. The form created is automatically populated with information previously entered in the Sites tab, Members tab and Project Details tab. Refer to Help Wiki: Fill out and authorise Project Details for the steps to complete and authorise the Project Details tab. To edit the other form fields that were not populated from the Project Details tab, click 'Edit'.   

WAHEAF.JPG         

You are only allowed to edit the section when its status is 'Pending'. If you wish to edit the form and it has a different status, the following will apply:

  • If the status is 'In Use': you may need to contact the Project Member who is editing the form.  The other Project Member must click 'Cancel' or 'Save & Close' to release the lock on the form.  If the Project Member is away for an extended period the CPI or CPI Delegate can 'Force Check-in the form. Alternatively, you may contact the RGS Administrator to 'Force Check-in' the form.

Force check in.jpg 

  • If the status is already 'Completed': the form must be unlocked first by clicking 'Unlock'.  This can be done by any Project Member.
  • If the status is already 'Authorised':  the section must be unauthorised first by clicking 'Unauthorise'. Only the CPI, CPI Delegate can unauthorise the ethics forms.

2. Update the relevant fields. All mandatory fields have a red asterisk (*) next to them. Placing your pointer over the information icon information icon.jpgon the right-hand side of the screen will provide you with tool tips and information about the section or field to be completed. This is only viewable on edit mode.

3.  Click 'Save' to save changes, 'Save & Close' to save changes and exit 'Edit' mode, or 'Cancel' to discard any changes made.

User tip: Click 'Save' every 5-10 minutes to ensure entered data is saved. You can click 'Save and Close' at any time and log out of the RGS and then return to the form later.

Save.jpg   

Mandatory fields         

If a mandatory field is left blank when you 'Mark Complete' or click 'Next', you will receive a notification error and the RGS will automatically highlight fields that require mandatory information entered.

Project Details Ethics Information mandatory field error.PNGUse the form index               

You may navigate through different sections of a form by clicking on a section title in the 'Form Index' found on the upper right-hand corner of the form.  However, note that whilst in edit mode you are only allowed to move to the next section once all mandatory fields for the current section have been provided. For example, there are seven sections within the WAHEAF that require completion:

WAHEAF2.JPG 

Pasting in data from other sources

You have the ability to paste data into the form from word documents by right clicking on the section and a 'paste' symbol appears. However note, that if you are pasting text with links to 'Endnotes' or 'Footnotes' for citations; the text should first be pasted into a word document to break the link/code with the 'Endnotes' or 'Footnotes' and then pasted into RGS. The Endnotes can then be added to the RGS field separately.

Enter data in multi-select fields

If a field allows multiple selections, click on the desired option to add it into the list.  If you have selected an option in error and wish to remove it, click on the X beside the option.  

Project Details Ethics Information nhmrc for.PNG                

Enter data in rich text fields

Rich text fields for entering free text show a character or word count on the bottom left-hand corner of the box.  Use this as guide to ensure you do not go beyond the limit; otherwise, you will be prompted with an error.   
Project Details Ethics Information rich text count.PNG
 
You may also drag the border of the box to extend its length.
Project Details Ethics Information rich text drag.PNG 
               

Click on your web browser's Refresh button to fetch the latest information

If changes were made to the Sites tab, Members tab or Project Details tab, click the web browser's Refresh button (typically F5 in your keyboard) to fetch the latest information and to refresh the current form.  Below is an example, if Google Chrome is used:
               
Web browser's refresh.png

4. If a Project Member has completed all of the form's fields and the form is ready for signing and authorisation, click 'Mark Complete'. The form's status is now 'Completed', this is to inform all Project Members that the form has been finalised and is ready for authorisation.   

Project Details Ethics Information mark as complete.PNG​​

Sign, authorise and unauthorise an ethics form

Once marked complete, if you have the authority to sign or authorise a form, a 'Sign' or 'Authorise' button will appear.

Sign and Authorise

The WAHEAF requires the PIs and then the CPI to sign the form in the Declarations section prior to authorisation. The CPI will automatically sign and authorise the WAHEAF, when they click 'Authorise' within the form. The WASM has no required signatures and requires authorisation only by the CPI. Only the CPI can authorise an ethics form.

1. To sign and/or authorise a WASM or WAHEAF, click on the embedded link in the form located in the project workspace's Forms & Documents tab, under 'Applications', 'Ethics Approval', 'Active' groupings.

2. For the WAHEAF, navigate to the 'Declaration' page. If you are the PI, click 'Sign' next to your name.  

 sign WAHEAF.png

3. If you are the CPI, the Authorise button will not appear until all the PIs have signed the WAHEAF. Once this is done, click 'Authorise'.

User tip: Select F5 to refresh the page if you are the CPI & PI and have selected Mark Complete and the Authorise button does not appear.

Sign Declaration.jpg 

After authorising a form, the 'Unauthorise' button should appear. To exit the form, click on the Forms & Documents tab at the top of the form.   

WASM.jpg 

Alternatively, a CPI can authorise and a CPI or CPI Delegate can unauthorise a form in the project workspace's Forms & Documents tab after selecting a form or document.

Forms and Docs authorise WAHEAF.png 

4. Once a form is authorised, the CPI and CPI Delegate will now be allowed to submit them to a HREC. Refer to Help Wiki: Ethics Submission, Validation and Review Assessment.

Unauthorise

Only the CPI and CPI Delegate can unauthorise an ethics form. Note that when you unauthorise the WAHEAF, you will have to re-invite the PIs to re-sign the form, prior to the CPI re-signing and authorising the form

1. You can unauthorise a form in the project workspace's Forms & Documents tab after selecting a form or document and clicking 'Unauthorise'.

2. Alternatively in the form, click 'Unauthorise'. Click 'Edit', make your changes and then click 'Mark Complete'.

3.  If you are the CPI click 'Authorise'. To exit the form, click on the Forms & Documents tab at the top of the form.

Unauthorise.jpg 

Systematic unauthorisation of the ethics forms

​Note that changes to the project will trigger certain forms to be automatically unauthorised:

Location of changes made WAHEAF​ WA Specific Module​ ​Site Specific Assessment Form Access Request Form​
Sites tab 
​UnauthoriseUnauthorise​​Unauthorise only the form that includes a site that has been removed​Unauthorise only the form that includes a site that has been removed
​Members tab​UnauthoriseKeep as 'Authorised'​​Unauthorise only the form(s) with changesUnauthorise only when the CPI is changed​
Project Details tab - Project HeaderUnauthorise​​Unauthorise​Unauthorise​Unauthorise
Project Details tab -
Ethics Information
​Unauthorise​Unauthorise​Unauthorise​Unauthorise
​Project Details tab - Governance Information​Keep as 'Authorised'​​Keep as 'Authorised'​​Unauthorise​Keep as 'Authorised'​
Project Details tab - Investigator Contact Information​​UnauthoriseKeep as 'Authorised'​​Unauthorise​Keep as 'Authorised'​​

 

Other references

Researchers Training Manual (Part A)

Researchers Training Manual (Part B)

​​

Copyright © Department of Health WA  |  Terms of Use  |  Privacy Policy

Technical Assistance:

Hours: 9.00am to 5.00pm AWST (Mon - Fri)
WA Health employees: Contact your Service Desk for password and sign in issues
All other enquiries: Email RGS.Support@health.wa.gov.au