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Add, fill out and authorise an ethics form

Other references

Researchers User Guide (Part A)

Researchers User Guide (Part B)

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​​​​​​​​​​​​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:

Ethics Forms.PNG 

Green – create, edit, force check-in, authorise and submit
Orange – create, edit

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 in the Applications tab under the Ethics Approval section.

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):

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

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

The form to be used in based on the type of review and whether the HREC is within WA Health and if a Specialist HREC (e.g. Department of Health HREC) is also reviewing the project as data linkage is a component of the project.  Refer to the Research Governance Procedures section 4 (ethics) and 7 (governance) for further information.

HREC forms.PNG

When the External Lead HREC has approved the ethics application, the CPI or CPI Delegate, must upload to the Applications tab under the Ethics Approval Active section, the approved HREA and supporting documents (including the HREC 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 Applications tab.

Forms and Docs menu.png 

2. Click on the '+' sign next to Ethics Approval to expand that section.  To add an ethics form, you must expand 'Ethics Approval' first and then 'Active' 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 message in the Ethics Approval section of the 'Applications' 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. Once the form has been added, you will be taken back to the Applications tab. Version 1.0 of the selected ethics form now appears under the 'Ethics Approval', 'Active' section of the tab.  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 HREC Office requires revisions to a form its status will be 'Additional Information Required' (AIR) in the 'Submitted' section, a new version of the form will automatically be created under the 'Active' section.  You must implement the required changes to the version in the Active section, which will then be submitted to the HREC Office for their review (refer to Help Wiki: Ethics Submission, Validation and Review Assessment).

Fill out an ethics form

1. The form is automatically populated with information previously entered in the Sites tab, Members tab and Project Details tab. To complete the rest of the form, click 'Edit'.   If you haven't clicked Edit you can click ‘Close’ to close the form and return to the Applications tab.  To navigate through the form at anytime click the 'Next' or 'Previous' buttons or you can use the Index to go to a specific section of the form.

WAHEAF.JPG         

You can only edit the form 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': This means another Project Member is editing the form, you will need to contact them, so they can click '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 (take it out of edit mode). Alternatively, you may contact the RGS Support to 'Force Check-in' the form.

Force check in.jpg 

  • If the status is already 'Completed': All mandatory fields in the form have been completed, the form must be unlocked first by clicking 'Unlock' located at the bottom of the form.  This can be done by any Project Member.
  • If the status is already 'Authorised':  the form 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, in red, 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, 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.  The index will show

  • Green is the sections have been completed
    Black is the last section edited or currently being edited
  • Grey is any section after the section last edited or being edited as answers given in a section will determine the questions asked in the following sections.

WAHEAF2.JPG 

Whilst in edit mode, you can only use the index to navigate through the completed section (green) up to the black section of the form. When you click ‘Edit’ you will be taken to the last edited section of the form.

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 

Pasting in data from other sources

You have the ability to paste data into the form from Word and other 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.  The Hyperlink in any text should be removed prior to pasting into a text field.

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 and/or authorise a form, a 'Sign & Authorise' button will appear.  Only the CPI can authorise the WAHEAF. The WASM can be authorised by either the CPI or CPI Delegate.

Forms and Docs authorise WAHEAF.png

1. To sign and authorise the WAHEAF, in the Applications tab under 'Ethics Approval', 'Active' click on the embedded link in the form name.

2. Navigate to the 'Declaration' page, click the Sign & Authorise button, this button is only enabled for the CPI.  

WAHEAF signature.PNG

Alternately is the form has the status of Complete the CPI can sign and authorise the form by going to the Applications tab and ticking the box under Select and clicking the Authorise button which will be enabled., and this is the same as opening the form and clicking the 'Sign & Authorise' button.

WAHEAF authorise.PNG 

When the WASM has the status of Completed it can be authorised by the CPI or CPI Delegate in the Applications tab by ticking the box under Select and clicking the Authorise button which will be enabled.

WASM for authorised.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 Applications tab after selecting the form clicking 'Unauthorise'.  The form can then be edited and the authorised again.

WASM unauthorised.PNG

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