Researchers Training Manual (Part A)
Researchers Training Manual (Part B)
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:
Project Member Role
All Project Members
All Project Members, except Sponsor
CPI or CPI Delegate
CPI and PI
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):
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.
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.
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.
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).
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).
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.
1. In the project's workspace, click on the Forms & Documents tab.
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).
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.
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.
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.
6. All Project Members can click on the embedded link in the form name to open it, allowing for viewing or editing.
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).
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'.
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:
2. Update the relevant fields. All mandatory fields have a red asterisk (*) next to them. Placing your pointer over the information icon
on 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.
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:
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.
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.
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.
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.
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.
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.
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.
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.
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.
Note that changes to the project will trigger certain forms to be automatically unauthorised:
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