Researchers User Guide (Part A)
Researchers User Guide (Part B)
1. When all forms and documents for the ethics application are authorised, the CPI or CPI Delegate can select 'Submit to Ethics' button in the Form & Documents tab (you do not have to select the forms and documents at this stage).
2. The 'Submit Project to Ethics' screen will launch and will display all authorised forms and documents. Select the HREC, and forms and documents for submission. Click 'Submit Project'.
An ethics application requires the form and documents to be submitted as a package. If the ethics form is not 'Completed' and 'Authorised' you will receive an error message and you will not be able to progress your application to ethics for review. An ethics application requires either a WAHEAF; or a WASM form and a HREA document uploaded to proceed with the submission.
3. You will receive a screen message advising the successful submission of your ethics application. The forms and documents will move to 'Submitted' in the Forms & Documents tab.
Note that you cannot submit another form or document until the validation of any previous submission has been completed.
1. If you are submitting to a WA Health Lead HREC and an Additional WA Health HREC (Specialist), you be able to submit the same forms and documents to both HRECs. Select the Lead HREC and submit the forms and documents as per steps above.
2. The forms and documents will move to the 'Submitted' section of the Forms & Documents tab. Click 'Submit to Ethics'.
3. The 'Submit Project to Ethics' screen will launch. Select the Specialist HREC, the forms and documents will now be displayed as submitted. Select them and then click 'Submit to Project'.
4. The forms and documents will move to 'Submitted' in the Forms & Documents tab and be displayed for both HRECs.
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 will only be able to select the Specialist HREC as currently RGS only allows submission of an ethics application to a WA Health HREC.
1. 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.
2. Prior to submission, the WASM and the Documents must be authorised by the CPI or CPI Delegate. The CPI, CPI, PI or PI Delegate must click "Submit to RG Office' to submit the approved ethics form and documents to the RG Office for their information.
3. The Submit External Ethics to RG Office screen will launch. Select the RG Office, WASM and documents for submission. Click 'Submit Project'.
4. The submitted WASM and documents will be displayed under 'Submitted' against the RG Office name and a .successful submission notification will display.
1. Following the successful submission of the ethics forms and documents, the EEO will validate the submission. Once completed, the CPI and CPI Delegate will receive an email informing them that the submission has been through the validation process and to review the outcome in RGS.
The outcome of the validation process is viewable in the Forms & Documents tab in the Submitted section. Click on the link in the 'Validation Date' to open the 'View Validation Assessment' screen.
At any time you can print or view a Form or Document(s). For forms click on the name link to view or select the form and click 'Print'. For documents either click on the name link to view or select the document and click 'View'. To print, select the document and click 'Print'.
2. The View Validation Assessment screen will launch for you to review the validation status and comments.
The EEO may decide that
addition information is required (AIR) from the CPI/CPI Delegate if a form or document contains insufficient or incorrect information. The EEO will assign the form or document an 'AIR' status (or Not Valid) and provide information in the 'Comments' box. The CPI/CPI Delegate can read the comment and address this when resubmitting the updated or the correct form/document.
If a form is given the validation status of 'AIR' in the 'Submitted' grid, a new version of the form is created in the 'Active' section of the 'Ethics Approval' (if WAHEAF or WASM). The CPI will need to provide the information requested and submit the new version of the form for validation and review.
If a document is given the validation status of 'AIR' in the 'Submitted' grid, then a placeholder is created in the 'Active' section of the 'Ethics Approval' for the document. The CPI can then provide the additional information and submit a new version of document.
If the review assessment is 'Not Valid', then no place holder is created, so another version of the form or document cannot be resubmitted.
1. If all the forms and documents are valid, they will be added to an ethics committee meeting (Alternative Review, Subcommittee and/or HREC meeting).You can track your project's ethics committee review in the Summary tab:
2. You can track the approval of your projects forms & documents in the Forms & Documents tab:
3. Following a review (at an ethics committee meeting), if the 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 review at the next ethics committee meeting.
4. Following a review (at an ethics committee meeting) If the EEO requires revisions to a document and has marked it as
'Additional Information Required' (AIR) in the 'Submitted' grid, a placeholder for the new version of the document will automatically be created under the 'Active' grid. You must upload the revised document version to this placeholder that addresses the EEO review comments, which should then be submitted to the HREC for review at the next ethics committee meeting.
5. The Project ethics approval status of the Lead HREC is displayed in the Project Header:
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