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Ethics Submission, Validation and Review Assessment

Other references

Researchers Training Manual (Part A)

Researchers Training Manual (Part B)

In this page... 

Submission

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). 

Ethics submission (1).png

     
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'.

Ethics submission (2).png 

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.

Submit to Ethics successful message.png
Note that you cannot submit another form or document until the validation of any previous submission has been completed.

WA Health Lead HREC (With a WA Health Specialist HREC)

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.

SUbmit to 2 HRECS.JPG 

2. The forms and documents will move to the 'Submitted' section of the Forms & Documents tab. Click 'Submit to Ethics'.

Submit to 2 HRECS1.JPG 

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'.

 Submit to 2 HRECS2.JPG

4. The forms and documents will move to 'Submitted' in the Forms & Documents tab and be displayed for both HRECs.

Submit to 2 HRECS3.JPG 

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 will only be able to select the Specialist HREC as currently RGS only allows submission of an ethics application to a WA Health HREC.

NMA submit ethics.JPG 

External Lead HREC Only

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.

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3. The Submit External Ethics to RG Office screen will launch. Select the RG Office, WASM and documents for submission. Click 'Submit Project'.

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4. The submitted WASM and documents will be displayed under 'Submitted' against the RG Office name and a .successful submission notification will display.

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Validation

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.

Validation email.JPG 

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'.

   Submitted ethics.JPG 

2. The View Validation Assessment screen will launch for you to review the validation status and comments.

Validation.JPG 

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.

validation2.jpg 

3. 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.  

EthicsAIR.JPG EthicsAIR3.JPG

4. 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.

EthicsAIR2.JPG 

EthicsAIR4.JPG 

5. If the review assessment is 'Not Valid', then no place holder is created, so another version of the form or document cannot be resubmitted.

EthicsAIR5.JPG 

Review Assessment

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:

Review Ass.jpg 

2. You can track the approval of your projects forms & documents in the Forms & Documents tab:

  • 'Review Decision Date' is when the committee review is completed and the EEO enters the decision of the review (i.e. generates a letter).
  • 'Status' reflects either the validation or committee review decision
  • 'Approval Decision Date' is the date the forms and documents were approved at the committee meeting. The Approval Decision Date for the WASM or WAHEAF is the same date as the HREC approval date.

Review Ass2.jpg 

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.

Review Ass3.jpg 

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. 

Review Ass4.jpg 

5. The Project ethics approval status of the Lead HREC is displayed in the Project Header:

Review Ass5.jpg 

 

Other references

Researchers Training Manual (Part A)

Researchers Training Manual (Part B)


 


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