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Submitting for ethics review

St Vincent's Hospital Sydney Ethics and Governance processes are independent of each other.

For an application to be reviewed at a given meeting, both the hard copy (with original signatures) and electronic copy submission must be received by the Research Office by the relevant submission deadline.

 

From August 31 2017 the HREA (Human Research Ethics Application) form will replace the NEAF and LNR. All new ethics applications regardless of study risk level should be generated on a HREA on the Online Forms website.

Please do not create a HREA at NHMRC’s HREA-generating website, because the ethics committee will not be able to import and review the application.


 

Process for submitting a low risk HREA

Low risk research is reviewed by the HREC Executive.

  1. You must submit a Protocol/Study Outline or completed HREA form to the Research Office SVHS.Research@svha.org.au to confirm your research is low risk.  
  2. Once confirmation has been received, please follow the submission instructions on the Low Risk HREA  - Submission Checklist  (updated August 2017).
  3. Please see information sheets below on how to 'lock' the HREA.

 

Process for submitting to the Full HREC

Research projects deemed greater than low risk are reviewed by the Full HREC.

 

The Research Office must be notified of your intention to submit. Failure to notify the office may result in your application not being able to be accepted onto the agenda for your requested meeting.

 

To submit a project for review by the Full HREC, please follow the Full HREC - Submission Checklist (Updated August 2017).

 

1. HREC Review of Phase ONE Clinical Trials

The Research Office must be notified of an intention to submit a Phase One trial at least 4 weeks prior to the submission deadline for a scheduled HREC meeting.

 

  1. a complete and signed set of study documents must be received 1 week prior to the usual submission deadline for the scheduled HREC meeting.
  2. The Research Office will identify the appropriate expertise for the review and facilitate this review in the required timeframe.  Please note that a $1,000 fee will be applied for this service (payment to the expert).
  3. For further information please contact the Research Office Manager directly on 8382 4960.

 

2. For other studies to be reviewed by the Full HREC

The Research Office must be notified of an intention to submit to the Full HREC at least 1 week before the submission deadline for the meeting.

 

Please see information sheets below on how to 'lock' the HREA.

 

National Mutual Acceptance

  • Currently, New South Wales, Queensland, South Australia, Victoria, Australian Capital Territory and Western Australia participate in National Mutual Acceptance (NMA). Under NMA, from 14 December 2015, all NEW multi-centre Human Research Projects submitted on a HREA conducted across public health sites in the participating jurisdictions are eligible for single ethical review. More information regarding NMA can be found on the NSW Health FAQ page or by contacting the Research Office.

 

 


 

Instructions on how to lock a HREA form (remove draft watermark)

 

Please refer to the relevant submission checklist and contact online forms HELPDESK for technical issues.