Your application is checked for validity before being assigned for review.
If your application is invalid (that is, either incomplete or outside the scope of HDEC review), we will advise you of this in writing.
Valid applications are assigned for HDEC review through one of these two pathways:
If your application is valid, we will advise you in writing of the pathway by which it will be reviewed. If this is the full review pathway, we will also provide details of the relevant meeting, and invite you to attend in person or by phone.
The HDEC review process is set out in detail in the Standard Operating Procedures for Health and Disability Ethics Committees (SOPs): Read more about the SOPs for HDECs.
Higher-risk applications are reviewed by the full review pathway. This means that a decision is made on the application at an HDEC meeting held in accordance with section 5 of the SOPs for HDECs. Final decisions on full review applications must be made within 35 days.
Lower-risk applications are reviewed by the expedited review pathway. This means that a decision is made on the application between meetings, by a sub-committee of HDEC members, including the Chair. Final decisions on applications reviewed by the expedited review pathway, which is described in section 6 of the SOPs for HDECs, must be made within 15 days.
HDECs must make one of the following decisions on each application they review:
We will advise you in writing of the decision that has been made on your application.
You should usually commence your study within 12 months of HDEC approval. HDEC approval is automatically cancelled where a study has not commenced within 24 months.
Procedural rules around amendments and other post-approval items are contained in sections 11 and 12 of the SOPs for HDECs. These require researchers to:
Serious adverse events do not need to be individually reported to HDECs.