In this section
Refer to advice on the New applications page that applies to all studies regardless of submission type. This will include:
If your study has received ethical approval from a certified HREC other than the RCH, as part of the National Mutual Acceptance (NMA) scheme, you need to submit a
Governance Only ‘Site Specific Assessment (SSA)’ Application.
There are no closing dates for SSA applications – they can be submitted for review at any time.
A governance only SSA submission in ERM can be done in either of two ways. The SSA form may be created by:
OPTION 1: Using the existing ERM Human Research Ethics Application (HREA) that has already been created by a lead site who uses ERM. Victoria and Queensland sites use ERM.
OPTION 2: Creating a Minimal Dataset Form (MDF) to be used as a proxy form when the lead site does not use ERM. In this option the HREA needs to be attached as an uploaded document when prompted. Following the completion of the MDF the SSA can be created as a sub-form for the governance application. NOTE: If an MDF has already been created by another participating site this can be used. Only one MDF is required so that the study maintains the one ERM Project Id number.
If OPTION 1: using the ERM HREA is applicable, the RCH REG office can access all the original ethics documents that were submitted to the HREC. Therefore these do not need to be re-uploaded to the SSA form. HOWEVER, if there have been subsequent amendments the REG office cannot access these and therefore you are prompted to upload these amended documents to the SSA.
In the above situation it can be difficult for the REG reviewer to determine what is the full set of current documents. Multiple ethics amendments further exacerbate this situation. To assist the REG reviewer to understand the full set of current documents and for us to subsequently provide a more efficient review we suggest providing a zip file of the current ethically approved set. This can be labelled 'Current Ethics Set [date]' and uploaded to the SSA at Supporting Documents.
If OPTION 2: using an MDF is applicable, the researcher needs to manually upload all the documents reviewed in the ethics application to the MDF. If amendments have occurred the same request to provide a zip file applies as above.
The following documents are required when submitting an SSA application for governance authorisation (as applicable):