Site-Specific Assessment - GH SJOG HREC

SSA - For projects reviewed by GH SJOG HREC

If your project is obtaining its ethics approval from the Grampians Health and St John of God Hospital Ballarat HREC, and it will involve research activity at or through Grampians Health, then there is an extra step that’s required AFTER you’ve secured your ethics approval: you need to obtain research governance authorisation of the project. 

And you cannot commence research activity until you’ve completed this final step.

This step is done via ERM, and essentially involves obtaining the signature of the relevant Head of Department to demonstrate their approval of the study, and making sure that any required agreements are in place with external organisations.

How do I get research governance authorisation after my GH SJOG HREC ethics approval?

1. First, create the “Site-Specific Assessment (SSA)” (or “Low Risk Site-Specific Assessment (LRSSA)”) sub-form in ERM

  • Navigate to your project in ERM.
  • Click the “Create Sub-Form” action tile on the left-hand side.
  • Choose the LR SSA sub-form (if you did the LR pathway, i.e. low risk ethics) or SSA sub-form (if you did a HREA, i.e. greater-than-low-risk ethics).
  • Complete the fields (a number should copy over from your ethics application).

2. Attach a Research Agreement if needed

If you’re collaborating with an organisation outside GH, including having non-GH staff members on the research team, a research agreement is likely needed.

See more: Contracts and Agreements

Please feel free to contact us to discuss.

3. Attach documents for any student investigators

If any members of the research team are students (e.g. university students), some extra paperwork is needed to cover their involvement. This is:

  • a copy of the Student Placement Agreement (fully executed, between the student’s university and GH)
  • a letter/document/email from the university confirming that that student is indeed enrolled in the course specified in the placement agreement
  • the student’s CV
  • a Confidentiality Agreement signed by the student

4. Get relevant signatures

The SSA/LRSSA, when completed with everything attached, needs to be signed by:

  • The GH Principal Investigator
  • The relevant Head of Department (HOD). If the HOD is on the project team, then they cannot sign approval – rather, the person to whom they report must sign as approving HOD.
  • ERM has a signing function that should make this pretty straightforward for anyone who has an ERM account.

Submit to us!

We will review the submission and let you know if anything’s missing. Otherwise, we will issue an authorisation letter – and organise for any research agreement to be signed by the correct person at Grampians Health – and you’ll be set to start your research!