Apply for governance authorisation

Each Queensland Health facility is responsible for research that's done onsite. You need a site-specific assessment (SSA) before your research project can start.

Overview

If you're planning to do research at a Darling Downs Health site, you’ll need to submit an SSA application using the Ethical Review Manager (ERM).

Make sure you have ethics approval before you submit your SSA application.

Help with your application

Your site-specific application isn’t valid until you’ve submitted all your paperwork. We won’t assess incomplete applications.

You’ll need your SSA approval letter before you start your research at the site.

The Darling Downs Health Research Governance Officer is able to help researchers with:

  • SSA forms and the application processes for site authorisation, including relevant site contacts such as Director of Finance and heads of department
  • Negotiation of research contracts, including getting Darling Downs Health legal review where required
  • Guidance regarding legislation, policies and standards relating to the conduct of research, including access to confidential health information under the Public Health Act 2005
  • Education and training for new and experienced researchers to enhance the quality and conduct of research and meeting good practice guidelines
  • Monitoring of research, including responding to concerns about research conduct.

How do I apply?

Step 1. Prepare your supporting documents

You'll need to submit the following supporting documents with your SSA application.

Required documents

  1. Cover letter listing all documents you are presenting for review (with versions and dates)
  2. Initial approval letter from the Human Research Ethics Committee (HREC) and any HREC approval letters relating to amendments made to study documents (if applicable)
  3. Human research ethics application
  4. Research protocol
  5. CV for the principal investigator.

Supporting documents

You only need to provide this information if it's relevant to your project.

  • Approved study documentation including:
    • a data collection tool such as a Queensland Advancing Clinical Research Fellowships (CRF)
    • the investigator brochure
    • questionnaires and other instruments
    • advertising materials including transcripts for ads, emails, websites, letters or phone calls
    • a letter of invitation or letter to a GP
    • participant diaries or wallet cards
    • a letter of support from the relevant Indigenous Health Group Research funding schedule (budget)
  • Medicines Australia Form of Indemnity
  • Insurance certificate
  • Clinical Trial Notification
  • Research contract
  • Good Clinical Practice (GCP) Certificate (for clinical trials only)
  • Public Health Act (PHA) approval.

The National Health and Medical Research Council has Participant information and consent form (PICF) templates for researchers. It’s not compulsory to use them, but they’re useful tools.

The SSA submission checklist (PDF 279 kB) will help you keep track of the documents you need for your application.

Step 2. Get signatures and endorsements

Study budget

You’ll need to fill in a Study budget template (PDF 94 kB) for your studies. This applies for actual or in-kind costs. It will then need to be signed off by the relevant departmental business manager or hospital business manager.

Our health research governance officer can help you get this signature.

Step 3. Submit your application

Submit your application using the Ethical Review Manager (ERM), along with all the documents approved by the Human Research Ethics Committee.

View ERM how-to guides.

Ethics and Research Governance Review Fees

Each research application has a fee for a new project and a major amendment to a project.

Read our Schedule of Fees (PDF, 157 kB).

Next steps

After the Research Governance Officer has done their review, you’ll get an email to let you know the outcome of your application.

Reporting requirements

If your research has been given ethics approval and governance authorisation you’ll have reporting requirements.

  1. Fill in the Commencement form (PDF, 864 kB) when you begin your research.
  2. Submit an Annual Report form (DOCX, 819 kB) on 30 April each year.
  3. Complete Final Report form (DOCX, 819 kB) – within 6 months of completing your study.

Last updated: April 2022