Research which involves a risk of harm is considered more than low risk research. (National Statement paragraphs 5.1.19 to 5.1.23) and is submitted via GEMS.

The SALHN Research Hub has a Training Resources page, which contains useful resources to assist you with the preparation, writing and submission of your application.

Good Clinical Practice training is required by all listed investigators, as per National Clinical Trials Governance Framework (Action 1.2 and 1.6.)  A free Good Clinical Practice course can be found under Training Resources.

SAC HREC meeting dates can be found on the Southern Adelaide Clinical Human Research Ethics Committee page.

Essential documents

  • HREA - in GEMs
  • Protocol
  • PICF
  • Surveys and questionnaires
  • Recruitment materials

For all research involving SALHN staff, patients, patient data or facilities, a Site-Specific Assessment (SSA) Governance application will be required. Research Governance is a review of the quality, safety, privacy, risk management, financial management and ethical acceptability of research specifically at SALHN. Please refer to our Research Governance page for more information.

Templates

Guidelines