Low risk research

As per the National Statement chapter 2.1.6, low risk research is defined as 'the only foreseeable risk is one of discomfort. Research in which the risk for participants is more serious than discomfort is not low risk'.

As a rule, Low Risk applications are reviewed out of session via the Expedited Review Panel and do not go to full committee, unless they contain a request for waiver of consent (active participation in the research), involve a vulnerable participant population or are being submitted under the National Mutual Acceptance (NMA).

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 on our Training Resources page / A-CTE.

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.

Low risk application submission

As of 01 April 2025, all low-risk applications are submitted on GEMs via the Low-Risk Pathway and will continue to be reviewed via the Expedited Review Panel.

Please review the National Statement carefully before choosing to complete a Low Risk Application Form via the ERP pathway. If incorrect, the reviewers will request you to resubmit your application via the Greater than Low Risk Pathway, also on GEMS.

The following triggers will identify your research as greater than low risk, in which case you will follow the Greater than Low Risk Pathway and submit your application via GEMS:

  • Studies among Aboriginal / Torres Strait Islander people
  • Involvement of vulnerable population groups such as mental illness, cognitive or intellectual impairment, pregnant women, or their foetus
  • Interventions which may cause a higher risk of harm and foreseeable burden to the individual, group, community, societal or global
  • You have requested an opt out or waiver of consent (where there is active participation)
  • Genetic testing studies
  • Creation of a databank, biobank, or registry
  • Exploration of sensitive personal or cultural issues.

Essential documents

  • HREA - in GEMs
  • Protocol
  • PICF
  • Surveys and questionnaires
  • Recruitment material
  • SSA (governance application)

Templates

Guidelines