Low risk research at SALHN
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 general rule, Low Risk applications are reviewed out of session 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).
If issues are identified by the committee that require further review, it may be referred to the next available full committee meeting.
The Office for Research has a Training Resources page, which contains useful resources to assist you with the preparation, writing and submission of your application.
Low risk application submission
Low risk applications are submitted via email and are reviewed by the Expedited Review Panel (ERP).
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 via GEMS.
Do not submit a low risk application via 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.
Low risk application documentation
- Low Risk Form - for ethics and SALHN governance concurrent application submissions (DOC 829KB)
- Low Risk Protocol (DOC 100KB)
- Participant Information Sheet/Consent Form Template
- Participant Information Sheet/Consent Form Contact Details (PDF 139KB)
Non-SALHN employee supporting documentation (required per person)
- SALHN Co-Principal Investigator Form (PDF 192KB)
- Current National Police Check issued within the past 12 months
- Insurance certificate of currency — showing that the non-SALHN employee is covered for indemnity by their organisation