Low Risk Research
Audit based research at Southern Adelaide Local Health Network (SALHN) has no patient contact and involves accessing patient’s medical records to collect data to answer a hypothesis.
There are two types of audits:
- Retrospective – accessing patients records between a date range that is in the past
- Prospective – accessing patient records between a date range from submission your application to any date in the future.
If the audit is prospective, please submit a low and negligible risk application.
Audit based research applications are reviewed out of session and do not go to full committee.
- Retrospective audit access request form for SAC HREC approval and governance authorisation at SALHN (DOC 89KB)
Low Negligible Risk
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 Negligible Risk (LNR) applications are reviewed out of session and do not go to full committee, unless they contain a request for waiver of consent, involve a vulnerable participant population or are being submitted under NMA.
If issues are identified by the committee in the review that require further review, it may be referred to the next available full committee meeting.
- Cover Letter for Ethics and Governance Submissions (DOC 92KB)
- Low and Negligible Risk Form - for ethics and SALHN governance concurrent application submissions (DOC 61KB)
- Study Protocol Template – for ethics and SALHN governance concurrent application submissions (DOC 99KB)
- Participant Information Sheet/Consent Form Template
- Participant Information Sheet/Consent Form Contact Details (PDF 139KB)
Non-SALHN employee supporting documentation
- Non-SALHN employee - Confidentiality Deed non-SALHN employee (DOC 299KB)
- SALHN Co-Principal Investigator Form (PDF 192KB)