Low and Negligible Risk
Clinical Case Reports
A SCHN Clinical Case Report (CCR) application is to be submitted via email from an organisational email address to the Research Ethics Office if you are:
- Conducting a retrospective review/case study of less than 10 patient records resulting in the potential for individual identification with publication.
Please note that consent will need to be obtained from the families for the patients’ records which are to be accessed.
The National Statement provides a broad definition of Low and Negligible Risk (LNR) research as:
- Negligible risk - any foreseeable risks is no more than inconvenience (e.g. short non-personal surveys).
- Low risk - only foreseeable risk are one of discomfort (e.g. non-invasive medical assessments or anxiety as result of interview/survey)
It is important to know that interviews/surveys may be considered as Greater than Low Risk (GLR) depending on the targeted population group or the content of the surveys/interviews.
If clarification is required by researchers regarding which level of risk their study would be classified as, it is strongly encouraged to consult with the Research Ethics Office regarding the level of risk in their projects before they begin preparing their applications.
Quality improvement projects
Quality Improvement (QI) projects can only be undertaken by SCHN staff and do not require approval from SCHN HREC.
The SCHN Clinical Governance Unit manages the review and approval of QIs. Please see our Intranet page for more information or email the Clinical Governance Unit Quality team.
Submission resources
- LNR submission guidelines
- LNR protocol template (optional resource to support your application)
- LNR submission checklist: LNRs and retrospective record review
- LNR prospective studies general tips
- LNR retrospective studies general tips
- CCR application form
- CCR information consent form template
- CCR general tips
Submission closing dates
There are no submission deadlines for new LNR submissions.