New projects which are considered to be low or negligible risk are eligible for expedited review by the HREC Executive.
The Research Office advises that researchers discuss their project with a member of Research Office staff PRIOR TO SUBMISSION to determine whether it is eligible for the low risk pathway or requires review by the full HREC.
Your submission must be prepared using the HREA via REGIS website, please contact the Research Office for further information.
All applications will be submitted on a HREA form regardless of risk level.
The HREA has been designed as a smart form to accommodate all risk levels: you only need to answer questions which relate to the type of research you are proposing.
HREA question 4.5 will ask under which review pathway you are intending to submit the application (greater than low risk,
low risk, negligible risk).
Applications not completed according to the requirements set out in the submission checklist will not be accepted.
National Statement Low Risk Definition
The National Statement defines low risk research as follows, "Research is 'low risk' where the only foreseeable risk is one of discomfort. Where the risk, even if unlikely, is more serious than discomfort, the research is not low risk." (Chapter 2.1)
Examples of low/negligible risk research include (but are not limited to):
Used of previously stored human tissue (consent for storage of that tissue for research will also need to be considered)
Anonymous questionnaires/surveys in non-sensitive populations
Medical record review/retrospective review where all data extracted are coded or de-identified.
Examples of research which are not LNR include (but are not limited to):
Collection of a blood specimen (although in some instances, an additional specimen may be added at the time of routine collection)
Research in sensitive/vulnerable populations
Research that changes a participant's standard management, for example changes to an intervention or addition of non-routine investigations.
SSA for Low Risk Projects
At NSLHD the Site Specific Authorisation (SSA) assessment for low risk projects is submitted concurrently with the HREA submission to the HREC Executive. Please consult the SSA Checklist to ensure that all documents are completed correctly. For more information, please refer to the Governance information on this website.
Guidance regarding appropriate sign-off from Health Information Services for studies using/accessing medical records can be found here.
If your study involves access to medical records, Health Information Services requires you to follow their standard practices and instructions for record retrieval. Note: this can only be done once you have both HREC and SSA approval/authorisation for your study.