According to The NHMRC National Statement on Ethical Conduct in Human Research (2023), low-risk research refers to research, including certain clinical trials, which pose no foreseeable risk greater than discomfort. Therefore, any research that carries a risk of harm beyond discomfort is not considered low-risk research and falls under the category of higher-risk research. Higher-risk research requires review by a HREC.
To conduct research studies within CALHN, both ethics approval and governance authorisation are required for all low risk projects. Submission types:
- Ethics and Governance review: All research projects that involve a CALHN site and are not ethically approved by an NMA certified HREC require CALHN ethics and governance review. Further information on the NMA scheme and participating sites is available from the NHMRC website.
- Governance only review: where a research proposal is approved by a SA Health HREC or interstate NMA HREC a governance review is required. Please note: Low-risk applications are not considered under the NMA scheme by SA Health, other than where a full HREC has reviewed the application.
- Ethics only review: Research projects conducted at an SA Health site that require ethical approval. Please contact the relevant research governance office for the initial governance review to ensure compliance with their site specific requirements before submitting to CALHN research office for ethics review.
For all submission types, an Ethics and Governance Application (EGA) Form must be submitted for assessment by the CALHN Expedited Review Panel (ERP).