Human Research Ethics Committee (HREC) submissions

The HREC conducts ethical and scientific reviews of research considered greater than low risk.

All research conducted at CALHN requires both ethical approval and governance authorisation. All greater than low risk applications are submitted and assessed via the Human Research Ethics Application (HREA) form through the SA Health Governance and Ethics Management System (GEMS). GEMS user guides are available on the SA Health website.

The CALHN HREC aligns with the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research (2023) and is accredited under the National Mutual Acceptance (NMA) scheme to review applications in the following areas:

• clinical trials – phases I, II, III, IV
• clinical research other than clinical trials
• population health and/or public health
• qualitative health research
• mental health.

The committee meets two times a month ensuring that research meets ethical and scientific standards in accordance with the NHMRC and relevant legislative policy and requirements.

Australian state and territory departments of health have signed a memorandum of understanding for mutual acceptance of scientific and ethical review of multi-centre human research projects undertaken in public health organisations, known as the NMA scheme.

CALHN is a participating NMA organisation and CALHN HREC is NMA certified.

Under the SA Health Research Ethics and Governance Policy Directive South Australian public health institutions do not accept HREC approval under the NMA scheme for:

• first in human
• phase 0 clinical trials
• phase 1 clinical trials
• Aboriginal and Torres Strait Islander projects. 

These projects must be submitted for ethical review by a SA Health HREC.

Search NMA on the SA Health website for further information about the National Mutual Acceptance scheme.