All Health/Medical Research projects must have ethical approval and Research Governance authorisation prior to commencing at a CALHN site.
Human Research Ethics review considers the ethical acceptability and scientific validity of research Health/Medical Research projects, evaluating benefits and risks of the project to participants. Applications are submitted and assessed via the Human Research Ethics Application (HREA) form.
Research Governance review considers CALHN’s responsibilities of managing the quality, safety, privacy, risk, finances and ethical acceptability of research. Applications are submitted and reviewed via the Site Specific Assessment (SSA) form.
Health/Medical Research Projects conducted at a Central Adelaide Local Network (CALHN) site that are greater than low/negligible risk, and/or that include participating sites outside of South Australia, require ethical review and approval by a full Human Research Ethics Committee (HREC) – either by the CALHN HREC or a HREC certified in the National Mutual Acceptance System.
Please note that Research GEMS does not currently support expedited review of low/negligible risk (LNR) research submissions. See LNR submission requirements here.
Ethical Review – National Mutual Acceptance
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 National Mutual Acceptance scheme (NMA).
CALHN is a participating NMA organisation and the Central Adelaide Local Health Network HREC is a NMA Certified Human Research Ethics Committee.
Please note: Under the SA Health Research Ethics Policy Directive South Australian public health institutions do not accept HREC approval under the NMA scheme for First in Human, Phase 0 and Phase 1 Clinical Trials, and Aboriginal and Torres Strait Islander projects. These projects must be submitted for ethical review by a SA Health HREC.
Further information about CALHN HREC member composition, meeting dates, submission deadlines and contact details is available here.
Further information about the National Mutual Acceptance scheme, and a list of participating HRECs and Organisations is available here.
Research GEMS – Submission guidelines
SA Health has implemented a new research application management system called Research Governance and Ethics Management System (Research GEMS) to replace Online Forms for submission of HREA and SSA applications.
Researchers must ensure that all relevant study documentation (eg study protocol, Participant Information and Consent Form etc) are provided via Research GEMS, in addition to completion of the relevant form(s).
CALHN GEMS Guideline – Preparing Project Registration and HREA
CALHN HREC Submission Covering Letter
CALHN GEMS Guideline – Preparing SSA Applications
CALHN GEMS Guideline – SSA Part C – Approvals from Departments and Services
CALHN Research GEMS Demonstration – BHI Presentation Slides 08 April 2021
For ethical enquiries and further information, contact CALHN Research Services
on 08 7117 2228, or via email at [email protected].
For governance enquiries and further information, contact CALHN Research Services on
08 7117 2230, or via email at [email protected].
For enquiries regarding submissions requiring only CALHN HREC review (i.e. not being conducted at a CALHN site) please contact the CALHN HREC team as above and the participating site’s local Research Governance Officer.
