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The CALHN HREC is responsible for the ethical and scientific review of research proposals including clinical trials and health/medical research projects. Applications are submitted and assessed via the Human Research Ethics Application (HREA) form.

HREC Information

Submission Documents

Investigator Initiated Research Documents

CALHN GEMS Guideline: Preparing Project Registration and HREA for Investigator Initiated Studies (2.72 MB)
CALHN Investigator Initiated Study Protocol Guideline Clinical Research (217 KB)
CALHN Investigator Initiated Study Protocol Guideline Interventional or Clinical Trial (238 KB)

The Central Adelaide Local Health Network Human Research Ethics Committee (CALHN HREC) is constituted in accordance 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 Scheme.

The CALHN HREC is accredited 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 twice each month, and is responsible for ensuring that research conducted by staff and external researchers meets ethical and scientific requirements in accordance with the NHMRC and relevant legislative policy and requirements.

For further information, contact CALHN Research Services on 08 7117 2229, or via email at Health.CALHNResearchEthics@sa.gov.au.

Ethics Review - National Mutual Acceptance and CALHN HREC

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 and Governance 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.

Submission Requirements

Submission requirements for Clinical Trials are available here.

Submission requirements for other Health/Medical Research Projects including Low/Negligible Risk research eligible for expedited review are available here.

All research projects conducted at CALHN require both ethics approval and governance authorisation. Greater than low risk applications are submitted via GEMS.

Research GEMS

COVID-19

Central Adelaide Local Health Network (CALHN) appreciates the support of our clinical researchers in ensuring the safety and care of our patients and staff during these challenging times. As developments surrounding the COVID-19 pandemic evolve, investigators and coordinators are asked to familiarise themselves with the current arrangements for new and existing research projects and clinical trials.

COVID-19 Vaccination Requirements for Contractors

Contractors who perform work at a CALHN site are required to be vaccinated against COVID-19.

This direction applies to all persons, including external consultants and contractors (including monitors and auditors), who attend a healthcare setting during their work or duties. It also includes those whose attendance is incidental (such as couriers, delivery drivers or suppliers). Such persons will be requested to provide evidence of vaccination status by clinical trial staff.

COVID-19 Research Submissions

Ethics and governance review of projects concerning COVID-19 will be expedited as required. Researchers wishing to conduct clinical studies regarding COVID-19 must consult with the CALHN Infectious Diseases department and/or the SA Pathology Microbiology and Infectious Diseases unit (whichever is applicable) to ensure the unit has sufficient capacity/capability to support the study.

Email: Health.CALHNResearchGovernance@sa.gov.au

Research Amendments in Response to COVID-19

Any queries and changes to current research projects should be communicated to CALHN Research Services at the following contacts:

Budgets
Email:: Health.CALHNResearchFinance@sa.gov.au

Grant funded projects
Email: Health.CALHNResearchGrants@sa.gov.au

Research projects/clinical trials reviewed by CALHN HREC (e.g. protocol changes/deviations or study suspension)
Email: Health.CALHNResearchEthics@sa.gov.au

Research projects/clinical trials reviewed by external HREC (e.g. protocol changes/deviations or study suspension)
Email:: Health.CALHNResearchGovernance@sa.gov.au

National Advice on Clinical Trials

National advice on the management of clinical research has been posted. The guidance provides general information and advice to researchers involved in clinical research, institutions conducting or overseeing research, HRECs, and sponsors in the context of the COVID-19 pandemic.

This advice and future updates is posted on the Department of Health Clinical Trials Page.

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CALHN HREC Submissions

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