Introduction

All research involving humans must be reviewed and approved by a Human Research Ethics Committee (HREC) before it begins. Retrospective approval cannot be granted.

Under the National Mutual Acceptance (NMA) scheme, a multi-centre research project in participating jurisdictions need only be ethically reviewed by one lead HREC. Participating jurisdictions in the NMA scheme are public health organisations in NSW, Victoria, ACT, Queensland, South Australia, Tasmania, Northern Territory and Western Australia. See: https://www.slhd.nsw.gov.au/concord/Ethics/NMAprojects.html 

The Sydney Local Health District HREC – Concord Hospital is accredited as a lead HREC within NSW for reviewing multi-centre research. In addition, the HREC is certified by the NHMRC as a reviewing HREC under the NMA Scheme for single ethical and scientific review of multi-centre research. The Sydney Local Health District (SLHD) HREC – CRGH is certified under the National Mutual Acceptance scheme to review all phases of clinical trials (phase 0. I, II, III and IV).  However, Early Phase Clinical Trials (studies up to but not including Phase II or with a Phase I component) must be submitted to Bellberry HREC, who have been appointed under the NSW Health Early Phase Clinical Trial Scheme to review adult EPCT applications that will be conducted at NSW Public Health Organisation institutions. For further information on submitting Early Phase Clinical Trial applications, please refer to: https://bellberry.com.au/im-a-researcher/multi-centre-trials/nsw-pho-epct/nsw-early-phase-clinical-trial-framework/

The Sydney Local Health District HREC - CRGH can also approve the inclusion of private sites (private hospitals and institutions, General Practices, schools etc.).

If you are unsure what phase your project is, please refer to the NSW EPCT quick reference guide for further guidance or contact the Concord Research Office on SLHD-ConcordEthics@health.nsw.gov.au

Clinical interventional research other than clinical trials; population health and public health research; qualitative research; mental health research; and other health and medical research can be reviewed by the Sydney Local Health District HREC - Concord Hospital.

The Sydney Local Health District HREC – Concord Hospital is not certified under NMA to undertake review of multi-centre research involving children. More information is available here.

For more than low risk research and high risk research, the HREC requires applicants to use the Human Research Ethics Application (HREA) form.

SITE SPECIFIC APPROVAL: Although a Lead HREC can provide overall ethical approval for a particular project, a Site Specific Assessment (SSA) application must be submitted for Research Governance assessment at each individual public-health site where the research will be conducted.

Research cannot commence at a public health site until the SSA is authorised.

For more information on SSA applications click here.

LOW AND NEGLIGIBLE RISK RESEARCH: An expedited review process is available for research to be conducted where the only foreseeable risks are discomfort or inconvenience. Further advice on what constitutes LNR Research is available here. Please note that the following are not eligible for LNR review:

• Interventions and therapies including clinical and non-clinical trials and innovations or new treatment modalities
• Active concealment or planned deception of participants
• Exposure of illegal activities
• Research specifically targeting Aboriginal or Torres Strait Islander people

Research involving the following are only eligible for low and negligible risk review where the research involves the collection of non-identifiable data and carries only a negligible risk:

• Human genetics
• Human stem cells
• Women who are pregnant and the human foetus
• People who are highly dependent on medical care who may be unable to give consent
• People with cognitive impairment
• People with an intellectual disability or a mental illness
• People who may be involved in illegal activities

SCIENTIFIC REVIEW: Research proposals involving a clinical drug or device trial or which would otherwise benefit from a scientific oversight are reviewed by the Scientific Sub-committee prior to ethical review by the HREC. To determine whether your application requires scientific review please complete the checklist here or contact the Research Office.