All research involving humans must be reviewed and approved by a Human Research Ethics Committee (HREC) before it begins. Retrospective approval cannot be granted.
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/
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 within NSW 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:
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:
Low risk research to be reviewed under the National Mutual Acceptance (NMA) scheme must still be submitted using the HREA but cannot currently undergo expedited review and will be reviewed at a meeting of the HREC.
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.