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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 and South Australia. The Sydney Local Health District HREC – RPA 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 HREC is certified to review the following types of research:
|• Clinical trials phase 0, I, II, III, IV
|• Clinical trials drugs and devices
|• Clinical trials surgery
|• Clinical trials other
|• Clinical interventional research other than clinical trials
|• Qualitative research
|• Mental health
|• Paediatric research
|• Other health and medical research (Dental research)
When a non-public health organisation such as a private hospital wishes to use the services of the Sydney Local Health District HREC - RPAH, an External Entity Agreement (EEA) will need to be drawn up. Please contact the RPAH Research Ethics and Governance Office for more information. For more than low risk research, the HREC requires applicants to use the National Ethics Application Form (NEAF).
SITE SPECIFIC APPROVAL (SSA): 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.
ACCESS REQUEST REVIEW: An Access Request Review, instead of SSA, should be completed for all human research projects that require support from a NSW Public Health Organisation in the form of access to participants, tissue or data but do not involve the conduct of research at that Public Health Organisation. Access Request Review should be used for:
- Recruitment through posters, leaflets, handouts and letters of invitation (but not direct enrolment)
- Distribution of surveys and questionnaires
- Access to data or tissue held at a public-health organisation.
For more information on Access Request Review applications click here.
LOW AND NEGLIGIBLE RISK RESEARCH (LNR): An expedited review process is available for research to be conducted within NSW where the only foreseeable risks are discomfort or inconvenience. 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 LNR 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
LNR research to be reviewed under the National Mutual Acceptance (NMA) scheme or interstate research must be submitted using the Human Research Application Form (HREA).
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.
The following checklist may assist researchers in determining whether a study requires Scientific Review. Checklist