Human Ethics

Important information – Automatic Withdrawal after Information Request

Following the HREC meeting, you will be notified in writing of the outcome of the Committee’s review within ten working days of the meeting, unless otherwise notified. If you have not responded to the HREC query letter within 40 days after receipt and have not asked the Executive Officer for an extension, your application will be WITHDRAWN from the REGIS system and you will need to submit a new application.

Check out the training page for free online ethics courses (it's worth it!)

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. See: https://www.slhd.nsw.gov.au/rpa/research/nma.html

The Sydney Local Health District HREC – RPA Hospital is accredited as a lead HREC 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, I-II

• Clinical trials phase 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)

* 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. See: Early Phase Clinical Trial applications

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

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.

LOW AND NEGLIGIBLE RISK RESEARCH (LNR): An expedited review process is available for research to be conducted 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

SCIENTIFIC REVIEW: Research proposals involving a clinical drug or device trial or which would otherwise benefit from a scientific oversight are reviewed by the Clinical Trials Sub-committee prior to ethical review by the HREC.

The following checklist may assist researchers in determining whether a study requires Scientific Review. Checklist