Research studies involving human participants, human tissue or clinical data require ethical review in accordance with the NHMRC National Statement on Ethical Conduct in Human Research.
NSW early phase clinical trials and human research ethics committees, certified by the NHMRC, are listed on the OHMR website. For advice on which HREC to select, please contact the ISLHD Research Governance Office: ISLHD-ResearchGovernance@health.nsw.gov.au.
For the purposes of ethical review, research is categorised as low risk or greater than low risk. Both require submission via REGIS (Research Ethics and Governance Information System).
Low risk research
The National Statement on Ethical Conduct in Human Research (2007) describes ‘low risk research’ as research in which the maximum foreseeable risk is discomfort, and ‘negligible risk research’ as research in which there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. Research in which the risk for participants is more serious than discomfort is classed as 'greater than low risk'.
It is important to understand that Risk Level and Review Pathway are not the same thing. Some projects must be reviewed by the HREC even though the risk level appears to be low. Examples include, and are not limited to:
- Research where the level of complexity or subject matter warrants a more specialised or rigorous review
- Research that makes direct comparisons between groups of people
- Research that involves randomly allocating people into different groups
- Research involving prospective collection of bio-specimens; including tissue normally removed and discarded as part of usual care
- Research involving vulnerable participants (including women who are pregnant and the human foetus; people highly dependent on medical care who may be unable to provide consent; people with a cognitive impairment, an intellectual disability or a mental illness; people who may be involved in illegal activities - see Chapter 4 of the National Statement)
- Research involving risk to the risk to the researcher
- Use, collection or disclosure of identifiable information without the participants’ consent
- Research involving genetic analysis
- Establishment of data registries
- Low risk research involving sites outside of NSW
Projects exempt from ethical review
Negligible risk research, such as retrospective audits of patient data, may be exempt from review. The Research Governance Office can supply an exemption on review of a protocol that outlines:
- Background and rationale for audit
- Dates range and estimated sample size
- Inclusion/exclusion criteria of records to be audited
- Data sources and fields that will be used i.e. medical records, eMR, specific databases
- Who will be collecting the data
- Data analysis plan
- Outline how the confidentiality of identifiable data will be protected e.g. use of individual codes, removal of identifiers from data set once complete etc.
Quality assurance and quality improvement activities also do not require ethical review and should be registered with the ISLHD Clinical Governance Unit.
Research policies and guidelines can be found here: https://www.medicalresearch.nsw.gov.au/policies-guidelines/
Fees for ethical review
Please note under Ministry of Health policy directive PD2023_015 Ethics and Governance Review Fees will be incurred for some studies reviewed by NSW Public Health Organisations. The fee structure can be found here.