Australian standards
In Australia, all research involving humans requires ethical approval before it starts.
The ethics of human research is governed by the National Statement on Ethical Conduct in Human Research issued by the National Health and Medical Research Council (NHMRC).
Human Research Ethics Committee (HREC)
Within Nepean Blue Mountains Local Health District (LHD) this approval is the responsibility of a Human Research Ethics Committee (HREC).
The HREC reviews applications for single site research to be conducted at facilities and services within Nepean Blue Mountains LHD.
It is also able to review applications for multi-centre human research being done in NSW public health organisations as well as Queensland, Victoria, South Australia, Western Australia and the Australian Capital Territory.
- Clinical Professor Ian Seppelt, Chair
- Kate Rafton, Lawyer
- Art Sideris, Lay Member
- Jana Smetana, Lay Member
- Neil Checkley, Religious Member
- Shannan Waddups, Health Professional
- Jane Thomas, Health Professional
- Dr James Mallows, Health Professional
- Dr Sonya Burgess, Health Professional
- Rebecca Graham, Health Professional
- Gaaya Kanapathipillis, Health Professional
- Dr Bhadran Bose, Health Professional
- Dr Loretta Luck, Researcher
- Dr Liora Ballin, Researcher
- Dr Rui Dan (Vicki) Xie, Researcher
- Dr Zelda Doyle, Researcher
- Dr Sviatlana Kamarova, Researcher
- Dr Tu Nguyen, Researcher
- Dr Ellie-Shue Chen-Chun, Researcher
The HREC meets 11 times a year and considers many new applications as well as reviewing the progress and compliance of all currently approved studies.
See our:
| Submission date | Meeting date |
|---|---|
| Tuesday 07 January | Tuesday 21 January |
| Tuesday 04 February | Tuesday 18 February |
| Tuesday 04 March | Tuesday 18 March |
| Tuesday 01 April | Tuesday 15 April |
| Tuesday 29 April | Tuesday 13 May |
| Tuesday 27 May | Tuesday 10 June |
| Tuesday 24 June | Tuesday 08 July |
| Tuesday 22 July | Tuesday 05 August |
| Tuesday 19 August | Tuesday 02 September |
| Tuesday 16 September | Tuesday 30 September |
| Tuesday 14 October | Tuesday 28 October |
| Tuesday 11 November | Tuesday 25 November |
The Low and Negligible Risk (LNR) Committee meets fortnightly to review low and negligible risk projects.
The Apollo Subcommittee provides ethical review of smaller scale projects such as audits, quality improvement and quality assurance type projects.
| Meeting date | |
|---|---|
| Thursday 16 January | Thursday 17 July |
| Thursday 30 January | Thursday 31 July |
| Thursday 13 February | Thursday 14 August |
| Thursday 27 February | Thursday 28 August |
| Thursday 13 March | Thursday 11 September |
| Thursday 27 March | Thursday 25 September |
| Thursday 10 April | Thursday 09 October |
| Thursday 24 April | Thursday 23 October |
| Thursday 08 May | Thursday 06 November |
| Thursday 22 May | Thursday 20 November |
| Thursday 05 June | Thursday 04 December |
| Thursday 19 June | Thursday 18 December |
| Thursday 3 July | |
Research Governance Officers
We have a framework for overseeing research, to ensure it meets appropriate standards of quality, safety, privacy, risk management and financial management. The Local Health District, facilities, managers and researchers have a shared responsibility and accountability for the conduct of research.
The Research Governance Officer (RGO) is responsible for assessing the suitability of a project to be conducted at a particular site and making a recommendation to the Nepean Blue Mountains Local Health District Chief Executive (or delegate) about whether to authorise the study to be conducted at their site.
Information for researchers
The approval of research applications involves:
- Scientific and ethical approval through HREC
- Site governance approval, through a Site Specific Application (SSA)
Applications are made through the Research Ethics and Governance Information System (REGIS).
Fees apply, and vary depending on the nature of the research project and its funding. Contact the Research Office for details.
Our standard operating procedures (SOPs) will guide you through the various stages of your research application.
Different procedures apply for research with different levels of risk.
Staff undertaking approved research must follow a strict set of guidelines throughout their project, and ensure that:
- no research is conducted without ethics approval from the HREC
- site authorisation is received from the relevant Research Governance Officer (RGO)
- all relevant information has been provided to the HREC
- all relevant guidelines and legal requirements are complied with
- monitoring requirements are complied with e.g. annual reports
- proposed protocol modifications and amendments are submitted to the HREC Committee for approval and to Research Governance for Authorisation
- significant safety issues, urgent safety measures and suspected unexpected serious adverse reactions are promptly notified to the HREC or RGO.
For more information see the Australian Code for the Responsible Conduct of Research 2018.
Case reports
A case report is a detailed narrative that describes, for medical, scientific or educational purposes, a medical event experienced by one or several patients. Case reports present clinical observations, usually collected in health care delivery settings.
They play an important role in advancing medical knowledge and training, and can help identify adverse and beneficial effects of treatments, or new diseases.
Case reports may require ethics approval as well as patient consent if they involve sensitive information or risk to privacy or the organisation. Contact the Research Office for advice.
Contact us
Call (02) 4734 1998 or email NBMLHD-Ethics@health.nsw.gov.au.
Correspondence to the Nepean Blue Mountains HREC can be sent to:
Postal address
The Chair, Human Research Ethics Committee
Research Office
PO Box 63
Penrith NSW 2750
Street address
Level 5, Building D
Nepean Hospital
Kingswood NSW 2747
Note: Please include the study title and (once known) HREC reference number, eg. YYYY/ETH in all correspondence.