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 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 Local Health District (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.
Our HREC members
- Clinical Professor Ian Seppelt, Chair
- Dr Alison Poulton - Deputy Chair
- Dr Faraz Pathan, Researcher
- Dr James Mallows, Researcher
- Jane Thomas, Health Professional
- Jeni Stevens, Researcher
- Junie McCourt, Researcher
- Kate Rafton, Lawyer
- Michael Turner, Religious Member
- Neil Checkley, Religious Member
- Michael Wood, Health Professional
- Penny Mahairas, HREC Executive Officer
- Art Sideris, Lay Member
- Dr Sonya Burgess, Researcher
- Jana Smetana, Lay Member
- Dr Rui Dan (Vicki) Xie, Researcher
- Richard Norris, Researcher
- Min Ye, Health Professional, Pharmacist
HREC roles and responsibilities
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.
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.
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.
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.
Call (02) 4734 1998 or email NBMLHD-Ethics@health.nsw.gov.au.
Correspondence to the Nepean Blue Mountains HREC can be sent to:
The Chair, Human Research Ethics Committee
PO Box 63
Penrith NSW 2750
Building D, Level 5
Kingswood NSW 2747
Note: Please include the study title and (once known) HREC reference number, eg. YYYY/ETH in all correspondence.