Research Ethics

At the very heart of Catholic health care is a distinctively person-centred vision based on belief in the essential dignity of each human person. Calvary Mater Newcastle seeks to foster a healing environment that acts in the best interest of patients and families. We adhere to the Catholic Health Australia’s Code of Ethical Standards that sets out the basic principles of care in the Catholic tradition. Click here to access the Code of Ethical Standards, which can be downloaded for free. These principles are applied to all research conducted at Calvary Mater Newcastle by our Catholic Health Australia (CHA) compliance subcommittee.

Ethical review bodies, which include Human Research Ethics Committees (HRECs), play a central role in the Australian system of ethical oversight of research involving humans. Ethics committees review research proposals ensuring they are ethical and comply with relevant standards and guidelines.

Calvary Mater Newcastle does not have an internal NSW Human Research Ethics Committee (HREC). Calvary Mater Newcastle researchers wishing to conduct research at Calvary Mater Newcastle can choose to have their project/s reviewed by Hunter New England (HNE) Human Research Ethics Committee or any of the current 17 NSW Lead HRECs.

If you are conducting a multi-centre clinical trial, researchers can access mutual acceptance states accredited HRECs. HNE HREC does not review early phase trials (FIH, Phase 1a or 1b), we recommend that all early phase clinical trials are reviewed by either Bellberry HREC (adults) or Sydney Children’s Hospitals Network HREC. For further information on Early Phase Clinical Trials please click here.

For a list of National Health and Medical Research Council (NHMRC) registered HRECs please click here.

Prior to commencing a research project it is important to determine what type of application is applicable. There are three types of ethics applications reviewable in HNE Health:

• Low/negligible risk research
• Research requiring full ethical review
• Review of non-research activities (quality assurance) that may result in external presentation/publication

For a greater understanding of the Human Research Ethics Committee review of research please view the HREC Flowchart.

All enquiries relating to Hunter New England HREC should be directed to Sarah Moberley at [email protected].

In addition, any research that is conducted as a result of our affiliation with the University of Newcastle must also be assessed and approved by the University’s Human Research Ethics Committee (HREC) before the research can commence.

The individual safety and methodological aspects, as well as risk assessment of all projects are also evaluated by the relevant safety committees and peer review processes.

This Research Governance Framework provides for the proper management and conduct of research within HNE Health, including Calvary Mater Newcastle. It supports the integration of research and health practice in the hope that patients and the community of the Hunter New England Area will receive clinical care and service delivery that reflect evidence and that research will address the health needs of the community.

Research Ethics and Governance Information System (REGIS)

The Research Ethics and Governance Information System (REGIS) is an online portal from the Office of Health and Medical Research (OHMR) to manage ethics and site governance of research projects in NSW. It facilitates the creation, processing and storage of ethics and site-governance applications as well as post-approval/authorisation, progress reports, safety notifications and amendments. It incorporates the new ethics application form (HREA).

It is mandatory for ALL NEW Single Site and Multi Site Applications to be completed and submitted through REGIS. Before commencing any new application for Ethics and Governance, you are advised to consult with the Calvary Mater Newcastle Research Office to which you are intending to submit your application for confirmation of local arrangements.

The Calvary Mater Newcastle Research Office contact details are 02 4014 4784 or [email protected]

Additional information can be found on the REGIS website here.

Resources for Researchers

• WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects
• The NHRMC National Statement on Ethical Conduct in Human Research
• National Mutual Acceptance of Single Ethical and Scientific Review of Multi-Centre Human Research Projects
• NSW Ministry of Health Office for Health and Medical Research (OHMR) Research Ethics and Governance
• Code of Ethical Standards for Catholic Health and Aged Care Services in Australia
• Early Phase Clinical Trials Framework for NSW