Ethics and Governance
In Australia, all research proposals involving humans must first be reviewed and approved by a Human Research Ethics Committee (HREC). These committees are registered and report to the National Health and Medical Research Council, and must act in accordance to standards articulated in the National Statement on Ethical Conduct in Human Research (2007) issued by the National Health and Medical Research Council (NHMRC). There are more than 200 HREC's in institutions and organisations across Australia. Many other countries have similar systems.
Research at the Calvary Mater Newcastle is governed by the Research Ethics and Governance Unit of the Hunter New England Local Health District as well as the Calvary Mater Newcastle Clinical Ethics Committee. The Hunter New England Human Research Ethics Committee (HNEHREC) is accredited to be a Lead Human Research Ethics Committee for the purpose of multicentre review in both clinical and general research. The Committee also reviews single site research within Hunter New England Health.
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.
Calvary Mater Newcastle Clinical Ethics Committee
Calvary Mater Newcastle Clinical Ethics Committee is not an officially recognised Human Research and Ethics Committee under the NHMRC guidelines. Any proposed research or clinical trial at Calvary Mater Newcastle must firstly receive the approval of HNEHREC. Once approved research is then reviewed and approved by Calvary Mater Newcastle's Clinical Ethics Committee.
The Clinical Ethics Committee fulfils a number of functions:
- Governance over clinical practice at Calvary Mater Newcastle under the auspices of Little Company of Mary Health Care to ensure that it is in accordance with Catholic ethical teaching.
- A review of all research and clinical trials at Calvary Mater Newcastle which have been approved by HNEHREC.
- Educational opportunities for hospital staff on relevant ethical issues.
- Advice to clinicians, nursing and other staff on ethical issues that they may encounter.
- Ethics forums are conducted throughout the year for all staff on relevant ethical issues.
- Calvary Mater Newcastle Clinical Ethics Committee Terms of Reference
- Calvary Mater Newcastle Ethics Committee Membership 2014 (shown below)
- The Code of Ethical Standards for Catholic Health and Aged Care services in Australia (Catholic Health Australia www.cha.org.au)
- National Statement on Ethical Conduct in Human Research (2007). (National Health and Medical Research Council www.nhmrc.gov.au)
When Little Company of Mary Health Care (LCMHC) became the new owners of the Mater in 2006, it recognised that the hospital enjoys a world renowned reputation for innovative research. LCMHC wished to preserve this reputation. It also wanted to establish a Clinical Ethics Committee to ensure that clinical practice including research was conducted in accordance with Catholic teaching. However, it was acknowledged that the HNEHREC is well regarded throughout Australia for its efficient and effective research application and approvals process and LCMHC did not want to compromise this.
Consultation during 2010 between senior staff of the hospital and the Manager of the Research Ethics and Governance Unit at Hunter New England Health (HNE Health), resulted in an agreement and a process was developed to enable HNEHREC research applications approved for Calvary Mater Newcastle, to be reviewed by the hospital's own Ethics Committee prior to the research being conducted. The cooperation between the two organisations ensured that any delay to the approval for research applications is kept to a minimum; with the hospital's Ethics Committee meeting occurring after the HNEHREC meeting each month. Calvary Mater Newcastle Clinical Ethics Committee in its current form held its first meeting in January 2011.
Calvary Mater Newcastle Clinical Ethics Committee continues to support the extensive research undertaken at the hospital and maintains close contact and full cooperation with HNE Health's Research Ethics and Governance Unit.
Calvary Mater Newcastle Ethics Committee developed a form of words on the risks to the unborn child, to be incorporated into the Patient Information and Consent Form for all research at the hospital which involved a reproductive risk. This statement has now been recommended by Catholic Health Australia to be used by all Catholic facilities in Australia where research is being conducted that involves reproductive risk.
Calvary Mater Newcastle Clinical Ethics Committee
|A/Prof Rosemary Aldrich||Chairperson Director of Medical Services, Calvary Mater Newcastle|
|Ms Mary Ringstad||Director of Mission, Calvary Mater Newcastle|
|Dr Fiona Boyd||
Visiting Medical Officer, Palliative Care, Calvary Mater Newcastle
|Ms Melissa Walker||Social Work, Calvary Mater Newcastle|
|Ms April MacNeill||Head of Pastoral Care, Calvary Mater Newcastle|
|Ms Mary-Claire Hanlon||Staff Member with a Special Interest, Calvary Mater Newcastle|
|Mr Dennis Carroll||Theologian and Ethicist; Member, Catholic Moral Theologians Association, Australia and New Zealand|
|Mr Stephen Tipper||Community Advisory Council Representative|
|Ms Crystal Tindall||Administrative Assistant, Calvary Mater Newcastle|