PCOC and ethics
This information is for palliative care providers wishing to participate in PCOC and unsure about whether they need to obtain separate ethical approval for participation. While processes and procedures differ between hospitals and health services, individual providers may not need to complete a separate ethics application for the following reasons:
PCOC has ethical approval
The purpose of an application to a Human Research Ethics Committee (HREC) is to allow a HREC to consider whether a project is ethically and scientifically acceptable. PCOC has obtained this approval from the University of Wollongong Human Research Ethics Committee for the collection, analysis and reporting of non-identifiable data from palliative care providers, and for collection of this information without patient consent.
PCOC is a clinical quality registry
PCOC is not a research project but rather a clinical quality registry1, which has the aim of supporting ongoing quality improvement processes, whereby information that is routinely collected by palliative care providers as part of routine clinical care and patient assessment is being used for quality improvement purposes.
Quality improvement (QI) projects, evaluations or routine monitoring projects may not require ethical review. The key role of ethics review is to champion consumers’ interests when interventions are proposed that might incur risks, suffering or inconvenience to patients or carers where these may occur other than through direct patient care.
PCOC is "negligible risk"
The National Statement on Ethical Conduct in Human Research (2007) (Updated May 2015) states that:
5.1.22 Institutions may choose to exempt from ethical review research that:
(a) is negligible risk research (as defined in paragraph 2.1.7)*; and
(b) involves the use of existing collections of data or records that contain only non-identifiable data about human beings.
*2.1.7 Research is ‘negligible risk’ where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. Where the risk, even if unlikely, is more than inconvenience, the research is not negligible risk.
The National Statement goes on to state:
5.1.23 Institutions must recognise that in deciding to exempt research from ethical review, they are determining that the research meets the requirements of this National Statement and is ethically acceptable. Approval by the University of Wollongong ethics committee has determined that PCOC meets these requirements and is ethically acceptable.
1 Clinical quality registry (CQR) is defined as ‘An organisation which systematically monitors the quality (appropriateness and effectiveness) of health care, within specific clinical domains, by routinely collecting, analysing and reporting health-related information. The information is used to identify outcome benchmarks, significant outcome variance, and inform improvements in healthcare quality. Ref: Australian Commission on Safety and Quality in Health Care, Framework for Australian clinical quality registries. Sydney. ACSQHC, March 2014.