Calvary Health Care

Pre-authorisation

Calvary’s research governance includes the review, approval and authorisation of research projects and grants (Projects); and the processes to manage and investigate potential breaches of the Australian Code for the Responsible Conduct of Research (the Code) across four stages.

Stage 1: Feasibility review and risk level assessment

Feasibility review and risk level assessment. In-principle support is given by the Local Research Office to progress to submit full application.

Stage 2: Site specific assessment

Ethical, governance and scientific review. Approval is given by the Local Research Committee (Region/Site). Ethical approval is through a National Health and Medical Research Council registered Human Research Ethics Committee (HREC).

Final authorisation is by Regional CEO or Site Executive.

Post-authorisation

Stage 3: Project delivery

Stage 4: Project closure

Definitions

Approval = denotes administrative approval to progress and involves approval of the Site-Specific Assessment and HREC approved documentation.

Authorisation = final requirement before a project can commence and constitutes research governance authorisation.

Low and negligible risk = the expression ‘low risk research’ describes research in which the only foreseeable risk is one of discomfort. Research in which the risk for participants is more serious than discomfort is not low risk.

The expression ‘negligible risk research’ describes research in which there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience (National Statement).

Higher risk (greater than low risk) = where the risk, even if unlikely, is more serious than discomfort, the research is not low risk.

All research involving human participants, human tissue or clinical data and conducted within Calvary Health Care, require ethical review in accordance with the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research (2023 updated National Statement is effective from 1 January 2024) The review and approval must be undertaken by a duly constituted and approved human research ethics committee, included in the List of Human Research Ethics Committees registered with NHMRC (Last updated 27 February 2024).

The research must also be underpinned by the mission and values of Catholic health care, as described in the Code Of Ethical Standards For Catholic Health And Aged Care Services In Australia (Catholic Health Australia, 2001). The aim of ethical review and approval is to ensure that high ethical standards are maintained in research projects conducted at Calvary, and to protect the interests of research subjects, investigators and staff at Calvary Health Care.

The research governance process is standardised across Calvary. Each Calvary region and large hospital site includes a Local Research Office (LRO) to provide governance support and coordinate research project and grant review.

Approval for Stage 2 differs within Calvary regions due to several variables. Such as: A research project that spans number of services within a geographical region will require regional approval; research to be conducted within a large hospital, will require Site Approval; and research to be conducted with Calvary aged care services may require approval through the Aged Care Research Sub-Committee.

The Clinical Trials Governance Framework aims to ensure that clinical trials are conducted in a safe environment and in a high-quality manner for improved health outcomes for patients and the community. The Governance Framework supports health services to reduce trial start up times, optimise pre-approval and participant recruitment time-frames, better engage trial sponsors and improve consistency in trial service delivery.

The Governance Framework is based on the Commission’s existing NSQHS Standards, in particular, Standard 1: Clinical Governance and Standard 2: Partnering with Consumers.

• Framework and User Guide, and FactSheets

• Resources