Calvary Health Care

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. In-principle support is given by the Local Research Office to progress to submit full application.

Stage 2: 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.

Stage 3 and 4: Approval of study activities and closure.

Below is a diagrammatic overview of approval and authorisation at each stage of the governance process.

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.

The research governance process at Calvary Health Care ensures that all research undertaken at Calvary has been reviewed for site-level feasibility, institutional governance, and scientific validity, meets ethical standards, and has appropriate authorisations and adequate levels of oversight and monitoring The process is designed to be efficient, straightforward, transparent and fair.

The governance process has four (4) sequential research stages (Figure 4):

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.

Calvary Health Care 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.

Governance of clinical trials 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