Calvary Health Care

Research governance refers to the processes by which institutions ensure they are accountable for the research conducted under their auspices. Calvary Health Care is accountable for all research involving humans conducted within its sites and ensures that research “delivery meets its objectives and conforms to relevant institutional, jurisdictional and national standards and applicable laws” (NHMRC, 2011, p.1). Approved research is governed by a process that ensures the highest ethical and scientific standards, compliance with relevant legislation, codes and guidelines, expert management and monitoring, and the protection of the rights and interests of all staff, patients, clients, residents and carers. Research governance at Calvary Health Care - Abides by:

• National Statement on Ethical Conduct in Human Research (2023) (NHMRC)

• Code of ethical standards for Catholic Health and Aged Care Services in Australia (2001) (Catholic Health Australia)

Is based on:

• Australian Code for the Responsible Conduct of Research (2018).

• Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders (2018).

• Ethical Considerations in Quality Assurance and Evaluation Activities (2014).

• Guide to managing and investigating potential breaches of the Australian code for the responsible conduct of research (2018).

• Management of Data and Information in Research: A guide supporting the Australian Code for the Responsible Conduct of Research (2019).

• National Clinical Trial Governance Framework and user guide for health service organisations conducting clinical trials (2022).

• Statement on Consumer and Community Involvement in Health and Medical Research (2016).

• The National Safety and Quality Health Service Standards (2nd Edition updated) (2021).

Accountability for research conducted at Calvary is led by the National Research Governance Committee and through to the Little Company of Mary Health Care Board. Local research committees within a Calvary region, or at larger hospitals, have oversight of research within their domain. An additional national stream-base committee for aged and home care will be established.

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 the institution.

Responsibility of the Human Research Ethics Committee

The responsibility of a human research ethics committee is to ensure that the interests of research participants are protected, to ensure that the research is ethically sound, and to audit the scientific, social, and legal validity of the research.

• Review a human research proposal to form a view on its ethical acceptability (in accordance with the National Statement).

• Ensure project is compliant with relevant guidelines, regulations and legislation (Calvary, State and Federal).

• Provide the Coordinating Principal Investigator, and/or the Principal Investigator, with the outcome of the ethical review of the human research project.

• Advise and receive reports from institutions regarding complaints or reports of research misconduct arising out of the conduct of approved human research.

• Monitor research for which it has given approval, through the receipt of safety, progress and any other required reports in conjunction with the participating institutions and their research governance offices.

Association between research governance and ethical review

Research governance is the responsibility of Calvary (as the authorising institution) and includes both ethical review and institutional review.

Ethical review and Institutional review (involving research feasibility review and Site-Specific Assessments) are components of research governance and are two distinct processes relating to the ethical approval and institutional authorisation of research involving humans. Ethical review is not a proxy for research governance review, and the two processes are independent of each other, however, the two processes may draw on relevant matters from each other.

Catholic Ethical Standards

At Calvary, the Code of Ethical Standards for Catholic Health and Aged Care Services in Australia (Catholic Health Australia, 2001) sets the standards in which ethical health care practices can be pursued across all services, while meeting all professional, scientific and legal requirements.

Aboriginal and Torres Strait Islander Peoples and Communities

Ethical research with Aboriginal and Torres Strait Islander Peoples and communities should improve the way all researchers work with Aboriginal and Torres Strait Islander people and their communities; develop and/or strengthen research capabilities of Aboriginal and Torres Strait Islander people and their communities; strengthen the application of research within communities; and enhance the rights of Aboriginal and Torres Strait Islander Peoples as researchers, research partners, collaborators and participants in research (NHMRC 2018, p.1).

Research conducted with Aboriginal and Torres Strait Islander Peoples and communities, is underpinned by six core values - Spirit and integrity, Cultural continuity, Equity, Reciprocity, Respect, and Responsibility – and each individual and community has the right to express how these values (and others) will be addressed in research.

The Australian Commission on Safety and Quality in Health Care’s 2022 National Clinical Trials Governance Framework embeds clinical trials into routine health service provision and strengthens the clinical and corporate governance arrangements for governments, hospital administrators, health services, private companies, trial sponsors and trial investigators.

It is mandatory for all public and private Australian hospitals, day procedure services and public dental services to be assessed concurrently for clinical and corporate services and clinical trial service provision to determine whether the National Safety and Quality Health

Service (NSQHS) Standards (ACSQHC, 2023) have been implemented. Clinical trials generate evidence to inform best-practice ways of providing care and treatment to patients. A robust clinical trials environment is essential for a self-improving health care system.

Clinical trial governance

Governance is the set of relationships and functions established by the hospital to ensure safe and high quality clinical trial service provision, that is integrated into clinical care and continuously improving. Clinical trial service governance incorporates both corporate and clinical governance at the hospital and ensures that everyone undertaking clinical trials is accountable to patients and the community.

The National Clinical Trials Governance Framework provides information about each component and action within the National Safety and Quality Health Service (NSQHS) Standards and the roles and functions of identified positions relating to clinical trial service provision. The document also provides suggested strategies to support health service organisations meet the actions within the Standards. The National Clinical Trials Governance Framework is also aligned with the NSQHS Standards, in particular, the Clinical Governance Standard and the Partnering with Consumers Standard.

Consumer and community involvement in research

Consumers and community members are a valued part of Calvary Health Care and contribute to all aspects of health and medical research. This is achieved through active involvement, from participating in health information sessions through to leading strategy and policy. Importantly, this is underpinned by the consumer right to participate in research.

The National Health and Medical Research’s (NHMRC) Statement On Consumer And Community Involvement In Health And Medical Research (2016) was developed in recognition of the contribution that consumers can make to research, and guides research institutions, researchers, consumers and community members. With:

Vision: Consumers, community members, researchers and research organisations working in partnerships, to improve the health and well-being of all Australians through health and medical research.

Values: Shared understanding, respect and commitment.

Purpose: To guide research institutions, researchers, consumers and community members in the active involvement of consumers and community members in all aspects of health and medical research.

Further, The Australian Code for the Responsible Conduct of Research (2007), the primary guidance for institutions and researchers in responsible research practices, states:

Appropriate consumer involvement in research should be encouraged and facilitated by research institutions and researchers.

In 2020, NHMRC also released a suite of resources related to consumer and community involvement in, and expectations of, health and medical research. The toolkit provides detailed information and tools on five individual areas of interest:

• Expectations and Value – Framework for Effective Consumer and Community Engagement in Research

• Measuring Alignment with Consumer and Community Expectations in Research

• Measuring Effectiveness of Consumer and Community Involvement in Research

• Considering Impact of Research from a Consumer and Community Perspective

• Self-assessment of Consumer and Community Involvement in Research