RRG Research and Clinical Trials Governance Framework V1 by Royal Rehab Group

Research and Clinical Trials Governance Framework

The Research and Clinical Trials Governance Framework provides a structured approach to ensure research and clinical trials are conducted in line with the Nationals Clinical Trials Governance Framework (2022), Australian Code for the Responsible Conduct of Research (2018) and National Statement on Ethical Conduct in Human Research (2023). This document was endorsed by the Royal Rehab Quality, Safeguards and Clinical Governance Board Sub-Committee and Board.

Acknowledgement of Country

In the spirit of reconciliation, Royal Rehab acknowledges the Traditional Custodians of Country throughout Australia and their connections to land, sea, and community.

We pay our respects to their Elders past, present and future and we extend our respects to all Aboriginal and Torres Strait Island peoples.

Royal Rehab is committed to the ongoing journey of Reconciliation.

Introduction

Royal Rehab has a history that dates back to 1899, when our founder, Susan Schardt, a remarkable and pioneering woman who was sight impaired at birth, displayed extraordinary vision for what was possible.

At the young age of 27, Susan changed the life of a man who was facing disability and homelessness by finding him accommodation and care. Royal Rehab’s legacy of excellence and unwavering commitment to improving lives is a testament to Susan’s vision and the values that drive us forward.

Today, we have grown to become a renowned provider of holistic, client-centred, high-quality care in rehabilitation and disability services, having helped over 61,000 Australians over our 125 years of service.

We are a charity with a clear purpose, to empower the people we serve so that they can achieve their full potential. Our approach is centred around offering tailored solutions to individuals based on their specific needs and where they are in their life’s journey. Whether it’s recovering from an illness or injury, improving function and overall wellbeing, or facilitating community participation, our goal is to empower individuals to become more independent, leading fulfilling lives.

Our Purpose

Together we empower people to reach their potential.

Our Vision

A world without limits for people with disability, illness and injury.

Our Strategy

Our strategic plan is driven by a powerful vision of creating a world without limits for people with disability, illness, and injury.

Our strategy is grounded in four key priorities:

1. Open up a world of possibilities

2. Nurture a culture where our people and customers thrive

3. Designed for efficient scale

4. Drive sustainable growth

Royal Rehab’s purpose, vision and strategy plays a crucial role in supporting the Research and Clinical Trials Governance Framework as they provide the foundation upon which the Framework is built, providing clarity for the delivery of research and ensuring that all research is conducted according to ethical principles and relevant legislation.

Framework

Purpose

The Research and Clinical Trials Governance Framework sets out a system for managing research at Royal Rehab. The framework provides a structured approach to research governance and reinforces the principles of the National Clinical Trials Governance Framework (2022), Australian Code for the Responsible Conduct of Research (2018) and National Statement on Ethical Conduct in Human Research (2023).

Governance of research and clinical trials is an integrated component of corporate and clinical governance at Royal Rehab. It ensures that everyone involved in research conducted at sites operated by Royal Rehab , or involving participants or data accessed through Royal Rehab remains accountable to clients and the community for ensuring that the delivery of research and clinical trial services are effective, integrated, high quality and continuously improving.

Royal Rehab’s model of research governance is best understood as founded in, and consistent with, broader concepts of corporate governance (Figure 1). Under this model, the following is recognised:

• Governance of research and clinical trial services is of equivalent value to financial, risk and other business governance.

• Corporate governance encompasses the establishment of systems and processes that shape, enable and oversee management of Royal Rehab.

• All elements of corporate governance are related. Decisions about other aspects of corporate governance can have a direct effect on research governance, and decisions about research governance can directly affect other aspects of corporate governance, such as financial performance and risk management.

• The Board is ultimately responsible for good corporate (including research) governance underpinned by strong leadership, engagement and capability of all Royal Rehab staff.

Corporate governance

Figure 1: National Model Clinical Governance Framework (2017). Corporate governance responsibilities.

Research and Clinical Trials Governance Framework:

• Defines the principles that underpin research governance across the organisation and the key components that operationalise those principles;

• Describes the roles and responsibilities and governance structure to ensure all research governance obligations are addressed and a culture of continuous improvement is supported across the organisation;

• Provides guidance to ensure ethical, legislative and regulatory requirements and best practice standards are met;

• Encourages the promotion of groundbreaking research solutions and technologies that can contribute to national, international or organisational growth and be translated into clinical service delivery; Facilitates collaboration between people with lived experience, research institutions, government agencies, industries, and international partners to tackle global challenges or national priorities;

• Facilitates the translation of research evidence into practice; and

• Ensures all research activity conducted at Royal Rehab, or involving Royal Rehab participants or data, meets the highest ethical, scientific, regulatory and professional standards.

Principles

Royal Rehab supports a shared understanding of research governance across the organisation, ensuring that robust research and clinical trials governance systems are implemented and operationalised effectively, supporting safe and quality involvement of patients/clients/consumers, their families, natural supports and data, as well as staff in research activities. The Framework consists of five key overarching principles designed to ensure all research is conducted ethically, transparently, and in compliance with legal and professional standards, with a particular emphasis on the safety, rights, and well-being of clients and participants (Figure 2).

Figure 2: Quality, Safeguards and Clinical Governance Framework five key principles.

Leadership and Culture

Royal Rehab acknowledges that effective research governance begins with strong leadership. At Royal Rehab, leaders play a crucial role in establishing a culture of accountability and driving the implementation of research governance policies, procedures and practices across the organisation to ensure the conduct of high quality research in line with the Australian Code for the Responsible Conduct of Research (2018) and National Statement on Ethical Conduct in Human Research (2023).

The strategic positioning of research at Royal Rehab is facilitated by:

• This framework informing and being informed by the organisational strategy

• A dedicated position (Director of Research) on the Group Executive Team to lead research and research governance across Royal Rehab

• The establishment of a Research Office under the leadership of the Director of Research and with a dedicated Research Governance Officer

• Creating opportunities for enhancing the Research Office through the addition of research grant development capability and a data scientist

• Using Research Governance practices in line with NSW Health requirements as benchmarks for Royal Rehab

• A suite of research and research governance policies and procedures

• Embedded reporting of research and research governance:

– All research projects are required to submit annual project reports

– Regular reporting of research activity by the Research Office to local business unit Quality, Safety and Clinical Governance Committees, which then report to the Board Quality, Safeguards and Clinical Governance Committee, and then to the Board as a whole

– Research activity is reported in the organisation’s annual report

Person-centered research priorities and practices

Royal Rehab respects the unique knowledge, insights, experience and expertise of research participants and ensures that processes are in place to protect their dignity and privacy. Royal Rehab supports, encourages and facilitates the conduct of responsible and ethical research of relevance and benefit to the various populations our service users come from. The organisation values highly, input from people with lived experience in decision making about research priorities and the conduct of research, and is committed to facilitating participation in research by people with lived experience.

The conduct of high quality research of relevance and benefit to the various populations Royal Rehab service users come from, is facilitated by:

• Person-centred service provision is grounded in principles of empowerment, collaboration, respect, and inclusivity. It aims to ensure that all clients have meaningful opportunities to participate in decisions that affect their care provision and receive services that are responsive to their unique needs and preferences.

• The organisation supports a person-centred approach, where the client is active in, and central to, all choices about their life in both day-to-day activities and long-term plans and goals.

• The organisation acknowledges the diversity of individuals’ backgrounds, experiences, and preferences and ensures that services are inclusive and responsive to the unique needs of each individual, regardless of factors such as culture, language, or disability.

• Clients are provided with relevant information about their options, rights, and available resources to support informed decision-making.

• The organisation gathers and incorporates feedback from clients, carers and families to continuously improve services and ensure they remain responsive to changing needs and preferences.

• The organisation seeks client input into documentation, service design and delivery and workforce issues. Review and discuss incident management and infection control data and continuous improvement strategies.

Workforce, capability, retention and engagement

Workforce capability and engagement are integral components of research governance. By investing in staff development, fostering a culture of engagement, and promoting continuous improvement, Royal Rehab enhances staff capability in relation to research governance and the responsible and ethical conduct of research at Royal Rehab.

Workforce capability and engagement in research and research governance is facilitated by:

• The positioning of the Royal Rehab Research Office as an internal resource for front line staff, managers and executives in relation to research and research governance matters

• The provision of education materials about research and research governance of relevance to the various Royal Rehab service delivery contexts, including a Royal Rehab Research Handbook modelled on the NSW Health Research Handbook

• Encouraging research integration within staff training and educational programs for health professionals to enhance the capacity for evidence-informed practice.

• Royal Rehab specific research and research governance policies and procedures accommodating variations across Royal Rehab’s diverse service delivery landscapes.

• Research Office support for staff interested in being members of a research team or in a support role for a research project

Safety, improvement and innovation

At Royal Rehab the organisational structure and research governance systems support the conduct of safe and innovative research which prioritises the safety of research participants in accordance with the National Statement on Ethical Conduct in Human Research. Monitoring our research governance practices helps identify opportunities for improving our systems.

Safety, improvement and innovation is facilitated by:

• Royal Rehab’s Research Office support for organisational involvement in the design and conduct of high quality interventional and observational research studies with potential to inform service improvement and innovation

• Embedding the collection and reporting of client reported experience and outcomes as routine practice

• A comprehensive suite of organisation wide research and research governance policies and procedures

• The conduct of regular research governance audits

• Regular reporting of research and research governance matters to local Quality, Safety and Clinical Governance Committees for sites involved in research

Risk mitigation and management

At Royal Rehab the organisational structure and research governance systems prioritise risk mitigation and management through a dedicated Research Office which is staffed by personnel with a high level of research and research governance knowledge and skills. The benefits of any research must justify any risks of harm or discomfort to participants. Risk mitigation and management is facilitated by:

• The requirement for all research involving Royal Rehab to have approval from a Human Research

• Ethics Committee and research governance site authorisation before commencement of the project

• Robust and systematic processes for review of applications for site research governance authorisation, including a detailed risk assessment

• Support from the Research Office for staff involved in decision making for site research governance authorisation

• Use of a research governance risk register to track the nature and level of risk within and across research projects involving Royal Rehab

• Robust tracking of currency of and compliance with research agreements, materials transfer agreements, insurance and indemnity and annual project reports

• Conduct of regular research governance audits

• Requirement for Principal Investigators of all research involving Royal Rehab to have completed

• Good Clinical Practice training within the past 3 years

• • The use of external researcher deeds to ensure clear communication of Royal Rehab’s

• requirements and expectations of external researchers involved in research activities on site

• • Secure storage for hard copy and electronic data and study documents for organisational

• research projects

• Secure storage for hard copy and electronic research governance records

• Ensuring Royal Rehab has the required infrastructure to be a sponsor of research and the internal management of research grant funding

Framework Implementation

Royal Rehab has adopted a structured approach to ensure that all critical aspects of research and clinical trial governance are integrated, embedded, and consistently followed across the Group. Each of the following component is critical in implementing and supporting research governance, as it promotes ethical, high-quality, and impactful research while safeguarding the rights and well-being of clients.

Component Application

Ethical Standards and Participant Protection

Regulatory Compliance

Protect the rights, dignity, and welfare of participants, ensuring that all research adheres to ethical principles such as informed consent and risk minimisation.

Ensure research complies with relevant regulatory requirements, including approvals for clinical trials involving therapeutic goods.

Actions

• Practices align with the Australian Code for the Responsible Conduct of Research and National Health and Medical Research Council (NHMRC) guidelines.

• Collaborate with Human Research Ethics Committees (HRECs).

• Protocols for obtaining informed consent, ensuring compliance with relevant standards.

• Ensure all research involving therapeutic goods complies with the Therapeutic Goods Administration (TGA) regulations.

• For privacy and data management, embed compliance with the Privacy Act 1988 and the Australian Privacy Principles (APPs).

• Set up clear workflows for obtaining necessary regulatory approvals from bodies like TGA, ensuring all clinical trials follow the required legal processes.

Integrity and Quality

Risk and Safety

Promote high-quality, reproducible research through rigorous methodology and transparent data reporting.

Implement mechanisms to identify, assess, and mitigate risks, ensuring participant safety throughout the research process.

• Follow the Australian Code for the Responsible Conduct of Research, which outlines how research should be conducted to maintain integrity and credibility.

• Register clinical trials in public databases to ensure transparency and allow for the public reporting of results.

• Incorporate robust data management policies that comply with national standards.

• Incident Reporting System that complies with regulatory requirements for reporting serious adverse events.

• All trials undergo a comprehensive risk-benefit analysis, reviewed and approved by HRECs.

• Research governance risk register is used to track safety and risk

• Continuous monitoring of trials, with provisions for pausing or halting studies if participant safety is at risk.

Transparency and Conflict of Interest Management

Informed Consent and Participant Engagement

Continuous Monitoring, Auditing, and Improvement

Ensure transparency in financial and personal interests that could bias research.

Ensure participants are fully informed about the research, including risks and benefits, and voluntarily consent to participate.

Embed processes for ongoing monitoring, independent audits, and continuous improvement in research practices

• Embedded processes to ensure all researchers disclose potential conflicts of interest in line with the Australian Code for the Responsible Conduct of Research.

• Follow the NHMRC’s requirement to share and communicate research for full transparency in research design and results.

• Communities and public are engaged in research initiatives.

• Standardised informed consent forms, ensuring clear communication about the nature of the research and participant rights.

• Clear communication of the process for withdrawal of participation provided to research participants.

• Regular audits of clinical trials and research activities to ensure compliance with ethical, legal, and scientific standards.

• Feedback mechanisms for researchers, participants, and oversight bodies to identify areas for improvement and adapt governance processes accordingly.

• Mandatory training programs for research staff, focusing on evolving best practices, ethical guidelines, and compliance with national and international standards.

Organisational structure

Organisational structures and processes are critical to the successful implementation of the Research and Clinical Trials Governance Framework. The governance structure within Royal Rehab has been designed to ensure we meet all governance obligations and supports a culture of continuous improvement and the achievement of performance expectations as they relate to safety and quality.

The organisational structure demonstrates the various layers of management with key responsibilities for all aspects of corporate governance, including research governance. The Group Executive Team plays a pivotal role in managing, making decisions, and developing strategies that affect the organisation for issues of Group wide significance (Figure 3). Within the Group Executive Team, the Director of Research plays a key role in relation to research and research governance.

Chief Executive Officer

Chief Financial Officer

Executive Manager, IT

General Manager, Home and Living

Chief Operating Officer

Executive Manager, Quality, Safety and Risk

General Manager, Community Services (NSW)

General Manager, Community Services (QLD/ VIC/DES)

Executive Manager Business Development and Support Services

Executive Director, Disability Services

Executive Manager, Health & Wellbeing Development

Executive Director, Royal Rehab LifeWorks Community & Sargood

Chief People Officer

Executive Manager, Learning and Organisational Development

Executive Manager Marketing and Communications

Executive Director, Hospitals Director of Medical Services

Director, Research

Figure 3: Executive Team

Roles and responsibilities

Responsibility for research governance is shared across various levels of the organisation, starting with the Board.

Role Responsibility

Board of Directors (the Board).

The Board set a clear vision, strategic direction and strong organisational culture that drives consistently safe, high-quality care and the conduct of research. The Board’s vision for research is included in the organisational strategy.

The Board oversees implementation of the Research Governance and Clinical Trials Framework to ensure legal, regulatory and operational responsibilities in line with corporate objectives via their Quality, Safeguards and Clinical Governance Sub-committee.

Chief Executive Officer (CEO)

Chief Operating Officer (COO)

Executive Directors & site General Managers

Director of Research

The CEO is responsible for developing and implementing strategic and operational plans that embed research governance. This includes delegation of research governance site authorisation responsibilities.

The COO is responsible for implementing strategic and operational plans that embed research governance. This includes line management of the Director of Research and the activities of the Research Office.

The Executive Director Hospitals, Executive Director Disability Services, Executive Director Royal Rehab LifeWorks Community and Sargood Sargood and General Managers are responsible for research governance authorisation of research projects involving their site. This includes authorisation of Site Specific Assessments and Access Requests.

The Director of Research provides leadership in relation to and is accountable for research governance. This includes ensuring research governance policies, procedures and practices are in line with regulatory requirements and best practice.

For research conducted in services provided by the Affiliated Health Organisation at Ryde, this includes ensuring research governance policies, procedures and practices are in line with the requirements of NSW Health.

Research Office

The Research Office manages all research governance enquiries and applications. They advise researchers about whether their project requires a Site Specific Assessment or meets the requirements for an Access Request.

The Research Office assesses site-specific aspects of new research applications; this includes preparing a summary of the project, conducting a risk assessment, and making a recommendation to the person with delegated responsibility for the project’s site authorisation as to whether a research project should be authorised at that site.

The Research Office is also responsible for post-authorisation activities such as managing and reviewing amendments of authorised research projects, having oversight of authorised projects through review of annual and final reports, and managing complaints related to the conduct of projects.

Principal Investigator

The Principal Investigator has responsibility for the overall conduct, management, monitoring and reporting of the aspects of a research project conducted at a particular site and submits the research project application for site authorisation.

In particular, this includes responsibility for ensuring that the research project is conducted responsibly, ethically and with integrity in line with approval conditions, and relevant local, State and National Statements, Guidelines and Policies.

The Principal Investigator is responsible for ensuring members of the research team and support staff are appropriately skilled and knowledgeable to undertake their delegated aspects of the research project and they are adequately supervised undertaking their delegated tasks.

Research Team Members and Support Staff

Committee Structure

Royal Rehab’s integrated committee structure prioritises a strong safety culture and commitment to quality research governance practices. Reporting of research governance matters starts in local business units and has reporting lines through to the Board (Figure 4).

Royal Rehab Board

Audit, Risk & Corporate Governance Board Committee

Planning & Development Board Committee

Quality Safeguards & Clinical Governance Committee (Mandated)

Quality, Safeguards & Clinical Governance Board Committee

Remuneration & Nominations Board Committee

Royal Rehab Foundation Board Committee

Consumer Advisory Committee (Mandated) Group Executive Team

Advisory Committee (Mandated - Hospitals only)

Local Business Unit Committees

The Board

Ultimate responsibility for the management of Royal Rehab rests with the Board of Directors. The Board oversees the implementation of research governance to ensure legal, regulatory and operational responsibilities in line with corporate objectives. The Board set a clear vision, strategic direction and strong organisational culture that drives consistently safe, high-quality care and the conduct of research to inform service delivery.

The Board has established five sub-committees and assigned to each committee duties to assist the Board in exercising its responsibilities. Research governance is reported as part of site Quality, Safeguards and Clinical Governance reporting into the Board Quality, Safeguards and Clinical Governance Committee which reports regularly to the whole Board on all matters relevant to the committee’s roles and responsibilities.

Local Business Unit Committees

The Board is supported by the Group Executive Team led by the Chief Executive Officer. The Group Executive Team has daily operational accountability for client care and safety, and all governance matters, including research governance. Research governance reports regularly to local business unit Quality, Safeguards and Clinical Governance Committees. The Medical Advisory/ Medical Advisory and Appointment Committee is responsible for credentialing external research staff wishing to be involved in the provision of clinical assessments or clinical interventions as part of research conducted in Royal Rehab hospitals.

Local Business Unit Committee Purpose

Quality, Safety & Clinical Governance Committee

Consumer Advisory Group Local Committee

Medical Advisory/ Medical Advisory and Appointment Committee (Hospitals Only)

Monitors and reports on the quality management systems in place, including clinical quality, safety activities, client satisfaction and engagement, continuous improvement, and research governance.

Monitors the consumer experience; involve consumers in the design and evaluation of services and their delivery; and review operational and strategic performance, from a consumer perspective.

Monitors and reviews any relevant clinical matters; credential all medical and allied health practitioners, who are not employed by Royal Rehab; and recommend improvements on any matters relating to client outcomes and safety.

Figure 4: Committee Structure

Standards and Compliance

The implementation of a shared understanding of research and research governance standards and practices is supported by industry and government documents. Broadly, research and research governance are guided by the Australian Code for the Responsible Conduct of Research (2018) and National Statement on Ethical Conduct in Human research (2023). In addition, the conduct of clinical trials in health services is supported by the National Clinical Trials Governance Framework (2022).

The National Clinical Trials Governance Framework and actions to achieve accreditation for clinical trial service provision remain embedded in routine practices across Royal Rehab, in particular, the implementation of actions against the following five components within the Clinical Governance Standard and the Partnering with Consumers Standard:

Clinical Governance Standard

Standard component Implementation Actions

Governance, leadership and culture

Patient safety and quality improvement systems

Clinical performance and effectiveness

Safe environment for the delivery of care

• Royal Rehab has established strong governance systems for overseeing research and clinical trials, ensuring ethical and regulatory compliance.

• The role of the Safety, Quality and Clinical Governance Committee is emphasised in setting the strategic direction and ensuring research aligns with client care goals.

• Integrated corporate and clinical trials governance systems are established, and used to improve the safety and quality of clinical trial service provision for clients, their carers and consumers

• Strategic planning processes capture initiatives to deliver safe and quality research and clinical trial services

• Monthly Executive Research Governance Report summary report on research and policy updates.

• Attendance at relevant external meetings, including the NSW Health Research Ethics and Governance Roundtable.

• Clinical trials are evidence-based and staff involved in the trials are competent and appropriately trained.

• Royal Rehab monitor the effectiveness of clinical trials and ensure they contribute to broader healthcare improvement goals.

• Development of relevant operational policies and forms to support and define research governance.

• Document research governance risk register.

• Safety and quality systems are established and used to manage and improve the provision of research and clinical trial service

• Serious incidents are reported and investigated

• Quality, Safeguards and Clinical Governance Framework in place

• The workforce has the right qualifications, skills and supervision to provide safe, high-quality clinical trial services to clients

• The environment in which clinical trials are conducted is safe and promotes high-quality clinical trials to patients.

Partnering with Consumers Standard

Standard component Implementation Actions

Partnering with consumers

• Systems are designed and used to support clients, carers, families and consumers to be partners in planning, design, measurement and evaluation of clinical trial services.

• Consumers may also work with Royal Rehab, in the design, and evaluation of clinical trials.

• Informed consent processes are a central focus, ensuring that participants are fully aware of the potential risks and benefits of the trial.

• Consumer Advisory Committee in place to assist facilities establish, maintain and enhance consumer engagement.

• Consumers included in the Board membership and various committees.

• Consumers participate in clinical governance and quality improvement activities.

References

Australian Code for the Responsible Conduct of Research (2018)

National Clinical Trials Governance Framework (2022).

The National Clinical Trials Governance Framework and User Guide for Health Service Organisations Conducting Clinical Trials

National Health and Medical Research Council (NHMRC) 2016 Standards for Guidelines

National Statement on Ethical Conduct in Human Research (2023)

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