Streamlined Governance Process
The RDGU at Epworth HealthCare has implemented a streamlined governance process. This process has been designed to ensure that the all ethical, legal, regulatory, strategic and logistical requirements of research being conducted at Epworth are being fulfilled within acceptable timelines.
There are a number of key components to the successful conduct of any research and we provide details on how we support researchers under the following headings. Please click on these headings below for further information.
We also recognise that many of our Visiting Medical Officers (VMOs) may be outside of Epworth physically, or research may only be done within their own rooms. For the purposes of ensuring that Epworth meets it’s obligations for ensuring good governance of research if any of the following criteria are met the research must be registered with the RDGU and authorised by Epworth prior to commencing:
- The research impacts directly or indirectly on Epworth patients- inpatients or outpatients
- Epworth is funding the research directly
- The project uses significant Epworth resources
- The research could impact on Epworth’s reputation
- Familiarise yourself with the Epworth Research Policy, strategy, Governance Handbook and relevant SOPs on our Resources for Researchers webpage
- Always refer to our Resources for Researchers webpage for the most current templates and guidance documents
- Read all of the steps in the process (including information dropdowns) before commencing with your application
COVID-19 Guidance for Research Studies (updated March 2021)
The COVID-19 pandemic is a rapidly evolving situation and the response measures required to effectively manage the impact of the pandemic on our patients and clinical trials must adapt accordingly. As the situation develops, contingencies and response measures will be reviewed regularly to ensure the safety of our patients and staff.
Please refer to the Epworth Research Coronavirus (COVID-19) Guidelines – March 2021 for further details. These guidelines are an update to our previous guidelines of July 2020.
All staff and participants for approved Epworth research projects should follow the most recent Epworth COVID-19 measures and policies.
Defining Research at Epworth
Research that meets any of the following criteria must be registered with the RDGU and authorised by Epworth prior to commencing:
- the research involves Epworth patients (inpatients or outpatients);
- Epworth is funding the research directly;
- the project uses significant Epworth resources; and/or
- the research could impact on Epworth’s reputation.
As per Epworth Research Policy, all research at Epworth must be in alignment with Epworth values and strategic intent.
All researchers are required to be familiar with the Epworth overarching strategy and Epworth Research Strategy when planning to undertake research at Epworth and are required to obtain evidence of approval from the relevant Director that a project meets this criteria as per the Epworth Research Governance Approval Hierarchy (see Epworth Research Governance Handbook Appendix A).
The Principal Investigator should discuss feasibility of the project with all relevant Epworth stakeholders as per the Epworth Research Governance Approval Hierarchy (see Epworth Research Governance Handbook Appendix A).
This should take place prior to registration with the RDGU. The feasibility process for interventional studies is outlined in the Feasibilities and Trial Start-Up SOP (SOP-TM-01).
The RDGU can help further advise on the relevant departmental and hospital approvals at registration if required.
All new research projects at Epworth must be registered with the RDGU.
Registration should take place after feasibility is confirmed and prior to submitting a project for external ethics review on behalf of Epworth (see Research Governance SOP (SOP-RG-01) for further information).
The following information is required to register a project:
- Study title
- Epworth PI (must have an Epworth appointment or affiliation)
- Sponsor (if clinical trial)
- Study Coordinator (if applicable)
- Epworth site(s)
- Project proposal or protocol (draft can be provided)
Any researcher engaged in health and medical research involving Epworth patients, staff and/or resources must be authorised to conduct research at Epworth.
The Researcher Credentialing Process ensures that all investigators conducting research at or for Epworth are qualified and authorised to do so. Research projects will not be granted governance authorisation until all listed researchers are authorised through this process.
Further information regarding the credentialing process and requirements are outlined in the Researcher Credentialing SOP (SOP-RG-04).
Researcher credentialing application to the RDGU are to be submitted through the online Researcher Credentialing Form.
Mandatory SOP training
All individuals involved in the conduct of clinical trials under the TGA Clinical Trial Notification (CTN) scheme at Epworth are required to complete and record their SOP training in SiteDocs prior to commencing any research activities (see also Documentation of Qualifications and Training Records SOP (SOP-QA-01).
We encourage all researchers to undertake appropriate training and the RDGU can provide advice and resources for researchers wishing to enhance their research capabilities.
Insurance and IndemnityAll studies must be able to provide evidence of adequate insurance coverage. For further information please refer to our Clinical Indemnity and Insurance SOP (SOP-RG-02).
A detailed budget must be developed for research being conducted at Epworth. It is the Principal Investigator’s responsibility to ensure all institutional costings have been adequately accounted for.
For investigator initiated studies the PI is responsible for ensuring all costs are covered by an identified funding source (i.e. research grant). This should be discussed with the Research Operations Manager or Clinical Institute Research Lead as early as possible to establish if the resourcing and operational requirements of the study can be met.
For further guidance refer to Developing Contracts and Budget SOP (SOP-RG-03).
Further information regarding opportunities for funding of research activities at Epworth can be found on the Epworth Medical Foundation Research Grants webpage.
Research agreements must be in place where projects involve multiple parties where the roles and responsibilities must be defined.
The requirement for an agreement should be identified early in the application preparation process. For further guidance on research agreement templates approved for use at Epworth and Epworth details to be included in research agreements see the Developing Contracts and Budget SOP (SOP-RG-03).
Only an authorised representative of Epworth is permitted to sign research agreements on behalf of Epworth.
Research agreements signed by all parties except Epworth should be submitted as part of the governance application to Epworth. Submissions will not be considered complete or processed until all required documents including the agreement for signing is provided. Epworth will sign the agreement last as part of issuing governance authorisation.
Studies involving exposure to ionising radiationPlease refer to Epworth SOP on conducting research involving ionising radiation (SOP-RG-05) for guidance on preparing and submitting documentation to demonstrate compliance with the legislative requirements for research involving ionising radiation.
Clinical Trial Notification Scheme (CTN)
The Epworth HealthCare site(s) where trial procedures are to be conducted must be listed on the CTN.
Please refer to Research Governance SOP (SOP-RG-01) Appendices for Epworth details to be included in the CTN.
Ethical consideration is an integral part of research governance, any research being undertaken at Epworth which is considered more than low-risk will require ethics review by a HREC certified by the National Health and Medical Research Council (NHMRC). Refer to the list of these HRECs.
Please refer to the Epworth Research Handbook for an overview of options and requirements for ethics review pathways accepted at Epworth.
The RDGU can assist in identifying the appropriate review pathway at registration.
Non-HREC Review Pathways
The RDGU oversees the review of Low and Negligible Risk projects deemed suitable for ethical consideration via the non-HREC review pathway as defined by the National Statement. Please see the Non-HREC Review SOP (SOP-RG-08) for further information.
If the project meets the criteria for non-HREC review all ethics and governance considerations will be addressed as part of the review.
Site Specific Research Documents
The Principal Investigator is responsible for ensuring the Participant Information and Consent Form (PICF) and other site-specific documents are based upon the current HREC approved Master documents and appropriately amended to include the site specific information.
The PICF content checklist form (SOP-RG-01-FORM-01) must be referred to when preparing the site specific PICF.
PI project declaration
The PI Declaration Form (SOP-RG-01-FORM-02) is equivalent to the SSA form used at other hospital sites.
The PI project declaration must accompany all applications where the study has been reviewed and approved by an external HREC and can be used as a guide to ensure all governance requirements are met prior to submitting the final documents for Research Governance Authorisation.
Submitting your streamlined governance application
We recognise that some information or components required for governance approval may arrive later than others. We encourage researchers to work with the RDGU to make sure that they fully understand what is required.
The RDGU will provide feedback on any of the components that comprise governance requirements at any time but a submission for authorisation will not be officially noted until all documentation is provided. That is, researchers can work with the RDGU in an iterative manner to ensure their documents will meet the requirements of Epworth and we encourage this to avoid any delays in approval. However, to avoid any ambiguity of what comprises an official submission the RDGU will time stamp a submission from the time that all necessary documentation is submitted. Details of what is required is outlined in SOP-RG-01.
The PI declaration form should only be signed and dated on the day that all paperwork comprising the governance submission is provided.
Research Governance Authorisation
The RDGU will provide written confirmation of Governance Authorisation to the Principal Investigator upon receipt of required documents and sign-off by the Group Chief Executive or delegate.
The Principal Investigator must ensure all conditions of Governance Authorisation are met prior to commencement of the project.
The following Research Governance Review fees apply to commercially sponsored clinical research conducted at Epworth HealthCare, effective from January 1st 2020.
Commercially sponsored studies
- Initial application: $5,500 Unit Cost (AUD) (exc GST)
- Amendment Fee: $600 Unit Cost (AUD) (exc GST)
EMF funded and external grant sponsored studies
Research Governance fees apply to all EMF funded and external grant sponsored studies at Epworth. Contact the research governance office to discuss the governance costs that may apply to your research project: [email protected]
Statistical advice and support
The Epworth Research Development and Governance Unit supports high quality research that is acceptable for publication. Expert biostatistician support is available to assist with development of hypotheses, outcome measures, endpoints, writing protocols, methods, papers and the conduct of the data analysis. Contact [email protected] for an initial consultation. There is no charge for this initial consultation. A cost estimate for agreed biostatistician support will be provided according to your project needs.
Post-Approval GovernanceThe Principal Investigator is responsible for meeting all reporting requirements as outlined in the Research Governance SOP (SOP-RG-01).
Internal Audits of Research at Epworth
Research conducted at Epworth HealthCare may be subject to internal auditing by the RDGU.
It is the Principal Investigator’s responsibility to ensure that adequate records are maintained to demonstrate compliance with governance requirements.
Further information regarding our quality management system can be found in our QMS protocol and associated Research Quality SOPs on our Resources for Researchers webpage.
Clinical Quality Registries
The Academic & Medical Services Division is responsible for the institutional approval and subsequent oversight of Clinical Quality Registries (CQRs) at Epworth. The RDGU in consultation with the Clinical Outcomes and Analytics Unit manages the institutional approval and subsequent oversight of CQRs at Epworth.
To register or discuss an existing CQR at Epworth please email: [email protected]
Quality Assurance and Quality Improvement Activities
The Quality Team within the Clinical Services (Corporate) Division is responsible for oversight of Quality Assurance (QA) and Quality Improvement (QI) activities at Epworth.
All internal QA/QI activities must be registered on the Epworth QI activity register on the intranet prior to commencing. The RDGU in consultation with the Quality Team provides additional support for projects that warrant further review.
As a rule QA/QI activities occurring solely within private practice will not require review and approval from Epworth as they are not deemed to be within our jurisdiction. However, where data from Epworth is required, such as from Epworth medical records we require notification to the RDGU and we may subsequently advise that approval from Epworth is also required. Please contact the RDGU if there is any uncertainty.