Research Management

Research governance is a framework through which institutions are accountable for the scientific quality, ethical acceptability and safety of the research they sponsor or approve to be conducted.

Calvary Mater Newcastle Governance Review Process

The governance processes for research conducted at Calvary Mater Newcastle is managed by the Calvary Mater Newcastle Research Office. Our Research Governance Officer is Melissa Gavenlock who can be contacted on 02 4014 4784 or at [email protected]

REGIS

The Research Ethics and Governance Information System (REGIS) is the portal that is used for research management of ethics and site governance in all NSW and ACT Public Health Organisations (PHOs).​

The Site Specific Assessment Form (SSA) is created when a study is registered on REGIS.

1. The applicant completes the SSA and uploads their Site Specific Documentation.
2. The applicant then submits the SSA to the Head/s of Department and Operational Executive to indicate their support of the project.
3. Once they indicate their support, the applicant must submit their SSA to the Research Governance Office. This is all done electronically through REGIS.
4. Calvary Mater Newcastle has an additional review process to assess compliance to the Catholic Code of Ethics. If this is a requirement, then the applicant will be notified by the Research Governance Officer.

(Please note: if your project is being conducted at the Calvary Mater Newcastle and Hunter New England sites, two separate SSAs must be completed.)

To review the Calvary Mater Newcastle Research Governance process in detail please click here.

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.

What is 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.

Source: Australian Commission on Safety and Quality in Health Care

Resources For Research

• Is my study research?
• Is my study a clinical trial?
• Current Awareness and FAQ’s for Researchers
• RGO submission self assessment
• Study start up tracker
• Parallel RGO Flow

Clinical Trials Guidance

• NSW Office for Health and Medical Research Clinical Trials Toolbox

Research Standard Operating Procedures

Calvary Mater Newcastle has established a set of Standard Operating Procedures (SOPs) specific to research. These SOPs provide a robust framework to ensure consistency in our method of practice for research. A copy of these can be obtained by contacting the Research Office at [email protected]

Research Financial Management

The end-to-end financial management of research funding involves Chief Investigators (CIs), Calvary Mater Newcastle Research Office, Calvary Mater Newcastle Finance Department, executive operational managers and the department/unit. This comprises of the following:

• Planning
• Day-to-day management
• Compliance and governance
• Accounting
• Reporting to funding and funding bodies

The awardee of the funding in most cases is Calvary Mater Newcastle and agreements and contracts are signed between the sponsor and the hospital (not the individual researcher). The Calvary Mater Newcastle Research Office can offer assistance to clinicians and researchers by:

• Supporting applications for grant funding and fellowships
• Providing advice in terms of finance and budgets
• Amendments for clinical trial budgets in REGIS
• Liaising with clinical trials managers and Calvary Mater Newcastle Finance to ensure that correct budgets and variations are maintained

Further detailed information regarding roles and responsibilities of research financial management can be found here

Research Governance Fees

The Research Governance Office at Calvary Mater Newcastle remains committed to supporting research activities within the hospital. In accordance with NSW Ministry of Health Policy all clinical trials reviewed by the office will be subject to a Governance Review Fee.

These fees ensure the Research Governance Office has adequate resources to support a strong governance framework and provide a high quality of service. Fees will vary depending on the type of submission, and the study sponsor/funding classification and will be invoiced as incurred.

Research Ethics and Governance Review of Clinical Trial Research Fees are mandated by the NSW Ministry of Health, Policy Directive and Information Bulletin as listed below:

PD2023_015 Fee Schedule for Research Ethnics and Governance Review of Clinial Trial Research

IB2023_026 Fees for Research Ethics and Governace Review of Clinical Trial Research

The Research Office can be contacted at [email protected]

Calvary Legal, Governance and Risk branch is responsible for the provision of legal services to Calvary Mater Newcastle.

The legal team provides advice, information and support for:

• General legal and compliance matters
• Contract planning, drafting, review and negotiation
• Privacy matters
• Trust and bequest administration
• Clinical Trials – Contracts, CDAs, Commercialisation, IP
• Research related matters including grants, partnerships, research contracts, collaborations, consultancies and related documents such as Confidentiality Agreements and Material Transfer Agreements

If you have a legal enquiry please contact the Research Office at [email protected]

Intellectual Property

There are two main types of Intellectual Property Rights (IPR).

• Copyrights and related rights
• Industrial property

As a researcher, you should clarify ownership of, and rights relating to, the research data you will be creating or collecting as part of your research project. Ownership and rights will determine how the data can be managed into the future, so these should be documented early in a project through your data planning.

If you are a Calvary Mater Newcastle staff member

In general, Calvary will own the intellectual property rights, including copyright, in research data originated by clinical and academic staff.

Contractors

Ownership of IP, including copyright, should be covered in the contract for services between Calvary Mater Newcastle and the contractor. If the contract is not explicit about any requirements for copyright and other IP to be assigned to Calvary, then the contractor will usually own the copyright and other IP in any data they create or compile.

External parties, collaborators and industry partners

Where research is conducted in collaboration with partners outside of Calvary Mater Newcastle, or for external agencies (e.g. funding bodies), ownership of copyright and other IP needs to be explicitly agreed to by the parties. Ownership of copyright and other IP will commonly be dealt with in a document such as a funding agreement, contract or a memorandum of understanding.

Using third party research data

The use of data from third parties will usually be subject to copyright and/or licensing agreements. If the data you wish to use is openly available online, you will need to check for copyright statements or reuse licenses to inform you as to, if and how, you can use the data in your research. Otherwise you will need to seek permission for the use and later publication of the data.

For detailed information on IPR, please refer to the World Intellectual Property Organisation

Policies, Procedures and Confidentiality Agreements

• FAQs legal and insurance NSW

Policies and procedures are available to Calvary Mater Newcastle staff via Calvary Connect intranet.

External enquiries, please contact the Research Office at [email protected] 

Safety Reporting

Serious breaches should be reported in accordance with the NHMRC guidance document: Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods 2018.

A serious breach could relate to a breach of Good Clinical Practice or to a protocol that is likely to affect:

• The safety or rights of a trial participant
• The reliability and robustness of the data in a clinical trial

Serious breaches must be reported to the reviewing HREC, within seven calendar days of confirmation that a serious breach has occurred. The HREC will review the incident and evaluate the impact on the ethics of the study and managed the incident appropriately.

It is the responsibility of the Principal Investigator to:

(i) report any suspected breach to the sponsor within 72 hours of becoming aware of it
(ii) report to their institution (via the Research Governance Officer) within 72 hours any serious breach that has been confirmed by the sponsor as occurring at their site

Adverse events

NSW Health’s ‘Safety Monitoring and Reporting for Clinical Trials Conducted in NSW public health organisations’ policy directive applies to all clinical trials conducted within public health organisations in NSW. The safety monitoring and reporting responsibilities of the Sponsor, Coordinating Principal Investigator, and Principal Investigator to the HREC and RGO are outlined within this policy. For more information regarding the policy please click here.

Complaints

For any complaints regarding the conduct of a Calvary Mater Newcastle research project, in the first instance, please contact the Calvary Mater Newcastle Research Governance Officer on 02 4014 4784 or email at [email protected]