Gold Coast Health requires annual progress reports. A final report is also due on the completion of a project or if the research is discontinued before the expected date of completion.

Other events, particularly during clinical trials, may also need to be reported. Researchers are encouraged to familiarise themselves with the requirements for the type of study.

We use the Ethics Review Manager (ERM) to facilitate and support the following:

• Commencement form  
• Annual Progress Report  
• Amendment Request Form 
• Safety Report (routine annual report) 
• Project Final Report/Site Closure Form for the final progress report  
• Protocol Deviation/Violation report 

An annual progress/final report template can be found here. 

As with the original application, post-approval amendments require a two-step process: 1) ethical approval, 2) governance authorisation. Researchers complete both steps within the Ethics Review Manager (ERM). Although it can forgotten, regular reporting is an important requirement for researchers. If researchers require more information about reporting, please contact our contact support centre for guidance.

A variety of funding sources are available to researchers including:

• Internal Gold Coast Health Grants
• Other Government Grants 
• Not-for-profit Partners 
• Academic Partners
• Commercial Sponsors

Each funding source will have its own criteria regarding processes, requirements, and limitations on how to apply for, and obtain, a grant.

The first step after being awarded a grant, or during contract negotiations, is to contact the Research Office via the contact support centre and notify us of a grant award. 

Researchers will be guided through the process specific to them and the type of funding awarded (such as grant agreements or clinical trial funding agreements) and advised what documentation needs to be provided to the Research Office.  

Each research project will have an individual account created, referred to as a Research Internal Order Number (ION). An ION will be established to receive and hold the grant funds. Grant funds are accounted for individually and will not be mixed with other sources of funds or other projects’ funds.

Once an ION is established, the Research Finance Team will raise an invoice to the funding body. The funding may be obtained in one transaction, or split into smaller portions and made available once certain milestones are met. This will be dictated by the Funding Agreement.

Research balances within an ION roll over year-on-year, with no risk of unspent funds not being fully available to researchers. Agreements or contracts with funders, however, may stipulate time limitations for the funds to be expended, which must be adhered to.
 

The official awardee of research funding in most cases is the Gold Coast Hospital and Health Service (GCHHS) and not the individual researcher. As such, agreements and contracts are signed between the sponsor / funding body and the GCHHS. The Research Office will hold the financial delegation over research funds and the researcher will have authority to instruct the Research Finance Team as to how they are to be spent. 

Researchers are expected to be proactive when managing research funding, with ultimate responsibility resting with them. The end-to-end financial management of research funding, however, may involve several members; being Principal Investigators (PIs), other staff on the research project team, and the Research Office.

All aspects of financial management detailed below is, therefore, a joint effort:

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

To ensure financial transactions are captured in an auditable manner with appropriate supporting documentation, the Research Finance Team will support researchers by: 

• Ensuring that Research Internal Order Numbers (IONs) for all funded studies are created in a timely manner.
• Liaising with Divisional Finance in relation to funds awarded and variations to ensure correct balances are maintained in finance systems (S4Hana and DSS).
• Reviewing and maintaining research study budgets.
• Regular ION monitoring to support the research team in executing their responsibility to monitor expenditure and ensure costs incurred are within funding amounts awarded.
• Providing budget advice in relation to practical operational expenses, e.g., cost and quoting requirement for purchasing items. 
• Providing financial assistance to the research team to modify budgets based on available surplus funds. 
• Accounting for research and related activities in accordance with accounting standards and the policies of Gold Coast Health.
• Ensuring availability of accurate and up-to-date financial information to research teams for monitoring expenditure, for both labour and non-labour expenses.
• Assisting research teams by providing training in financial matters and understanding financial information. 
   

We're actively increasing the number of health service and clinical research projects, and the number of staff engaged in research and education using evidence-based practice. 

Across Gold Coast Health, a total of 67 new research projects started during the period (2021–2022), with $2.69 million awarded ($1.7 million from commercial partners and $1 million from government, not-for-profit organisations, and universities). Most research activities were supported by new and existing partnerships, including 11 commercial companies, nine universities, four not-for-profit organisations, and six government (including other hospital and health services).

Our collaborative research groups support research enterprise in key areas through the bringing together of a range of professionals with different skills, talents and experience that creates a culture of continuous learning and development. Gold Coast Health has 11 collaborative research groups covering a diverse range of research areas, including cancer, infectious diseases, mental health, orthopaedics, emergency care, pharmacy, allied health, maternity and children’s health, and patient and family-centred care.

With support from conjoint appointments at Griffith and Bond University, we continue to establish ourselves as a health service where high–quality research is translated into patient care.

The Clinical Trial Unit can manage and coordinate commercial and investigator-driven research projects. Together with other specialist trial groups including oncology and haematology, trauma and intensive care, clinical trials have become part of the hospital journey. 

In 2022, the unit continued to provide support to 30 principal investigators across 17 departments with 58 active clinical trials. The number of departments active in clinical trials has grown by four, and the number of active trials has grown by 10, in comparison to the previous reporting period. Of the active trials, 53 per cent are commercial trials.

Patients and their carers are included in our research from the design state through to delivering the outputs of research. Researchers are delivering on projects that optimise patient care by training clinicians in new interventions, using research to validate clinical guidelines, evaluate new service assessment pathways and, most importantly, to empower patients and their families be engaged with the care they receive.

By embedding research and evidence-based practice into health service delivery and patient care, we are helping our clinicians to deliver world-class care - a key objective of Gold Coast Health's strategic plan.

We partner with like-minded organisations to improve lead changes or improvements in clinical practice, health service delivery and patient care in the community. We also focus on the consumer and the importance of engaging consumers in all aspects of the research process, including having a voice on committees involved in decision-making processes.

Our engagement goal is to achieve authentic connections and partnerships with the community so that the health service accurately reflects and responds to the needs and perspectives of everyone they serve. A key focus point is shared decision-making where patients are empowered to be actively involved in their care, be it clinical or research. 

Learn more about community and consumer engagement.

The library staff continually review and update the book collection to meet the needs of researchers and the organisation. They also assist staff from across the health service in accessing and utilising information resources, and provide consultations for more complex information retrieval.

GCH librarians can assist individuals and teams of researchers in all aspects of literature searching, from advising on literature search methodology to collating bibliographies of relevant resources and developing comprehensive search strategies across multiple databases.

Submit a request for a literature search here. 

Library staff deliver regular online training sessions covering literature search skills, research databases, and full-text access. Librarians also provide training in the use of citation managers (e.g., EndNote). Citation managers are invaluable tools for keeping track of literature and when developing a manuscript or thesis. As research journals often have specific style requirements, citation managers can save a considerable amount of time in the referencing process.

View and register for upcoming training sessions here. Request individual or group training here. 

Planning to conduct a systematic review or other form of evidence synthesis? It is recommended that you engage with a research librarian for methodological guidance and to organise a preliminary search of the literature for your topic. 

Access the library guide for systematic reviews here.
 

Every month, Gold Coast Health Library Services collates publications involving GCHHS authors. Access the 2024 list of publications.

Ethics approval can be obtained from any certified Human Research Ethics Committee (HREC) within Australia (excluding Bellberry). Details on Queensland Health HRECs can be found here.

The purpose of the Gold Coast Hospital and Health Service Human Research Ethics Committee [EC00160], in accordance with the National Statement, is to ensure that all human research is conducted in an ethical manner. The HREC’s responsibility and scope is defined in the Terms of Reference. The HREC’s composition is set out here. For some applications, the HREC may obtain additional/external expert opinion for scientific/technical assessment, research study evaluation, and compliance with regulatory requirements.  

All research undertaken at our facilities should follow the principles and responsibilities set out in the following guidelines:

• National Statement on Ethical Conduct in Human Research
• Australian Code for the Responsible Conduct of Research

• Tips when preparing your research protocol
• Research protocol template
• Submission guidelines for projects 
• Ethics and Governance guide to parallel submissions

Research projects may involve low- to negligible-risk or medium-high risk to participants or the organisation. Researchers may consider their project low- or negligible-risk, but it is ultimately the decision of the Chair of the Human Research Ethics Committees (HREC) if the threshold for low-risk has been breached. If in doubt, researchers are welcome to use contact support centre for guidance.

Researchers are required to complete a Human Research Ethics Application (HREA) as part of their submission. The HREA is available in the Ethics Review Manager (ERM) system. Resources are available on the Office of Research and Innovation website [previously Health Innovation, Investment and Research Office (HIIRO)] website to support researchers in using ERM.

It is recommended that researchers first complete their protocol and its associated documents (including obtaining any required approvals) prior to commencing their HREA. When completing the HREA researchers may choose to refer to their protocol to answer questions rather than duplicating work in their HREA. The submission guidelines for projects outlines the requirements for each project type. 

Researchers will generally need the following for submission to an ethics committee:

1. Protocol
2. Curriculum vitae (PrincipaI Investigator only)
3. Letter of Support template Ethics
4. Participant Information Sheet and Consent Form (PICFs) [if applicable]
5. Advertising material [if applicable]

Depending on the nature of the study, further information may be requested.

Application for full committee review

Meeting and submission dates (and associated requirements) for GCHHS HREC can be found below:

• GCHHS HREC Meeting and submission dates 2025
• GCHHS HREC Terms of Reference
• GCHHS HREC Composition

Meeting and submission dates (and associated requirements) for all Queensland Health HRECs can be found here. 

Application to the Gold Coast Hospital and Health Service Human Research Ethics Committee for low- and negligible-risk review

Projects deemed to be low- or negligible-risk are reviewed out of session by a sub-committee of the HREC. These may be submitted at any time.

We aim to:

• protect the human rights and safety of people taking part in our research projects
• promote high quality, ethical and responsible research through our review processes.
   

Our HREC works in line with the NHMRC's National Statement on Ethical Conduct in Human Research 2023 (National Statement).

We consider both the ethical and scientific validity of research projects in our hospitals and health centres.

We can review multicentre projects that are occurring across Australia as we participate in the National Mutual Acceptance Scheme.

For more information, see our terms of reference and current GCHHS committee composition.  
 

The Gold Coast HREC meets 11 times per year. Meetings are held at 5 pm on the last Wednesday of every month, except December. 

• GCHHS HREC meeting and submission dates 2025

The Gold Coast HREC welcomes expressions of interest across all categories of HREC membership. 

In particular, we are looking for volunteers to join our HREC in the following categories:

• Category B (community perspectives)
• Category D (pastoral or community care)

As a HREC member you are invited to all meetings. We request that you:

• attend a minimum of 6 full HREC meetings per year, and
• participate in out of session reviews, including the review of low risk and urgent research. 

The time commitment for volunteering as a Gold Coast HREC member is approximately 5 hours per month. 

Our HREC also provides all members with access to the PRAXIS HREC Essentials training course free of charge.

How to join

1. Read the EOI form
2. Email your EOI and your CV to GCHEthics@health.qld.gov.au

Contact us

• Name: Acting HREC Coordinator 
• Email: GCHEthics@health.qld.gov.au
• Phone: 07 5687 3879

Research application fees vary depending on the type of submission and the research project sponsor/funding type. View the GCHHS Schedule of Research Application Fees for the current 2024-2025 fees. For submissions that are not sponsored or led by a Queensland Health Hospital and Health Service, please include the GCHHS Research Fees form with the relevant ethics/SSA submission via Ethical Review Manager (ERM). Failure to upload the form will delay review of the submission.

Research that may be exempted from HREC review:

• is negligible risk research*, and 
• involves the use of existing collections of data or records that contain only non-identifiable data about human beings. 

*Where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. Where the risk, even if unlikely, is more than inconvenience, the research is not negligible risk. 

Quality activities (assurance or improvement) may be undertaken and led by Gold Coast Health staff members. If researchers are planning to submit a manuscript for publication or to present findings to an external audience, they may require evidence of acknowledgement that their study does not require ethical review. All quality activities should be registered on the GCH Innovation Portal (accessible on the QH network only) which includes the latest contact details for divisional Safety and Quality Coordinators. If you have any questions about registering your quality activity please contact GCAdminClinicalGovernance@health.qld.gov.au. 

Researchers should complete the Queensland Exemption Form in the Ethics Review Manager (ERM) system to gain acknowledgement prior to submission for publication.   

Research Versus Quality Improvement Activity Decision Aid (*accessible on the QH network only)  

Exemption of Ethical Review for Research or Quality Improvment Activities (*accessible on the QH network only)  

Clinicians and researchers may have a case study they seek to publish. It is a requirement to obtain acknowledgement and registration from the Gold Coast Hospital and Health Service (GCHHS) Human Research Ethics Committee (HREC) delegates prior to submission for publication.

Researchers are required to provide participants with the following forms:

• Clinical Case Study and the Human Research Ethics Committee (HREC) 
• Request to Publish Case Study Participant Information Sheet 
• Case Study Report Participant Consent Form
• Consent to Clinical Digital Images (if applicable *accessible on the QH network only)  

Researchers are then required to submit completed and signed versions of the above forms to Ethics Review Manager (ERM) to gain acknowledgement prior to commencing their project.

Up to three (3) clinical cases can be submitted via this pathway. For clinical cases of more than three participants it is considered a case series and will require submission to the HREC.

• Office of the Australian Information Commissioner
• Guidelines for Ethical Research in Australian Indigenous Studies
• Keeping research on track II: a guide for Aboriginal and Torres Strait Islander peoples about health research ethics
• Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities
• Ethical Research Involving Children

1. Log into Ethics Review Manager.
2. Select the tile Create Project from the list of Actions on the left-hand side - Enter the Project Title, choose Queensland Health as the jurisdiction and Exemption Form as the Main Form type, then select Create Project. 
3. Complete the questions as prompted
   • For Question 2, please choose the Gold Coast Hospital and Health Service Human Research Ethics Committee (EC00160) to ensure that the project is submitted to the GCHHS Research Office for review. Please note, despite submission through this portal, the proposed activity does not undergo ethical review.
   • Please ensure ALL members of the project team are listed under Question 4. The Primary Applicant should be listed as the Principal Investigator and must be a GCHHS staff member. Additional members of the project team should be listed as Associate Investigators 
4. Upload complete and signed documents under Question 7 (select Study Plan / Project design) along with any other supporting documents, including a Letter of support from the Head of Department.
5. Once the Exemption Form is completed and all supporting documents are uploaded, the Principal Investigator should complete the Signatures and Declarations page and sign the form. This can be done electronically (recommended) or alternatively, print the form, obtain the "wet-ink" signature, and upload this page to the Exemption Form. 
6. To submit the application, select the Submit tile from the list of Actions on the left-hand side and follow the prompts. This will submit your application to the GCHHS Research Office for processing. 

Once a study has been approved by an ethics committee, a researcher must turn their attention to applying for a site specific authorisation (SSA). This considers site suitability, legal compliance, financial management, accountability, and risk management and ensures research conforms to relevant institutional, jurisdictional and national standards, and applicable laws. Only one SSA form is required to cover GCHHS sites. Where possible, REGOs may recommend a parallel SSA submission following the initial response from the Human Research Ethics Committee (HREC).

Recognition of ethics approval by other institutions can be made, but this can depend on the type of committee that originally processed the application. For multi-site research approved under the National Mutual Acceptance (NMA) scheme, a re-evaluation of the ethical component of a study may not be necessary. If in doubt, contact the Research Ethics and Governance Officers (REGOs) for guidance.

Please note, if researchers have received ethics approval elsewhere, they still must receive governance authorisation prior to commencement. Researchers can access the application form for governance authorisation via the Ethics Review Manager (ERM).

Researchers will generally need the following for submission of a governance application:

1. Ethics approved documents (protocol, PICFs, advertising material, approval letter)
2. Approved budget 
3. Good Clinical Practice Certificate [if applicable]
4. Letter of Support from the Head of Department

Researchers can access the application form for governance authorisation via the Ethics Review Manager (ERM). All SSA applications must be submitted on the ERM platform. Guidance on accessing the ERM Applications system and navigating the forms is available here. The GCHHS Checklist for Researchers may be a useful tool to ensure all necessary information and documentation have been provided for a governance submission.

A research collaboration agreement (RCA) may be required for collaborative studies. Completion of the RCA is lead by a Gold Coast Health Research Ethics and Governance Officer (REGO) in collaboration with and an external researcher’s research office. The need for a RCA is triggered when a researcher submits their site specific authorisation (SSA), but can be discussed prior to submission to improve timeliness.

All researchers are responsible for managing the ongoing approval of their research including changes to the research protocol or supporting documentation. Learn more about reporting and your research.

• Research Projects Granted a Waiver of Consent in 2023
• Research Projects Granted a Waiver of Consent in 2022
• Research Projects Granted a Waiver of Consent in 2021
• Research Projects Granted a Waiver of Consent in 2020

Biostatistician | Research Office

Ian.hughes2@health.qld.gov.au 
P: (07) 5687 8200

Monday to Friday
Gold Coast University Hospital
Level 2 Block E – Pathology and Education
1 Hospital Boulevard
Southport, QLD 4215

Biostatistician | Institute for Evidenced-Based Healthcare
majones@bond.edu.au
P: (07) 5595 5523

Tuesday & Wednesday
Faculty of Health Sciences and Medicine
Building 5, Level 2
Bond University
14 Robina Drive
Robina QLD 4226 

Thursday & Friday
Gold Coast University Hospital
Bond University Annex
Level 2 Block E - Pathology and Education 
1 Hospital Boulevard
Southport QLD 4215

The Research Office provides, through Gold Coast Health IT, the statistical Software Stata 17. We encourage our researchers to use Stata. Accordingly, we provide Introduction to Stata group classes as well as one-on-one teaching on more advanced aspects of Stata specific to the researchers’ needs. Short videos on the most common uses of Stata are being prepared for our website. 

• Click on “IT Support” in the middle of the home screen of your computer.
• Start writing Stata in the search window
• Choose “Stata Install”
• Choose “STATA- Application Support”
• At the bottom of the page click on “Log a job for this”
• Fill in the form. “STATA” will appear as an option in the “Application” window (if not, write it in the next window, “Other/Unknown Software”)
• In the next window, type in the asset number of the computer you want Stata installed on
• Complete the “best way to contact” question
• IT will then install Stata remotely. It should appear on your computer within 48 hours. It will be found under “S” in the list of applications that appears when you click on the windows icon in the bottom left corner of your home screen. The icon can be moved to your desktop. 

Introduction to using Stata at Gold Coast Health

Stata - Cheat Sheet

Handling Dates and Times in Stata

Stata commands to use 

Dr Ian Hughes and Assoc. Prof. Mark Jones are available to give seminars or workshops to groups such as Departments or specialist trainees on any aspects of statistics, data management, the process of research, or interpretation of research literature. Both Dr Ian Hughes and Assoc. Prof. Mark Jones are involved in the Evidence-Based Practice workshops provided by Bond University’s Institute for Evidence-Based Healthcare (IEBH). These workshops are tailored to the specific needs of groups within Gold Coast Health, e.g. Departments, Profession, Specialty. If you are interested, please contact the IEBH for details and to organise a workshop.

General statistical and data management resources as well as more advanced statistics references are also available below. 

No matter where you are in your research journey, to get the most out of your consultation it is best to come prepared. If you are still in the early stages of formulating a research question, try to have some idea of what the basic aim is for your research and what the rationale is behind that. You may be asked to forward your Protocol if you have begun writing the Background or to provide some relevant literature prior to the meeting.

For any consult, make a list of any specific questions you may have and be ready to take notes. Remember, research is a team game and the Biostatisticians and the other Staff in the Research Office are part of your team.

The primary role of the Biostatisticians is to assist you in the statistical aspects of your research. We provide general and specific advice and mentoring in relation to the use of statistical tools such as Excel and Stata. For simple techniques we will demonstrate the technique so that you are able to replicate these for the rest of your analyses. For more complex analyses, we will provide you with background material for the method so that you understand the principles and we will undertake the analysis for you, usually in your presence. We will then go over the results so that you are able to interpret them correctly. If multiple complex analyses of the same type are required it is the expectation that you learn the technique yourself, whilst being mentored, or to seek external statistical assistance.

Large research studies often require there to be an associated Data and Safety Monitoring Board (DSMB). Our Biostatisticians are available to sit on these DSMBs.

Gold Coast Health employees are encouraged to engage in research and to undertake postgraduate research-based degrees. Our Biostatisticians are happy, given capacity and relevant expertise, to be approached to supervise students at Honours to PhD levels.

• Online Stat Book
• Statistics Online Course
• Stats 500
• Introduction to Statistics
• Statistical Language

• Nominal, Ordinal, Interval and Ratio
• Nominal Ordinal Interval Ratio & Cardinal
• Data types - Wikipedia

• Central Technology - Wikipedia
• Describing Data
• Descriptive Statistics - Wikipedia
• Measures of Spread: an introduction
• Standard Deviation
• Statistical Language - Measures of Spread
• Statistical Language - Measures of Central Tendency
• Mean, Mode and Median

• Random Variables - Wikipedia
• Schaum's Outline of Probability and Statistics
• Random variables and Probability Distributions
• Intro to Probability
• Categorical & Quantitive Variables
• MIT
• Random Variables Stats Library

Meta-analysis is a quantitative, formal, epidemiological study design used to systematically assess the results of previous research to derive conclusions about that body of research. Typically, but not necessarily, the study is based on randomized, controlled clinical trials.

MetaInsight

The research question should be something that needs answering. Something that is important to the end users of the research; in health this is often consumers. Involving consumers early in a research study can significantly benefit researchers, as it improves the likelihood that the project is relevant to those who will benefit most from it. Read more.

Data are valuable products in research so it's important to know how to use it. For further information about accessing and using, collecting, managing and analysing data, click here.

Every study needs a well-written, comprehensive research protocol. All research, including low-risk studies, require a protocol with sufficient detail for ethical, governance, and methodological appraisal. Even Quality Assurance and Improvement projects, along with clinical audits, should be grounded with a well-designed protocol. Read more.

A systematic review is a comprehensive and structured review of the literature and is aimed to clearly establish what is known about a topic. Read more.

Our library provides immeasurable value to Gold Coast Health researchers by assisting in all aspects of literature searching and reference management - whether you're in the planning stages of a project, conducting a systematic review, or writing for a publication. Learn more about this service.

Although there are some exceptions, almost all research studies conducted at Gold Coast Health must be submitted for ethical approval and governance authorisation before a study can commence. These steps assess the potential benefits and harms to participants (ethics) and the organisation (governance). The Research Ethics and Governance Officers (REGOs) process all research applications at Gold Coast Health. Read more.

Once a study has been approved by an ethics committee, a researcher must turn their attention to applying for a site specific authorisation (SSA). This considers site suitability, legal compliance, financial management, accountability, and risk management and ensures research conforms to relevant institutional, jurisdictional and national standards, and applicable laws. Only one SSA form is required to cover Gold Coast Health sites. Where possible, the Research Ethics and Governance Officers (REGOs) may recommend a parallel SSA submission following the initial response from the HREC. Read more.

Researchers are required to report on their project's progress after it has been granted ethics approval and governance authorisation. Ethics approval is conditional on satisfactory reporting and may be revoked if researchers do not provide timely reports. Read more.

All research projects conducted at Gold Coast Health undergo monitoring and quality assurance using a risk-based approach. 

Monitoring and quality assurance focuses on overseeing the progress of clinical research with a focus on the prevention and mitigation of risks to data quality and to processes that are critical to participant protection and study integrity. Read more.

To attribute your Gold Coast Hospital and Health Service affiliation when publishing, it is recommended that the following text be used: Gold Coast Hospital and Health Service, Gold Coast, Queensland, Australia 

Preparing research for submission to an academic journal requires care and attention. Journal editors must screen many submissions and ensuring research is clearly presented, following journal-specific guidelines is important. 

More information on peer-reviewed publications can be found here. 

Researchers may use a variety of means to disseminate their findings, including through the production of outputs and the use of other communication strategies. Read more.

When research is published it is often the culmination of a lot of hard and thoughtful work. It is, therefore, important that it is seen. The library and communications teams can help with promotion of work completed.

We encourage you to reach out to our contact support centre for advice or assistance with the promotion of research.