Health research is a series of steps to collect and analyse information to better understand a health topic or medical condition. Health research can help advance treatments, management plans or improve the way the health services are delivered.

Health consumers have unique experiences and understandings of a medical issue or of a health service. Consumer partners help researchers do research by sharing this important knowledge. This improves the research project and makes sure that the research is helpful and relevant to consumers and communities. 

There are lots of ways consumer partners can help improve research at Gold Coast Health. These include:

You do not need research experience to be a consumer partner. You just need to be open to sharing your ideas and opinions and be able to work in a team. You can bring a support person to help you if you would like.  

There are lots of benefits to being a consumer partner such as:

• Developing new interests. 
• Meeting new people in the health service.
• Being informed about research you care about which you can share with your community. 
• Contributing to knowledge and improving the health service.
• Learning new skills.

We recommend using our contact support centre to get in touch if you would like to become a consumer research partner or have any queries. Once you have made an enquiry, a staff member from the Office for Research Governance and Development will contact you to speak to you about research topic you are interested in getting involved in, and how we can best support you to do so.  

Gold Coast Health also has a Consumer Advisory Group and an Always Care Consumer Network that researchers and consumers may wish to engage with.  

A donation to Gold Coast Hospital Foundation is one of the most meaningful ways to make a bigger impact in your community. Your generosity can help fund health research, provide enhanced treatment options and support patient care across our health facilities, including Gold Coast University Hospital, Robina Hospital, and community-based health centres such as family and child health, post-operative care, rehabilitation and mental health. Find out how you can donate now. 

Given the peer-review process can be lengthy, some researchers advocate for the publication of preprints. Preprints are complete manuscripts that are yet to be formally peer-reviewed. They can be posted on servers before peer-review and publication in an academic journal. All preprints are given a unique DOI, and can therefore be cited. Once posted, researchers are also able to provide commentary outside of the traditional journal peer-review process, which can also help strengthen a researcher’s paper. MedRxiv and the Open Science Framework are two of the most commonly used examples in medicine.

These can provide colleagues with rapid access to local research findings. They can also be a great way of accessing feedback prior to presentation at external meetings or peer-review publications. 

Presenting work to external colleagues provides researchers an opportunity to showcase their work and receive feedback. They can also generate other research ideas or future collaborations.

Researchers are encouraged to present their work at the Gold Coast Hospital and Health Service (GCHHS) annual research showcase. The showcase presents a wonderful opportunity to present local data to the GCHHS community. 

Posters presentations focus the reader to pertinent information about a study. The benefit of posters is that they can remain on display for long periods of time and allow others to read the information at their leisure. 

Poster presentations delivered at scientific meetings can also be displayed in a researcher’s department to inform colleagues/patients of the research being done in the area.

Poster templates are available for staff on the forms and templates page. 

Research at Gold Coast Health provides the evidence-base for best practice, innovative service delivery and improved community outcomes. Our coordinated approach is informed by our research strategy 2022-2024, and lead by our research groups, collaboratives and partnerships.  

Gold Coast Health is in the region of south-east Queensland servicing over 630,000 residents and is projected to be home to approximately one million people by 2050. We accept patients from neonatal to end of life from all Gold Coast areas extending north, to Beenleigh and receive patient referrals in Northern and Regional New South Wales to the south.  

Our current sites include Gold Coast University Hospital, Robina Hospital, Varsity Day Surgical Hospital, health precincts and community clinics.  

The Gold Coast University Hospital is based in the heart of the Gold Coast Health and Knowledge Precinct (GCHKP), a 200-hectare site dubbed Asia-Pacific’s emerging health and innovation hub offering further opportunities for collaboration. The precinct includes Griffith University, Gold Coast Private Hospital and Lumina Gold Coast.

Our Research Ethics and Governance Officers will guide you simultaneously through both ethics and governance processes, to facilitate a streamlined review of your application. 

The Human Research Ethics Committee (HREC) works on a 60-day clock to approve research. This timeframe is taken from the closing date until you are advised whether your application has been approved. On average, we approve: 

• standard risk applications within 27 days 
• low- and negligible-risk applications within 14 days. 

This does not include site specific assessment (SSA) authorisation.

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

• GCHHS HREC Meeting Dates 
• GCHHS HREC Terms of Reference
• GCHHS HREC Composition

Gold Coast Health has a centralised clinical trial unit and conducts clinical trials in almost 30 different speciality areas. We offer partners and sponsors peace of mind by having one single point of contact for clinical trial activities. Read more about our Clinical Trials.

• Bond University
• Griffith University
• Southern Cross University

• Office of Research and Innovation - Queensland Health
• Evidence-Based Practice Professorial Unit
• Gold Coast Health and Knowledge Precinct
• Gold Coast Hospital Foundation
• Health Translation Queensland
• Institute for Evidence-Based Healthcare
• Menzies Health Institute Queensland  
• NHMRC Centre of Research Excellence in Wiser Wound Care

The closing dates for the GCHHS HREC applications and HREC meeting dates can be found here. Closing dates for all Queensland Health HRECs can be found here. 

The Human Research Ethics Committee (HREC) works on a 60-day clock to approve research. This timeframe is taken from the closing date until you are advised whether your application has been approved. On average, we approve:

• standard risk applications within 27 days
• low- and negligible-risk applications within 14 days.

This does not include site specific assessment (SSA) authorisation.

Ethics approval is granted for an initial three-year period, with continuation dependant on the submission of an annual report.

• Choose an achievable start and finish date, allowing processing time for the Human Research Ethics Committee (HREC) and Research Governance Officer. We recommend a minimum of one-year for a project.
• Research data must comply with the ‘Australian Code for the Responsible Conduct of Research 2018’ and the supporting guide ‘Management of Data and Information in Research’ 
• Include version numbers and dates on supporting documents.
• Head of Department (HoD) approval, and/or letters of support, must be signed by the appropriate personnel. In instances where a HoD is part of the research team, HoD line manager approval is required. 
• Include key references to support the study.
• Have someone review your submission for errors you may have overlooked. Complete a spelling and grammar check to ensure your documents are professionally presented, and regardless of level of risk, you must have a protocol. The Human Research Ethics Application (HREA) is not your protocol or study plan.

Yes, please ensure that you upload all documents into ERM. Any documents requiring review post ethics approval or governance authorisation are also to be submitted.  These can include:

• Annual reports
• Final reports
• Safety reports
• Protocol deviations
• Any changes to Human Research Ethics Committee (HREC) approved documents, such as participant information and consent forms (PICF), protocol, surveys etc
• Changes to study personnel

Yes, you will be required to submit a report for each research project. Annual reports are due on the 30th April each year. Based on information in the progress report, the Human Research Ethics Committee (HREC) or Research Governance Office may decide to undertake a monitoring visit.

Ethics review is required to ensure that the rights, safety and welfare of participants is respected, whereas governance is to ensure that the research adheres to the relevant institutional standards, including financial, legal, contractual and legislation requirements. 

Our Ethics and Governance Officers will guide you simultaneously through both processes, to facilitate a streamlined review of your application.

Any changes to your research project that occur after ethical approval has been obtained must also be ethically approved. This includes changes in study procedures, overall direction of project, project title, source/manner of recruitment, consent forms, advertising materials, research personnel and research sites.

Steps to submit an Ethics Amendment for your project:

1. Log into ERM Splash Page - ERM Applications (ethicalreviewmanager.com)
2. When you are in the “Work Area” page, select the HREA for the project that you wish to submit the amendment for.
3. On the left-hand side of the screen, click on the “Create Sub Form” tile from the Actions pane.
4. Select the jurisdiction that the application will be submitted to.
5. Select the form to be created (QLD Amendment Form) and click on the “Create” button to continue.
6. Follow the prompts to complete the Submission and upload any required supporting documentation. At a minimum, the submission should include a cover letter addressed to the HREC Chairperson and all new and updated documents for which ethical approval is being sought. Please contact the Research Ethics Officer if you are unsure what documents are required.
7. Click the “Submit” on the left-hand side of the screen once all signatures have been obtained.
8. To confirm the status of an application, please check the top right-hand side of the screen – the status should now be ‘submitted’. If not, please click the ‘Submit’ tile.

Please note: Amendments must also be authorised by the participating sites’ Research Governance Office. Once ethical approval for an amendment has been obtained, the amendment should also be submitted to the Research Governance Office via ERM as a ‘Post Authorisation Notification Form’.

Steps to submit a Post Authorisation Notification (PAN) for your project:

1. Log into ERM Splash Page - ERM Applications (ethicalreviewmanager.com) 
2. Select your project from the “Work Area” page.
3. Use the “Project” tab to select the intended SSA. “SSA Form Qld - Gold Coast HHS RGO” should appear darker grey in the Project Tree when selected. Any previously submitted PANs will appear below this item in the Project Tree.
4. On the left-hand side of the screen, click on the “Create Sub Form” tile from the Actions panel.
5. Select “Post Amendment Notification” as the form to be created and click on the “Create” button to continue.
6. Follow the prompts to complete the PAN form and upload any required supporting documentation. At a minimum, the submission should include the ethics approval letter for the amendment along with the ethically approved versions of any new and updated documents relevant for the site. Please contact the Research Governance Officer if you are unsure what documents are required.  
7. Click the “Submit” tile on the left-hand side of the screen. To confirm the status of an application, please check the top right-hand side of the screen – the status should now be ‘submitted’. If not, please click the “Submit” tile.

For other GCHHS HREC approved templates that may be required to support your project, please refer to the Standard Reporting Templates.
 

We welcome research feedback to continuously improve on our research-related processes. Please use the form in our contact support centre to initiate your contact with us. 

Any complaint will be investigated promptly and you will be informed of the outcome.

The Delegation for signing off Confidential Disclosure Agreements (CDAs) at Gold Coast Hospital and Health Service sits with the Manager for the Research Office. Please contact GCHResearch@health.qld.gov.au in relation to CDA submissions. 

If the lead Principal Investigator (PI) resigns, moves to another role or is otherwise unable to continue in their capacity as Lead PI then the recipient must submit a suitable replacement Lead PI for consent from Gold Coast Health. Any replacement Lead PI must meet or exceed the same criteria by which the original Lead PI was appointed.

A letter of support should be signed by the line manager of the lead Principal Investigator (PI) and the lead in the areas where most of the research will be performed, e.g., Head of Department (HoD) or Clinical Director. 

The collaborator letter is only needed when a project will make significant use of resources and space at an institution outside of Gold Coast Health and signed by the relevant leadership in that institution who has authority for the use of resource/space. 

Yes, the letter of support signed for a grant application can be used for Human Research Ethics Committee (HREC)/Governance applications. 

When budgeting for project staff FTE (full time equivalent), you should add at least 30% to allow for oncosts.  In the case of Medical Officers with individual contracts that can vary widely, you should obtain a formal costing for Medical staff from the research finance team.
The Consumer Advisory Group (CAG) is a group of community representatives who partner with Gold Coast Health to improve our local health system. It is important to include consumers in your research so we can continue to meet the healthcare needs of our diverse consumers in the community we serve. View the Health Consumers Queensland website for support on how to remunerate your consumer representative.

All links and templates for supporting documents will be provided within the guideline and application form for the relevant grant.  
 

Any amount exceeding the AUD 5000 cap will be the responsibility of the author, their operational area, or other nominated source.

Once your final manuscript draft has been submitted to the publisher and you have received the first reviewer response, you should then commence your application and upload this latest version.
 

We recommend using our contact support centre to connect with our Clinical Trial Unit.

Yes, the Clinical Trial Unit is part of the Office of Research Governance and Development at Gold Coast Health. It is dedicated to the management and coordination of clinical trials, supporting clinicians throughout Gold Coast Health.

The Clinical Trial Unit facilitates the delivery of device and pharmaceutical clinical trials in each phase. 

The team includes:

• Principal Investigators
• Associate Investigators
• Clinical Trial Manager - responsible for the operational activity of the Clinical Trial Unit, budgets and contracts 
• Clinical Nurse - Senior Clinical Trial Coordinators - responsible for study start up activity, education and oversight of clinical trial activity
• Clinical Nurse - Clinical Trial Coordinators - responsible for coordinating and delivering Clinical Trials
• Registered Nurse - Clinical Trials  

The Clinical Trial Unit works with both internal collaborators such as Pharmacy, Imaging, Pathology and external services to deliver our clinical trials. 

Each member of the Clinical Trial Unit receives clinical trial training, education and support to deliver high quality clinical trials. In addition, each member has a valid Good Clinical Practice refreshed every two years and a current research CV updated two yearly. 

Whilst the clinical team provides an around the clock service for urgent participant safety enquiries, the Clinical Trial Unit currently operates a weekday only service. 

Gold Coast Hospital and Health Service (GCHHS) offers Good Clinical Practice (GCP) compliant facilities and resources expected from Clinical Trial sites. Learn more about what we have to offer.

Clinical Trial related Procedures are currently under review and development to ensure compliance with the Clinical Trials Governance Framework. However, the Research Policy at Gold Coast Health endorses the current use of the National Clinical Trial Standard Operating Procedures (SOPs). 

The Clinical Trial Manager can advise the current timelines for study start up activity, but the guide below provides an estimation. Please note all Clinical Trials require at least 16 weeks to process through the stages, however this can sometimes be much longer depending on the requirements.

Gold Coast Health currently operates Ethical Review Manager (ERM) to correspond with Human Research Ethics Committee (HREC) and Research Governance.

Feasibility: Protocol review with Clinical Team and completion of Feasibility Questionnaire 2-4 weeks 
Site Selection: Meet the team and Site Qualification Visit 2-3 weeks 
Pre Site-Selection: Pre Start Up Agreement 1-2 weeks 
HREC Submission: 6-8 weeks from application to initial feedback (if Lead Site). Gold Coast Health can only accept HREC approval from an NMA listed HREC 
Pre Governance Submission: 5 weeks, if QCAT or PHA approval is required a further 3 weeks should be anticipated
Governance Review: 4-6 weeks
Post Governance Authorisation: Staff Training and SIV 2 weeks - SITE ACTIVATION

Gold Coast Hospital and Hospital Service (GCHHS) has Research Monitors within the Office for Research Governance and Development implementing Risk-Based Monitoring. These roles perform monitoring of behalf of GCHHS when clinical trials are sponsored. All research activity and clinical trials can be monitored. 

Monitoring can be defined as the act of overseeing the progress of clinical research and of ensuring that it is conducted, recorded, and reported in accordance with the study protocol, Standard operating procedures (SOP), Good Clinical Practice (GCP) and the applicable regulatory requirements.

Monitoring is designed to detect, correct and prevent potential or existing problems. Participation in the monitoring program is aimed at sharing best research practice and improving compliance with the approved protocol, 
•    National Statement on Ethical Conduct in Human Research 2007 (updated 2018), 
•    Australian Code for the Responsible Conduct of Research, 2018 (the 2018 Code),
•    Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2), 
•    ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice, 
•    Risk based management and monitoring of Clinical Trials involving Therapeutic Goods 

During a monitoring visit, a research monitor will come and visit the research team in their clinical area and spend around half a day reviewing the project documents and the data. A member of the research team should be available to answer questions. At the end there will be a time to discuss findings and recommendations.