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.
Getting started with ethics
Before starting a research project, researchers must have ethics approval.
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:
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:
- Curriculum vitae (PrincipaI Investigator only)
- Letter of support from the Head of Department
- Participant Information Sheet and Consent Form (PICFs) [if applicable]
- 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:
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.
Other types of reviews and approvals
Some lower-risk activities, including quality improvement and clinical audits, don't need to go through a full ethics review process.
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.
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
- Log into Ethics Review Manager.
- 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.
- 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 Office for Research Governance and Development 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
- Upload complete and signed documents under Question 7 (select Study Plan / Project design) along with any other supporting documents.
- 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.
- 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 Office for Research Governance and Development for processing.
Each facility is responsible for research that involves any of its sites.
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:
- Ethics approved documents (protocol, PICFs, advertising material, approval letter)
- Approved budget
- Good Clinical Practice Certificate [if applicable]
Additional approvals required by legislation or policy
Depending on the type of research being undertaken, additional levels of approval may be required according to current legislation or policy. Researchers will be notified by the REGOs accordingly.
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.