Human Research Ethics

Scope of Ethical Review

All human research projects conducted by JCU staff, students, and adjunct staff in Australia or Singapore must receive formal ethical approval from the JCU HREC prior to commencement if they involve human participants, their data, or biological materials. Applications are accepted only when the research is undertaken under the auspices of James Cook University.

Human research, as defined by the National Statement on Ethical Conduct in Human Research, includes any study conducted with or about people, their data, or tissue. This encompasses activities such as surveys, interviews, focus groups, clinical trials, observational research, access to oral histories or personal documents, collection and use of biological samples, and use of identifiable or non-identifiable data from published or unpublished sources. All such activities require formal ethical approval before proceeding.

Undergraduate Student Projects

Undergraduate students conducting research involving human participants as part of their coursework must obtain ethical approval. In certain instances, a single ethics application may be submitted by the supervising lecturer to cover multiple student projects within a course. Students and staff must consult with the Ethics Team to determine the appropriate process and secure formal approval.

Teaching Activities

Teaching activities that involve physiological or psychosocial experiments, collection of biological samples, administration of substances, recording of personal information, or survey administration require formal ethics approval prior to commencement.

Exempt and Quality Assurance Research

Certain human research activities may be exempt from formal ethics review in accordance with Sections 5.1.15 to 5.1.18 of the National Statement. Requests for exemption must be formally submitted and approved via the GECO system before the research begins.

Quality assurance activities typically do not require ethical approval; however, these activities must adhere to established ethical principles. Researchers unsure whether their project qualifies as quality assurance must seek formal assessment and confirmation from the Ethics Team prior to commencement.

Research Involving Aboriginal and Torres Strait Islander Peoples

Research involving Aboriginal and Torres Strait Islander peoples requires formal ethical review and approval, with additional cultural considerations applied to ensure respect and compliance with Indigenous protocols. Researchers should consult with the Ethics Team for specific guidance and approval requirements. Detailed information regarding this process can be found on our Aboriginal and Torres Strait Islander Research Ethics page

External Ethics Approval Acknowledgement

Where human research has received ethical approval from external institutions, JCU requires formal external acknowledgement or ratification before the project can proceed under JCU’s auspices. To facilitate this process, researchers must submit an application to the Ethics Office including:

• A copy of the external ethics approval documentation
• The research protocol or proposal reviewed by the external committee
• Any participant information sheets, consent forms, and related materials approved externally
• Confirmation that the external review meets requirements consistent with JCU’s ethical standards
• Details of the research team, including investigators and supervisors
• Any relevant correspondence or conditions attached to the external approval

The Ethics Office will review these materials to ensure alignment with JCU policies and may request further information before granting formal ratification. Researchers should allow adequate time for this review prior to commencing their project.

Uncertainty About Ethical Review Requirements

If there is any uncertainty about whether a research project requires ethical approval, researchers must seek advice from the Ethics Office before initiating any activity. Retrospective ethics approval will not be granted.

Complaints, Concerns, and Feedback

Concerns or complaints regarding human research conducted under JCU’s auspices should be formally lodged through the Ethics Office following established procedures.

Researchers intending to seek ethical clearance for their research are advised to undertake the following preparatory steps to ensure a thorough and compliant application:

• Familiarise themselves with the National Statement and associated guidance documents.
• Review the Human Research Ethics Committee (HREC) Application Guide thoroughly.
• Complete training in human research ethics to understand the ethical principles and requirements relevant to their research.

Submission Process

GECO Application Forms

Please be advised that, effective 1 January 2025, all Human Research Ethics Applications, Amendment Requests, and Progress or Final Reports must be submitted exclusively through the GECO online system.

GECO Draft Templates

To facilitate the preparation of your application, draft templates are provided below. These templates are designed for drafting purposes only and must not be submitted as final applications. Completed drafts should be transferred into the GECO system for formal submission.

• HREC Application Drafting Template

Participant Information Sheets and Consent Forms (PISCF) for:

Surveys

• PISCF Survey - Confidential (personal details provided)
• PISCF Survey - Anonymous (no personal details provided)

Interviews

• PISCF - Interviews

Focus Groups

• PISCF Focus Groups

Ethics Advisor Review

Ethics Advisor reviews will be conducted within the GECO system. However, an Ethics Advisor Review Report template is available to assist in preparing these reviews. This document may be uploaded to GECO alongside any commentary provided to researchers.

Further Information

For further reference, please consult the JCU HREC Terms of Reference to understand the committee’s scope and operational framework or contact the Ethics Office.

Human Ethics Advisors are academic employees of James Cook University nominated for appointment by the Dean of College to provide expert review and guidance on ethics applications for teaching and research involving human participants. They review applications across broad discipline areas and offer tailored advice to academic staff and students on ethical considerations.

The primary role of Human Ethics Advisors is to support researchers by reviewing draft applications and advising on compliance with ethical requirements, thereby helping to ensure that submissions meet the required standards prior to formal consideration by the HREC. This proactive engagement aims to enhance the quality of applications, minimise the need for revisions, and prevent avoidable delays in the ethics review process.

Advisors also provide recommendations to the HREC regarding the approval of applications and review amendments to ethics approvals as required. It is recommended that researchers contact a Human Ethics Advisor in advance to confirm their availability for application review.

Click here for the full list of Human Ethics Advisors at JCU.

Lower Risk Research Applications

Lower risk research applications are reviewed by the HREC Executive Review Panel. These applications can be submitted at any time, with a typical review turnaround of 14 to 21 business days after receipt by the Ethics Office

Higher Risk Research Applications

Higher risk research projects require full ethical review by the HREC to ensure a thorough and rigorous evaluation of the potential risks involved, as well as the adequacy of measures proposed to protect participant welfare. Such research may involve participants who are considered vulnerable due to age, cognitive capacity, cultural background, or socio-economic status. It may also include studies addressing sensitive or potentially distressing topics, employing invasive or physically intrusive procedures, involving deception, or collecting identifiable personal information that could jeopardise confidentiality and privacy. The full committee review process provides an essential framework for carefully balancing the potential benefits of the research with the ethical obligation to minimise harm and respect participant rights.  Researchers should take careful note of the following information regarding submission requirements to the

Submissions in GECO and Indicative Timeframes

To ensure your application is reviewed at the next scheduled Ethics Committee meeting, it must be submitted in GECO well in advance of the published meeting deadline. Once submitted, your application must progress through multiple levels of approval (e.g., Academic Supervisors, Ethics Advisors, Facility Managers, Deans, etc.). This process can take time, particularly if revisions are requested or if there are unforeseen delays. Applications submitted on the day of the deadline will likely not be reviewed until the following month’s meeting.

As each application varies, it is difficult for our office to provide a definitive timeframe for submission. The duration depends on factors such as the complexity of the project, the number of required approvers, whether changes are requested, and potential delays. In most cases, 2–3 weeks may be sufficient, but the process can take significantly longer.

Until the application status in GECO is listed as "With Ethics Office," the responsibility for its progress lies with the research team. We strongly recommend that you proactively contact all relevant approvers to notify them that your application is awaiting their review. This will help support a smooth and timely approval process.

Please note, the JCU Ethics Office will not be aware of your application until it reaches the status "With Ethics Office" in GECO

If you have any concerns, please contact the JCU Ethics Office

2025 HREC Meeting Date and Submission Deadlines - NOTE: The MEETING DEADLINE is the date the FINAL VERSION OF THE APPLICATION reaches the ETHICS OFFICE (NOT THE DATE YOU PRESS SUBMIT ON THE FIRST VERSION).

Instructions:

1. Email your Ethics Advisor to make sure they are available to review your application before choosing them in GECO.
2. Finalise your application, choose your Ethics Advisor and press submit
3. Email your Student Supervisors to let them know they need to review and approve your applicaiton
4. Email your Ethics Advisor to let them know once it reaches them
5. Incorprate the Ethics Advisors feedback and resubmit
6. Email every approver once it gets to them to let them know your application is with them to review and approve (click the person's head symbol in the Ethics Review screen to see the approval pathway)
7. The application needs to go through the above steps and be status 'WITH ETHICS OFFICE' before it will be accepted for the meeting

APPLICATIONS NOT "WITH ETHICS OFFICE" BY THE MEETING DEADLINE WILL NOT GO TO THE NEXT MEETING