Human Research Ethics Committee
The University of Tasmania Human Research Ethics Committee is established and functions in accordance with the principles outlined in the National Statement on Ethical Conduct in Human Research (2023), as published by the National Health and Medical Research Council.
The University of Tasmania HREC reviews applications submitted by University staff and students, as well as researchers external to the University on a fee-for-service basis.
Expressions of interest are sought for membership to the University of Tasmania Human Research Ethics Committee (HREC).
Members are required to attend 1-2 meetings per month of approximately 2 hours duration, plus allocate some time for preparation (reading and reviewing applications). Meetings are held via Zoom and members external to the University can choose to receive a small stipend for each meeting attended.
Please contact the Research Ethics Unit if you have any questions about becoming a member:
- HREC: Human.Ethics@utas.edu.au
Applications
Almost all human research requires ethical review. The Research Ethics Unit has created several tools designed to aid you in determining whether your research project requires ethical approval.
- Decision Support Tool:
Assists you in determining whether your project requires ethical review and if so, the most appropriate application category to submit for your research via our Ethics Review Manager (ERM). - Principles and Elements of Human Research Ethics Tool:
Assists you in contemplating ethical considerations and the National Statement when designing your research project. - 4 Tips for Human Ethics Applications Video (Watch video)
With Professor Gregory Peterson, Chair, HREC.
When is Human Ethics approval required as defined by the National Statement on Ethical Conduct in Human Research (2023):
Human research is conducted with or about people, or their data or tissue. Human participation in research is therefore to be understood broadly, to include the involvement of human beings through:
- taking part in surveys, interviews or focus groups;
- undergoing psychological, physiological or medical testing or treatment;
- being observed by researchers;
- researchers having access to their personal documents or other materials;
- the collection and use of their body organs, tissues or fluids (eg skin, blood, urine, saliva, hair, bones, tumour and other biopsy specimens) or their exhaled breath;
- access to their information (in individually identifiable, re-identifiable or nonidentifiable form) as part of an existing published or unpublished source or database.
Applications are submitted and managed via our Ethics Review Manager (ERM). Please ensure you refer to, and understand, the levels of risk defined by the National Statement on Ethical Conduct in Human Research (2023) when applying for ethics approval.
The University of Tasmania Human Research Ethics Committee (University HREC) has adopted the following risk profiles in accordance with the National Statement on Ethical Conduct in Human Research 2023.
| Lower risk research | Higher risk research |
|---|---|
|
No risk of harm or discomfort; potential for minor burden or inconvenience or No risk of harm; risk of discomfort(+/- foreseeable burden) |
Risk of harm (+/- foreseeable burden) |
The University uses a licenced copy of the Human Research Ethics Application (HREA) developed by NHMRC. HREC application types are as follows:
- Lower Risk Application
- Lower Risk Audit Application
- Higher Risk Application
- Lower Risk Clinical Trial Application
- Higher Risk Clinical Trial Application
The Research Ethics Unit has created several tools designed to aid you in determining whether your research project requires ethical approval. See 'When is Human Ethics approval required?' above.
The HREC meets on a weekly basis, initial responses to a submission should be received within 5 business days.
The University of Tasmania has adopted the World Health Organization (WHO) definition of a clinical trial.
The WHO defines a clinical trial as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.
Interventions include but are not restricted to:
- Drugs
- Process-of-care changes
- Preventive care
- Cells and other biological products
- Surgical procedures
- Radiological procedures
- Devices
- Behavioural treatments
Find out more information on Clinical Trials Governance at the University.
The University of Tasmania has a Prior Approval Pathway for research projects that have already been granted approval from an NHMRC registered Australian HREC.
The University of Tasmania cannot independently join the National Mutual Acceptance Scheme, as the scheme is restricted to institutions that operate in the publicly funded health sector.
To submit a Prior Approval Application you will need the following:
- A copy of the approved application form
- Any approved study documents, such as the protocol/project description, surveys, telephone scripts, recruitment materials, etc.
- Any amendments or modifications to the project since original ethics approval was granted
- A copy of the letter of approval, including the approved document listing
- Master participant information sheets and consent forms
- Tasmania-specific participant information sheet and consent forms (with their own version control)
- All other documents applicable to the research in Tasmania
An expedited review process exists for research projects that meets the following criteria:
- Scope: Research within the field of public health emergencies, defined as an event, either natural or man-made, that creates a health risk to the public.
- Criteria: Research must be in the public interest and required to be conducted within a set passage of time, therefore the timely collection of data is of utmost importance.
If you require expedited research ethics approval, and you meet the criteria listed above:
- Submit your application/amendment via Ethics Review Manager (ERM).
- Contact the Research Ethics Unit at human.ethics@utas.edu.au to request an expedited review - please ensure you include your ethics reference number.
Ethics Applications and Amendments that are not led by the University of Tasmania (the University) or the Department of Health (Tasmania) (DOH) are subject to fees and charges as per the fee structure below.
- 2024 fee schedule - Fees incur an annual increase by the Australian CPI
- All fees are inclusive of GST
| Submission/Review Type | Commercial or Industry Sponsor Fee * | External Researcher / NFP Fee * |
|---|---|---|
| Lower Risk Application | $3,756 | $412 |
Lower Risk Audit | $3,756 | $412 |
| Higher Risk Application | $8,208 | $824 |
| Clinical Trial Low | $8,208 | $824 |
| Clinical Trial High | $8,208 | 824 |
| Amendment - Full Committee | $908 | $450 |
| Amendment - Chair | $452 | $190 |
* Applications or amendments with Ethics Approval from another NHMRC registered Australian HREC receive a 50% discount.
- External Researchers are those not affiliated with the University or Department of Health Tasmania and include:
- Other Universities
- ACNC registered Not-for-profit / Charity organisations
- The HREC reviews external applications on a case-by-case basis as outlined in the HREC Terms of Reference (PDF 259.9 KB).
The University of Tasmania uses the Ethics Review Manager (ERM) to manage all aspects of the lifecycle of Research Ethics Approvals. To maintain ethics approval for your project, all reporting obligations need to be met and the University of Tasmania HREC must be notified of any modifications. Further details of the submission requirements and form types are outlined below. Any enquiries about managing your research project can be directed to the Executive Officers in the Research Ethics Unit. Please include your ethics reference number in any communications.
Email: Human.Ethics@utas.edu.au
Phone: +61 3 6226 6254
Any amendments are to be submitted to the University of Tasmania HREC via ERM as soon as possible if revisions are required to an approved Human Research Ethics Project. It is the responsibility of the Chief / Principal Investigator to ensure HREC approval is obtained for all amendments prior to implementation. Please provide tracked and clean copies of any amended documentation in your submission.
The following are examples of changes that would require an amendment submission:
- Revisions made to the research aims or methods outlined in the approved project description/protocol.
- Changes to the research team listed in the application
- Addition or removal of participant groups, study sites, recruitment locations
- Changes to the participant recruitment or consenting processes
- Modifications made to the participant information and consent form
- Revisions to the inclusion/exclusion criteria
- Addition of, or modifications to, any recruitment materials or the way in which the research will be advertised
- Changes to collection use and management of data
- Any new study documentation
This includes annual progress reports, extension requests and final reports. Ethics approval is granted for four years and is contingent upon the receipt of annual progress reports. You will be sent a courtesy reminder on the due date for your progress / extension report. A final report is to be submitted at the conclusion of the project.
The following examples can be managed via the annual report submission:
- Minor protocol deviations (see ‘Protocol Deviations’)
- Progress to date, or outcome in the case of completed research
- Participant withdrawal of consent
- Recruitment close
- Publications and project outputs
Annual Safety Reporting
As per the NHMRC guidelines, An Executive Summary of safety information produced for international regulators, such as a Development Safety update Report (DSUR), may serve as the annual safety report provided to the HREC.
The sponsor is responsible for reporting to the reviewing HREC, in accordance with NHMRC - Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (2016) (PDF)
Clinical Trial Safety Reporting
- Significant Safety Issue (SSI) implemented as an Urgent Safety Measure (USM) - Notification period within 72 hours of the Sponsor knowledge
- Significant Safety Issue (SSI) not implemented as an Urgent Safety Measure (USM) - Notification period within 15 days of the Sponsor knowledge
Other Safety Notifications
- Notification of temporary halt or termination of trial for safety reasons – Notification period within 15 days (Acknowledgement form required)
- Notification of Amendment due to safety information – Submission of an amendment as soon as possible without undue delay
A protocol deviation is any change, non-compliance, or departure from the approved protocol. Protocol deviations may be minor or major. Minor protocol deviations do not carry significant ethical or administrative consequences. Minor protocol deviations can be reports to the HREC at the time of the annual progress report.
Major protocol deviations are those that affect participant's rights, safety, or wellbeing and/or the accuracy and reliability of the study data. Any protocol deviations that affect participant safety must be reported. Protocol deviations may result from the action of a participant or researcher. Major deviations need to be reported as soon as possible.
The following are examples of minor protocol deviations:
- A study visit is conducted (for example a study visit is conducted outside of the required timeframe, or a procedure is missed) and there are no safety concerns;
- Incorrect execution of the consent form (for example participant did not date their signature);
- Participant declines to complete scheduled research activities.
The following are examples of major protocol deviations:
- Failure to obtain valid informed consent or complete the study screening processes according to the approved protocol (i.e., not following the inclusion/exclusion criteria);
- Use of an unapproved version of the Participant Information and Consent Form, recruitment materials or recruitment methods;
- Visit non-compliance (e.g., a study visit is conducted outside of the required timeframe, or a participant monitoring visit is missed) and there are safety concerns;
- Loss of laptop computer or data storage device that contains identifiable, private information about participants;
- Changes to the research methodology, data collection methods, plan for disseminating the research results without prior approval.
Submission for Acknowledgement –
This form should be completed for documents that require acknowledgement only, rather than approval by the HREC.
For example:
- Insurance certificates
- File notes
- Protocol clarification memos
- Sponsor newsletters
- Notification of temporary halt or termination of trial for safety reasons, if not able to provide information immediately via a Significant Safety Issue Notification (SSI)
- Notification of amendments to come, due to new safety information