Research Division

About Human Research Ethics

The University of Tasmania Human Research Ethics Committee (HREC) (PDF 272.3 KB) operates a state-wide service and reviews all research with or about humans, their data or tissue conducted by Tasmanian institutions, including research conducted at interstate University of Tasmania (UTAS) campuses.

The University of Tasmania HREC operates in accordance with the requirements of the National Statement on Ethical Conduct in Human Research.

The University of Tasmania HREC meets on a weekly basis. There are no deadlines for submissions.

The University of Tasmania HREC reviews applications submitted by UTAS staff and students, as well as researchers external to UTAS on a fee-for-service basis.

When is Human Ethics Approval Needed?

As per the National Statement on Ethical Conduct in Human Research:

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information (in individually identifiable, re-identifiable or nonidentifiable form) as part of an existing published or unpublished source or database.

Almost all human research requires ethical review. Please ensure you refer to, and understand, the levels of risk defined by the National Statement on Ethical Conduct in Human Research when applying for ethics approval.

Submitting a Human Ethics Application

Please go to Ethics Review Manager (ERM) to submit your application.

Full Application

Research projects that carry higher than low or negligible risk, as per the National Statement on Ethical Conduct in Human Research.

Clinical Trial Application

The World Health Organization (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

Please refer to our Clinical Trial Decision Aid (PDF 74.8 KB) to help determine whether your research project is a clinical trial.

Low Risk Application

Research projects that carry low or negligible risk, as per the National Statement on Ethical Conduct in Human Research.

Prior Approval Application

The Prior Approval pathway is for research projects that have already been granted approval from a NHMRC registered Australian HREC, as the University of Tasmania (UTAS) is not part of the National Mutual Acceptance (NMA) scheme.

If your project already has approval from a NHMRC registered Australian HREC, you can submit a Prior Approval Application. You will also need to provide 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

Notification of UTAS Involvement in External Research

To be completed when a University of Tasmania staff member or student is conducting human research at another institution/organisation, where no aspects of the project are taking place in Tasmania and ethics approval has been granted from another NHMRC registered Australian Human Research Ethics Committee (HREC).

Please refer to our Prior Approval Decision Aid (PDF 97.3 KB) to help determine which form to submit.

Expedited Review for Public Health Emergencies

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

Managing your Research Project

Item	Submission/Form Type	Timeframe to Submit to HREC	Further Information UTAS HREC Tier Review Levels
Initial ethics application	Application	ASAP	Refer to Submitting a Human Ethics Application.
Changes to the Protocol	Amendment	ASAP	All amendments must be submitted with clean and tracked copies of the revised documents.
Changes to the Information Sheet/Consent Form	Amendment	ASAP	All amendments must be submitted with clean and tracked copies of the revised documents.
Changes to any other study documentation	Amendment	ASAP	All amendments must be submitted with clean and tracked copies of the revised documents.
Changes to sample size, recruitment or recruitment methods	Amendment	ASAP	All amendments must be submitted with clean and tracked copies of the revised documents.
Investigator Brochure Update	Amendment	ASAP	All amendments must be submitted with clean and tracked copies of the revised documents.
Changes to any investigators	Amendment	ASAP
Serious Adverse Events	Serious Adverse Event	Within 24 hours
Serious Adverse Events or SUSARS at other sites	International/Australian Safety Report	Bi-annually
Protocol deviation (major)	Protocol Deviation	As soon as possible	Refer to Protocol Deviations - Guidance Notes via the Help > Templates tab in ERM.
Protocol deviation (minor)	Annual Report (Progress, Extension or Final)	Annually	Please provide within the appropriate section of the annual report form.
Participant withdrawal of consent	Annual Report (Progress, Extension or Final)	Annually	Please note within the appropriate section of the annual report form.
Complaints related to the study conduct	Email to Human.Ethics@utas.edu.au	Within 72 hours	Supporting documentation should be submitted.
Recruitment close	Annual Report (Progress, Extension or Final)	Annually	Please note within the appropriate section of the annual report form.
Changes to the study status	Significant Safety Issue (SSI) Notification or Submission for Acknowledgement (if not able to provide information immediately via a SSI)	Within 72 hours	If a study is placed on hold or suspended (for example), this must be notified to the HREC as soon as possible. An explanation for the change of status must be provided.
Notification of temporary halt or termination of trial for safety reasons	Submission for Acknowledgement	Within 15 days
Significant Safety Issue (SSI) implemented as an Urgent Safety Measure (USM)	Significant Safety Issue (SSI) Notification	As soon as possible and no later than 72 hours of the Sponsor becoming aware of the USM
Significant Safety Issue (SSI) not implemented as an Urgent Safety Measure (USM)	Significant Safety Issue (SSI) Notification	Within 15 days of the Sponsor becoming aware of the SSI
Annual Safety Report, Development Safety Update Report (DSUR) or Executive Summary	Annual Safety Report	Annually
International/Australian Line Listings Chief Investigator	International/Australian Safety Report	Bi-annually
Study closure	Final Report	ASAP
Publications	Annual Report (Progress, Extension or Final)	Annually
Sponsor newsletters or recruitment updates	Submission for Acknowledgement	ASAP	For noting only

Guidelines, Resources & Training

Human Ethics Training (UTAS Staff/Students Only)

Human Research Ethics at the University of Tasmania (Ethics101)

Human Ethics Review Fees

2022 fee schedule
All fees are inclusive of GST

Submission/Review Type	Commercial or Industry Sponsor Fee	External Researcher Fee
Full Application Clinical Trial Application	$7,888	$792
Low Risk Application	$3,610	$396
Amendment – Committee Review	$872	$432
Amendment – Chair Review	$432	$182
Invoice Reissue Fee	$125

External Researchers are those not affiliated with the University of Tasmania (UTAS) or Department of Health (DOH) Tasmania and include:
- Other Universities
- Sponsorship from collaborative or non-profit groups
- Not-for-profit organisations
Applications or amendments submitted by researchers affiliated with the University of Tasmania (UTAS) or Department of Health (DOH) Tasmania are not charged directly to the researcher
Applications or amendments with prior approval from another NHMRC registered Australian HREC are charged at 50%