Human Research Ethics

We review all research with or about humans, their data or tissue conducted by Tasmanian institutions.

The University of Tasmania Human Research Ethics Committee (HREC) 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 campuses.

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. More information on the review of external research can be found in the Human Research Ethics Committee (HREC) Terms of Reference (PDF 272.3 KB).

Find out more about membership HREC (Staff login)

Applications

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(in individually identifiable, re-identifiable or nonidentifiable form) as part of an existing published or unpublished source or database.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

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

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

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) ARCHIVED DOCUMENT LINK to help determine whether your research project is a clinical trial.

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

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 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

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.

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:

  • 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

$7,315 $735

Low Risk Application

$3,348 $367
Amendment – Committee Review $808 $400
Amendment – Chair Review $400 $169
Invoice Reissue Fee $116  
  • External Researchers are those not affiliated with the University of Tasmania 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 or 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%

Managing your research project

Item Submission / Form Type Timeframe to Submit to HREC Further Information
University of Tasmania HREC Tier Review Levels (PDF 240.2 KB)
Initial ethics application Application ASAP Refer to Submitting a Human Ethics Application above.
Changes to the Protocol 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.
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  
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.
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  
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