Does your teaching or research  require ethics and compliance approval?

• Activities that require approval
• Human projects that do not require approval
• Type of approval needed
• Application forms
• Approval process
• Insurance cover for your project

Activities that require approval

With the exception of some human research projects, all teaching or research protocols that use the following subjects/material, require you to submit an application for approval. Information about permits and permissions is accessible from the following links.

• Animal products* such as bone material, organ samples, skin, fur etc
• Animals
• Biological material* (any product derived from plant or animals)
• Chemicals
• Embryos*
• Genetically modified organisms (even ones listed as 'exempt dealing')
• Human participants (including clinical drug trials)
• Human tissue
• Plant and equipment, devices, pressure vessels etc - please complete a Project Proposal Safety Authorisation form (OHSW70) (Word doc) and submit it to your Head of School/Institute Director.
• Radiation or radioactive substance (ionising or non-ionising)

All activities using animals, genetically modified organisms or chemicals, regardless of whether the findings will be published, require approval. Investigators must not commence teaching or research until approval has been granted from the relevant Committee

* Please note: It does not matter whether you are extracting the biological material for the purpose of the project, using the product of another project, or importing the product from another organisation etc. If any part of your project involves the use of biological material, ethics approval must be sought from the relevant Committee.

Human projects that do not require approval

Activities that do not require ethics approval are those which:

• will not be reporting on or publishing the results of the findings externally and/or
• use questionnaires containing no sensitive questions that participants might feel uncomfortable answering (eg questionnaires to test current course content, or ask for comments regarding possible changes).

For example, staff members do not need to obtain ethics approval if they are conducting research for the purpose of reviewing current teaching programs, courses, services, policies, procedures, or for quality improvement purposes, provided the nature of the research is non-invasive and the findings will not be published or presented externally.

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Type of approval needed

• All projects involving human participants (including clinical trials, human tissue and personal and/or health information held in databases eg Medicare, WorkCover, hospital records) require approval from the Human Research Ethics Committee (HREC).
• All projects conducted for undergraduate, honours or masters by coursework purposes which are uncontentious and non-invasive require approval from the Divisional Ethics Committee
• All projects using animal subjects and samples taken from animals (organs, tissues, embryos etc) require approval from the Institute of Medical and Veterinary Science (IMVS) Animal Ethics Committee (AEC).
• All projects using animal products (ie the researcher is being given the product and is not undertaking the extraction themselves) require approval from the IMVS AEC.
• All projects using chemical compounds require approval from the Chemical Hazards Subcommittee.
• All activities using biological material (derived from plants or animals) require approval from the Institutional Biosafety Committee.
• All activities using genetically modified organisms (including exempt dealings) require approval from the Institutional Biosafety Committee.
• All projects using non-ionising or ionising radiation require approval from the Radiation Safety Committee.
• All activities using plant, equipment, devices or pressure vessels that are not part of the normal plant, equipment, devices or pressure vessels assessed and managed by the school or institute under its routine Occupational Health Safety and Welfare (OHS&W) responsibilities, require approval from relevant Head of School/Director of Research Institute.
• All clinical trials require approval from the Therapeutic Goods Administration.

Approval may be required from more than one Committee if your project/activity uses a variety of the above subjects/material. For example, approval must be gained from both HREC and the Radiation Safety Committee if the project subjects participants to an X-ray.

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Application forms

Human Research Ethics Committee

• Guidelines for preparing ethics protocols - RTF (pc) and Word (Mac)
• Ethics application form - RTF (pc) and Word (Mac)
• Clinical Drug Trials Notification Form (Therapeutic Goods Administration) (PDF file, 136kb)
  Participant Information Sheet guidelines
• Model Consent Form - RTF (pc) and Word (Mac)
• Model Consent Form for use when taped materials, photographs or original works are to be retained - RTF (pc) and Word (Mac)
• Application for extension to ethics approval - RTF (pc) and Word (Mac)
• Project completion form - RTF (pc) and Word (Mac)
• Use of human tissue samples in subsequent research - RTF (pc) and Word (Mac)