University of Tasmania, Australia

Finance and Administration Form (158.0KB)

This is a compulsory form that must be submitted in conjunction with your ethics application form. It lets us know about the local researchers and where the project will be undertaken in Tasmania.

Full Application

Full applications are submitted on the National Ethics Application Form (NEAF) which is an online form created by the NHMRC. You must sign into the NEAF by creating a username and password. This will allow you to save the NEAF periodically as you complete it. The NEAF generates questions according to the information given by researchers in response to specific questions. For this reason it is important to answer all questions accurately and in as much detail as necessary. When completing the description of the project in plan language section, the Committee request that researchers ensure lay language is used so that it is comprehensible by lay members of the committee.

If you are requesting a waiver of consent (for example, you are proposing a retrospective audit), do not use the NEAF. Under section 2.3.6 of the National Statement, waivers of consent can only be granted over low risk research. Therefore, you must use the Low Risk Application Form (see below).

Prior Approval Application (166.0KB)

If your project already has approval from a NHMRC registered Australian HREC, including clinical trials already approved for another Tasmanian site, you should complete a prior approval application form. Please submit this along with a copy of the approved application, and a copy of the formal letter of approval.

Low Risk Application (229.0KB)

If your project is only low risk (that is, the only risk to participants is no more than discomfort), you may submit a low risk application.

You should also use this form if you are requesting a waiver of consent.

Privacy Form (75.3KB)

If your project involves the collection, use or disclosure of personal information without the consent of the participant, please complete and submit this form. You will need to refer to the Guidelines Under section 95 of the Privacy Act 1988 and the Guidelines approved under Section 95A of the Privacy Act 1988 prior to completing this form.

TSRAC study protocol pro forma

HREC Indemnity Form for Medical Trials

A study protocol must be submitted with full (i.e. NEAF applications that have not been approved by another HREC) applications to the Health and Medical HREC. This is to ensure the effective and efficient review of applications by the Tasmania Scientific Research Advisory Committee. Please see the pro forma document for instructions as to what information should be included.

Where the Tasmania Health and Medical HREC (HREC) is reviewing a clinical trial being conducted by non-UTAS investigators, the commercial sponsor must provide an indemnity in the form of Medicines Australia Form of Indemnity for Clinical Trials: HREC review only in favour of the HREC to cover its decisions in relation to the involvement of all non-UTAS investigators in commercially sponsored clinical trials.

Amendment Form (95.5KB)

Use this form to request a change to an existing project that has been approved by the HREC. Please see the submission form for further information. Please submit the signed version of this form with the initial submission.
As of 1 November 2012, a submission fee will be charged for the review of substantial amendments to commercially sponsored clinical trials. Please see the submission form for further information. Please submit the signed version of this form with the initial submission.

Position Statement
Information Sheet
Consent Form

Progress, Final Report and Request for Extension Form (182.5KB)

Use this form to submit an annual progress report to the committee, or a final report once the project is complete.
If your project is not complete after 4 years and you require ongoing ethics approval, this form allows you to apply for an extension of ethical approval.

Local Serious Adverse Event

To report a serious adverse event occurring at your site, please contact one of the Ethics Officers to request that a Local SAE form be sent to you. A link to a secure online form will be emailed to you for you to complete and submit to the HREC. After submission, you will receive an automatic email to acknowledge receipt of the SAE.

Serious Adverse Events Occurring at Other Sites (94.0KB)

If your project is also taking place at other sites, Serious Adverse Events occurring at other sites must be reported to the Health and Medical HREC at least every 6 months. Reports from international data safety monitoring boards/committees should be submitted with a signed copy of this form.

Protocol Deviations (80.5KB)

All protocol deviations should be reported to the HREC as soon as you become aware of the event. Please see the Protocol Deviations Guidance Notes (87.7KB) for further information.