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Human Research Ethics - Medical

 

 

According to the Terms of Reference, the Tasmania Health and Medical HREC has responsibility for the review of all research projects and clinical trials involving human participation that are undertaken under the auspices of the Department of Health and Human Services or the University of Tasmania that involve the following:

    1. Invasive physiological clinical, and/or medical interventions
    2. Research involving the use of human tissue (including blood, reproductive and other tissues)
    3. Human genetic research
    4. Staff, patients or resources of any hospital in Tasmania (both Public and Private)

The Scientific Research Advisory Committee (SRAC) are a sub committee of the Health and Medical HREC.  SRAC consider the scientific merit of research proposals before they are considered by the Health and Medical HREC.

The Chair of the Health and Medical HREC is Mr Murray Shanley.
The Chair of the Scientific Research Advisory Committee is Professor Mark Nelson.

 


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PROCESSES FOR APPLICATIONS TO HEALTH AND MEDICAL HREC

  1. Use the scope checker to determine if your application is low risk or if a full application is needed.
  2. Complete the application forms as required, ensure it is signed by the relevant people, and submit electronically or in hard copy to the Ethics Officer, Pte Bag 1 Sandy Bay. If you submit electronically a signed hard copy will need to be sent in the mail. You will need to attach all the relevant documentation to the application. Note: you only need to send ONE hard copy of the application and supporting documentation (including protocols and investigator brochures.)
  3. Your project will be given a unique ethics reference number. You will need to ensure you have this number with you each time you contact the office in relation to your project.
  4. When your project has been seen by either SRAC or the HREC or the Chairs, you will be contacted by email. If you need to make changes you will be advised of this.
  5. When all changes have been recieved and approved, you will recieve an email notification of approval. You may then commence your research. A hard copy letter will follow. You must keep this for your records. Ethics approval is valid for 4 years.
  6. Every year on the anniversary of your approval you must complete an annual report form and return it to the Ethics Officers On comletion of your project you must complete a final report.
  7. On average, a full application to the Health and Medical HREC takes 52 days from submission to approval, though some projects may take longer than this.

NOTE:

Applications for ethics approval for Clinical Trials that are sponsored by a commercial organisation are charged at a rate of $4000 plus GST per application. An invoice will be forwarded to the relevant orgainsation after the application has been processed. Payment must be made in Australian dollars, and the University of Tasmania will only invoice an Australian Company.