Ethics approval is granted for 4 years on the condition that researchers submit an annual progress report to the committee, plus a final report once the project is complete. If the project is not complete after 4 years, you can apply for an extension of ethical approval.
The National Statement (2007) Chapter 5.5 requires that researchers report, at least annually, on:
- progress to date, or outcome in the case of completed research;
- maintenance and security of records;
- compliance with the approved proposal; and
- compliance with any conditions of approval.
Your approval letter will let you know the date on which your first report is due, and you will receive an automatic reminder via email approximately 6 weeks beforehand.
Health and Medical Human Research Ethics Committee - Changes to Ethics Approval Periods and Reporting Requirements
As the NHMRC are moving towards a continual review system of the National Statement rather than five-yearly reviews, it is pertinent that researchers are conducting research which reflects current guidelines. The Human Research Ethics Committee monitoring processes also need to be aligned to reflect these current guidelines in order to perform its monitoring obligations. As such the Tasmania Health and Medical HREC (HREC) has the changed the way approval periods will be granted, the length of approvals and the review of extension requests.
Changes as of 1 March 2014
- All new projects will receive an initial approval period as determined by the HREC at the time of review of the application. Consideration will be given to the proposed length of the study as outlined in the application form, with specific consideration applied for different types of applications; for example registry projects. The default approval period will be a maximum of 4 years with an additional 1 year available upon approval of an extension request.
- A maximum of 6 years approval in total will be granted; this includes the initial approval and up to two 1-year extension requests. At the conclusion of the approval period a new application is required to be submitted to the Committee for review. Clinical Trials in Follow-up Phase are exempt from this maximum approval period and the Committee will make a determination of how long the approval will be extended upon submission of an extension request at the conclusion of the 6 year initial approval
- All Extension Requests will be reviewed by the full HREC.
- In the case of Prior Approval Applications (applications made to the HREC on the basis of approval from a NHMRC registered HREC) which have a lead site outside of Tasmania, at the end of the approval period, applicants will be required to submit a new Prior Approval Application
Report forms can be obtained from:
The committee also appreciates receiving a copy of any publications or abstracts of publications which have resulted from the research project.
Please note that annual reports are not the place to report incidents such as adverse events. The committee should be notified of these as soon as possible after they occur.