Participant in a Research Project
If you are a participant in a research project that has ethics approval from a Tasmanian HREC, and you would like to make a complaint about the conduct of the research, you should call the Executive Officer on the HREC (Tasmania) Network on +61 3 6226 7479 or email Human Ethics. The Executive Officer will then follow up your concerns with the Chair of the committee and the Chief Investigator of the project.
If you are a Researcher who has a complaint or an ethical concern about a project you should contact the Executive Officer to discuss the issues on 6226 7479 or email Human Ethics. The complaint will be referred to the Chair and may be included on an HREC agenda and discussed at the next HREC meeting. The researcher may be invited to appear before the Committee to discuss the concerns.
Complaints against the HREC
These should be referred in the first instance to the Executive Officer or Chair of the relevant HREC. If the complainant is still dissatisfied, he/she may refer the complaint to the relevant University of Tasmania or Department of Health and Human Services authority.
Other interested people
Members of the public or other interested parties who have concerns or complaints may contact the HREC Chair or Executive Officer.
When a concern or complaint is received by the Executive Officer he/she will inform the Chair of the nature of the concern/complaint and any action that he/she has taken. The complaint and the action taken will be discussed with the researcher and reported to the HREC. The HREC will make a decision on any further action to be undertaken.
All concerns and complaints are formally recorded, treated very seriously and handled promptly. If a concern or complaint is unresolved at the Committee level, it is referred to the Deputy-Vice-Chancellor (Research).
For more information, please see our complaints policy.
Adverse events occurring at any site for which you are responsible should be reported to the HREC as soon as possible after they occur.
If your project has been approved by the Social Sciences HREC, please contact the Executive Officer to report an adverse event.
Adverse events for Health and Medical HREC approved projects can be reported on these forms. 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 on a 6 monthly basis, in line with the NHMRC Australian Health Ethics Committee (AHEC) Position Statement, Monitoring and reporting of safety for clinical trials involving therapeutic products, May 2009. Ideally this should be in the form of a report from an international data safety monitoring board or committee.
It is the responsibility of the Chief Investigator to ensure that all research projects are conducted in accordance with the terms set out in the application approval letter, any subsequent amendment approval letters and in accordance with the National Statement on the Ethical Conduct Human Research (NHMRC 2007).
Any activity that occurs that does not confirm to what has been approved by the HREC should be reported; for example, the use of unapproved recruitment procedures or use of an unapproved version of the patient information sheet and consent form. Please use the following protocol deviation form and guidance notes to report protocol deviations.