Reporting and Monitoring Requirements for Researchers (9)

9.1. AUTEC may, as part of the conditions of approving a proposal, require an independent review or audit of approved research or innovative practice at any time.

9.2. Researchers are required to submit annual progress reports (Refer to Form EA2, Appendix G) to AUTEC as a condition of ethical approval.  Reports may be required more frequently.  Researchers will be advised in the approval letter of such a requirement.

9.3. Researchers are required to immediately report any serious or unanticipated adverse events to the Committee.

9.4. Researchers are required to advise participants if new information relating to the safety or integrity of the study becomes available.

9.5. Researchers are required, on the completion of an approved and implemented proposal, to report on the findings of the research or the outcomes of the treatment (refer also Section 10 General Provisions Relating to Approval).

9.6. Where an approved application has been abandoned, researchers are required to report on the reasons for its abandonment.

9.7. As part of the conditions of approving a proposal, AUTEC requires researchers to provide a summary of the research findings or treatment outcomes to all participants (refer to Form EA3, Appendix H).

NOTE:  Reference should also be made to Section 11 Responsibilities of Researchers .