Annual and final reporting
The National Statement on Ethical Conduct in Human Research (2007), which the Hunter New England Human Research Ethics Committee is obliged to adhere to, include the requirement that the Committee monitors the research protocols it has approved. In order for the Committee to fulfill this function, it requires:
- A report of the progress of the protocol to be submitted at 12 monthly intervals. A proforma for the annual report will be sent two weeks prior to the due date.
- A final report be submitted at the completion of the protocol, that is, after data analysis has been completed and a final report compiled. A proforma for the final report will be sent two weeks prior to the due date.
As of January 2018 the Hunter New England Local Health District has adopted the NHMRC Guidance: Safety monitoring and reporting in clinical trials involving therapeutic goods https://www.nhmrc.gov.au/guidelines-publications/eh59
I line with these guidlines the safety reporting requirements for the Hunter New England Research Ethics and Governance Office is as follows.
For Commercial Sponsored Trials
See the following link http://www.health.nsw.gov.au/ethics/Pages/safety-pathways.aspx
For Non Commercial Sponsored Trials
Please complete the HNEHREC SAE Reporting Form and submit to HNELHD-HREC@health.nsw.gov.au
If you require further information, please contact Dr Nicole Gerrand by emailing Nicole.firstname.lastname@example.org