16 May 2016
The National Health and Medical Research Council (NHMRC), with the assistance of a Working Committee of the Australian Health Ethics Committee (AHEC) is revising the 2009 AHEC Position Statement on Monitoring and reporting of safety for clinical trials involving therapeutic products.
The Council of the NHMRC has released a revised Position Statement for consultation and now seeking public comment. A copy of the revised Position Statement is available from the online consultation portal.
The revised Position Statement seeks to clarify the responsibilities of all parties in relation to reports of adverse events, including serious adverse events and suspected unexpected serious adverse reactions. It outlines the minimum requirements regarding safety reporting and monitoring with the intention to remove the existing duplication in reporting requirements between a Principal Investigator, a sponsor and the approving Human Research Ethics Committee (HREC), and to clarify reporting requirements so that the most appropriate body receives the necessary reports.
The revision is part of a broader program of work to move towards a nationally consistent approach to the way clinical trials are conducted and overseen and the consultation closes 27 May 2016.