Consultations continue despite ‘caretaker’


Consultations on the Medical Research Future Fund strategy and priorities, the monitoring and reporting of safety for clinical trials and the Australian Research Council’s examination on how universities are translating their research into benefits and incentives for collaboration, are all open now for comment, during the Federal Government’s caretaker period in the lead up to the July election.

Medical Research Future Fund (MRFF) Strategy and Priorities

The Australian Medical Research Advisory Board, following its first meeting last week, is determining the MRFF’s Australian Medical Research and Innovation Strategy (Strategy) and related Priorities.

The Advisory Board has agreed to a two-stage consultation process to inform the development of these documents: the first stage is a public call for submissions, which is now open; and the second stage will follow in July with targeted consultation events.

A consultation paper (incorporating the building blocks for the Strategy) and a pro forma for articulating priorities, together with instructions for making a written submission until 6 June 2016 is available on the Department of Health consultation hub.

NHMRC to revise monitoring and reporting for clinical trials

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.

ARC’s examination on translation and incentives for collaboration

As part of the National Innovation and Science Agenda (NISA), the Government announced the development of a national engagement and impact assessment, which will examine how universities are translating their research into economic, social and other benefits and incentivise greater collaboration between universities, industry and other end-users of research.

The Australian Research Council (ARC) and the Department of Education and Training will develop and implement an assessment, which will run as a companion to Australia’s national evaluation of university research quality—Excellence in Research for Australia (ERA).

As part of the development of the assessment, the consultation seeks the views of stakeholders on the framework for developing the national assessment of the engagement and impact of university research.

The consultation paper is available online and the consultation is open until 24 June 2016.