Update on NHMRC Development of a Human Research Ethics Application (HREA)

As part of the initiative to have streamlined and efficient ethics approval, NHMRC is developing the Human Research Ethics Application (HREA) as a replacement for the National Ethics Application Form (NEAF). The aim of the HREA is to be a concise streamlined application to facilitate efficient and effective ethics review for research involving humans. The application will assist researchers to consider the ethical principles of the National Statement on Ethical Conduct in Human Research (2007) in relation to their research, rather than focus on requirements for approval.

The application is being designed to be compatible with existing IT systems used to manage ethics applications and to streamline other processes, such as reporting.

The HREA is being developed with input from representatives from HRECs, public and private hospitals, academic institutions and commonwealth and state government departments. NHMRC have also established a Human Research Ethics Application Advisory Group which includes representation from universities, hospitals, the Australian Research Council and Universities Australia. The memberships of this group is:

Prof Paula Swatman (Chair) University of Tasmania
Dr Gary Allen Griffith University
A/Prof Lisa Askie Australian New Zealand Clinical Trials Registry
Ms Sarah Brown Universities Australia
Ms Melissa Hagan Queensland Health
Prof Mark Israel University of Western Australia
Dr Rob Loblay Royal Prince Alfred Hospital
Ms Sue Jenkins-Marsh Townsville Hospital and Health Service
Dr Sophie Mepham Benetas
Prof Marian Simms Australian Research Council
Ms Kylie Sproston Bellberry
Ms Jenefer Tan Universities Australia
Mr Justin Withers Australian Research Council
Dr Karolyn White Maquarie University
Adj/Prof Nik Zeps St John of God Subiaco Hospital

NHMRC considers the continued engagement and feedback from all stakeholders to be integral to the development of the application. As such there will be continued opportunity for stakeholders to provide feedback at multiple stages during the development of the application

Please note this video demonstrates an early draft version of the HREA and the questions shown may change.

Current Activities

  • NHMRC is working with the HREA Advisory Group to develop the content of the application on which stakeholder feedback will subsequently be sought.
  • NHMRC is holding discussions with IT providers to ensure the application is technologically compatible with existing systems used in institutions to manage ethics applications.
  • NHMRC has commenced the build of the software application.
  • Undertaking user testing of the application.
  • Seeking HRECs and ethics officers to assist in the refinement of the application’s content and accompanying guidance material.
  • Ongoing targeted consultation with stakeholders on the draft application.

Future Activities

  • Finalise the build of the application.
  • Undertake broad user testing of the application.
  • Provide education and training on the HREA.
  • Provide assistance in transitioning onto the HREA from NEAF.

Completed Activities

  • In May 2014 NHMRC undertook a targeted consultation on the proposed structure and content of Building a new application form for use in human research. Stakeholders were asked to provide comment on a number of aspects, including the suitability of key proposed features, the applicability for low risk research, indicative content and any potential barriers.
  • In July 2014 NHMRC engaged an IT provider to design the IT requirements and solution for the proposed application.
  • In September 2014 NHMRC published the outcomes of the consultation and began to work with the Human Research Ethics Application Advisory Group to progress the development of the content and structure of the application.
  • In June 2015 NHMRC engaged an IT provider to commence the IT development of the application.
  • In June 2015, NHMRC developed a proof of concept for the IT solution for the application.

Further information

Please contact the Clinical Trials section (link sends e-mail).