All research involving humans conducted within the NSW public health system must be ethically and scientifically reviewed and approved by a Human Research Ethics Committee (HREC) in accordance with the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (2007).
In addition, all human research that takes place in NSW Public Health Organisations, or that requires support from a NSW Public Health Organisation in the form of access to participants, tissue or data requires site authorisation. Site authorisation must be reviewed and authorised by the Chief Executive or their delegate before commencement.
NSW Health and Medical Research Ethics and Governance Reform
The Office for Health and Medical Research is actively reforming the health and medical research pre-approval process in NSW as part of the NSW Health and Medical Research Governance Reform Program. The Program’s overall objective is to provide timely, efficient and high quality review and monitoring for health and medical research in NSW. The Program also addresses barriers to undertaking clinical trials in NSW. The Research Ethics and Governance Information System (REGIS) and the research ethics and governance metrics program is a key outcome of the reform program.
The Reform Framework was developed through extensive consultations with stakeholders involved in clinical research. A Discussion Paper was developed to identify the most significant barriers to – and options for – timely, efficient review. In December 2013, the Discussion Paper and a Consultancy Survey sought feedback from a wide variety of Research Ethics and Governance stakeholders. The intention of the survey was to identify and prioritise the key areas of reform. Based on the stakeholder feedback, an Action Plan was developed, and the Reform Framework and Action Plan were endorsed by Chief Executives of all 18 local health districts and related agencies in 2014.
Research Ethics and Governance Information System (REGIS)
The Research Ethics and Governance Information System (REGIS) is being progressively implemented in all local health districts across NSW and the ACT.
The system is used by researchers to develop and submit both research ethics and site assessment applications for single-site and multi-site research conducted at public health organisations NSW and ACT. Research offices, including Human Research Ethics Committee Executive Officers and Research Governance Officers, members and expert reviewers, and Department Heads use the system to process, review and manage research projects throughout the study.
REGIS is a joint initiative between eHealth and the Office for Health and Medical Research. It was built by Canberra based F1 Solutions on their OmniEthics platform.
For more information and regular monthly updates on the REGIS transition, please visit the REGIS website.
Research ethics and governance metrics
As of 1 July 2016, the Office for Health and Medical Research has collected data from NSW local health districts, specialty health networks and NSW Ambulance to generate ethics and governance metrics for health and medical research, including clinical trials. Some strategic metrics, such as study approval timelines and clinical trials enrolment have been incorporated into the 2017-18 Service Agreements with relevant NSW Health organisations.
More information on the metrics program, including a data collection manual and how each metric is calculated, is available on the metrics page.
Updated 1 year ago