B08a.Quality Standards for HRECs and their Host Institutions

Tracks
Clinical Research
Wednesday, June 4, 2025
1:30 PM - 2:30 PM
Parkside 1

Chair & Speakers

Agenda Item Image
Michael Swarbrick
Assistant Director Clinical Trials Policy Section
Australian Government, Department of Health, Disability and Ageing

Quality Standards for Human Research Ethics Committees and their Host Institutions

Abstract

The Australian Government Department of Health, Disability and Ageing, in collaboration with all state and territory governments via the enduring Inter-Governmental Policy Reform Group, is leading national reforms to enable a vibrant, optimal health and medical research ecosystem. These reforms will make it easier for patients, researchers, industry and sponsors to find, conduct, participate in and invest in high-quality and ethical human research, including clinical trials.
One important reform is the development of quality standards and an accreditation scheme for Human Research Ethics Committees (HRECs) and their host institutions.
Currently, ethics review processes can be inconsistent and inefficient, leading to delays – especially for studies involving multiple sites. This can also slow down research and reduce public trust in the system.
To address this, the Department of Health and Aged Care has developed Quality Standards for HRECs and their Host Institutions. The standards aim to improve the quality, consistency and efficiency of ethics reviews while maintaining the highest standards of integrity.
Accreditation of HRECs and their host institutions to the Quality Standards will improve transparency, build trust and confidence about ethics review processes, and reassure communities about their participation in health and medical research.
The accreditation scheme will be open to HRECs hosted by public and private health organisations, universities, medical research institutes, and the not-for-profit sector.
Public consultations on the Draft Quality Standards and options for the accreditation scheme were held in early 2025. We present preliminary findings from the consultations and outline the next steps for the project.

Biography

Michael Swarbrick is an Assistant Director in the Clinical Trials Policy Section, Australian Government Department of Health, Disability and Ageing. He has two decades of experience in biomedical research, working at universities and medical research institutes, in Australia and the United States of America.
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