Draft Quality Standards for Human Research Ethics Committees and their Host Institutions

Overview

In Australia, any research posing more than a low risk to participants must be reviewed and approved by a Human Research Ethics Committee (HREC).

HRECs promote the ethical conduct of human research by advising on the protection of, and respect for, research participants, as well as its scientific value.

Australian HRECs are usually affiliated with an institution or governing body, which establishes and maintains an HREC as part of its responsibility for research. Health organisations, universities, research institutes, government agencies and private organisations are all examples of institutions.

The quality of ethics reviews can vary considerably between HRECs, reflecting differences in the HRECs' expertise, local policies, and differences in legislation in the states and territories.

Variation in the quality of ethics reviews can undermine trust and confidence in the ethics review process. This is particularly important for studies that are to be conducted at more than one site (multi-site research).

This current work is aimed at:

• improving the consistency and efficiency of ethics review processes
• building confidence in ethics reviews, to support mutual acceptance. 

Why your views matter

Australian health and medical research ranks among the best in the world, but we need to remain competitive in this sector so that:

• Australians will continue to have access to cutting-edge medical treatments
• Australia can continue to attract investment in health and medical research. 

We want to hear from you about how we can improve the consistency and efficiency of ethics review processes in Australia. 

We have developed a set of Quality Standards for HRECs and their Host Institutions (Draft Quality Standards), which aim for the highest levels of integrity and ethics/scientific review. 

All HRECs in Australia will be eligible to nominate themselves and their host institutions for accreditation to the Quality Standards. Accreditation will reassure the community that the HREC is competent to protect the rights and welfare of research participants, and that the research conducted by the host institution meets ethical standards.

The consultation survey is intended to help us understand your views on, and attitudes towards, issues related to ethics review of health and medical research and how it can be improved in the future. 

Completing the consultation survey generally takes about 30 minutes, depending on your familarity with the ethics review process. You can stop the survey at any point, and return to complete it later on.

What happens next

Feedback from the consultation survey will be used to refine the Draft Quality Standards and to inform the design of the future accreditation scheme. 

We will conduct a pilot of the accreditation scheme in mid/late-2025.