A joint statement has been released reflecting the shared views of state and territory Departments of Health, the Therapeutic Goods Administration (TGA), National Health and Medical Research Council (NHMRC) and the Clinical Trials Project Reference Group (CTPRG).
This guidance provides general information and advice to institutions conducting or overseeing research, Human Research Ethics Committees (HRECs), researchers and sponsors in the context of the COVID-19 pandemic.
The advice represents current thinking and best practice at the government level and will be reviewed and updated regularly to reflect changes in government policy, public health advice and the needs of those conducting and participating in public research in Australia.
The key principles of the guidance are:
- The safety and well-being of patients, research participants and their families, and health care professionals, researchers and other staff involved in patient care and research.
- Public health systems remaining able to respond to the needs of the community; those impacted by COVID-19 and in terms of their regular workloads.
- The conduct of research related to COVID-19 as a significant priority while considering the initiation and continuation of other ongoing and proposed research that may also be critical for the well-being of patients, participants, communities and the research sector.
- Ongoing compliance with or adherence to regulations, guidelines, codes, policies and other standards, while allowing for interpretation of research responsibilities in the context of COVID-19, informed by flexibility, consultation and good sense to retain the focus on the safety and well-being of those most at risk in our institutions and communities.
If you have information or resources you would like to bring to our attention, please contact us here at ACTA via info@clinicaltrialsalliance.
ACTA would like to acknowledge and thank the Medical Research Future Fund (MRFF) and the National Health and Medical Research Centre (NHMRC) for investing in clinical trials research related to treatment of COVID-19 respiratory illnesses
We would also like to thank members of the ACTA Community who have helped keep us up to date, with special acknowledgment for Melanie Gentgall, CEO,PRAXIS Australia and Anita van der Meer, Manager, Clinical Trial Support Unit, NSW Office for Health and Medical Research.