This statutory review has now been completed and the Final Report was tabled in Parliament on 22 February 2023.
The Final Report recommended two substantial amendments to the existing legislation. The first being to expand the scope of the legislation to include a wider range of registered health professionals who are able to enrol incapacitated adults in research. Currently only medical practitioners are able to act as ‘lead researchers’ and enrol a represented or incapacitated person in research or trials.
The Guardianship and Administration Amendment (Medical Research) Bill 2023 was introduced into State Parliament on 22 February 2023 and proposes that all registered health practitioners, rather than just medical practitioners, should be able to act as lead researchers, thus ensuring that vulnerable people have access to a wider range of new therapies.
The Bill also seeks to implement the second recommendation of the Final Report, being to remove the ‘sunset clause’ contained in the current Act which aims to remove the ability to enrol represented persons in urgent medical research in situations where their consent cannot be first obtained. The final report found this has caused a detrimental impact on medical research in Western Australia and recommended that the sunset clause on urgent medical research be deleted. Under the current legislation the sunset clause will take effect on 8 April 2024 so, from that date onwards, no new medical research projects can be commenced in which represented persons may be involved.
The Bill was read for a second time on 23 March 2023 but it is not yet known when it will be passed and the changes become operational.
