The Therapeutics Goods Administration (TGA) hosted the sixth meeting of the Human Research Ethics Committee (HREC) and TGA Clinical Trials Discussion Forum (the Forum) on 14 July 2026.
The Forum is an open group for HREC chairs or their delegates and aims to provide a mechanism for collaboration between the TGA and HRECs. The Forum is not an advisory or policy decision-making group and is not a statutory committee of the TGA.
Presentations were made on:
N=1 therapeutics: balancing ethics with opportunity. Participants discussed:
Informed consent
Expectation setting in N=1 research
Ethics oversight in N=1 research
Processes, regulation and ethics in N=1 research
TGA medical devices update: ISO14155 changes and 2025/26 high-risk CTN reviews.
The Next forum is anticipated to be held in October 2026. HRECs are invited to provide suggestions and to lead future forum discussions.
