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HDEC Update 24 August 2020

A standard condition of HDEC approval is all intervention trials must be registered on a clinical trial database prior to commencement.

As registries around the world respond to COVID-19 and reprioritise applications this has resulted in long delays to trial registration and risks substantial delays to ethically-approved research.  From today HDEC will temporarily suspend the need for registration to be completed before trials begin in New Zealand. Researchers should still submit their study for registration before trial procedures begin, but approved confirmation from the registry is temporarily no longer a pre-requisite to begin. Studies that take this action must provide an update to HDEC in their first annual progress report.

Under the e-SOP provisions this does not constitute a substantial amendment or protocol deviation and does not require submission of a Post-Approval Form. 

While this waives the HDEC requirement for registration to be completed prior to commencement, researchers should ensure this does not contravene any locality requirements, and researchers should have the study submitted prior to commencement 

HDEC will update their website when this temporary measure is halted.