HDEC emergency COVID-19 operating procedures will no longer be operational
Effective at the end of Friday 22 May, the HDECs will no longer be offering the expedited 5-day review pathway for COVID-19-related applications and post-approval forms.
All new submissions will instead be reviewed via the standard full or expedited review pathways, as per the standard operating procedures. This decision was made due to the return to alert level 2, and may be reversed if the government returns to alert levels 3 or 4.
As the E-SOP is no longer operational, all amendments regardless of their nature need to be submitted for HDEC review prior to implementation (except where they address urgent safety measures). Studies that were halted during levels 3 and 4 and are now re-starting according to the previously HDEC-approved protocol are not required to notify HDECs via an amendment. However, where the protocol has been amended this must be submitted for review.
Studies may resume while following government and DHB safety guidelines
The HDECs believe that, where government and DHB safety guidelines are followed, the risk of transmission of COVID-19 to study participants in alert levels 1 and 2 are minimal. As such, the equipoise of clinical studies is not expected to be significantly affected, however researchers should take a common sense approach when considering the risk:benefit ratio of each study.
HDEC Secretariat working from home
The secretariat will be working from home at level 2 and as such will have limited capacity to answer the 0800 line. If you are not able to get through on this number please either send an email or call us on our personal work numbers which you will find in our emails.
We are still experiencing a high workload so please expect a delay in our response.