30 June 2020
IT system and revised Standard Operating Procedures
As part of the NEAC Roadshow in February the HDEC did a presentation on the Modernisation of Ethics project that covered the review of the IT System, HDEC Standard Operating Procedures and the HDEC Terms of Reference. The IT system was scheduled to be in place by 1 July 2020. Unfortunately, due to the COVID-19 response this project and the delivery of the IT system has been delayed. It is now expected that the IT System will be available towards the end of the year. If you have experienced difficulties in applying the NEAC standards to the current HDEC application form, please contact the HDEC Secretariat for advice.
Scope of Review Process
In March 2020 the HDEC Secretariat suspended the scope of review service to researchers due to the COVID-19 work load. As we are now in level 1 on the National COVID -19 framework, this service is now available. For all scope of review requests please complete the scope of review form on our web page and send through to the HDEC Secretariat. Please allow up to 7 working days turn around for our response.
If you submitted a scope of review request prior to or during the lock-down period and have not received a response, please get in contact with the HDEC Secretariat.
COVID-19 emergency Standard Operating Procedures (eSOP)
The Secretariat are still receiving applications under the COVID-19 eSOP. The eSOP was stood down on Friday 22 May 2020. The decision was made due to the return to alert level 2 and may be reversed if the government returns to level 3 or above. All new submissions will be reviewed via the standard full or expedited review pathways, as per the Standard Operating Procedures.
Contacting the HDEC Secretariat
The HDEC Secretariat is based at the Ministry of Health in Wellington. As the Ministry of Health is still active in the COVID-19 response the team is spending 70% of their time in the office. The HDECs email and the 0800 service is fully functional. Please send an email in the first instance unless your query is urgent. If you have sent an email and do not get a response within 3 working days, please call us on 0800 4 ETHIC.
25 May 2020
The 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.