COVID-19 update – August 2020
In response to the increase of the National COVID-19 Alert System to Level 3 in the Auckland region, the HDEC has now reactivated the COVID-19 HDEC under the COVID-19 Emergency Response eSOP (Word, 194 KB).
The eSOP will only apply to new COVID-19 research applications and substantial amendments to previously approved research that affect regions placed in Level Three or Four. A nation-wide study may submit an amendment under the eSOP if it involves sites/participants in a Level Three region. Studies unaffected by Level Three restrictions will continue to be reviewed under standard pathways.
The eSOP has been amended and is now Version 3.
Some key changes include:
If researchers have submitted and received approval for an amendment of protocol under Level Three or Four of the (and have since reverted back to the pre COVID-19 approved protocol in Level One or Two) you are not required to submit an amendment again if the National COVID-19 alert level increases. Instead the HDEC asks that this be communicated to the HDEC in the next annual progress report
It may be appropriate for some deviations to the study protocols to occur without prior notification to the HDEC. Where they are required for urgent safety measures, they must be reported to the HDEC as soon as practicable but must be reported within a month of the deviation. However, where the deviations are due to government requirements and do not significantly impact on participant safety (such as verbal/electronic consent, remote check-ups etc, these can be reported as a summary as part of the annual progress report process.
When the eSOPs are deactivated, changes to revert back to the previously HDEC approved protocol should be treated as a minor amendment under the HDEC SOPs.
Determining if health and disability research is an essential service
When this eSOP is activated, new and existing research will operate within the restrictions set by the National COVID-19 Alert System and the Ministry of Business, Innovation and Employment.
Non COVID-19 related research, involving healthy participants should not be commenced by researchers in regions affected by Level Three or Four of the National COVID-19 Alert System.
It is paramount that researchers prioritise the safety of participants and staff. All research, including that related to the pandemic, should consider the risk of transmission of the virus that participation entails, and must be justified in light of that risk. Participants must be adequately informed of any risk of transmission.
Researchers should also consider how their research might consume medical resources which might otherwise be made available to clinical staff working in response to the pandemic.
Only Clinical Trials where enrolled participants receiving a product with therapeutic intent should continue during a Level Three and Four response of National COVID-19 Alert System.
Any new recruitment and screening of participants for pre-Level Three or Four approved Clinical Trials may continue so long as:
- there is no contravening of the relevant isolation status at that level of alert as per the National COVID-19 Alert System, and
- continuing would have no adverse effect on the provision of care for those patients during the DHB’s COVID-19 response.
The HDEC continue to meet as scheduled via Zoom. However, due to COVID-19 work taking precedence there may be delays to receiving decisions. Please contact the Secretariat if you require any further information.
The Ethics Secretariat is based in Wellington. As Wellington is under Level 2 we will be predominately working from home. To get in touch with us please contact 0800 4 ETHIC.