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.
3 April 2020
1. The HDECs have now established the new emergency committee and are ready to receive COVID-19 related applications. COVID-19 must still meet all standards within the National Ethics Standards and be accompanied by evidence of scientific review.
2. The HDECs ask that all applications for research intended to start in the near future ensure that the research operates within the restrictions set by the Alert Level 4. This means that there should be no new studies recruiting healthy volunteers. The HDECs will still be receiving applications for ethical review for new studies designed to commence once the restrictions are lifted
3. Within the COVID-19 setting, 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.
4. 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.
5. Where amendments are made due to advice issued by the sponsor, researchers need to detail what that advice will specifically mean for the study in NZ, and should produce a letter/email informing the participants of the updated procedures. Where those changes are due to government-mandated restrictions and do not increase the risk to participant safety, they may be implemented immediately and reported to HDEC via the regular expedited pathway as a protocol deviation. Where they could add risk, HDEC should be contacted to request that the protocol deviation be reviewed by the emergency committee.
6. Where recruitment or screening is suspended due to the pandemic, this may be submitted via the regular expedited review pathway (not to the emergency committee).
7. Where participants are already recruited in a study, suspending the study should be reported by submitting an amendment form, and will be assigned to the emergency committee. Halting the study may occur prior to HDEC approval if doing so is urgent.
8. Only Clinical Trials where enrolled participants receiving a product with therapeutic intent should continue during a level 3 and 4 response of the National COVID-19 Response Plan.
Any new recruitment and screening of participants may continue so long as:
a. there is no contravening of the relevant isolation status at that level of alert as per the National COVID-19 Response Plan, and
b. continuing would have no adverse effect on the provision of care for those patients during the DHB’s COVID-19 response.
If these are not met, then recruitment and screening must discontinue.