COVID-19 Emergency Response: Ethical Review Operating Procedures (eSOP)
Knowledge generated through high-quality research in the anticipation of, during, and after an outbreak is critical to help prevent ongoing outbreak of illnesses, exacerbation of disability and death, and to support the recovery process, including that of the New Zealand health system.
The purpose of this eSOP is to ensure that there are practical and effective actions put in place to ensure that a robust but rapid research ethics review is undertaken. Given the public health emergency, this guidance is being implemented without prior public comment because the Health and Disability Ethics Committees (HDECs) have determined that prior public participation for this guidance is not feasible or appropriate.
Only new ethics research applications that have a COVID-19 research element and meet the scope of HDEC review (Section 3 Of the HDEC SOPs), and amendments to existing studies to either add or respond to a COVID-19 research element will be covered by this emergency SOP. All other research applications will continue to be reviewed under the HDEC SOP.
While COVID-19 is a public health emergency, the ethical principles and values that are at the centre of New Zealand’s health and disability ethical review processes must continue to be upheld. The HDEC acknowledges that in the DHB context human resources may need to be regularly assessed, with research staff being pulled into essential clinical practice. This may mean that certain monitoring and reporting duties and quality assurance activities related to clinical trials may also need to be reassessed.
This eSOP must be read in conjunction with the relevant statutes, legislation and standards listed in the Standard Operating Procedures for Health and Disability Ethics Committees and the National Advisory Ethics Committee’s Getting Through Together: Ethical values for a pandemic.
Submitting research applications
We ask all researchers who submit a COVID-19 related application (new study or a post approval form related to a currently approved study) through Online Forms to also notify us of submission via the HDEC email (firstname.lastname@example.org) with the following wording in the subject line ‘COVID -19 new study’ or ‘COVID-19 Amendment’. This will allow the Secretariat to easily identify and triage applications to the correct pathway.