Frequently Asked Questions

FAQ Link

Please see the FAQ list on the HDEC website at: https://ethics.health.govt.nz/frequently-asked-questions/

1 September 2021 - go live

The data migration from the current system to the new one happens over two weekends. The first weekend brings all ETHICS RM study data and meta data. You will be able to see all of your study documents from 1 September 2021, however, you cannot open the supporting documents. This is due to the substantial amount of data needing to transfer. The second weekend starting 4 September 2021 will migrate all supporting documents. As of 8 September 2021 you can open all supporting documents.

03 December 2021 - Version 1.25 Update

Version 1.25 of the HDEC application form is live. This update simplifies the signature/authorisation process and the response to provisional approval process. HDEC Form changes: The cultural section of the form will now correctly display in 'data only' studies that require a waiver of consent for existing health-data but not active participation. Locality and sponsor authorisation requests are now behind simplified 'yes/no' questions. If an authorisation is invalidated the system will no longer accept the application without it being reobtained. A 'response to provisional approval' section has been added to end of the form. If your study receives a provisional approval you may upload the response here when the form is returned to you for changes. HDEC Annual Progress Report: PR17.1 and PR18.1 have been fixed and will no longer ask for participant withdrawal numbers if the preceding questions were answered 'no'.

23 February 2022 - Version 1.26 Update

ERM Update 23/02/2022 - Version 1.26 Please note that updating a form will wipe any signatures and these will need to be re-obtained. HDEC form: The options for locality and sponsor authorisation have been revised and will allow more flexibility. Observational studies that require full review will now properly trigger the peer review question. A new question (H8) has been added to the end of the form to allow any additional clarifications, requests or requirements to be communicated to the HDEC Secretariat. Question C16 on ethnicity data will now correctly display. The ionising radiation section will no longer display further questions when answered 'no'. The question for number of New Zealand participants should now correctly display for international trials. A COG option has been added to amendments and progress reports to allow COG studies to commnicate specific requirements. The SCOTT form will now allow multiple miscellaneous documents.

25 March 2022 - Version 1.27 Update

ERM Update 25/03/2022 - Version 1.27 Please note that updating a form will wipe any signatures and these will need to be re-obtained. This is a minor update and is not mandatory. Forms created before 25/03/2022 are still able to be submitted. HDEC Forms Update: An 'administrative section' to import details from the main application has been added to post-approval forms. This will fix the issue some applicants have had with the correct study title and/or CI details not appearing on HDEC approval letters. The administrative section in amendment forms may edited in the event of a change of Coordinating Investigator or study title. The screening algorithm has been revised and should now allow observational studies that involve tissue to be submitted. The COG option on the amendment form will now correctly unlock the form.

23 March 2021 - ECART ERM Progress

We are nearly at the stage where ECART applications will be brought into ERM. For the time being we are not accepting applications through these forms as they are being tested prior to release of training materials etc., but they will be coming soon. Check here for more updates but for the time being we appreciate your patience.