To change an aspect of your study protocol or study documents, you may need to submit an amendment to Health and Disability Ethics Committees (HDEC) via the New Zealand Online Forms for Research website.(external link)
Only substantial amendments need to be reviewed by HDEC. You do not need to submit non-substantial (‘minor’) amendments. HDEC can be notified of minor amendments as part of the annual progress report.
Section 11, paragraphs 186 to 192 of the HDECs SOPs give examples of substantial amendments and state that research teams, not the coordinating investigator (CI), are responsible for deciding if an amendment is substantial.
If an amendment changes a study significantly, then it will need to be submitted to HDEC. Researchers who are unable to decide if their amendment is substantial can submit an amendment for review. The HDEC Secretariat will review the amendment and decide whether or not the amendment is substantial.
Substantial amendments include:
Minor amendments include:
For help in determining if an amendment is substantial, you can contact the HDEC Secretariat: