To change an aspect of your study protocol or study documents, you may need to submit an amendment to Health and Disability Ethics Committees (HDECs) via the New Zealand Ethics Review Manager (ETHICS RM)(external link).
Only substantial amendments need to be reviewed by HDECs. You do not need to submit non-substantial (‘minor’) amendments. HDECs can be notified of minor amendments as part of annual progress reports.
Section 11, paragraphs 186 to 192 of the HDECs SOPs(external link) give examples of substantial amendments and state that research teams, not the co-ordinating 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 HDECs. Researchers who are unable to decide if their amendment is substantial can submit an amendment for review. The HDECs Secretariat will review the amendment and decide whether or not the amendment is substantial.
Substantial amendments include:
Minor amendments include:
For help in determining whether an amendment is substantial, you can contact the HDECs Secretariat at: