Change your study protocol
How to make a change to an aspect of your study protocol or study documents.
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.
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:
- significant changes to the design/methodology of the study
- significant changes to the type or number of procedures that participants will undertake in the study
- changes relating to the safety of the physical or mental integrity of participants or to the risk/ benefit assessment for the study
- significant changes to the study’s documentation (such as participant information sheets)
- the appointment of a new CI for the study
- any other significant change to the study protocol or the information provided in the application for approval.
Minor amendments include:
- minimal or administrative changes to study documentation
- updated versions of the investigator’s brochure (where the study involves a new medicine)
- changes to the research team other than the appointment of a new CI
- changes in funding arrangements, except where these may alter the ability of participants to access publicly funded compensation in the event of injury
- changes in arrangements for recording or analysing study data or for storing or transporting samples
- any extension of the study beyond the expected end date given in the application form, except where this is related to other changes that are substantial.
For more information
For help in determining if an amendment is substantial, you can contact the HDEC Secretariat: