After HDEC approval

What to do once you are given approval

You should usually commence your study within 12 months of HDEC approval. HDEC approval is automatically cancelled where a study has not commenced within 24 months.

Procedural rules around amendments and other post-approval items are contained in sections 11 and 12 of the SOPs for HDECs. These require researchers to:

• obtain HDEC approval for all substantial amendments
• submit annual progress reports
• inform the HDEC of substantial protocol deviations or violations
• notify the HDEC of the study’s conclusion or early termination
• submit a final report.

Serious adverse events do not need to be individually reported to HDECs.

All post-approval submissions are reviewed online by a subcommittee made up of members from the original approving Committee, unless informed otherwise. The target timeframe for these decisions are 15 days as outlined in the Standard Operating Procedures.

Annual Reporting

It is a standard condition of every study approved by HDEC that they must submit an annual progress report. The due date is dictated by the approval date of the study and is outlined in the approval letter. Failure to submit an annual report for review can result in HDEC approval being withdrawn. A study must submit a report annually until the study is completed.

Annual reports are appropriate for reporting minor errors or deviations, however anything listed under the protocol deviation guidance should be submitted as such instead.

Changes to your approved study

To change or add 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.

Substantial amendments

An amendment refers to any change to the approved study. This can include new documents, or existing documents with changes made to them.

Section 11, paragraphs 186 to 192 of the HDECs Standard Operating Procedures (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:

• 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

Minor amendments submitted will be marked as invalid and acknowledged for filing only. 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.

Further information

Please refer to chapters 11 and 12 of the Standard Operating Procedures for more information.

The Ethics RM manual can be referred to for information on how to submit post-approval items such as a progress report or amendment.

For help in determining whether an amendment is substantial, you can contact the HDECs Secretariat at:

• email: HDECS@health.govt.nz