How to apply for HDEC review

If your study requires Health and Disability Ethics Committees (HDEC) review please follow these steps to complete an online application.

• Unsure if your study proposal needs HDEC approval? Find out if your study requires HDEC review.

Applying for HDEC review online

What you need to know:

• How to set up an account on the New Zealand Online Forms for Research website.
• What documentation to submit and the correct file formats to use.
• How to request and submit electronic signatures.

What you need to do:

1. Follow the instructions in the manual

The Online Manual provides an illustrated, step-by-step guide to setting and managing your account and submitting an application.

• Download the Online Manual (PDF, 5 MB)

Refer to the manual for setting up your account, creating a 'project' and answering the screening questions. (The questions will help you work out if you need to apply for HDEC review.)

There's also specific guidance on:

• Online Forms: application forms and file uploads
• Online Forms: requests and approvals

2. Set up an account on the Online Forms website

Your application must be submitted through the New Zealand Online Forms for Research website. Once you have set up your secure, online account you can:

• answer questions in an online form
• upload supporting document
• request and submit electronic signatures from other parties involved in your research
• track the progress of your application.

• New Zealand Online Forms for Research website

3. Check the documentation you need to submit

Check the list of documents required for all applications as well as any additional documents for particular types of study. Refer to the guides to help you complete your application.

Documentation required

All applications must include:

• a study protocol
• evidence of appropriate scientific peer review. If the study involves a new medicine, such evidence is not mandatory as the Standing Committee on Therapeutic Trials (SCOTT) will address any issues of scientific validity, however please include written confirmation that SCOTT review will be sought for the study. Read the guidance on submitting scientific peer review.
• a brief CV for the coordinating investigator (CI).

Additional documents required

Additional documents are required for these studies.

Studies involving a new medicine:

• An investigator’s brochure.

Studies involving participants:

• Participant information sheet(s)
• Consent form(s)
• An assent form if participant is a child
• Copies of any advertising that will be used to recruit participants
  • Read the guidance on recruitment and advertising materials
• Read the guidance involving potentially vulnerable participants.

Studies involving surveys or questionnaires:

• Copies of the surveys or questionnaires.

Commercially sponsored intervention studies:

• Evidence of the insurance held by the study sponsor
• The professional indemnity held by the CI.

Previously declined applications:

• A copy of HDEC’s letter declining the application
• A cover letter from the CI explaining how the new application addresses the reasons given by HDEC for declining the previous application.

Forms and templates can be downloaded in the section: Guides, templates and forms

Help with completing your application

Check the guidance for uploading files to the Online Forms website:

• Online Forms: application forms and file uploads.

If you have questions or require more information on completing an application, you can contact the HDEC Secretariat:

• freephone: 0800 438 442
• email: HDECS@moh.govt.nz