Health and Disability Research (HDEC)

This page contains the sections:

  • What is health and disability research?
  • Determining whether or not your research requires HDEC review
  • How do I apply for ethics approval from an HDEC?
  • Human Ethics contacts

What is health and disability research?

Health and disability research in New Zealand must be reviewed by a Health and Disability Ethics Committee (HDEC), unless it is considered to be out of scope for those committees. If considered to be out of scope for HDEC review, human health research studies of University of Auckland staff and students must be submitted for review by the Auckland Health Research Ethics Committee (AHREC), unless an exemption applies.


Health and disability research is defined in Section 1 of the NEAC National Ethical Standards for Health and Disability Research and Quality Improvement (December 2019).


The HDEC Standard Operating Procedures for Health and Disability Ethics Committees (2019) provides further explanation of the health and disability research studies that require HDEC review. These SOPs also contain information about research studies that are out of scope for review by an HDEC.

Determining whether or not your research requires HDEC review

1.  Review the summary of the scope of studies reviewed by HDECs

2.  Read the full explanation of the scope of HDEC review in Section 3
of the HDEC Standard Operating Procedures (SOPs)

3.  Complete the screening sections of the HDEC ETHICS RM form – these sections will help determine whether HDEC review is required and if so, what review pathway the study will go through

4.  Based on the information provided to these screening questions, an out of scope letter will be generated if the study is not eligible for HDEC review

5.  As noted on the ETHICS RM form, if you receive an HDEC letter stating the study is not in scope for HDEC review, it is evidence only that the proposed study does not meet the conditions for HDEC review, and ethics review should then be obtained from AHREC for human health research prior to starting the study. 

AHREC reserves the right to obtain confirmation from the HDECs that the study is not eligible for their review in cases where there is ambiguity about the eligibility criteria.

How do I apply for ethics approval from an HDEC?

1.  HDEC application process:

  • Information about the HDEC application process, meeting deadlines, registration to access ETHICS RM and training videos to use ETHICS RM form is available from the HDEC website
  • HDEC applications submitted by University staff and students require ‘sponsor authorisation’, ‘HOD Approval’ and ‘locality authorisation’, as explained below.

2.  University of Auckland requirements prior to submitting an HDEC application:

Prior to submission of your ethics application to HDEC you should complete the key activities outlined below and request / obtain the required authorisations. See the Human Health Research Decision Tree: HDEC Application – Key Pre-Submission Activities for more details.

Summary list of the required activities

  1. Confirm the role of the Coordinating Investigator (CI)
  2. Confirm Insurance Cover, Study Locality(s) and SCOTT / GTAC Approval
  3. Obtain Sign-off by Academic Head (complete the Pre-submission approval form)
  4. Request Sponsor authorisation (required if you are staff or student; not related to funding)
  5. Share the HDEC application with the Ethics and Integrity team
  6. Request Locality authorisation (can be obtained after approval)

More information on each activity follows.

Please note: This list is not a checklist of all the activities that a CI must consider when establishing their study – it is a list of key activities that, if omitted, may slow down the HDEC approval process and/or introduce additional risk to the University, e.g., through inadequate insurance for a study.

1. Confirm Role of the Coordinating Investigator (CI)

  • Applications for HDEC review of new applications and substantial amendments must be submitted or authorised by the Coordinating Investigator (CI) of the research study. The CI has overall responsibility for the conduct of the study.
  • The CI must be professionally based either wholly or partly in New Zealand. An international study will need to have a local CI for the New Zealand part of the study.
  • Where the University of Auckland is the sponsor/host of the study, the CI must be a University employee.

2. Confirm Insurance Cover, Study Locality(s) and SCOTT / GTAC Approval

3. Obtain Sign-off by Academic Head (Head of Department/ School or other nominated Head)

  • Complete the University’s Infonetica Ethics RM Pre-Submission Approval for HDEC Applications form
  • Read the Create HDEC application approval request and Submit HDEC application approval request guides for more details on how to complete and submit the form
  • Request sign-off from the Academic Head of your Department/School/Institute via this form. This sign-off is required before the submission to HDEC can be authorised by the Ethics and Integrity team
  • A list of Academic Heads (or delegates) who will provide sign-off is available from the Submission section in the University Ethics RM form
  • Email confirmation will be sent to you once the Pre-submission approval sign-off has been noted by the Ethics and Integrity team.

Please note, sponsor authorisation cannot be granted without Academic Head approval.

In approving submission of the application to HDEC, the Academic Head approval provides:

  • Approval for the study to be conducted in their department
  • Confirmation that they have sighted and are satisfied with the Risk Assessment as outlined on the HDEC application form, and have consulted appropriately within their Faculty/LSRI where they have any concerns
  • Confirmation that they have consulted appropriately within Faculty/LSRI if they have any concerns in regards to level of reputational risk
  • Confirmation that they are satisfied that adequate consideration of insurance cover has been under taken
  • Approval that the resourcing (people/facilities/budget) is adequate in their department to carry out the study

4. Request Sponsor authorisation

  • If you are a staff member or student of the University of Auckland, add the University as local sponsor in question H6 – Local Sponsor of the HDEC form (see the definition of “Sponsor” below):
  • Request authorisation by adding the humanethics@auckland.ac.nz email address on the submission page (Sponsor’s declaration)
  • Submit the HDEC application once Academic Head approval has been completed via the Pre-submission approval form. A request for sponsor authorisation will automatically be sent to the sponsor email address when the HDEC form is submitted. Authorisation can be requested from more than one sponsor, as relevant.

Additional information about sponsor authorisation:

  • If the study has been initiated by or is for the benefit of a commercial organisation, i.e., a pharmaceutical company, then sponsor authorisation should be requested from both the University and the commercial organisation.
  • More than one sponsor can be nominated if the study is supported by more than one institution and there are co-investigators from both institutions.
  • The HDEC Standard Operating Procedures define a sponsor as "the person or organisation with responsibility for the initiation, management and financing arrangements of the study." The University of Auckland is registered as a sponsor for studies of University staff and students with the HDECs. The term “sponsor” does not mean “funder” in this instance.
  • At the University of Auckland, sponsor authorisation has been delegated to the Ethics and Integrity Team. The Ethics team keeps a record of HDEC applications submitted by University staff and students to enable the Risk Office to ensure that adequate insurance cover for researchers and study participants is in place.

5. Share the HDEC application with the Ethics and Integrity team

Sharing an application:

  • Open the HDEC application in ETHICS RM (HDEC system)
  • Select “Roles” from the left-hand menu
  • Add the humanethics@auckland.ac.nz address, select “Read only”
  • Click on “Share Role”.

6. Request Locality authorisation

Each locality involved in a research study needs to assess its suitability for the safe and effective conduct of the research and authorise the research if it is satisfied that this is the case. Locality authorisation must be obtained from each locality and can be done after submission, but must be done before commencement of the study. Locality approval is requested through the HDEC ETHICS RM online system.

Where any part of the research is being undertaken on University premises, i.e., the University is a human health research ‘site’, locality approval should be sought from the applicable Academic Head (i.e., Head of School / Department etc.) or their delegate.

If District Health Board patients, facilities or staff are involved in the study, you should contact the relevant DHB Research Office to obtain locality approval, including for audits where the researcher needs permission from a DHB to access their data.

How do I apply for ethics approval from an HDEC?

Online forms

  • Applications for HDEC review must be submitted through HDEC's ‘Online Forms’ website.
  • Before creating an application you will need to create an account in Online Forms.
  • The Online Forms website allows you to answer questions in the HDEC application form, upload documents, request electronic signatures from other parties involved in your research, and track the progress of your application.
  • Please refer to the Online Forms User Manual for detailed guidance on creating and submitting an application.
  • HDEC applications require ‘sponsor authorisation’, ‘HOD Approval’ and ‘locality authorisation’, as explained below.

How do I request authorisation from the University of Auckland?

Prior to submission of your ethics application to HDEC you should complete the key activities outlined below and obtain / request the required authorisations. See below and the Human Health Research Decision Tree: HDEC Application – Key Pre-Submission Activities for more details.

PLEASE NOTE: The following list is not a checklist of all the activities that a CI must consider when establishing their study – it is just a list of key activities that, if omitted, may slow down the HDEC approval process and/or introduce additional risk to the University e.g. through inadequate insurance for a study.

1. Confirm Role of the Coordinating Investigator (CI)

  • Applications for HDEC review of new applications and substantial amendments must be submitted or authorised by the Coordinating Investigator of the research study. The CI has overall responsibility for the conduct of the study.
  • The CI must be professionally based either wholly or partly in New Zealand. An international study will need to have a local CI for the New Zealand part of the study.
  • Where the University of Auckland is the sponsor/host of the study, the CI must be a University employee.

2. Confirm Insurance Cover, Study Locality(s) and SCOTT / GTAC Approval

3. Obtain Sign off by Academic Head (Head of Department/ School or other nominated head)

Please obtain sign off from Academic Head of your Department/School/Institute using the Infonetica Ethics Review Manager (Ethics RM) Pre-Submission Approval for HDEC Applications form. This sign-off is required before the submission to HDEC can be authorised by the Ethics team.

Please see the Create HDEC application approval request and Submit HDEC application approval request guides for more details on how to complete and submit the form.

In approving submission of the application to HDEC, Academic Head approval provides:

  • Approval for the study to be conducted in their department
  • Confirmation that they have sighted and are satisfied with the Risk Assessment as outlined on the HDEC application form, and have consulted appropriately within their Faculty/LSRI where they have any concerns
  • Confirmation that they have consulted appropriately within Faculty/LSRI if they are any concerns in regards to level of reputational risk
  • Confirmation that they are satisfied that adequate consideration of insurance cover has been under taken
  • Approval that the resourcing (people/facilities/budget) is adequate in their department to carry out the study

Please see the Sign-off HDEC application approval request user guide for more details on how to sign-off an approval request.

A list of Academic Heads (or delegates) who will provide sign-off will be available from the sign-off page in Ethics RM.  

Please note, sponsor authorisation as described below, will not be granted without Academic Head approval.

4. Request Sponsor authorisation

  • Sponsor authorisation is required prior to submission of an application.
  • If you are a staff member or student of the University of Auckland, you must add the University as sponsor (see below) and request authorisation.
  • If the study has been initiated and is for the benefit of a commercial organisation i.e. a pharmaceutical company then sponsor authorisation should be requested from both the University and the commercial organisation.
  • The Standard Operating Procedures define a sponsor as "the person or organisation with responsibility for the initiation, management and financing arrangements of the study." The University of Auckland is registered as a sponsor for studies of University staff and students with the HDECs.
  • At the University of Auckland, the authorisation has been delegated to the Ethics and Integrity Team.  The following sponsor information must be added in question a.5.2 of the HDEC form:
  • To enable the Ethics team to authorise the application, sign-off by your Academic Head (Head of your Department/School or other nominated head) is required (please see more information about this in the step above).
  • Once all questions in the Online Form have been completed and Academic Head approval has been obtained (as outlined above), sponsor authorisation can be requested through the ‘Authorisations’ tab of the HDEC online system. An email will be sent from the HDEC system to the Ethics team with the request for sponsor authorisation.

5. Request Locality authorisation

Each locality involved in a research study needs to assess its suitability for the safe and effective conduct of the research and authorise the research if it is satisfied that this is the case. Locality authorisation must be obtained from each locality and can be done after submission, but must be done before commencement of the study.  Locality approval is also requested through the HDEC online system.

Where any part of the research is being undertaken on University of Auckland (UoA) premises i.e. the UoA is a human health research ‘site’, locality approval should be sought form the applicable Academic Head (i.e. Head of School / Department etc.) or their delegate.

Human Ethics contacts

Role Name Contact
Ethics and Integrity Manager Dr Elizabeth Visser e.visser@auckland.ac.nz
ext 83711
Ethics Advisor Colleen Altagracia humanethics@auckland.ac.nz
ext 88293
Ethics Advisor Fiona Cheal humanethics@auckland.ac.nz
ext 81338
Ethics Advisor Dr Madhavi Manchi ahrec@auckland.ac.nz
ext 85405