Apply for approval from a Health and Disability Ethics Committee (HDEC)

Find out what you need to do as the co-ordinating investigator to prepare and submit your application for HDEC approval.

HDEC application information

  • Information about the HDEC application process, meeting deadlines, registering to access Ethics RM, and training videos to use Ethics RM is available on the HDEC website.
  • Determine if the study is in scope for HDEC review by completing the screening sections of the HDEC form. Proceed to the next step if it is in scope. If not, submit an application to the Auckland Health Research Ethics Committee (AHREC).
  • Prior to submission of the HDEC form, University staff and students must complete the University’s ‘Pre-submission approval form’ (signed off by the academic head) and request sponsor authorisation (signed by the Ethics team).

HDEC application submission process for University staff and students

Prior to submission of your ethics application to HDEC, you should complete the key activities outlined below and request/obtain the required authorisations.

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 introduce additional risk to the University, e.g. through inadequate insurance for a study.

1. Confirm the role of the co-ordinating investigator (CI)

  • Applications for HDEC review of new applications and substantial amendments must be submitted or authorised by the co-ordinating 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. Complete the HDEC form and add sponsor information, but do not submit it yet

Add the University as local sponsor in question H5 – Local Sponsor of the HDEC form (see the definition of “Sponsor” below)

Organisation: The University of Auckland

Email address: humanethics@auckland.ac.nz

  • The University of Auckland should be listed on the HDEC form as a ‘sponsor’ if you are a staff member or student of the University, regardless of whether the study is for a commercial company or led by a different institution.
  • Authorisation can be requested from more than one sponsor, as relevant.
  • Once completed, save a PDF copy of the HDEC form to attach to the University’s pre-submission approval form: click on the “View as PDF” button on the left-hand menu.

4. Complete the University’s Ethics RM ‘Pre-Submission Approval for HDEC Applications’ form

Note: Sponsor authorisation cannot be granted without academic head approval.

5. Academic head approval scope

In approving submission of the application to HDEC, the academic head's 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 the faculty/LSRI if they have any concerns about the level of reputational risk
  • Confirmation that they are satisfied that adequate consideration of insurance cover has been undertaken.
  • Approval that the resourcing (people/facilities/budget) is adequate in their department to carry out the study.

6. Request sponsor authorisation when submitting the HDEC application

  • Request authorisation by adding the humanethics@auckland.ac.nz email address on the submission page (sponsor’s declaration) - Please tick the box: Yes, my study requires authorisation from the sponsor now.

Note: The HDEC form currently only mentions sponsor authorisation for commercial sponsors, but this will be changed in the future and should be used for requesting University sponsor authorisation.

  • A request for sponsor authorisation will automatically be sent to the sponsor's email address when the HDEC form is submitted.

Additional information about sponsor authorisation:

  • University of Auckland sponsor authorisation has been delegated to the Ethics team. The Ethics team keeps a record of HDEC, AHREC and UAHPEC applications submitted by University staff and students and reports them to the Risk Office, which is responsible for ensuring that adequate insurance cover for researchers and study participants is in place.
  • If the study has been initiated by or is for the benefit of a commercial organisation (e.g. a pharmaceutical company), sponsor authorisation should be requested from both the University (as host) and the commercial organisation.
  • More than one sponsor can be nominated if the study is supported by more than one institution/company, 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 HDEC studies of all University staff and students. The term “sponsor” does not mean “funder” in this instance.

7. Share the HDEC application with the Ethics team

To enable the Ethics Team to access HDEC applications, the application will need to be shared:

  • 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"

8. 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 (head of school/department, etc.) or their delegate.
  • If Te Whatu Ora, Health New Zealand, patients, facilities or staff are involved in the study, you should contact the relevant district's research office to obtain locality approval, including for audits where the researcher needs permission from Te Whatu Ora to access their data.

For more information about the research process in Te Whatu Ora districts:

Auckland or email researchoffice@adhb.govt.nz

Auckland (South and East) or email researchoffice@middlemore.co.nz

Waitematā or email research@waitematadhb.govt.nz

Waikato or email research@waikatodhb.health.nz

Contact

Head of Research Ethics
Email: Dr Dana Wensley

Human Ethics Manager
Email: Dr Madhavi Manchi

Research Ethics and Regulatory Co-ordinator
Email: Fiona Cheal

Human ethics enquiries
Email: humanethics@auckland.ac.nz

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