Health and Disability Research (HDEC)
This page contains the sections:
- What is health and disability research?
- What are Health and Disability Research Committees?
- Does my research require HDEC review?
- How do I apply for ethics approval from an HDEC?
- How do I request authorisation from The University of Auckland?
- Will I still need to submit Form A or Form B for clinical trial applications?
- Which HDEC will my application go to?
- Human Ethics contacts
What is health and disability research?
According to the Standard Operating Procedures for Health and Disability Committees (August 2014), issued by the Ministry of Health, health and disability research is research which aims to generate knowledge for the purpose of improving health and independence outcomes.
There are two main types of health and disability research: intervention studies and observational studies.
For the purpose of the Health and Disability Ethics Committees (HDECs), health and disability research does not include research that creates or uses a human gamete, human embryo or hybrid embryo. Such ‘human reproductive research’ needs to be approved by the Ethics Committee on Assisted Reproductive Technology (ECART).
What are Health and Disability Research Committees?
Health and Disability Ethics Committees (HDECs) are Ministerial committees which were established under Section 11 of the New Zealand Public Health and Disability Act. The function of these committees is to secure the benefits of health and disability research by ensuring that such research meets established ethical standards. For example, HDECS provide protection for participants in research in the health and disability sector.
Currently there are four regional HDECs: Northern A, Northern B, Central and Southern.
The online HDEC application system allows researchers to select review by the HDEC nearest to them or to submit their application to the next available HDEC meeting (which may or may not be the nearest committee).
View details of HDEC meetings.
Does my research require HDEC review?
HDECs provide protection for participants in research in the health and disability sector. However, not all health and disability research requires review by a HDEC. Research is likely to require HDEC review if it involves one or more of the following:
- Human participants recruited in their capacity as:
- Consumers of health or disability support services, or
- Relatives or caregivers of consumers of health or disability support services, or
- Volunteers in clinical trials
- The use, collection or storage of human tissue (as defined by the Human Tissue Act 2008), unless:
- informed consent has been obtained for such use and tissue will not be made available to researchers in a form that could reasonably be expected to identify the individual(s) concerned, or
- one or more of the statutory exceptions to the need to gain informed consent (ref section 20(f) of the Human Tissue Act 2008 (or Right 7(10)(c) of the Code of Health and Disability Services Consumer’s Rights 1996) applies.
- The use or disclosure of health information (as defined by the Health Information Privacy Code 1994), unless:
- this use or disclosure has been authorised by the individuals concerned, or
- health information will not be disclosed to researchers in a form that:
- could identify, or could reasonably be expected to identify, the individuals concerned, or
- would allow for the information to be matched with other data sets.
Exemptions to the main criteria
Your study may be exempt from HDEC review if it falls into one of the following categories:
- Minimal-risk observational studies
- Audits and related activities
- Student-led research
- Studies on low-risk devices.
Regardless of the exemptions listed above, a research project requires HDEC review if it:
- Involves the use of human tissue samples taken as part of New Zealand’s Newborn Metabolic Screening Programme (‘Guthrie cards’), or
- Is funded by the Health Research Council and is not able to be reviewed by an HRC-approved institutional ethics committee, or
- Involves the establishment or maintenance of a tissue bank.
In order to establish whether or not your research requires HDEC review:
- Refer to the Standard Operating Procedures for Health and Disability Ethics Committees. A full explanation of the scope of HDEC review is contained in Section 3 of the Standard Operating Procedures (SOPs).
- Work through the Does your study require HDEC review? flowchart
- Complete the HDEC Scope of Review Form and email the completed form to: email@example.com
- If you are still unsure whether your research requires HDEC review please contact HDEC for further advice.
Research outside the scope of HDEC review
All Human Health research at the University of Auckland which falls outside of the scope for HDEC review should be directed to the Auckland Health Research Ethics Committee (AHREC) for ethics approval. If District Health Board patients, facilities or staff are involved in the study you should contact the DHB research office; this includes audits where the researcher needs permission from a DHB to access their data. Information about obtaining approval for Auckland DHB and Counties Manukau DHB (CM Health) is available on the AHREC Ethics RM form or in the AHREC Applicants’ Manual. For all other DHBs, the respective Research Office should be contacted.
For more information about the research process in DHBs:
How do I apply for ethics approval from an HDEC?
- 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
- Confirm adequate insurance cover is in place for your study – please see page 2 – Insurance for Human Health Research in Human Health Research Decision Tree: HDEC Application – Key Pre-Submission Activities
- Confirm if any of your research is being conducted overseas – if it is, please contact the Risk Office.
- Confirm if SCOTT or GTAC review is required – see Human Health Research Decision Tree: HDEC Application – Key Pre-Submission Activities for more details
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:
- Organisation: The University of Auckland
- Department: Ethics and Integrity
- Email address: firstname.lastname@example.org
- 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.
Will I still need to submit Form A or Form B for clinical trial applications?
No, these forms have not been required by HDEC since 1 July 2012. Your answers to questions in the new online form will allow the HDECs to determine whether or not ACC cover may be available for participants in your study.
Which HDEC will my application go to?
Where an application will be reviewed by the full review pathway, the applicant may indicate that they would prefer their application to go to the geographically closest HDEC. Where this preference is not indicated, the application will be allocated to the next available HDEC meeting.