Health and Disability Research
if you are planning a research project in the health and disability field, you may need to obtain approval from a Ministry of Health accredited Health and Disability Ethics Committee (HDEC).
- » 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?
- » How do I inform the Research Office of the outcome of the HDEC meeting and/or when my application has been approved?
- » Will I still need to submit Form A or Form B for clinical trial applications?
- » Which HDEC will my application go to?
What is health and disability research?
According to the Standard Operating Procedures for Health and Disability Committees (May 2012), 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 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 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 committee meeting (which may or may not be the nearest committee).
Details of HDEC meetings can be found here: http://ethics.health.govt.nz/about-committees/meeting-dates-venues-minutes
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. Your 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)
- The use or disclosure of health information (as defined by the Health Information Privacy Code).
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:
(i) Be guided by the information in this section.
(ii) 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).
(iii) Work through the ‘Does your study require HDEC review?’ flowchart which can be found here: http://ethics.health.govt.nz/applying-review
(iv) Work through the first 10 questions on the HDEC online form as these screen applications to see if HDEC review is necessary. However, please note this is only a guide: to be certain that your research does not require HDEC review, HDEC recommends submitting a full application.
(v) 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 research at The University of Auckland which falls outside of the scope for HDEC review should be directed to UAHPEC 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.
For more information about the research process in DHBs:
- Auckland DHB research office: http://www.adhb.govt.nz/researchoffice/
- Counties Manukau DHB: http://www.fmhs.auckland.ac.nz/som/sacs/research/process-cmdhb.aspx or contact Researchoffice@middlemore.co.nz
- Waitemata DHB: http://www.knowledgecentre.co.nz/ApprovalProcess/tabid/57/language/en-NZ/Default.aspx or contact email@example.com
- Waikato DHB: http://www.waikatodhb.govt.nz/page/pageid/2145847065/Research_approval_process or contact firstname.lastname@example.org.
How do I apply for ethics approval from an HDEC?
- Applications for HDEC review must be submitted through HDEC's ‘Online Forms’ website http://www.ethicsform.org/nz
- 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.
- The link to the HDEC application form and to the ‘Application process FAQs’ can be found at http://ethics.health.govt.nz/applying-review/how-do-i-apply
- HDEC applications require ‘sponsor authorisation’, ‘HOD Approval’ and ‘locality authorisation’, as explained below.
How do I request authorisation from The University of Auckland?
- Sponsor authorisation is required before submission of an application
- If you are a staff member or student of The University of Auckland, you must add The University of Auckland as sponsor (see below)
- 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 with the HDECs.
- At The University of Auckland, the authorisation is given by the Research Office and the following sponsor information must be added in question a.5.2:
- Organisation: The University of Auckland
- Department: Research Office
- Email address: email@example.com
- In addition, proof of HOD approval needs to be provided in order for the Research Office to authorise the research as a sponsor – see below.
- Once all questions in the Online Form have been completed and the proof of HOD approval has been uploaded, sponsor authorisation can be requested through the ‘Authorisations’ tab. An email will then be sent to the Research Office asking for authorisation.
- Please refer to pages 22 and 23 of the Online Forms User Manual for more instructions.
Sign off by Head of Department or School
Please obtain sign off from the Head of your Department/School using the Head of Department Approval form and attach the completed form to the online application. This form is required before the submission to HDEC can be authorised.
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.
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.
How do I inform the Research Office of the outcome of the HDEC meeting and/or when my application has been approved?
- In order for the RO to receive the outcome of the HDEC meeting and/or the approval letter for your application, the RO email needs to be added to your application. This is done by clicking on "My Project" on the left hand menu, selecting the Email notification tab, and adding the following email address: firstname.lastname@example.org in the required field. Please refer to pages 32 and 33 of the Online Forms User Manual for more instructions.
- If the email address is not added, please ensure that all communications that you receive from an HDEC about the application is sent to the RO by email.
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 will 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.