New Zealand Health and Disability Ethics Committees


 
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How to Apply for Ethical Review

How to Apply for Ethical Review


Choosing the correct health and disability committee to submit your research application


Research that is to be conducted entirely within the boundaries of the Northland, Waitemata, Auckland, Counties-Manukau, Waikato, Lakes, Bay of Plenty and Tairawhiti district health boards should be submitted to the Northern X or Northern Y Regional Ethics Committee.

Research that is to be conducted entirely within the boundaries of the Taranaki, Whanganui, Hawke's Bay, Midcentral, Wairarapa, Hutt and Capital & Coast district health boards should be submitted to the Central Regional Ethics Committee.

Research that is to be conducted entirely within the boundaries of the Nelson-Marlborough, West Coast, Canterbury and South Canterbury district health boards should be submitted to the Upper South A or Upper South B Regional Ethics Committee.

Research that is to be carried out entirely within the boundaries of the Otago and Southland district health boards should be submitted to the Lower South Regional Ethics Committee.

Research that is to be carried out in more than one of these regions should be submitted to the Multi-region Ethics Committee.

In the Northern or Upper South Regions, there are two committees for the region. Both committees review all types of applications. Applications should be submitted to the Committee with the next available agenda closing date. Applications received when an agenda is full but prior to the agenda closing date will be placed on the next available committee agenda within the same region.
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Studies involving more than one site


If a study is to be conducted at a number of sites, all of which are within the jurisdiction of a single regional ethics committee, the application should be sent to that committee.

For instance, an application involving research at Auckland Hospital, Middlemore Hospital, Waikato Hospital and Tauranga Hospital should be sent to the Northern Regional Ethics Committees.

If a proposal involves any study locality outside the jurisdiction of a given regional ethics committee, that committee cannot review the proposal. Studies with sites in more than one ethics committee region are reviewed by the Multi-region Ethics Committee.

If you are unsure which committee you should send your research proposal to, you should contact the National Co-ordinator.
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Number of application copies to be submitted


The following is required:
  • 13 copies (including the original) of the application form.
  • 13 copies of the information sheet and consent form.
  • 13 copies of any other information eg. data collection sheets, questionnaires.

The above must be collated behind the application copies, not collated separately. Where there is more than one site, forward one copy of each site information sheet/consent form with the original copy of the application form, and one copy of only the main site information sheet/consent form collated with each copy of the application form.
  • 2 copies of any protocols
  • 2 copies of any investigator brochures

If there is a very large document eg. a large questionnaire, only 2 copies need to be submitted.

Use the Guidelines checklist to ensure the application is complete and ensure that the information sheet/consent form and any other appendices are at the back of each copy – not separately collated.
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Committee meeting dates


The meeting dates and agenda closing datesof each committee are publicised on this website.

Researchers’ attendance at meetings


Researchers may attend the meeting in person or by teleconference. They may be asked to leave the meeting when the Committee makes its decision on the proposal.

Researchers should contact the administrator if they wish to attend.
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Process of ethical review


Committee Administrators, who prepare meeting agendas and papers and circulate them to committee members, will receive the application. Administrators check that applications are filled out correctly and accompanied by all relevant additional documentation.

If there is a problem with the application, the Administrator will contact the researcher as soon as possible. Otherwise, the application will be added to the agenda for the next available committee meeting.

Once a health and disability ethics committee has considered your application, it can make one of four decisions on it. It can approve the research straight away, in which case the research can proceed, or it can approve subject to conditions that must be met before final ethical approval is given. Research must not commence until final ethical approval is given.

In rare circumstances a health and disability ethics committee may decline an application, stating its reasons for doing so. A health and disability ethics committee may also defer consideration of an application where it states its reasons for doing so. Deferring consideration will usually mean that the application will be considered at the next meeting of the committee.

Researchers will be informed of the outcome of the committee's consideration of their application. If the decision of the committee is to decline, the researcher may wish to access the complaint or second opinion processes.

Health and disability ethics committees weigh the following principles when considering research applications.
  • Respect for persons
  • Informed consent
  • Privacy and confidentiality
  • Validity of research proposal
  • Minimisation of harm
  • Justice
  • Cultural and social responsibility
  • Compensation for research participants
  • Respect for tikanga Maori and other cultures.

A chart summarising the process of ethical review described below is also available.
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Notification of the Committee’s decision


Researchers will receive notification of the Committee's decision within 7-10 days of the meeting at which their application is discussed.

The decision on the application will not be available informally from the committee Administrator prior to this.

Locality Assessment


Locality assessment is a separate process to ethical review. However, an ethics committee must ensure that locality assessment has been carried out before final ethical approval is given to a study.

Ethical review asks: ‘Does this proposed study meet generally accepted ethical standards?'

Locality assessment asks: ‘Given that this research would meet established ethical standards, is this particular locality and local researcher satisfactory?'
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Locality organisations


In most cases, locality assessment of a study is undertaken by the organisation(s) where the study will take place – for example DHBs, PHOs, iwi service providers, disability organisations. These are called locality organisations.

The locality organisation of a study is not necessarily the same as the investigator's employer organisation, or the study's funder or sponsor organization.

In some circumstances – for instance, where there is no locality organisation – the ethics committee that reviews the application will carry out locality assessment.

Locality issues


Locality assessment asks the following questions.
  • Is the investigator's local role in the study appropriate?
  • Have the resources (other than funding, which often depends on ethics committee approval) and/or facilities that the study requires locally been identified? Are they appropriate and available?
  • Has the investigator identified and satisfactorily addressed any cultural or other issues specific to this locality, or to participants for whom study recruitment or participation is primarily at this locality?
  • Has the investigator included the key local contact details in the Information Sheet for participants?


Page last updated: 13 December 2007
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