Ethical Review Process

What Research Requires Ethical Review

Health and disability research that involves human participants (whether health or disability support services consumers, healthy volunteers or members of the community at large) must be submitted for ethical review where the research:

• compares an established procedure with other procedures that are not regarded as established
• involves access to personal information for purposes other than direct consumer care or clinical audit
• seeks to further scientific or professional knowledge by means of questionnaires, interviews or other techniques of information gathering, or by means of laboratory analysis of human blood or tissue from living people, cadavers, or discarded body tissue
• is conducted by a government department, except where a statutory exclusion applies (e.g. Statistics New Zealand)
• is observational research or a physiological study
• is a clinical trial
• involves the use of radiation, organ imaging or surgical technique
• involves innovative practice
• is a new treatment or intervention which uses pain or deprivation of basic food or drink as a means to change behaviours.
• is a study that requires ethics committee review, in accordance with the National Ethics Advisory Committee’s Ethical Guidelines for Observational Studies.

Observational studies

For further information on observational studies, refer to the Ethical Guidelines for Observational Studies: Observational Research, Audit and Related Activities (www.neac.health.govt.nz).

In most cases, ethical approval for research involving human participants will be required. However, this is not always the case. If you are in doubt as to whether your research requires ethical approval, you should either:

• contact the National Co-ordinator of Ethics Committees
• contact the Administrator of the health and disability ethics committee that would review your research if a review was necessary.

Assisted human reproduction

Research involving assisted human reproduction is reviewed by the Ethics Committee on Assisted Reproductive Technology (ECART) and should not be submitted to a health and disability ethics committee.

Page last updated: 13 December 2007