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Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities

Date of publication: Dec 2006

The National Ethics Advisory Committee (NEAC) has developed guidelines on conducting observational studies in an ethical manner that are intended to facilitate high quality studies, protect the interests of participants, and underpin public assurance of good study conduct. The guidelines are available below, along with a two-page summary guidance sheet for easy reference.

Observational studies give us the evidence we need to tell whether our services are of high quality and environments are safe. Use of these Ethical Guidelines for Observational Studies (“Guidelines”) will help ensure that these studies meet high ethical standards and generate benefits for the sector and wider communities in terms of:

gains in the safety and quality of services, programmes, and environments
getting observational studies, and thereby also quality and safety, further built into health and disability sector culture and routines
providing assurance to the public on these matters.

The Guidelines base their requirements for ethical review on the principle that intensity of ethical scrutiny should be proportional to the level of risk of the activity. On this basis, the Guidelines state that: observational research requires ethics committee review; audits and related activities do not require ethics committee review unless there is a specific requirement for this; and, public health investigations do not require ethics committee review.

Document availability

This publication is available in PDF format.

Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities (PDF, 262 KB)

Summary Guidance Sheet: Observational Studies and Ethics Committee Review (PDF, 140 KB)

If you would like to order a hard copy of the guidelines please email moh@wickliffe.co.nz or call 04 496 2277 quoting HP number 4217. Please let us know your name, your physical address and how many copies you would like.

Related information

Media release from the Minister of Health

The New Zealand Health and Disability Ethics Committees website has information and advice on the ethical review of observational studies, application forms, and contact details for ethics committees

Useful links
The Health Research Council

National Ethics Advisory Committee

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Resources

Publications

Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities