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New ethical guidelines being released

21 December 2006

New ethical guidelines being released

New ethical guidelines for researchers doing observational studies will improve safety and quality in the health system, Health Minister Pete Hodgson said today.

The Ethical Guidelines for Observational Studies have been prepared by the National Ethics Advisory Committee (NEAC), an independent advisor to the

"Observational studies give us vital evidence about our health and how best to protect and improve it. This means they need to be a routine part of doing things safely and well. These studies use personal information for the public and it is essential that they meet high ethical standards," Pete Hodgson said.

In an observational study, investigators look at health information but do not change participants' healthcare. They include audits, public health investigations, and epidemiological research. They contrast with intervention studies, where someone's care is changed, for example in a clinical trial of a new medicine.

Reasons to do observational studies include finding the source of a disease outbreak such as food poisoning and assessing the safety of a health service such as a cancer screening programme.

The new guidelines have a wide scope and are designed for investigators working out how best to conduct a study. They also state whether the different
kinds of observational studies need to be reviewed by an ethics committee.

NEAC developed the guidelines through a public consultation process that included a questionnaire for ethics committee members and researchers, two discussion documents, interviews, workshops and an independent peer review.

"The quality of the guidelines reflects the many improvements suggested by stakeholders along the way."

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