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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

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 Subject :Ethical Guidelines for Intervention Studies in New Zealand.. 2009-11-30 18:28:34 
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NEAC has developed guidelines on conducting intervention studies that aim to contribute to better health outcomes for New Zealanders by further developing best practice in intervention studies.

In an intervention study, an investigator intervenes to prevent, diagnose or treat illness or disease, and also studies the effects of the intervention for its safety and/or benefit. A clinical trial of a new blood pressure medicine is an example of an intervention study.

The evidence that intervention studies provide is a fundamental driver of innovation, patient safety and improved care so healthcare organizations should welcome the conduct of well-designed intervention studies. Intervention studies also have the potential both to benefit and to harm participants, so it is important that they are scientifically and ethically sound.

These Guidelines aim to help investigators to think through and address the ethical issues in their studies. They bring together in one document, and build on, the best current national and international guidance on intervention studies. The Guidelines also aim to assist ethics committees, study sponsors, organisations that host research and others with an interest in intervention studies. They also address New Zealand-specific issues (eg, compensation for injury).

Document availability

Ethical Guidelines for Intervention Studies
If you would like a hard copy of this publication please email neac@moh.govt.nz

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