NEAC published revised ethical guidelines for health and disability research in New Zealand to align with the Ministry of Health’s new procedural rules for health and disability ethics committees (www.ethics.health.govt.nz).:

• Ethical Guidelines for Intervention Studies (2012) (doc 356 KB), and
• Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities (2012) (doc, 188 KB).

These guidelines set out the established ethical standards that all researchers must meet when undertaking health and disability research, whether or not that research requires health and disability ethics committee review.
These guidelines are also of use to ethics committees, research sponsors and for training and educating researchers.

NEAC’s review did not fundamentally change the existing ethical standards set out in these guidelines. A more comprehensive review of the guidelines is planned for 2015.

The revised guidelines were subject to a targeted consultation in May to June 2012 and NEAC is grateful to all those that submitted comments.

What has changed in the guidelines?

The main changes to these guidelines include:

• Increased emphasis of the importance of peer review to help optimise scientific validity and additional advice about the features of a robust peer review process.
• Additional advice about research that involves particular vulnerable populations and strengthened definition of ‘vulnerable people’ in research.
• Additional advice to help researchers determine the features of observational research that may present more than minimal risk to participants and therefore require health and disability ethics committee review.
• Removal of advice about locality assessment from the observational guidelines as this is covered by the procedural rules for health and disability ethics committees.
• Additional advice that researchers should be familiar with relevant sources of international and domestic ethical guidance, including guidelines relating to research involving Māori.
• Commitment to a full review of the guidelines by the end of 2015.