Ethical Review in New Zealand

History

History of ethical review in New Zealand, including recent changes.

• Changes to the system of ethical review since 2001
• History of ethical review before 2001

Changes to the System of Ethical Review since 2001

Although ethical approval has been part of the New Zealand health research system since the 1950s, our current system of independent ethical review developed largely in response to the Cartwright Inquiry, which finished in 1988.

Further changes were made following the Gisborne Cervical Screening Inquiry (www.csi.org.nz), which recommended in 2001 that the National Ethics Advisory Committee (www.neac.health.govt.nz) review the current processes for ethical review of health and disability research in New Zealand.

Summary of changes that occurred in December 2004 following the review by the National Ethics Advisory Committee

'One study, one review'
All applications for research will be reviewed by just one ethics committee. Previously, some research required ethical review by up to thirteen ethics committees.

Number of ethics committees reduced
The number of ethics committees has been reduced from fifteen to seven.

Ethics committees established in law
The seven new ethics committees are established under section 11 of the New Zealand Public Health and Disability Act 2000.

Previously, ethics committees were merely established administratively by the Ministry of Health.

Appointments made by public process
All appointments and reappointments to ethics committees will now be made through the public appointments process, rather than by the committees themselves.

Reasons for changes
The primary role of all health and disability ethics committees will continue to be the protection of the rights, health and well-being of consumers and research participants and, in particular, those persons with diminished autonomy.

These changes were made to:

• ensure that research participants continue to be protected from the potential risks of research
• streamline the review of research applications
• provide statutory authority and a clear framework of public accountability for ethics committees.

'One study, one review'
The changes reflect the fact that there is one standard for ethical approval in New Zealand, and that only one review of an application is necessary in order to determine whether or not that application meets the standard.

Where previously national research had to be ethically approved by up to 13 different committees, a dedicated Multi-region Ethics Committee will now be responsible for ensuring that multi-region research is ethically sound.

This change will streamline the process of ethical review for multi-region studies, allowing well-designed research to go ahead without unnecessary delay and still providing for the protection of research participants.

Number of ethics committees reduced
Under the former system of ethical review, a large proportion of the workload of some ethics committees in smaller centres was taken up with reviewing multi-region and national studies.

As these will now be reviewed only once, by the Multi-region Ethics Committee, there was a need to re-evaluate the appropriate number of ethics committees for New Zealand.

Ethics committees established in law
Health and disability ethics committees are now established in statute, under the New Zealand Public Health and Disability Act 2000.

A statutory basis gives the committees a clear source of public authority in the exercise of their functions, as well as a clear line of accountability to Parliament.

Appointments made by public process
Members of ethics committees will now be appointed and reappointed through the transparent and rigorous public appointments process, which is designed to ensure the appointment of the best candidates.

History behind the changes
The changes to the system of ethical review of health and disability research are the result of a long process of review and improvement.

The changes were recommended by the National Ethics Advisory Committee, an independent advisory committee to the Minister of Health on ethical issues of national significance concerning health and disability, in a report to the Minister on 12 December 2003 - Review of the Current Processes for ethical Review of Health and Disability Research in New Zealand: Report to the Minister of Health (www.neac.govt.nz).

The National Ethics Advisory Committee was asked to address four matters related to New Zealand's system of ethical review as a result of the Gisborne Cervical Screening Inquiry.

This Inquiry was set up in 2000 to investigate the under-reporting of cervical smear abnormalities in the Gisborne region, and reported to the Government in 2001.

The four matters which the National Ethics Advisory Committee was asked to address involved:

• reviewing the operation of ethics committees and their impact on research in New Zealand
• reviewing the current processes for ethical review of national and multi-centre research
• considering the application of an appeal process
• developing guidelines on observational studies.

The changes that were made in December 2004 were a result of the National Ethics Advisory Committee's work on the first three of these matters.

Ethical Guidelines for Observational Studies: Observational Research, Audit and Related Activities (www.neac.health.govt.nz) were published in December 2006.

History of ethical review before 2001

Although ethical approval has been part of the New Zealand health research system since the 1950s, our current system of independent ethical review developed largely in response to the Inquiry into the Treatment of Cervical Cancer at National Women’s Hospital (Cartwright Inquiry). The Inquiry finished in 1988.

Read the history of ethical review in New Zealand until 2001 (Word, 44 KB).


Page last updated: 13 December 2007