New Zealand Health and Disability Ethics Committees


 
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Ethical Review Process

Other Review that May be Required


Some research may require review from a different committee or require additional review.

Research and innovative treatment involving assisted human reproduction


If your application is for research or innovative treatment involving assisted human reproduction, you will need to apply for ethical approval from the Ethics Committee on Assisted Reproductive Technology (www.ecart.health.govt.nz). In this case, your research will not also need to be reviewed by a health and disability ethics committee.

Manipulation of human genetic material


If your application is for research involving the manipulation of human genetic material, as in gene therapy, you will need to apply for approval from the Gene Technology Advisory Committee (GTAC) (www.hrc.govt.nz) of the Health Research Council.

Research involving a clinical trial of a pre-registration medicine


If your application is for research involving a clinical trial of a pre-registration medicine, you will need to apply to the Standing Committee on Therapeutic Trials (SCOTT) (www.hrc.govt.nz) of the Health Research Council.

SCOTT is a committee of the Health Research Council. It is convened to provide recommendations to the Director-General of Health on the scientific validity of applications for clinical trials on new medicines. All clinical trials involving pre-registration medicines will need the approval of SCOTT to proceed.

Section 30 of the Medicines Act 1981 empowers the Director-General of Health, on the advice of the HRC, to permit the use of medicines that have not received marketing consent to be used in clinical trials for the purpose of obtaining clinical and scientific information.

Trials involving post-registration medicines do not need the approval of SCOTT, but will still need to undergo the ethical review process.

Page last updated: 13 December 2007