Good Clinical Practice: A Question & Answer Reference Guide - May 2017 - 716

GCP: A Question & Answer Reference Guide
in residence while the clinical trial medicines are administered." As of 2 December 2016, seventy-two (72) sites
were certified according to a list posted at http://www.medsafe.govt.nz/regulatory/CSSites.htm/ (last searched
February 2017 - please note that one hospital can have multiple sites).
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Q. Do clinical trials with medical devices need regulatory approval in New Zealand?

A. No, Medsafe does neither regulate nor approve clinical trials for medical devices, but Medsafe does request
to be informed by email on such trials (via DART@moh.govt.nz). However, an HDEC needs to approve the trial,
except for studies involving a device there is (or would be) classified as a low-risk (class I) by the Australia's TGA
('Australian regulatory guidelines for medical devices' page 77 ff, please refer to the Q&As for Australia).
In addition Medsafe recommends organizations planning to conduct medical device clinical trials in NZ "to
familiarize themselves with the 'Part 11 Guideline' and ISO 14155:2011 and ensure compliance with such
guidance".
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Q. What is the age of majority in New Zealand?

A. According to the 'Age of Majority Act 1970 No 137' (of September 2007) "for all the purposes of the law of
New Zealand a person shall attain full age on attaining the age of 20 years."
Regarding children's consent to treatment and research the NEAC's 'Ethical Guidelines for Intervention
Studies,' Appendix 2 states that "legally valid consent should be obtained from the child, parent or guardian as
appropriate:
* "The consent of a child of and over the age of 16 must be obtained, and has the effect as if the child were of
full age;
* If the child is below the age of 16, but has the competence to understand the nature, risks and consequences
of the research: The consent of the child must be obtained, which has the same effect as if the child were of
full age;
* If the child is below the age of 16, and lacks the necessary competence to give legally effective consent:
* The child's parent or legal guardian must give permission for the child's participation
* The child's assent must be obtained unless the child is unable to communicate
* The refusal of a child to participate in research must be respected unless, according to the research protocol,
the child would receive therapy for which there is no medically acceptable alternative.
* "Care must be taken to ensure that no pressure is placed upon a child to consent to participate in research,
especially if the procedures are not intended to be of direct benefit to the child participant.
* "The requirement for written consent should take into consideration the age and competence of the child."
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Q. Are there any specific requirements regarding the membership and composition of Ethics Committees
in NZ?

A. Yes. Over and above the minimum requirements of ICH GCP according to the 'HRC Guidelines for approval of
Ethics Committees' and 'SOPs for HDECs' the following requirements applies:
* The EC should have a lay person (with no primary background in health research and no affiliation to the
institution or organisation responsible for the committee), and a non-lay Deputy Chairperson;
* The membership requirements must be "fit for purpose," including members with experience and expertise in:
* awareness of te reo Māori and the understanding of tikanga Māori,
* ethical and moral reasoning,
* law,
* the perspectives of wider community,
* the design and conduct of intervention studies,
* the design and conduct of observational studies,
* the provision of health and disability services,
* the perspectives of student community.
A member can fall into more than one of the above categories;
* There should be a balance of Māori, gender, lay versus non-lay, and other cultural considerations, in this order
of priority;

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Table of Contents for the Digital Edition of Good Clinical Practice: A Question & Answer Reference Guide - May 2017
