1. Overview 1
1.1 Introduction 1
1.1.1 The Treaty of Waitangi 1
1.1.2 Human ethics 1
1.1.3 Animal ethics 1
1.2 Health Research Council Ethics Committee (HRC EC) 1
1.2.1 Functions 2
1.2.2 Membership 2
1.3 National Ethics Advisory Committee (NEAC) 3
1.4 Ethics Committee on Assisted Reproductive Technology (ECART) 3
1.5 Health and Disability Ethics Committees (HDECs) 3
1.6 Approval by HRC EC 3
1.7 Approved ethics committees 4
1.7.1 Institutional ethics committees 4
1.7.2 Health and disability ethics committees 5
1.8 Resource documents relevant to research ethics 5
1.8.1 New Zealand Acts of Parliament 5
1.8.2 New Zealand guidelines, regulations and documents 5
2. Matters relating to ethical review 7
2.1 Principles for research involving human participants 7
2.1.1 Informed consent 7
2.1.2 Scientific design and conduct of the study 8
2.1.3 Risks and potential benefits 8
2.1.4 Selection of study population and recruitment of research participants 8
2.1.5 Payments for participation in research 9
2.1.6 Protection of research participants’ privacy and confidentiality 9
2.1.7 Cultural responsiveness 9
2.2 Research requiring ethics approval 10
2.3 Scope of ethics committee review 10
2.4 Special case HRC contracts 11
2.4.1 Preliminary work under an HRC contract 11
2.4.2 Research contracts 11
2.4.3 Career development contracts (CDAs) 11
2.5 How to obtain ethics approval 11
2.5.1 Application to an approved ethics committee 12
2.5.2 Locality authorisation 12
2.5.3 Ethics committee decision 12
2.6 Retrospective approval 13
2.7 Reviews of decisions by ethics committees 13
2.7.1 Reconsideration 13
2.7.2 Review by HRC EC (Second opinion) 13
2.7.3 Appeal 13
2.8 Complaints 15
2.9 Independent Comment 15
3. Use of a new medicine 17
3.2 Clinical trials 17
A useful human research ethics reference produced by the HRC (New Zealand).
3.2.2 Genetic Technology Advisory Committee (GTAC) 18
3.3 Observational studies 18
3.4 Social, community-based, public health or health services interventions 19
3.5 Surveys of the general population 19
3.6 Collection and use of human materials 20
3.7 Research involving children 20
3.8 Research involving personal health information 20
3.9 Research involving Māori 20
3.10 International collaborations 21
3.11 Research undertaken at an overseas location 21
3.12 Genetic modification 21
3.13 In vivo human gene manipulation proposals 22
3.14 The choice of diseases for clinical therapy or research 22
3.15 Research involving use of placebos 23
3.16 Research involving animals or animal materials 24
4. General legal issues in research 25
4.1 Intellectual property rights 25
4.2 Copyright 25
4.3 Conflict of interest 25
4.4 Scientific misconduct 26
4.5 Compensation for injuries suffered by participants in research 26
4.6 Civil liability 26
4.7 Practicing certificates for ethics committee members 27
