Guides, templates and forms

Guidance for completing your application for HDEC review, templates, legislation, and regulations.

User guides for the ETHICS RM website

• These will be available in due course

Updated application and post approval forms

• HDEC Application [PDF, 6.1 MB]
• HDEC Amendment [PDF, 337 KB]
• HDEC Protocol Deviation [PDF, 211 KB]
• HDEC Progress Report [PDF, 769 KB]
• HDEC Conclusion of Study [PDF, 181 KB]
• HDEC Final Report [PDF, 560 KB]

Guides for HDEC review applications

• Cultural questions – guidance
• Scientific peer review submissions – guidance
• Tissue banks – guidance

Forms and templates

• Assent form instructions and checklist [DOC, 681 KB]
• Data and tissue management plan template [DOCX, 65 KB]
• Data-only management plan template [DOCX, 59 KB]
• Features of informed consent – checklist template [DOC, 475 KB]
• Future Unspecified Use of Tissue Participant Information Sheet Consent Form template [DOC, 70 KB]
• HDEC Tissue Bank Application form [DOCX, 202 KB]
• Model patient information sheet and assent form (for patients 7–11 years old) [DOCX, 3.7 MB]
• Optional information sheet and informed assent form for future scientific research (for patients aged 7–11 years) [DOCX, 5 MB]
• Optional patients aged 12–15 years information sheet and informed assent form for future scientific research [DOCX, 5 MB]
• Participant Information Sheet and Consent Form Template [DOC, 156 KB]
• Pregnancy Follow-up (Child) Information Sheet and Consent Form Template [DOCX, 46 KB]
• Partner Pregnancy Information Sheet and Consent Form Template [DOCX, 51 KB]
• Reproductive risks in participant information sheets template [DOCX, 24 KB]
• Scientific peer review template [DOCX, 327 KB]

Acts, ethical standards and regulations

• NZ Legislation website(external link)
• National Ethical Standards for Health and Disability Research and Quality Improvement(external link)
• Guideline on the Regulation of Therapeutic Products in New Zealand Part 11: Clinical trials – regulatory approval and good clinical practice requirement (pdf, 273 K - Medsafe.govt.nz)(external link)