Guides, templates & forms

On this page:

• User guides for the Online Forms website
• Guides for HDEC review applications
• Forms and templates
• Acts, standards, regulations

User guides for the Online Forms website

• Online Forms: application and files – guidance
• Online Forms: requests and approvals – guidance
• Online Forms User Manual (PDF, 5 MB)

Guides for HDEC review applications

• Cultural questions – guidance
• Potentially vulnerable study participants – guidance
  • Intellectual disability – guidance
  • Terminally ill participants – guidance
  • Younger participants – guidance
  • Older participants – guidance
  • Specific categories of healthy participants – guidance (students, employees,  prisoners)
  • Features of informed consent – checklist template (doc, 475 KB)
• Recruitment and advertising – guidance
• Submitting scientific peer review – guidance
• Use of health information and data – guidance (with/without consent)
  • Identifiability of data – guidance
• Use of human tissue – guidance
  • Future unspecified use of tissue – guidance
  • Tissue banking – guidance

Forms and templates

• Assent form instructions and checklist (doc, 681 KB)
• Future Unspecified Use of Tissue Participant Information Sheet Consent Form template (doc, 6.9 KB)
• HDEC Tissue Bank Application form (Word, 201 KB)
• Model patient information sheet and assent form (for patients 7–11 years old) (doc, 2.4 MB)
• Optional information sheet and informed assent form for future scientific research (for patients aged 7–11 years) (doc, 3.5 MB)
• Optional patients aged 12–15 years information sheet and informed assent form for future scientific research (doc, 3.5 MB)
• Participant Information Sheet and Consent Form Template (doc, 113 KB)
• Reproductive risks in participant information sheets template (docx, 19 KB)
• Scientific peer review template (doc, 341 KB)
• Scope of review form (docx, 222 KB)

Acts, ethical standards and regulations

• NZ Legislation website
• Ethical standards for health and disability research
  • Ethical Guidelines for Observational Studies
  • Ethical Guidelines for Intervention Studies
• 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)