compliance cultural safety NZ, SOP for ethics governance Māori consultation, SOP for consent cultural adaptation NZ, SOP for inspection readiness cultural aspects, SOP for trial subject protection Māori NZ, SOP for cultural approval documentation NZ, SOP for ethics cultural competency NZ, SOP for protocol amendments cultural considerations NZ, SOP for cultural training research staff NZ”,
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Published on 21/12/2025

Māori Consultation and Cultural Safety in Trial Design and Consent SOP

Department	Clinical Research
SOP No.	CS/NZ-HDEC/201/2025
Supersedes	N.A.
Page No.	1 of 22
Issue Date	28/08/2025
Effective Date	05/09/2025
Review Date	05/09/2027

Purpose

The purpose of this SOP is to define procedures for engaging in Māori consultation and ensuring cultural safety in trial design and informed consent processes in New Zealand. It ensures respect for indigenous rights, cultural protocols, and compliance with Health and Disability Ethics Committees (HDEC) and GCP requirements.

Scope

This SOP applies to all clinical trials in New Zealand where Māori consultation is required. It covers early engagement with iwi (tribal) representatives, cultural safety reviews, translation and adaptation of participant information, and ethical oversight of informed consent. It applies to sponsors, investigators, CROs, and cultural advisors.

Responsibilities

• Sponsor: Initiates Māori consultation during trial design and ensures cultural considerations are embedded.
• Principal Investigator (PI): Engages with local Māori communities and ensures informed consent reflects cultural needs.
• Regulatory Affairs (RA): Includes consultation evidence in submissions to HDEC.
• Cultural Advisor: Provides expert review of consent forms and patient information materials for cultural appropriateness.
• Quality Assurance (QA): Audits cultural consultation documentation and ensures compliance with HDEC guidance.

Accountability

The sponsor’s Clinical Operations Lead is accountable for initiating Māori consultation. The PI is accountable for ensuring cultural safety practices are observed at the site level.

Procedure

1. Early Engagement

1. Identify Māori groups relevant to the trial’s geographic and therapeutic scope.
2. Engage iwi representatives at trial planning stage.
3. Document outcomes of engagement in Consultation Log (Annexure-1).

2. Trial Design Considerations

1. Ensure cultural safety is reflected in recruitment strategies.
2. Adapt participant information sheets (PIS) and consent forms for cultural relevance.

3. Informed Consent Process

1. Ensure consent discussions are culturally appropriate, allowing whānau involvement.
2. Offer translated or culturally adapted versions of ICF/PIS.

4. Documentation and Ethics Submission

1. Include evidence of Māori consultation in ethics submissions to HDEC.
2. Maintain acknowledgment from iwi representatives where applicable.

5. Monitoring and Audits

1. QA team verifies that cultural safety processes are implemented and documented.
2. CAPA actions must be initiated if gaps are identified.

Abbreviations

• HDEC: Health and Disability Ethics Committees
• PIS: Patient Information Sheet
• ICF: Informed Consent Form
• PI: Principal Investigator
• RA: Regulatory Affairs
• QA: Quality Assurance
• CRO: Contract Research Organization
• CAPA: Corrective and Preventive Action
• Iwi: Tribal group in New Zealand
• Whānau: Extended family network

Documents

1. Consultation Log (Annexure-1)
2. Cultural Review Log (Annexure-2)
3. Informed Consent Adaptation Log (Annexure-3)

References

• New Zealand Health and Disability Ethics Committees (HDEC)
• ICH E6(R2) Good Clinical Practice
• WHO Clinical Trial Standards

Version: 1.0

Approval

Prepared By	Checked By	Approved By
Name: Rajesh Kumar Date: 20/08/2025 Signature: __________	Name: Sunita Reddy Date: 22/08/2025 Signature: __________	Name: Dr. Meera Iyer Date: 28/08/2025 Signature: __________

Annexures

Annexure-1: Consultation Log

Date	Iwi Group	Discussion Outcome	Representative
05/08/2025	Ngāti Whātua	Supportive of trial subject engagement	Hemi Raukawa

Annexure-2: Cultural Review Log

Date	Document	Reviewer	Comments
10/08/2025	PIS v1.0	Maria Te Rangi	Recommended whānau inclusion statement

Annexure-3: Informed Consent Adaptation Log

Date	ICF Version	Adaptation	Approved By
12/08/2025	v1.1	Added cultural guidance paragraph	PI

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for Māori consultation and cultural safety in trial design and consent.	New SOP created for New Zealand cultural and ethical compliance.	Head of Clinical Research

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