Kia ora,

Under the Official Information Act 1982, I request copies of existing documents held by the Ministry of Health that describe how ethical oversight and informed-consent governance are addressed for public vaccination programmes, where those programmes are not conducted as research and are therefore outside the remit of Health and Disability Ethics Committees.

Specifically, please provide any documents (including but not limited to policies, guidance, briefing papers, legal interpretations, or internal frameworks) that address one or more of the following:

1. Governance responsibility
Documents that identify which body or bodies are responsible for ethical oversight of informed consent in the context of public vaccination programmes (as distinct from research studies).
2. Ethical framework outside HDEC scope
Any guidance or analysis explaining how ethical considerations are assessed, assured, or reviewed for vaccination programmes that do not require HDEC approval.
3. Interface with consent obligations
Documents describing how ethical considerations are integrated with informed-consent requirements under:
• the Code of Health and Disability Services Consumers’ Rights; and/or
• Medicines Act–related guidance or interpretations.
4. Reviews or acknowledgements of governance boundaries

Any internal reviews, gap analyses, or briefing material that discuss the absence of ethics-committee oversight for programme-based vaccination, or that explain how this is mitigated or addressed in practice.

This request is limited to existing information and does not seek the creation of new analysis or opinion.

If no documents are held that meet one or more parts of this request, please confirm that explicitly and identify which parts are affected.

If any portion of this request would be more appropriately held by another agency, please consider transfer under section 14 of the Act.

Kind regards,
Spencer Jones