Follow-up system-level oversight and governance of informed consent in healthcare
SPENCER JONES made this Official Information request to Ministry of Health
Currently waiting for a response from Ministry of Health, they must respond promptly and normally no later than (details and exceptions).
From: SPENCER JONES
Dear Ministry of Health,
Subject: Follow-up request – system-level oversight and governance of informed consent in healthcare
Kia ora,
Thank you for your response dated 12 March 2026 (Ref: H2026078575) regarding responsibility for assuring informed consent requirements in relation to medicines regulation, immunisation programmes, and population-level use of medicines.
Your response indicates that accountability is distributed across clinicians, professional regulators, the Health and Disability Commissioner, and healthcare providers, and that the Ministry is not aware of any agency with formal responsibility for reviewing or assuring consent adequacy at a system level.
To better understand how this governance model operates in practice, I request the following information under the Official Information Act 1982.
1. Policy analysis or risk assessments
Please provide any policy advice, briefing papers, reports, or risk assessments since 2000 that discuss:
- the governance of informed consent across the health system;
- whether system-level monitoring or assurance of consent practices should exist; or
- risks arising from distributed responsibility for consent oversight.
2. Inter-agency discussions
Please provide any documents, correspondence, or meeting records involving the Ministry of Health, Health NZ, the Health and Disability Commissioner, or professional regulators that discuss:
- system-level monitoring of informed consent practices;
- governance or oversight of consent in national health programmes (including immunisation programmes); or
- gaps in accountability for informed consent compliance.
3. Audits or evaluations
Please provide any audits, evaluations, or reviews conducted or commissioned by the Ministry since 2000 that assess:
- whether informed consent practices are being applied consistently across the health system; or
- whether systemic risks exist in relation to consent practices.
4. Cabinet or Ministerial advice
Please provide any Cabinet papers, Ministerial briefings, or regulatory impact analyses that consider:
- oversight or governance arrangements for informed consent within the health system; or
- proposals to establish or consider a formal consent-assurance function.
5. Consideration of governance models
If no such documents exist, please confirm whether the Ministry has ever formally examined the implications of the distributed accountability model described in the response of 12 March 2026.
If any part of this request would require substantial collation or research, I would welcome assistance under section 13 of the Act to refine the request.
Kind regards,
Spencer Jones
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SPENCER JONES left an annotation ()
Following the Ministry’s response of 12 March 2026 (Ref: H2026078575), I have submitted a follow-up Official Information Act request to better understand the governance structure for informed consent in relation to medicines regulation, vaccination programmes, and population-level use of medicines.
The Ministry’s response indicates that responsibility for informed consent is effectively distributed across multiple actors, including the Health and Disability Commissioner (which enforces the Code of Health and Disability Services Consumers’ Rights), individual clinicians, professional regulators such as the Medical Council of New Zealand, and healthcare providers through their own clinical governance arrangements.
However, the response also states that the Ministry is not aware of any agency with formal responsibility for reviewing or assuring consent adequacy at a system level, and that it is not aware of any agency considering establishing a formal consent-assurance or consent-governance function.
This raises an important governance question: if responsibility is distributed across several actors, which organisation—if any—is responsible for identifying system-wide risks or monitoring whether consent practices meet legal and ethical standards across the health system as a whole?
The follow-up OIA request therefore seeks any policy advice, briefing papers, risk assessments, audits, or inter-agency discussions that may have examined this issue.
This request connects to several other OIA requests on related topics, including requests concerning consent processes, vaccination governance, and regulatory oversight of medicines and public health programmes. Taken together, these requests aim to map how consent governance is structured across the health system.
From a research perspective, the follow-up request is particularly useful because it will likely reveal one of three outcomes:
1. Internal policy or risk-assessment documents exist that discuss potential governance gaps or system-level oversight of informed consent.
2. The issue has never been formally analysed within government policy advice.
3. Responsibility for system-level oversight sits with an organisation that has not yet been clearly identified in public documentation.
All three outcomes provide valuable information for researchers examining health governance and accountability structures.
Future readers of this thread may therefore find it useful to review the related OIA requests linked above in order to understand how informed consent oversight operates across different parts of the New Zealand health system.
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