Follow-up system-level oversight and governance of informed consent in healthcare
SPENCER JONES made this Official Information request to Ministry of Health
The request was partially successful.
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
From: OIA Requests
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Kia ora Spencer
Thank you for your request under the Official Information Act 1982 (the
Act) on 12 March 2026 for:
“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."
We will endeavour to respond to your request as soon as possible and in
any event no later than 13 April 2026 being 20 working days after the day
your request was received. If we are unable to respond to your request by
then, we will notify you of an extension of that timeframe.
If you have any queries regarding your request, please feel free to
contact the OIA Services Team on [1][email address]. If any
additional factors come to light which are relevant to your request,
please do not hesitate to contact us so that these can be taken into
account.
Under section 28(3) of the Act, you have the right to ask the Ombudsman to
review any decisions made under this request. The Ombudsman may be
contacted by email at: [2][email address] or by calling 0800
802 602.
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|Ngâ mihi |
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OIA Services Team
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SPENCER JONES left an annotation ()
Annotation – System-Level Governance of Informed Consent in Healthcare (NZ)
This request sought clarification on which agency in New Zealand has system-level oversight responsibility for informed consent in healthcare, including whether any national body monitors compliance, governance structures, or systemic issues.
The response is useful because it highlights the distributed nature of responsibility for informed consent oversight in New Zealand.
In practice, oversight appears to be shared across several bodies, including:
• Te Whatu Ora / Health New Zealand – responsible for delivery of public health services and operational clinical governance within the health system.
• Manatū Hauora / Ministry of Health – responsible for health policy and stewardship of the system.
• Health and Disability Commissioner (HDC) – responsible for investigating complaints and enforcing the Code of Health and Disability Services Consumers’ Rights, which includes the right to informed consent.
• Professional regulatory bodies (such as the Medical Council, Nursing Council, and others) – responsible for professional standards and practitioner conduct.
This means that oversight of informed consent often occurs through complaint investigation, professional discipline, or organisational governance processes, rather than through a single central monitoring authority.
For researchers examining health governance and patient rights, this thread may therefore be relevant when considering:
• how informed consent obligations are monitored at a national level
• which agencies hold different parts of the oversight function
• whether there is any single entity responsible for system-wide monitoring of informed consent practices.
This thread may also be relevant when read alongside other OIA requests examining health system governance, advisory structures, and regulatory responsibilities across New Zealand agencies.
SPENCER JONES left an annotation ()
Investigator Annotation – System-Level Governance of Informed Consent in New Zealand
This thread is useful because it helps clarify a recurring governance question: who, if anyone, holds system-level oversight responsibility for informed consent across New Zealand healthcare?
1. Legal framework
In New Zealand, the core legal foundation for informed consent is the Code of Health and Disability Services Consumers’ Rights, especially Right 7, which provides that services may be provided only if the consumer makes an informed choice and gives informed consent, subject to limited exceptions. Right 7 also states that consumers are presumed competent unless there are reasonable grounds to believe otherwise, and the Code requires written consent in some higher-risk situations. 
A second important layer is the Health Practitioners Competence Assurance Act 2003 (HPCAA). That Act is aimed at protecting public health and safety through a regime for practitioner competence, fitness to practise, and professional accountability. It supports informed-consent governance indirectly through practitioner regulation, but it is not itself a single central monitoring statute for consent practice across the whole health system. 
Additional topic-specific consent frameworks also exist. For example, the Ministry of Health publishes consent guidance under the Human Tissue Act 2008, and ethics bodies publish informed-consent standards for research contexts. That means informed consent in New Zealand is governed through a layered framework: consumer rights law, practitioner regulation, service-provider governance, research ethics, and topic-specific legislation. 
2. Institutional oversight structure
The institutional picture appears fragmented rather than unified.
• The Health and Disability Commissioner (HDC) administers and enforces the Code of Rights, including the right to informed consent, primarily through complaints, investigations, advocacy, and systemic recommendations. 
• Health New Zealand / Te Whatu Ora and other providers are responsible for operational clinical governance, policies, and frontline consent processes within their own services.
• The Ministry of Health / Manatū Hauora holds a stewardship and policy role across the system, but does not appear to function as a single real-time auditor of informed-consent compliance across all providers.
• Professional regulators under the HPCAA oversee practitioner competence and conduct.
• In research and specialised fields, bodies such as HDEC, NEAC, and ACART contribute ethical or sector-specific consent oversight. 
In other words, informed-consent oversight appears to be distributed across rights enforcement, provider governance, professional regulation, and ethics review, rather than concentrated in one national system-monitoring authority.
3. Apparent systemic monitoring gap
That distribution matters. A fragmented structure can protect rights in multiple ways, but it may also create a system-level monitoring gap: there may be no single agency routinely collecting national data on informed-consent failures, auditing consent quality across all settings, or producing a consolidated view of recurring consent-governance risks.
This thread is therefore useful not only for what it says about agency responsibilities, but for what it may imply about the architecture of oversight itself: New Zealand has clear legal rights relating to informed consent, but system-wide monitoring may be diffuse, reactive, and complaint-led rather than centrally integrated. The HDC framework is strong on rights and redress, but that is not the same thing as a single national governance body continuously tracking informed-consent performance across the healthcare system. 
4. Research value
For researchers and investigators, this thread may be useful when read alongside requests concerning:
• HDC complaint and investigation data
• Health NZ clinical-governance policies
• Ministry stewardship and monitoring functions
• practitioner-regulator standards under the HPCAA
• ethics and consent guidance in research or specialist sectors
Taken together, those sources may help answer a larger question: not whether informed consent is legally recognised in New Zealand, but whether the current oversight model is sufficiently integrated to detect and respond to systemic consent failures across the health system.
SPENCER JONES left an annotation ()
Research Index – Informed Consent Governance in New Zealand Healthcare
This annotation links together the legal framework, oversight institutions, and potential information sources relevant to informed consent governance in New Zealand’s health system.
The purpose is to help researchers, investigators, and policy analysts understand which agencies hold different parts of the record and where further Official Information Act (OIA) requests may locate relevant material.
⸻
1. Core Legal Framework
Informed consent in New Zealand healthcare operates through several overlapping legal and regulatory instruments.
Code of Health and Disability Services Consumers’ Rights
The primary legal framework is the Code of Health and Disability Services Consumers’ Rights, administered by the Health and Disability Commissioner (HDC).
Key provisions include:
• Right 6 – Right to be fully informed
• Right 7 – Right to make an informed choice and give informed consent
The Code applies to all health and disability service providers.
⸻
Health Practitioners Competence Assurance Act 2003
The HPCAA establishes the regulatory system for registered health practitioners.
It governs:
• practitioner competence
• disciplinary processes
• professional conduct
Professional regulatory authorities (e.g. Medical Council, Nursing Council) may investigate cases where informed consent obligations were breached by practitioners.
⸻
Additional consent-related legislation
Depending on context, informed consent may also intersect with:
• New Zealand Bill of Rights Act 1990
• Human Tissue Act 2008
• Mental Health (Compulsory Assessment and Treatment) Act 1992
• Health Information Privacy Code
These instruments affect how consent operates in specialised situations such as:
• research participation
• treatment capacity
• use of personal health information
• tissue donation.
⸻
2. Institutional Oversight Structure
Oversight of informed consent is distributed across multiple institutions.
Health and Disability Commissioner (HDC)
Functions include:
• investigating complaints
• enforcing the Code of Rights
• issuing systemic recommendations
• producing case reports.
HDC investigations are one of the main sources of documented consent failures.
⸻
Ministry of Health / Manatū Hauora
Responsible for:
• national health policy
• stewardship of the health system
• guidance and regulatory frameworks.
The Ministry may hold documents relating to:
• national consent guidance
• health system governance structures
• policy advice regarding consent.
⸻
Health New Zealand / Te Whatu Ora
Responsible for operational healthcare delivery across the public health system.
Records may include:
• clinical governance policies
• consent protocols
• internal audits of consent processes
• incident reporting systems.
⸻
Professional Regulatory Authorities
Examples include:
• Medical Council of New Zealand
• Nursing Council
• Dental Council
• Pharmacy Council.
These bodies oversee practitioner competence and discipline under the HPCAA.
⸻
Ethics and research oversight bodies
In research contexts, consent oversight may involve:
• Health and Disability Ethics Committees (HDEC)
• National Ethics Advisory Committee (NEAC)
• Advisory Committee on Assisted Reproductive Technology (ACART)
These bodies oversee ethical standards and consent procedures for research and specialised medical interventions.
⸻
3. Institutional Information Flow
The governance structure for informed consent typically operates through the following pathway:
Health legislation and policy
│
▼
Ministry of Health stewardship
│
▼
Health system governance (Health NZ)
│
▼
Provider-level consent processes
│
▼
Patient complaints / adverse events
│
▼
Health and Disability Commissioner investigations
│
▼
Professional regulator disciplinary actions
Because information is distributed across several institutions, no single agency appears to hold a complete dataset on informed-consent compliance across the health system.
⸻
4. Potential System-Level Monitoring Gap
The distributed oversight structure means:
• consent governance may be complaint-driven rather than proactively monitored
• information about systemic consent failures may be fragmented across agencies
• different bodies may hold partial datasets rather than a consolidated national picture.
This is why OIA requests across multiple agencies may be required to reconstruct system-level oversight arrangements.
⸻
5. Suggested FYI Research Pathways
Researchers examining informed consent governance may wish to explore OIA requests directed to the following agencies:
Health and Disability Commissioner
Possible topics:
• annual statistics on informed consent complaints
• systemic reviews of consent failures
• policy guidance issued to providers.
⸻
Ministry of Health
Possible topics:
• national consent policy frameworks
• stewardship reviews of consent governance
• advice to Ministers on informed-consent issues.
⸻
Health New Zealand
Possible topics:
• national clinical governance policies
• incident reporting systems involving consent
• internal audits of consent procedures.
⸻
Professional regulatory authorities
Possible topics:
• disciplinary cases involving informed consent
• professional practice standards relating to consent
• training and competency requirements.
⸻
Ethics oversight bodies
Possible topics:
• research consent standards
• ethics committee review procedures
• consent guidance for clinical trials.
⸻
6. Why This Thread Matters
This request helps clarify a key governance question:
Which agency, if any, has system-level oversight responsibility for informed consent across New Zealand healthcare?
The response suggests that responsibility is distributed across multiple institutions, rather than concentrated in a single oversight authority.
Understanding how those responsibilities are divided is important for anyone researching:
• patient rights
• healthcare governance
• regulatory accountability
• systemic oversight of clinical practice.
From: OIA Requests
Kia ora
Thank you for your request for official information, received on 12 March
2026 for:
“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.”
We are contacting you in accordance with section 18B of the Official
Information Act 1982 (the Act) as your request, as it is currently worded,
is for a very large volume of information. Your request may be refused
under section 18(f) of the Act as the information requested cannot be made
available without substantial collation or research.
In order to provide you with information sooner and in order to work
within a more manageable request, are you happy to refine your request to
the timeframe of 2018 onwards.
Please respond by 25 March so that we can consider your refinement in our
response to your request.
Please note, under section 15 of the Official Information Act 1982, any
clarification or amendments made to a request within seven working days
after the date it is received, that request may be treated as a new
request and the time limit for the response restarts.
We look forward to receiving your response.
Ngâ mihi,
OIA Services Team
Ministry of Health | Manatû Hauora
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From: SPENCER JONES
Dear OIA Requests,
Subject: Clarification of OIA Request – Informed Consent Governance
Kia ora,
Thank you for your response and for engaging under section 18B of the Official Information Act 1982.
I am happy to refine the request to assist with manageability. However, given the subject matter concerns system-level governance design, limiting the request to 2018 onwards risks excluding key foundational policy work.
To enable a practical response while preserving the intent of the request, I refine as follows:
Refined Scope
1. Priority timeframe
Please prioritise the period 2018–present for all parts of the request.
2. Earlier material (pre-2018) – targeted
For the period 2000–2017, I request:
any foundational policy papers, Cabinet papers, or regulatory analyses that:
establish or describe the governance model for informed consent; or
consider whether system-level monitoring or assurance should exist
3. If no documents exist
For any part of the request where no documents are held, please confirm:
whether the issue has ever been formally considered by the Ministry
4. Key documents
If full retrieval remains substantial, I am happy to receive:
summaries of key documents; or
a list of relevant documents (titles, dates, authors)
to enable further refinement if required.
Clarification of intent
This request is focused on:
system-level governance and oversight, not individual clinical practice
I trust this refinement will assist in progressing the request.
Kind regards,
Spencer Jones
SPENCER JONES left an annotation ()
🔎 Public Annotation – Request Refinement Under s18B (Scope vs System Insight)
The Ministry of Health has responded by invoking section 18B of the Official Information Act, advising that the request may be refused under section 18(f) due to the volume of information requested, and asking that the timeframe be reduced to 2018 onwards.
This indicates that the request is being treated as large in scope, but it is important to note:
⚖️ 1. This is not a refusal
At this stage, the request is still in progress.
The Ministry has not refused the request, but is seeking clarification or refinement.
📊 2. Scope of the request
The original request (2000–present) was intentionally framed to capture:
early policy development around informed consent
structural decisions about governance and accountability
whether system-level monitoring has ever been considered
These elements are often established well before recent years, so limiting the request to 2018 onwards risks excluding foundational material.
🔍 3. What this response suggests
The Ministry’s position suggests that:
relevant information may span multiple decades
retrieval across that timeframe may require substantial collation
However, no indication has yet been provided as to:
whether such system-level analyses actually exist
whether the issue has ever been formally examined
🔄 4. Next step (refinement approach)
A refinement has been proposed that:
prioritises 2018–present for manageability
retains targeted requests for pre-2018 foundational policy and governance documents
This approach aims to:
reduce administrative burden
preserve access to key system-level information
⚠️ 5. Why this matters
This request relates to system-level governance of informed consent, including:
how accountability is distributed across agencies
whether any body is responsible for monitoring consent practices at a national level
whether risks associated with this model have been formally assessed
Understanding whether such oversight exists—or has ever been considered—is important for transparency and public accountability.
🔗 6. For researchers and observers
This thread may be of interest to those examining:
healthcare governance frameworks
regulatory accountability gaps
system-level oversight in public health programmes
Further updates will follow once the scope is clarified and the Ministry responds.
From: OIA Requests
Tēnā koe Spencer,
Thank you for your request under the Official Information Act 1982 (the
Act) to the Ministry of Health-Manatū Hauora on 12 March 2026. You
requested:
"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."
Part of your request asks for information which is more closely aligned
with the functions of the Office of the Health and Disability
Commissioner. For this reason, the Ministry has decided to transfer part 2
of your request to their agency under section 14(b)(ii) of the Act. You
can expect a response from their agency in due course. Their contact email
is: [1][email address]. The Ministry would like to apologise for the delay
in transferring this part of your request.
The Ministry will endeavour to respond to the remaining parts of your
request by 22 April 2026, being 20 working days after the date your
request was received.
Under section 28(3) of the Act you have the right to ask the Ombudsman
to review any decisions made under this request. The Ombudsman may be
contacted by email at: [2][email address] or by calling 0800
802 602.
Ngā mihi,
OIA Services Team
Ministry of Health | Manatū Hauora
M[3]inistry of Health information releases
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legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
distribute or copy this message or attachments.
If you have received this message in error, please notify the sender
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References
Visible links
1. mailto:[email address]
mailto:[email address]
2. mailto:[email address]
mailto:[email address]
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https://www.health.govt.nz/about-ministr...
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From: OIA Requests
Kia ora Spencer
Please find attached the response for your request for official
information.
Ngā mihi
OIA Services Team
Ministry of Health | Manatū Hauora
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If you are not the intended recipient, do not read, use, disseminate,
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SPENCER JONES left an annotation ()
PUBLIC ANNOTATION – STATUS AND GOVERNANCE ASSESSMENT
This request should not be marked as “information received.” The response provided by the Ministry of Health / Health NZ is materially incomplete and reflects a pattern of systemic limitation rather than full disclosure.
Key issues identified:
1. INCOMPLETE RESPONSE / PARTIAL DISCLOSURE
The response does not provide substantive documentation demonstrating system-level oversight, governance frameworks, or operational assurance mechanisms for informed consent in healthcare. Instead, it relies on high-level descriptions and general policy references.
2. ABSENCE OF EVIDENCE OF ACTIVE OVERSIGHT
No clear evidence has been provided showing:
- Routine monitoring systems
- Audit or assurance processes
- Cross-agency governance structures
- Enforcement or accountability mechanisms
This indicates a likely gap between policy intent and operational reality.
3. IMPLIED NON-EXISTENCE OF CENTRALISED SYSTEMS
The absence of structured records suggests that either:
(a) such systems do not exist in a coordinated form, or
(b) they are not retrievable within reasonable effort
This raises potential relevance of OIA section 18(e) (information does not exist) or 18(f) (substantial collation), though neither has been transparently applied or justified.
4. SYSTEMIC FRAGMENTATION
The response reinforces a decentralised governance model where responsibility for informed consent is distributed across providers without clear system-level oversight. This creates a structural accountability gap.
5. SEARCH ADEQUACY CONCERNS
There is no detailed explanation of:
- What systems were searched
- Which teams or directorates were consulted
- What keywords or parameters were used
This limits confidence that the request has been fully and properly assessed under section 13 (duty to assist).
6. GOVERNANCE RISK SIGNAL
Taken together, the response suggests a potential absence of:
- Integrated governance oversight
- Central reporting or monitoring capability
- System-wide accountability for informed consent practices
This is a significant public interest issue.
STATUS CLASSIFICATION (FYI):
✔ “I’ve received some of the information”
✘ Not “all information received”
NEXT STEPS (PUBLIC RECORD):
A follow-up OIA will be issued to:
- Test whether governance systems exist but were not disclosed
- Require explicit confirmation of non-existence where applicable
- Request audit, monitoring, and assurance documentation
- Clarify cross-agency responsibilities and escalation pathways
This annotation is provided to assist other requesters and to document emerging governance patterns across health system OIAs.
— End of Annotation —
From: SPENCER JONES
Dear OIA Requests, Ministry of Health / Health New Zealand
REF: Follow-up to OIA Request – System-Level Oversight and Governance of Informed Consent in Healthcare
Purpose:
This request is a targeted follow-up to clarify gaps and ambiguities in your prior response. The earlier reply did not provide sufficient evidence of system-level governance, monitoring, or assurance mechanisms. This request therefore seeks definitive confirmation of whether such systems exist, and if so, their structure and operation.
This is a precision request. If information does not exist, please explicitly confirm this under section 18(e) of the OIA.
SECTION 1: EXISTENCE OF SYSTEM-LEVEL GOVERNANCE
1.1 Does any centralised or system-level governance framework exist for monitoring, auditing, or assuring informed consent practices across the New Zealand health system?
If YES:
Provide:
(a) The name of the framework/system
(b) Governing agency or responsible unit
(c) Date of establishment
(d) Scope (national, regional, service-level)
(e) Any formal documentation (policies, terms of reference, operational manuals)
If NO:
Explicitly confirm that no such centralised governance framework exists.
SECTION 2: MONITORING AND AUDIT SYSTEMS
2.1 Identify all systems, processes, or programmes used to monitor compliance with informed consent requirements across public health services.
Include:
- Routine audit programmes
- Clinical governance reviews
- Incident reporting systems linked to consent failures
- National quality or safety indicators
For each identified system, provide:
(a) Description of function
(b) Responsible entity
(c) Frequency of monitoring
(d) Whether outputs are centrally aggregated or reported
If none exist at a system level, explicitly confirm.
SECTION 3: DATA COLLECTION AND REPORTING
3.1 Does any national dataset, reporting mechanism, or registry exist that captures:
- Informed consent compliance
- Consent-related adverse events
- Breaches or complaints linked to consent processes
If YES:
Provide:
(a) Dataset name and custodian
(b) Data fields collected
(c) Reporting outputs or summaries
(d) Whether data is publicly reported or internally used
If NO:
Explicitly confirm that no such dataset or reporting mechanism exists.
SECTION 4: CROSS-AGENCY GOVERNANCE AND ACCOUNTABILITY
4.1 Identify all agencies or entities with formal responsibility for oversight of informed consent practices, including but not limited to:
- Ministry of Health
- Health NZ
- HQSC
- HDC
- Professional regulatory bodies
Provide:
(a) Defined roles and responsibilities
(b) Any coordination mechanisms between agencies
(c) Any inter-agency agreements, memoranda, or governance structures
4.2 If no formal cross-agency governance structure exists, explicitly confirm.
SECTION 5: ENFORCEMENT AND ESCALATION PATHWAYS
5.1 Describe the mechanisms by which systemic issues in informed consent are:
- Identified
- Escalated
- Remediated
Provide:
(a) Formal escalation pathways
(b) Thresholds for intervention
(c) Responsible decision-makers
If no formal system-level escalation mechanism exists, explicitly confirm.
SECTION 6: SEARCH ADEQUACY AND DECISION BASIS
6.1 Please describe the steps taken to respond to both the original request and this follow-up, including:
- Systems searched
- Teams or directorates consulted
- Search terms or parameters used
This is requested to enable assessment of compliance with section 13 (duty to assist).
IMPORTANT CLARIFICATIONS
- If any part of this request is refused under section 18(f) (substantial collation), please:
(a) Provide a breakdown of the estimated work required
(b) Consider releasing information in summary or sample form under section 16
(c) Confirm whether narrowing the scope would enable release
- If information is withheld, please specify the exact statutory ground and reasoning.
- If information does not exist, this should be explicitly confirmed under section 18(e). Silence or omission will be treated as non-compliance.
PUBLIC INTEREST
This request relates to system-level governance of informed consent, a foundational component of patient rights, clinical ethics, and public trust. There is a strong public interest in transparency regarding whether effective oversight mechanisms exist.
I look forward to your response within the statutory timeframe.
Kind regards,
Spencer Jones
From: OIA Requests
Kia ora Spencer,
Thank you for your request under the Official Information Act 1982 (the
Act), received by the Ministry of Health - Manatū Hauora on 22 April 2026.
You requested:
"This request is a targeted follow-up to clarify gaps and ambiguities in
your prior response. The earlier reply did not provide sufficient evidence
of system-level governance, monitoring, or assurance mechanisms. This
request therefore seeks definitive confirmation of whether such systems
exist, and if so, their structure and operation.
This is a precision request. If information does not exist, please
explicitly confirm this under section 18(e) of the OIA.
SECTION 1: EXISTENCE OF SYSTEM-LEVEL GOVERNANCE
1.1 Does any centralised or system-level governance framework exist for
monitoring, auditing, or assuring informed consent practices across the
New Zealand health system?
If YES:
Provide:
(a) The name of the framework/system
(b) Governing agency or responsible unit
(c) Date of establishment
(d) Scope (national, regional, service-level)
(e) Any formal documentation (policies, terms of reference, operational
manuals)
If NO:
Explicitly confirm that no such centralised governance framework exists.
SECTION 2: MONITORING AND AUDIT SYSTEMS
2.1 Identify all systems, processes, or programmes used to monitor
compliance with informed consent requirements across public health
services.
Include:
- Routine audit programmes
- Clinical governance reviews
- Incident reporting systems linked to consent failures
- National quality or safety indicators
For each identified system, provide:
(a) Description of function
(b) Responsible entity
(c) Frequency of monitoring
(d) Whether outputs are centrally aggregated or reported
If none exist at a system level, explicitly confirm.
SECTION 3: DATA COLLECTION AND REPORTING
3.1 Does any national dataset, reporting mechanism, or registry exist that
captures:
- Informed consent compliance
- Consent-related adverse events
- Breaches or complaints linked to consent processes
If YES:
Provide:
(a) Dataset name and custodian
(b) Data fields collected
(c) Reporting outputs or summaries
(d) Whether data is publicly reported or internally used
If NO:
Explicitly confirm that no such dataset or reporting mechanism exists.
SECTION 4: CROSS-AGENCY GOVERNANCE AND ACCOUNTABILITY
4.1 Identify all agencies or entities with formal responsibility for
oversight of informed consent practices, including but not limited to:
- Ministry of Health
- Health NZ
- HQSC
- HDC
- Professional regulatory bodies
Provide:
(a) Defined roles and responsibilities
(b) Any coordination mechanisms between agencies
(c) Any inter-agency agreements, memoranda, or governance structures
4.2 If no formal cross-agency governance structure exists, explicitly
confirm.
SECTION 5: ENFORCEMENT AND ESCALATION PATHWAYS
5.1 Describe the mechanisms by which systemic issues in informed consent
are:
- Identified
- Escalated
- Remediated
Provide:
(a) Formal escalation pathways
(b) Thresholds for intervention
(c) Responsible decision-makers
If no formal system-level escalation mechanism exists, explicitly confirm.
SECTION 6: SEARCH ADEQUACY AND DECISION BASIS
6.1 Please describe the steps taken to respond to both the original
request and this follow-up, including:
- Systems searched
- Teams or directorates consulted
- Search terms or parameters used
This is requested to enable assessment of compliance with section 13 (duty
to assist)."
The reference number for your request is H2026081957. We will endeavour to
respond to your request as soon as possible and in any event no later than
21 May 2026 being 20 working days after the day your request was received.
If we are unable to respond to your request by then, we will notify you of
an extension of that timeframe.
If you have any queries regarding your request, please feel free to
contact the OIA Services Team on [1][email address]. If any
additional factors come to light which are relevant to your request,
please do not hesitate to contact us so that these can be taken into
account.
Under section 28(3) of the Act you have the right to ask the Ombudsman to
review any decisions made under this request. The Ombudsman may be
contacted by email at: [2][email address] or by calling 0800
802 602.
Ngā mihi,
OIA Services Team
Ministry of Health | Manatū Hauora
M[3]inistry of Health information releases
-------------------------------------------------------------------
Dear OIA Requests, Ministry of Health / Health New Zealand
REF: Follow-up to OIA Request – System-Level Oversight and Governance of
Informed Consent in Healthcare
Purpose:
This request is a targeted follow-up to clarify gaps and ambiguities in
your prior response. The earlier reply did not provide sufficient evidence
of system-level governance, monitoring, or assurance mechanisms. This
request therefore seeks definitive confirmation of whether such systems
exist, and if so, their structure and operation.
This is a precision request. If information does not exist, please
explicitly confirm this under section 18(e) of the OIA.
SECTION 1: EXISTENCE OF SYSTEM-LEVEL GOVERNANCE
1.1 Does any centralised or system-level governance framework exist for
monitoring, auditing, or assuring informed consent practices across the
New Zealand health system?
If YES:
Provide:
(a) The name of the framework/system
(b) Governing agency or responsible unit
(c) Date of establishment
(d) Scope (national, regional, service-level)
(e) Any formal documentation (policies, terms of reference, operational
manuals)
If NO:
Explicitly confirm that no such centralised governance framework exists.
SECTION 2: MONITORING AND AUDIT SYSTEMS
2.1 Identify all systems, processes, or programmes used to monitor
compliance with informed consent requirements across public health
services.
Include:
- Routine audit programmes
- Clinical governance reviews
- Incident reporting systems linked to consent failures
- National quality or safety indicators
For each identified system, provide:
(a) Description of function
(b) Responsible entity
(c) Frequency of monitoring
(d) Whether outputs are centrally aggregated or reported
If none exist at a system level, explicitly confirm.
SECTION 3: DATA COLLECTION AND REPORTING
3.1 Does any national dataset, reporting mechanism, or registry exist that
captures:
- Informed consent compliance
- Consent-related adverse events
- Breaches or complaints linked to consent processes
If YES:
Provide:
(a) Dataset name and custodian
(b) Data fields collected
(c) Reporting outputs or summaries
(d) Whether data is publicly reported or internally used
If NO:
Explicitly confirm that no such dataset or reporting mechanism exists.
SECTION 4: CROSS-AGENCY GOVERNANCE AND ACCOUNTABILITY
4.1 Identify all agencies or entities with formal responsibility for
oversight of informed consent practices, including but not limited to:
- Ministry of Health
- Health NZ
- HQSC
- HDC
- Professional regulatory bodies
Provide:
(a) Defined roles and responsibilities
(b) Any coordination mechanisms between agencies
(c) Any inter-agency agreements, memoranda, or governance structures
4.2 If no formal cross-agency governance structure exists, explicitly
confirm.
SECTION 5: ENFORCEMENT AND ESCALATION PATHWAYS
5.1 Describe the mechanisms by which systemic issues in informed consent
are:
- Identified
- Escalated
- Remediated
Provide:
(a) Formal escalation pathways
(b) Thresholds for intervention
(c) Responsible decision-makers
If no formal system-level escalation mechanism exists, explicitly confirm.
SECTION 6: SEARCH ADEQUACY AND DECISION BASIS
6.1 Please describe the steps taken to respond to both the original
request and this follow-up, including:
- Systems searched
- Teams or directorates consulted
- Search terms or parameters used
This is requested to enable assessment of compliance with section 13 (duty
to assist).
IMPORTANT CLARIFICATIONS
- If any part of this request is refused under section 18(f) (substantial
collation), please:
(a) Provide a breakdown of the estimated work required
(b) Consider releasing information in summary or sample form under section
16
(c) Confirm whether narrowing the scope would enable release
- If information is withheld, please specify the exact statutory ground
and reasoning.
- If information does not exist, this should be explicitly confirmed under
section 18(e). Silence or omission will be treated as non-compliance.
PUBLIC INTEREST
This request relates to system-level governance of informed consent, a
foundational component of patient rights, clinical ethics, and public
trust. There is a strong public interest in transparency regarding whether
effective oversight mechanisms exist.
I look forward to your response within the statutory timeframe.
Kind regards,
Spencer Jones
-----Original Message-----
Kia ora Spencer
Please find attached the response for your request for official
information.
Ngā mihi
OIA Services Team
Ministry of Health | Manatū Hauora
-------------------------------------------------------------------
Please use this email address for all replies to this request:
[FOI #34050 email]
Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[4]https://aus01.safelinks.protection.outlo...
If you find this service useful as an Official Information officer, please
ask your web manager to link to us from your organisation's OIA or LGOIMA
page.
-------------------------------------------------------------------
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From: HDC OIA
Please reply to this email. It is important for our complaint history that
this email thread is retained.
Dear Spence Jones,
Please find our response attached.
OIA Team
Office of the Health and Disability Commissioner | Te Toihau Hauora,
Hauātanga
PO Box 1791, Auckland 1140
Freephone 0800 11 22 33
Website [1]hdc.org.nz
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References
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From: OIA Requests
Kia ora Spencer,
Thank you for your correspondence. The Ministry stands by its response and
has nothing further to add.
Under section 28(3) of the Act, you have the right to ask the Ombudsman to
review any decisions made under your requests. The Ombudsman may be
contacted by email at: [1][email address] or by calling 0800
802 602.
Ngā mihi,
OIA Services Team
Ministry of Health | Manatū Hauora
--------------------------------------------------------------------------
From: SPENCER JONES <[FOI #34050 email]>
Sent: Wednesday, 22 April 2026 18:18
To: OIA Requests <[email address]>
Subject: Re: Response to your official information act request, ref:
H2026080033 CRM:0105803
Dear OIA Requests, Ministry of Health / Health New Zealand
REF: Follow-up to OIA Request – System-Level Oversight and Governance of
Informed Consent in Healthcare
Purpose:
This request is a targeted follow-up to clarify gaps and ambiguities in
your prior response. The earlier reply did not provide sufficient evidence
of system-level governance, monitoring, or assurance mechanisms. This
request therefore seeks definitive confirmation of whether such systems
exist, and if so, their structure and operation.
This is a precision request. If information does not exist, please
explicitly confirm this under section 18(e) of the OIA.
SECTION 1: EXISTENCE OF SYSTEM-LEVEL GOVERNANCE
1.1 Does any centralised or system-level governance framework exist for
monitoring, auditing, or assuring informed consent practices across the
New Zealand health system?
If YES:
Provide:
(a) The name of the framework/system
(b) Governing agency or responsible unit
(c) Date of establishment
(d) Scope (national, regional, service-level)
(e) Any formal documentation (policies, terms of reference, operational
manuals)
If NO:
Explicitly confirm that no such centralised governance framework exists.
SECTION 2: MONITORING AND AUDIT SYSTEMS
2.1 Identify all systems, processes, or programmes used to monitor
compliance with informed consent requirements across public health
services.
Include:
- Routine audit programmes
- Clinical governance reviews
- Incident reporting systems linked to consent failures
- National quality or safety indicators
For each identified system, provide:
(a) Description of function
(b) Responsible entity
(c) Frequency of monitoring
(d) Whether outputs are centrally aggregated or reported
If none exist at a system level, explicitly confirm.
SECTION 3: DATA COLLECTION AND REPORTING
3.1 Does any national dataset, reporting mechanism, or registry exist that
captures:
- Informed consent compliance
- Consent-related adverse events
- Breaches or complaints linked to consent processes
If YES:
Provide:
(a) Dataset name and custodian
(b) Data fields collected
(c) Reporting outputs or summaries
(d) Whether data is publicly reported or internally used
If NO:
Explicitly confirm that no such dataset or reporting mechanism exists.
SECTION 4: CROSS-AGENCY GOVERNANCE AND ACCOUNTABILITY
4.1 Identify all agencies or entities with formal responsibility for
oversight of informed consent practices, including but not limited to:
- Ministry of Health
- Health NZ
- HQSC
- HDC
- Professional regulatory bodies
Provide:
(a) Defined roles and responsibilities
(b) Any coordination mechanisms between agencies
(c) Any inter-agency agreements, memoranda, or governance structures
4.2 If no formal cross-agency governance structure exists, explicitly
confirm.
SECTION 5: ENFORCEMENT AND ESCALATION PATHWAYS
5.1 Describe the mechanisms by which systemic issues in informed consent
are:
- Identified
- Escalated
- Remediated
Provide:
(a) Formal escalation pathways
(b) Thresholds for intervention
(c) Responsible decision-makers
If no formal system-level escalation mechanism exists, explicitly confirm.
SECTION 6: SEARCH ADEQUACY AND DECISION BASIS
6.1 Please describe the steps taken to respond to both the original
request and this follow-up, including:
- Systems searched
- Teams or directorates consulted
- Search terms or parameters used
This is requested to enable assessment of compliance with section 13 (duty
to assist).
IMPORTANT CLARIFICATIONS
- If any part of this request is refused under section 18(f) (substantial
collation), please:
(a) Provide a breakdown of the estimated work required
(b) Consider releasing information in summary or sample form under section
16
(c) Confirm whether narrowing the scope would enable release
- If information is withheld, please specify the exact statutory ground
and reasoning.
- If information does not exist, this should be explicitly confirmed under
section 18(e). Silence or omission will be treated as non-compliance.
PUBLIC INTEREST
This request relates to system-level governance of informed consent, a
foundational component of patient rights, clinical ethics, and public
trust. There is a strong public interest in transparency regarding whether
effective oversight mechanisms exist.
I look forward to your response within the statutory timeframe.
Kind regards,
Spencer Jones
-----Original Message-----
Kia ora Spencer
Please find attached the response for your request for official
information.
Ngā mihi
OIA Services Team
Ministry of Health | Manatū Hauora
-------------------------------------------------------------------
Please use this email address for all replies to this request:
[FOI #34050 email]
Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[2]https://aus01.safelinks.protection.outlo...
If you find this service useful as an Official Information officer, please
ask your web manager to link to us from your organisation's OIA or LGOIMA
page.
-------------------------------------------------------------------
****************************************************************************
Statement of confidentiality: This e-mail message and any accompanying
attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
distribute or copy this message or attachments.
If you have received this message in error, please notify the sender
immediately and delete this message.
****************************************************************************
References
Visible links
1. mailto:[email address]
2. https://fyi.org.nz/help/officers
hide quoted sections
SPENCER JONES left an annotation ()
Public annotation – systemic informed consent governance
This response is important because it confirms a significant structural issue in New Zealand’s health governance framework: informed consent is legally required, but system-level governance and assurance appear fragmented.
The Ministry of Health released 14 documents, including screening ethics papers, informed consent material, HDC Code review material, surgical mesh material, literature reviews, and National Quality Forum documents. However, the key finding is not simply what was released. The key finding is what the Ministry says it could not locate.
The Ministry states:
“The Ministry has not identified work towards a national governance model for informed consent since 2000.”
It also states:
“The Ministry has not been able to locate any briefings or policy advice about the governance of informed consent across the system.”
This is significant because the request was not about individual clinical consent disputes. It was about system-level governance, monitoring, and assurance.
The documents released show that informed consent has been considered in specific contexts, especially screening, surgical mesh, training environments, and adverse events. But the response indicates there is no single national governance framework for informed consent across the health system.
This matters because informed consent is not merely a form or a clinical conversation. The released 2010 screening documents describe informed consent as requiring effective communication, balanced information, voluntariness, understanding of risks and harms, and decision-making at multiple stages of a screening pathway. They also recognise risks such as routinisation, pressure to participate, poor communication, information imbalance, and lack of practical support for consumers.
The 2010 Health Report also states that informed consent must be built into screening programme design from the outset, and that public scrutiny of screening processes could affect public confidence. That is an important historical marker: these issues were recognised at policy level more than a decade ago.
The HDC response is also important. The HDC refused the transferred part of the request under section 18(f), stating that almost all submissions and many meetings or correspondence would reference informed consent to some extent, and that locating the requested information would require reviewing hundreds, if not thousands, of documents.
That refusal may itself be informative. It suggests that informed consent is widespread across HDC work, but not easily retrievable as a system-level governance category.
For researchers, this points to a diffuse-accountability model:
1. The Code of Health and Disability Services Consumers’ Rights creates consumer rights.
2. Individual providers and clinicians are responsible for obtaining consent.
3. HDC investigates complaints after problems arise.
4. Health NZ is developing a national informed consent policy due mid-2026.
5. The Ministry has not identified a national governance model or cross-system assurance framework since 2000.
The research issue is therefore not whether informed consent exists as a legal right. It clearly does. The issue is whether anyone has system-level responsibility for monitoring whether informed consent is working consistently across national health programmes, including vaccination, screening, population-level interventions, and high-risk clinical contexts.
This response should be read alongside related OIAs on consent accountability, system-level assurance, health governance, vaccination programmes, and diffuse accountability across health agencies.
Research roadmap from this response:
* Request the Health NZ national informed consent policy due mid-2026.
* Ask Health NZ what audit, monitoring, and reporting mechanisms will sit behind that policy.
* Ask HDC whether informed consent complaint trends are coded, analysed, or reported at system level.
* Ask MoH whether Cabinet, Ministers, or Health NZ have been advised of the absence of a national informed consent governance model.
* Ask whether informed consent assurance is monitored in vaccination, screening, surgical, teaching, and population-health programmes.
* Ask whether “consent failure” is treated as a clinical incident, governance risk, patient safety risk, or only as a complaints issue.
In short, this OIA does not close the issue. It confirms the next stage of investigation: New Zealand appears to have informed consent rights, but no clearly identified national assurance body responsible for checking whether those rights are being consistently protected across the health system.
Things to do with this request
- Add an annotation (to help the requester or others)
- Download a zip file of all correspondence (note: this contains the same information already available above).
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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.
Link to this