Use of terminology in hospital consent documentation for vaccines
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
Kia ora,
Pursuant to the Official Information Act 1982, I request the following information. This request is interpretive and governance-focused, and does not seek general restatement of consent law.
Part A – Terminology governance
Any national-level guidance, directives, circulars, or internal position statements held by Te Whatu Ora that address whether the terms:
“biologics”,
“biological medicines”, or
“biogenic agents”
are recognised, used, discouraged, or excluded in public-hospital clinical governance, policy, or consent documentation.
If no such documents exist, please explicitly confirm whether Te Whatu Ora has:
adopted a position that such terminology has no interpretive or operational role in hospital consent processes; or
left interpretation entirely to local or regional discretion.
Part B – Consent thresholds and escalation
Any documents describing criteria or thresholds (other than general treatment risk) that would trigger:
enhanced consent requirements,
additional disclosure obligations, or
ethics escalation
for injectable medicines or vaccines used in hospital settings.
Confirmation of whether biological mechanism, platform, or origin (as distinct from clinical risk) is ever a factor in determining consent approach in Te Whatu Ora hospitals.
Part C – Ethics interface
Any guidance or correspondence held by Te Whatu Ora relating to the interface between hospital consent processes and HDEC ethics guidance, specifically addressing when a treatment moves from standard care into enhanced ethical scrutiny.
Scope
This request seeks existing documents or formal positions only. It does not seek new analysis, legal advice, or hypothetical commentary. If any part of the request is considered too broad, I request assistance under section 13 to refine scope.
Kind regards,
Spencer Jones
From: OIA Requests
Kia ora Spencer,
Thank you for your request for official information, dated 22 December
2025 for:
"Part A – Terminology governance
Any national-level guidance, directives, circulars, or internal position
statements held by Te Whatu Ora that address whether the terms:
“biologics”,
“biological medicines”, or
“biogenic agents”
are recognised, used, discouraged, or excluded in public-hospital clinical
governance, policy, or consent documentation.
If no such documents exist, please explicitly confirm whether Te Whatu Ora
has:
adopted a position that such terminology has no interpretive or
operational role in hospital consent processes; or
left interpretation entirely to local or regional discretion.
Part B – Consent thresholds and escalation
Any documents describing criteria or thresholds (other than general
treatment risk) that would trigger:
enhanced consent requirements,
additional disclosure obligations, or
ethics escalation
for injectable medicines or vaccines used in hospital settings.
Confirmation of whether biological mechanism, platform, or origin (as
distinct from clinical risk) is ever a factor in determining consent
approach in Te Whatu Ora hospitals.
Part C – Ethics interface
Any guidance or correspondence held by Te Whatu Ora relating to the
interface between hospital consent processes and HDEC ethics guidance,
specifically addressing when a treatment moves from standard care into
enhanced ethical scrutiny.
Scope
This request seeks existing documents or formal positions only. It does
not seek new analysis, legal advice, or hypothetical commentary. If any
part of the request is considered too broad, I request assistance under
section 13 to refine scope."
As you have already placed the same request with Health New Zealand - Te
Whatu Ora, a formal transfer of your request under section
14(b)(i)/14(b)(ii) of the OIA has been deemed unnecessary. You can instead
expect a response from Health New Zealand under reference HNZ00104357.
Should you wish to follow up, Health New Zealand can be contacted via
[1][email address].
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: [email address] or by calling 0800 802
602.
Ngâ mihi,
OIA Services Team
Ministry of Health | Manatû Hauora
M[2]inistry of Health information releases
------------------- Original Message -------------------
From: SPENCER JONES <[FOI #33361 email]>;
Received: Mon Dec 22 2025 19:18:17 GMT+1300 (New Zealand Daylight Time)
To: OIA Requests <[email address]>; OIA <[email address]>;
Subject: Official Information request - Use of terminology in hospital
consent documentation for vaccines
Kia ora,
Pursuant to the Official Information Act 1982, I request the following
information. This request is interpretive and governance-focused, and does
not seek general restatement of consent law.
Part A – Terminology governance
Any national-level guidance, directives, circulars, or internal position
statements held by Te Whatu Ora that address whether the terms:
“biologics”,
“biological medicines”, or
“biogenic agents”
are recognised, used, discouraged, or excluded in public-hospital clinical
governance, policy, or consent documentation.
If no such documents exist, please explicitly confirm whether Te Whatu Ora
has:
adopted a position that such terminology has no interpretive or
operational role in hospital consent processes; or
left interpretation entirely to local or regional discretion.
Part B – Consent thresholds and escalation
Any documents describing criteria or thresholds (other than general
treatment risk) that would trigger:
enhanced consent requirements,
additional disclosure obligations, or
ethics escalation
for injectable medicines or vaccines used in hospital settings.
Confirmation of whether biological mechanism, platform, or origin (as
distinct from clinical risk) is ever a factor in determining consent
approach in Te Whatu Ora hospitals.
Part C – Ethics interface
Any guidance or correspondence held by Te Whatu Ora relating to the
interface between hospital consent processes and HDEC ethics guidance,
specifically addressing when a treatment moves from standard care into
enhanced ethical scrutiny.
Scope
This request seeks existing documents or formal positions only. It does
not seek new analysis, legal advice, or hypothetical commentary. If any
part of the request is considered too broad, I request assistance under
section 13 to refine scope.
Kind regards,
Spencer Jones
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SPENCER JONES left an annotation ()
Public Annotation – System-Level Governance Pattern Observed
Across multiple Official Information Act requests on FYI.org.nz, a consistent procedural pattern has emerged that is relevant to this request.
Where an OIA probes system-level governance questions (for example: national terminology standards, consent frameworks, ethical escalation thresholds, or governance interfaces between agencies), responses frequently take the form of:
• deflecting the request to an operational delivery body (e.g. a service provider or implementing agency);
• indicating that matters are handled “locally” or “operationally”; or
• declining to respond substantively on the basis that another agency is better placed to answer.
This pattern occurs even where no formal national-level governance document, directive, or position statement is produced, and even where the request explicitly seeks confirmation of whether such documents exist.
This does not necessarily indicate bad faith or non-compliance. Rather, it highlights a structural feature of the system:
governance responsibility is often implicit, distributed, or undocumented, while operational responsibility is explicit and delegated.
The practical effect, however, is a degree of governance opacity for matters that sit between policy, ethics, consent, and service delivery. That opacity is precisely what requests of this nature are intended to clarify—whether by identifying existing national guidance, or by confirming that no such guidance exists and that interpretation is left to operational discretion.
This request should therefore be read as part of a broader effort to understand where governance accountability formally sits, not as a critique of any individual agency’s conduct.
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