For technology appraisals and highly specialised technologies guidance, consultees can appeal the final draft guidance, or the process followed using the appeal process. For medical technologies and diagnostics guidance, stakeholders can use the resolution process on the final draft guidance and the process followed.
The resolution process is a final quality-assurance step to ensure that NICE acts fairly, follows its own processes, and produces clear, accurate guidance. It happens after NICE has approved the final draft guidance for publication and before it is published. After approval, NICE sends all stakeholders the final draft guidance. Resolution does not apply to decisions about selecting technologies for evaluation. It also does not apply to the external assessment report or other documents produced during guidance development, unless the resolution request on these documents is important for an issue in the guidance itself.
After receiving the final draft guidance any stakeholder can ask for factual errors to be corrected. Only consultees can raise a resolution request based on a breach of the published process.
If NICE either does not receive a resolution request, or receives a request that can be resolved quickly, the guidance is published as soon as possible after the resolution period ends. If NICE receives a resolution request that needs further investigation, it suspends publishing the guidance while it investigates the request and informs stakeholders of the delay to publication.
NICE only considers resolution requests that clearly meet one or both of the following grounds:
Ground 1: Breach of NICE's published process for the development of guidance.
Ground 2: Factual errors in the guidance.
A factual error is an objective error of material fact in the final draft guidance. Conflicting scientific or clinical interpretations or judgements are not considered to be factual errors. For example, if a resolution request states that a statistic quoted in the guidance is incorrect, NICE establishes whether the final guidance misquoted the statistic, or if one statistic was preferred out of several because the committee considered it to be more reliable. The former is a factual error; the latter is a difference of scientific or clinical judgement.
NICE sends the final draft guidance and, when a draft guidance consultation has taken place, any consultation comments and NICE's response to those comments, to all stakeholders.
Eligible stakeholders must make a resolution request on one or both of the grounds within 21 days. Requests should specify the resolution they seek. NICE can then fully understand the nature of their concern and take appropriate action.
All eligible resolution requests are subject to an initial scrutiny process. NICE investigates the matters raised and decides whether the request is in the scope of the resolution process. Initial scrutiny continues for 21 days after the resolution request period ends. If multiple resolution requests are made, either from the same or different sources, each request is treated separately.
If the programme director considers that the resolution request does not meet ground 1 (breach of process), or does not have a reasonable prospect of success, NICE informs the consultee that made the request and publishes the guidance.
If the programme director considers that ground 1 appears to have been met, a resolution panel is convened.
If the associate director considers that the resolution request does not meet ground 2 (factual errors), or does not have a reasonable prospect of success, the person or organisation that made the request is informed and NICE publishes the guidance.
If the associate director considers that the guidance contains a factual error or a point that needs clarification, but this does not affect the committee's recommendations, the guidance is amended and signed off internally without being referred to a resolution panel. NICE then publishes the final guidance.
If the associate director considers that there may be a major factual error that may affect the committee's recommendations, the programme director will convene a resolution panel.
If there are multiple resolution requests, not all requests may qualify to be referred to a resolution panel. To avoid pre-empting the outcome of resolution, NICE informs everyone who has submitted a resolution request that the panel will be convened, and that NICE will tell them the outcome of their request after the panel's decision is made.
|
Outcome of initial scrutiny |
NICE action |
|---|---|
|
Ground 1 not met |
Guidance is published |
|
Ground 1 met |
Resolution panel is convened |
|
Ground 2 not met |
Guidance is published |
|
Ground 2 met, minor factual error |
Guidance is amended and published |
|
Ground 2 met, major factual error |
Resolution panel is convened |
The panel consists of 2 NICE board members: 1 non-executive director and 1 executive director not previously involved in developing guidance on the technology. The panel is to decide whether there has been a breach of process or factual error and, if so, what action is appropriate.
The resolution panel meeting is held within 35 days after the initial scrutiny process. The meeting is usually held virtually. The NICE team prepares a briefing, which the panel uses when considering resolution requests. For ground 1, this means establishing what process was followed when developing the guidance and what events or omissions are alleged in the resolution request. In the case of ground 2, this involves setting out what evidence is behind the alleged errors.
The briefing is shared with the consultee making the resolution request. They have 10 days to comment on the briefing, then their comments are provided to the panel.
The resolution panel may hold a meeting where the panel members meet (without other parties) to consider the written evidence and make a decision. The panel may decide to hold an oral meeting where both the NICE team and the consultee attend to answer the panel questions and provide clarification. Committee members may also attend. These attendees are not members of the panel and do not contribute to the outcome of the resolution. Consultees cannot bring legal representation to the panel meeting.
If the resolution panel decides that there has been no breach of process, NICE can publish the final guidance. If the panel decides that there has been a breach of process, it decides what action is appropriate. This may involve repeating part of the evaluation process and, if necessary, referring the guidance back to the committee or doing another consultation, or both.
If the resolution panel decides that there are no factual errors, NICE can publish the final guidance. If the panel decides that there are factual errors or elements to be clarified, NICE produces an amended version of the guidance. The panel decides whether the error can be corrected and the amended version of the guidance approved by NICE before publication, or whether the committee should review the wording of the amended guidance because of the error.
NICE considers whether to publish the amended guidance or whether there is a need for further consultation. Further consultation normally happens if:
NICE makes a substantive change to the wording of the recommendations, or
changes to the guidance not involving the recommendations are significant or likely to be of interest to the people who made the resolution request.
|
Outcome of resolution panel meeting |
NICE action |
|---|---|
|
Ground 1 not met |
Guidance is published |
|
Ground 1 met |
Appropriate action as decided by resolution panel |
|
Ground 2 not met |
Guidance is published |
|
Ground 2 met |
Appropriate action as decided by resolution panel |
NICE implements the panel's decision and informs everyone who made resolution requests of the resolution outcome. This normally happens within 7 days of the panel reaching its final decision. This timescale does not apply if the committee needs to reconsider the recommendations. The resolution panel's decision is final and there are no further opportunities for redress within NICE.
Once the appeal or resolution process is complete and any changes to guidance following those processes are complete, final guidance is published on the NICE website and all stakeholders are informed. NICE also publishes a lay version for patients and carers, known as 'information for the public'.
The following documents are available on the NICE website when guidance is published (all confidential information will be removed from the documents before publication):
guidance
external assessment report, any additional analysis and clarification questions and responses
any technical engagement responses
any evidence submissions
consultation comments (anonymised) and NICE's responses
further analysis or correction, if any, done by NICE or the external assessment group after the external assessment report (in an addendum)
implementation support tools (usually at the same time as the guidance, and within 3 months of publication at the latest) when the technology is recommended (as an option)
equality impact assessment
a lay explanation of the recommendations.
If NICE is advised of any potential errors in the guidance or the supporting documents after publication, these are dealt with according to NICE's standard procedures.