Process and methods
The resolution process takes place after the NICE guidance executive has approved the guidance for publication and before it is published. 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 prevents the inadvertent publication of guidance that contains factual errors or is developed other than in accordance with either this document or the programme's methods guide.
If NICE receives a resolution request, it suspends publishing the guidance while it investigates the request. If NICE does not receive a request, the guidance is published as soon as possible after the resolution period ends.
The resolution process applies only to guidance. Resolution does not apply to the committee's decisions about selecting technologies for evaluation. It also does not apply to the assessment report or other documents produced in the course of developing the guidance, unless the resolution request on these documents is material to the issue regarding the guidance itself.
The resolution panel only considers resolution requests that clearly meet one or both of the following grounds.
6.1.1 Ground 1: breach of NICE's published process for the development of medical technologies guidance
An example would be when a step is missed in the process.
A factual error is an objective error of material fact in the final guidance. Conflicting scientific or clinical interpretations or judgements are not considered to be factual errors. For example, if a consultee states that a statistic quoted in the guidance is incorrect, NICE establishes whether the final guidance misquoted the statistic, or if 1 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.
After the guidance executive approves the guidance for publication, NICE emails all consultees who responded to the draft guidance. It is important that any organisation or person who may wish to make a resolution request submits a consultation response at the appropriate time. They should bear in mind that the guidance may have changed significantly from the consultation document, because of comments received during consultation and considered by the committee when formulating its final guidance.
Consultees have 15 working days after the email alert to request resolution on 1 or both of the grounds in section 6.1. NICE accepts requests by email, fax or letter addressed to the associate director of MTEP. Consultees making 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. The associate director investigates the matters raised and reports the findings to the centre director (or their nominated deputy). The centre director decides whether the request falls within the scope of the resolution process. Initial scrutiny continues for 15 working days after the resolution request period ends. If multiple resolution requests are made, either from the same or different consultees, each request is treated as outlined below.
If the centre director considers that the resolution request does not meet ground 1 (breach of process; section 6.1.2), or does not have a reasonable prospect of success, the associate director informs the person or organisation who made the request and NICE publishes the guidance. If the centre director considers that ground 1 appears to have been met, the associate director convenes the resolution panel.
If the centre director considers that the resolution request does not meet ground 2 (factual errors; section 6.1.3), or does not have a reasonable prospect of success, the associate director informs the person or organisation who made the request and NICE publishes the guidance. If the centre director considers that the guidance contains a minor factual error or a point that requires clarification but does not affect the committee's recommendation(s), the guidance is amended and signed-off by the committee chair without being referred to the resolution panel. NICE then publishes the guidance in the usual way. If the centre director considers that there is a major factual error that cannot be remedied by minor amendment, they instruct the associate director to convene the resolution panel.
For multiple resolution requests, not all requests may qualify for referral to the panel. In order to avoid pre-empting the outcome of resolution, NICE informs all consultees that the panel is to be convened, and that NICE will tell them the outcome of their request after the panel's decision is made.
The resolution panel comprises 2 NICE board members, 1 non-executive director and 1 executive director not previously involved in developing guidance on the technology. The aim of the panel is to decide whether there has been a breach of process or factual error and, if so, what action is appropriate.
The associate director organises the resolution panel meeting, which takes place no more than 20 working days after the initial scrutiny process has ended.
The MTEP team prepares a briefing, which the panel uses when considering the resolution request. For ground 1, this means establishing what process was followed when developing the guidance and what events or omissions were alleged in the resolution request. In the case of ground 2, this involves setting out what evidence lies behind the alleged errors.
The associate director, and if needed the committee chair and the programme director, attend the meeting to provide clarification. They are not members of the panel and do not contribute to the outcome of the resolution. Members of the MTEP team may also attend the meeting to answer questions.
If the resolution panel decides that there has been no breach of process (ground 1), NICE can publish the 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 assessment process and, if necessary, referring the technology back to the committee and/or carrying out another consultation.
If the resolution panel decides that there are no factual errors (ground 2), NICE can publish the 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 must decide whether the error can be corrected and the amended guidance approved by the guidance executive before publication, or whether the committee should review the amended guidance wording in light of the error identified.
NICE considers whether to publish the amended guidance or whether there is a need for further consultation. This need normally arises 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 consultees.
The associate director implements the panel's decision and informs all consultees who made resolution requests of the outcome of resolution. This normally occurs 2 days before NICE publishes the guidance, although this timescale does not apply if the committee needs to reconsider its recommendations.
The resolution panel's decision is final and there are no further opportunities for redress within NICE.