Process and methods

15 The resolution process

The resolution process is a final quality assurance step, intended to ensure that NICE acts fairly, follows its own processes and produces clear, accurate guidance. It is a final quality and content check for those stakeholders who have taken part in guidance development. The resolution process takes place after the Guidance Executive has approved the guidance for publication and before it is published. When resolution requests are received, publication of the guidance is delayed.

The resolution process is not needed when no consultation comments are received or if stakeholders who provided consultation comments do not return their confidentiality statement.

15.1 Grounds for resolution

The resolution panel (see section 15.5) only considers resolution requests that meet 1 or both of the following grounds:

Ground 1: breach of NICE's published process for the development of interventional procedures guidance. This would encompass, for example, a failure to refer new evidence to the Committee even though it is relevant.

Ground 2: factual errors in the proposed guidance. This encompasses cases in which there is an objective error of material fact in the proposed final guidance. It does not include disagreements surrounding scientific or clinical interpretation, or judgement, whether this refers to the appropriateness of guidance itself, or to the weight given to 1 piece of research or evidence over another. For example, if a consultee argues that a statistic quoted in the guidance is incorrect, NICE will establish whether the proposed final guidance misquoted the statistic or whether there were 2 or more pieces of evidence available and 1 piece was preferred because the Committee considered it to be the more reliable. The latter would not constitute a factual error, but a difference of scientific or clinical judgement.

The resolution panel does not consider a resolution request unless the grounds for resolution are clearly identified and meet either 1 or both of the grounds set out above. Resolution requests concerning the scientific judgement of the Committee are not permissible.

15.2 Eligibility to make a resolution request

After the Guidance Executive authorises publication, all consultees who responded to the consultation document and completed a confidentiality statement are alerted electronically to the start of resolution. They are given access to the revised guidance document, updated literature search and anonymised consultation comments with NICE's responses to them.

Only consultees who responded to the consultation process are eligible to make a resolution request. It is therefore important that any organisation or individual who may wish to make use of the resolution process submits a consultation response at the appropriate stage. Individuals and organisations should bear in mind that the prepublication guidance may be significantly different from the consultation document because of consultation responses received and considered by the Committee when formulating its final recommendations.

15.3 Resolution requests

Individuals and organisations have 15 working days after the alert to request resolution on 1 or both of the grounds of breach of process and factual accuracy. Requests may be made by email, fax or letter to the Associate Director of the programme. Those making requests should specify the remedy that they seek, so that NICE can fully understand the nature of their concern and provide an appropriate remedy.

If a request is received, publication of guidance is paused pending an investigation of the points raised. When no requests are received, the guidance is published as soon as possible after the deadline for receipt of resolution requests has passed.

15.4 Initial scrutiny of resolution requests

All resolution requests are subject to an initial scrutiny process. If a request is received, the programme team investigates the matters raised and reports the findings to the Centre Director who, as part of the initial scrutiny process, decides whether the request falls within the scope of the resolution process. The initial scrutiny process will be completed within 15 working days of the close of the resolution period.

If, on initial scrutiny of a resolution request, the Centre Director considers that the breach of process ground (ground 1) does not appear to have been met, or does not have a reasonable prospect of success, the programme team relays this decision to the organisation or individual requesting resolution and the guidance proceeds to publication. If the Centre Director considers that the breach of process ground (ground 1) appears to have been met, the programme team convenes the resolution panel (see section 15.5).

If the Centre Director considers that the factual error ground (ground 2) does not appear to have been met, or does not have a reasonable prospect of success, the programme team relays this decision to the body or individual requesting resolution and the guidance proceeds to publication.

If the Centre Director considers the guidance contains a minor factual error or a point that needs clarification, new wording is produced and signed off by the Committee Chair without being referred to the resolution panel. An example of a minor factual change in this context would be one that would not have had an impact on the recommendations of the Committee had it been known when they considered the procedure, for example, a minor amendment to the description of the way in which the procedure is carried out. The guidance then proceeds to publication.

If the Centre Director considers that a major factual error appears to have been made, the programme team convenes the resolution panel. The resolution panel would need to meet, for example, if the consultee raises a substantial challenge to the contents of the guidance document that could not be remedied by minor amendment.

Sometimes more than 1 resolution request is received for a procedure, but not all requests are referred to the resolution panel. Then, the consultees whose requests have not been referred to the panel are informed that the panel is to be convened, and that they will be told of the outcome of their request at a later date when the outcome of the panel is made known. This is to avoid pre‑empting the outcome of resolution.

Table 3 Initial scrutiny of resolution requests

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

15.5 The resolution panel

The resolution panel consists of 2 NICE Board members (a Non‑Executive Director and an Executive Director). The resolution panel decides whether there has been a breach of process or factual error and, if so, what action is appropriate.

Meeting

If the initial scrutiny process finds that the resolution grounds have been met, the resolution panel will normally meet within 20 working days of the conclusion of the initial scrutiny process.

The programme team prepares a briefing for the resolution panel, which forms the basis for its consideration of the resolution request. In the case of ground 1, this means establishing what process was followed in the development of the guidance and what events or omissions have been alleged by the party requesting resolution. In the case of ground 2, this involves setting out what evidence and judgements lay behind the parts of the guidance that are alleged to contain errors.

The Committee Chair and Programme or Associate Director attends meetings of the resolution panel to provide clarification to the panel members if needed. The Chair is not a member of the panel and does not formulate the outcome of resolution. Members of the programme team may also attend to answer questions from the resolution panel members.

The outcome of resolution

  • Ground 1: breach of process

With requests for resolution under ground 1, the resolution panel will find either that there has been no breach of process (so the guidance is published as proposed) or that there has been a breach of process.

If there has been a breach, the resolution panel decides what action is appropriate to remedy the breach. This is likely to mean repeating the process from a certain point, and may include referral back to the Committee or reopening consultation when necessary.

  • Ground 2: factual error

With requests for resolution under ground 2, the resolution panel will find either that there are no factual errors and that the guidance will be published as proposed, or that there were factual errors (or elements to be clarified), in which case an amended version of the guidance is produced.

When a factual error is identified in the guidance, the resolution panel considers whether the error can be corrected before publication or whether the Committee should review the wording of the guidance document in light of the error identified.

If it is decided under ground 2 that the wording of the guidance should be changed, the programme team, in consultation with the Centre Director, considers whether there is a need for further consultation or whether to publish the guidance containing the amended wording without further consultation. Further consultation would normally be needed if there is a proposal from resolution to review or revise a recommendation in the guidance. Other changes to the guidance not involving the actual recommendations could also result in further consultation before the guidance is published if these changes are significant.

Table 4 Outcome of resolution panel meeting

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

15.6 Communicating the outcome of resolution

The programme team implements the panel's decision and informs the individual or organisation that initiated the resolution process, and all other consultees who made a resolution request on that procedure, of the outcome of resolution. This normally occurs 2 days before the guidance is due for publication. This does not apply if the Committee needs to reconsider the guidance.

The decision reached by the resolution panel and communicated to the person who requested the resolution is final in terms of NICE's process.

It is essential that NICE interventional procedures guidance is factually accurate and supports safe practice. Occasionally, questions of factual accuracy or safety are raised after resolution has closed or after the guidance has been published. The programme team may then investigate any factual inaccuracies or issues of safety, irrespective of timing. This may involve NICE making changes to items published on the website, including the guidance itself.