Developing NICE guidelines: the manual

The committee chair

The chair guides the committee in terms of task (developing the guideline, focusing on any referral, the scope and timescale) and process (how the group works). The chair helps the committee to work collaboratively, ensures a balanced contribution from all committee members, and is mindful that some members may need support to ensure full participation.

The chair is appointed for their expertise and skill in chairing groups, and although they may have some knowledge of the topic, this is not their primary role in the group. Specialist knowledge is provided by other committee members, including in many cases a topic adviser (see the section on topic-specific committees).

The chair ensures adherence to NICE's equality scheme and that the committee takes account of NICE's principles. The chair and a senior member of the developer's team consider any potential conflicts of interest of committee members. The chair also ensures that the guideline recommendations reflect the evidence and the committee's considerations. The chair should ideally be appointed before guideline scoping and may contribute to early development of the scope. NICE has some chairs who may be appointed to chair more than 1 topic‑specific committee (see the section on topic-specific committees). More details on the role of the chair can be found in the appendix on guideline committee Terms of Reference and Standing Orders.

Core members of standing committees

The number of core members of a standing committee depends on the complexity and breadth of the guideline programme, but is usually between 6 and 12. This number allows members to contribute effectively to discussions while including a broad range of experience and knowledge. Core members should include at least 1 practitioner member.

Some core members will have experience of commissioning or implementing interventions, services or care at regional and local levels. Others will have specific expertise in assessing the quality of the evidence presented to the committee, and in its interpretation.

Core members should include at least 1 lay member. Lay members help ensure that the committee's recommendations are relevant to specific groups or to the general public. They also help to identify where the recommendations should acknowledge general or specific preferences and choice by people using services, family members and carers, or members of the wider public.

Core members of a standing committee are appointed to a single committee for a 3‑year term in the first instance. All members are eligible for re‑appointment after 3 years.

Topic expert members of standing committees

When a new guideline is allocated to a standing committee, the core members of the committee are complemented by topic expert members. They have specialist knowledge of the topic and may include providers, commissioners and practitioners, and should include at least 1 lay member. The lay member either has direct experience of the topic or is a member of a relevant organisation or support group. The number of topic expert members varies but should be no more than half of the total number of committee members.

Topic expert members are usually recruited for a specific guideline, but may be appointed for up to 3 years, at the discretion of NICE, so that they can work on subsequent related guidelines. This might mean they move between standing committees during their term, depending on the guidelines being produced. All members are eligible for reappointment after 3 years.

The process of appointing topic expert members is completed at least 6 weeks before the first committee meeting for the guideline and takes into account the final scope of the guideline. Topic expert members are full members of the committee, with voting rights. They join in discussions, contribute to formulating recommendations and count towards the quorum.

The topic adviser of a topic-specific committee

A topic adviser with specialist knowledge may be appointed to a topic-specific committee (for example, when the committee chair does not have topic expertise). The topic adviser is a member of the committee but also supports the developer. The topic adviser contributes to the development of the scope (see the chapter on the scope) and is therefore appointed before scoping work starts.

The topic adviser's exact responsibilities depend on the guideline and the expert input needed. Responsibilities may include working with the technical analyst on the evidence reviews (if topic-specific knowledge is needed), or checking the guideline to ensure that the terminology and language are correct.

Practitioner and professional members of topic-specific committees

Practitioner and professional members of a topic-specific committee may be recruited before the scope is finalised (see the section on stages of scope development in the chapter on the scope). They should reflect the views and experiences of practitioners, professionals, providers and commissioners working in the area covered by the guideline.

Practitioner and professional committee members have appropriate knowledge and skills; detailed research expertise is not necessary, although an understanding of evidence-based practice is essential and some experience of service transformation or delivering integrated services across boundaries is desirable. Practitioner and professional members contribute their own views to the committee and do not represent the views of their professional organisations.

A topic-specific committee usually includes between 9 and 11 practitioner or professional members (occasionally when the topic is very broad, more members may be recruited). The spread of interest and experience of practitioner and professional members is agreed between the developer and members of NICE staff with responsibility for guideline quality assurance.

Lay members of topic-specific committees

All committees have at least 2 lay members with experience or knowledge of issues that are important to people using services, family members and carers, and the community affected by the guideline. This helps to ensure that the guideline is relevant to people affected by the recommendations and acknowledges general or specific preferences and choice.

Lay members usually have direct experience of the condition, services or topic being covered by the guideline – as a patient, person using services, carer or family member, or as a member or an officer of a lay stakeholder organisation or support group. However, they do not represent the views of any particular organisation.

When appropriate, lay members may be recruited before the scope is finalised (see the section on stages of scope development in the chapter on the scope).

Expert witnesses

If the committee does not have sufficient evidence to make recommendations in a particular area (for example, if there are gaps in the evidence base or subgroups are under-represented), it may call on external experts (expert witnesses) who can provide additional evidence from their experience and specific expertise, to help the committee to consider and interpret the evidence.

Once the committee has established that it needs evidence in a particular area from an expert witness, committee members and NICE's people and communities team are asked by the developer to nominate experts who might fulfil this role. Expert witnesses may also be identified by the developer or NICE staff with a quality assurance role, or if required, by active recruitment through stakeholder organisations and the NICE website. Experts may be drawn from a wide range of areas as appropriate, including government and policy, research, practice, people using services and carers or the community and voluntary sector.

Before seeking expert testimony from children or other vulnerable groups, expert advice should be sought about the ethics and implications of the involvement. Adjustments and additional support may be needed, such as giving testimony via video recording, or in private session. There is no minimum age for young people providing expert testimony. If a child or young person attends a committee meeting, they must be accompanied by their parent, carer or other appropriate adult with responsibility for their welfare (see appendix 1 on children, young people and safeguarding in NICE's patient and public involvement policy).

Expert witnesses attending a committee meeting are invited to answer questions from members of the committee. They may be invited to present their evidence at a committee meeting in the form of expert testimony based on a written paper. The written expert testimony paper may be shared with the committee before the meeting or the paper may be submitted by the expert after the meeting. Sometimes the developer writes up the expert testimony and agrees this with the witness after the meeting. Expert testimony papers are posted on the NICE website with other sources of evidence when the guideline is published.

Expert witnesses are not members of the committee; they do not have voting rights, and they should not be involved in the final decisions or influence the wording of recommendations.

Committee support roles

The committee is assisted by a range of people, who have a role in:

These are technical and project management staff from the developer or NICE staff with a quality assurance role. Other NICE staff (such as content designers and members of the NICE resource impact assessment team) also attend some meetings. They are not committee members and do not have voting rights at committee meetings.

Public access to meetings

Enabling public access to NICE advisory body meetings is part of NICE's commitment to openness and transparency. It enables stakeholders and the public to better understand how evidence is assessed and interpreted, how consultation comments are taken into account and how recommendations are formulated. Public access to all guideline committee meetings is not possible because of financial pressures. In addition, all or part of a meeting may need to be held in closed session because expert evidence involves the disclosure of a person's health problems, or the consideration of national policy that has not been agreed by ministers, or the drafting of recommendations might affect commercial interests.

Standing committee meetings are usually held in public; topic-specific committee meetings are held in private. Public access to standing committee meetings is arranged according to the NICE policy (see the appendix on guideline committee Terms of Reference and Standing Orders).

To promote public access to standing committee meetings, NICE publishes a notice with a draft agenda, alongside details of how the meeting can be accessed, on its website in advance of the meeting.

Standing committee meetings may be held entirely in public or split into 2 parts: part 1 with the public having access, and part 2 a closed session with no public access. On rare occasions a standing committee meeting may be entirely closed. The decision to hold a closed session is made by the committee chair and the NICE centre director responsible for the guideline.

Declaring interests

All committee members, including the chair, and anyone who has direct input into the guideline (including the developer and expert witnesses) must declare any potential conflicts of interest in line with NICE's policy on declaring and managing interests for NICE advisory committees. For committee members, including the chair, this happens on application for committee membership. Any relevant interests, or changes to interests, should also be declared publicly at the start of each committee meeting. Before each meeting, any potential conflicts of interest are considered by the committee chair and a senior member of the developer's team. Any decisions to exclude a person from all or part of a meeting should be documented. Any changes to a member's declaration of interests should be recorded in the minutes of the meeting. Declarations of interests are recorded in a register for each guideline and are published on NICE's website.

Code of conduct and confidentiality

NICE has developed a code of conduct for committee members (see the appendix on code of conduct for committee members), which sets out the responsibilities of NICE and the committee, and the principles of transparency and confidentiality.

Everyone who sees documents containing confidential information or who is party to part 2 (closed session) discussions about a guideline before public consultation must sign a confidentiality agreement before becoming involved.

If committee members are asked by external parties – including stakeholders, their professional organisation or the media – to provide information about the work of the committee, they should contact the developer for advice.

Terms of Reference for committees

Details of the role of committee members, and the procedural rules for managing the work of committees, can be found in the appendix on guideline committee Terms of Reference and Standing Orders.

All committee members should be committed to developing NICE guidelines according to NICE's methods and processes, and to working within NICE's equality scheme.

New members, with the exception of co‑opted members, should not usually be added to the committee after the first meeting, because this may disturb the group dynamic. However, when a resignation leaves a gap in experience and expertise, recruitment of new members is considered.

Induction

All committee members, including topic expert members and co‑opted members, receive an induction from NICE or the developer covering:

The induction may be scheduled on appointment of the member, or during an early committee meeting. To work effectively, committee members may need training and support in some technical areas of guideline development, such as systematic reviewing and economics. Such sessions are arranged by NICE or the developer, as required. Before beginning their work in a committee, members may also be invited to observe a meeting of another committee.

All committee members are encouraged to provide information to NICE staff about any needs they have for additional support to enable them to participate fully in the work of the committee.

Training for the committee chair

The person selected to perform the role of committee chair may need support and training so that they can carry out their role effectively. The chair needs in‑depth knowledge of the NICE guideline development process and an understanding of group processes. Anyone appointed as a committee chair is required to attend the chairs' induction session provided by NICE, which in addition to the above covers the key tasks that the chair is expected to perform, including:

In addition to the specific induction session, the developer should identify and meet any additional training needs of a committee chair. The developer may consider a 'buddying' approach in which a new committee chair learns from someone with previous experience.

Training for lay members

Lay members of the committee are offered support and training by NICE's people and communities team. This is in addition to the induction and any training they receive alongside other members of the committee, and allows specific questions and needs to be addressed. The training advises lay members about effective participation in guideline development and gives them the opportunity to learn from people who have had a lay role on previous committees. Public involvement advisers also offer ongoing support tailored to a lay member's needs.

General principles

The committee is multidisciplinary and its members bring with them different beliefs, values and experience. All these perspectives are valued by NICE and should be considered. Each member should have an equal opportunity to contribute to the development of the guideline, and should receive any additional support they need to do this. For this reason, it is important for the chair to check that the terminology used is understood by all committee members and is clarified if needed. The chair should ensure that there is sufficient discussion to allow a range of possible approaches to be considered, while keeping the group focused on the guideline scope, the evidence being reviewed, and the timescale of the project.

Meeting documentation

Meeting documentation is usually sent to committee members to arrive at least 5 working days before a committee meeting.

The developer takes formal minutes during committee meetings and these are reviewed and approved at the next meeting. The approved minutes of each meeting are posted on the NICE website during guideline development. The information includes:

Meeting schedule

The number of committee meetings depends on the size and scope of the topic. There are usually between 2 and 15 meetings for each topic; most are 1‑day meetings, but some may take place over 2 days.

Record-keeping

The developer should maintain records throughout guideline development and ensure that record-keeping standards are appropriate for audit. The following information should be readily available if requested by NICE staff with a quality assurance role:

Reaching agreement

Committee members need to make collective decisions throughout guideline development. This can include agreeing the review questions (see the chapter on developing review questions and planning the evidence review) and protocols (see the section on planning the evidence review in the chapter on developing review questions and planning the evidence review), interpreting the evidence to answer these questions (see the chapters on reviewing evidence and incorporating economic evaluation) and developing recommendations (see the chapter on interpreting the evidence and writing the guideline).

There are many different approaches to making group decisions, and there are no rules that set out which approach should be used in which circumstances. Also, because committees work in different ways to reflect their individual membership, it is difficult to be prescriptive about the approach that should be used. In most cases, the committee reaches decisions through a process of informal consensus. In all cases the approach used should be documented.

The role of the committee chair in reaching consensus is to ensure that:

The chair needs to allow sufficient time for all committee members to express their views without feeling intimidated or threatened, and should check that all of them agree to endorse any recommendations. If the committee cannot come to consensus in a particular area, the reasons for this should be documented, and the wording of the recommendation reflect any underlying uncertainty (see the chapter on interpreting the evidence and writing the guideline).

Formal consensus within the group

In exceptional circumstances, some committees may choose to use formal voting procedures or formal consensus methods for certain decisions (for example, when members disagree or when there is no evidence; see the appendix on guideline committee Terms of Reference and Standing Orders). NICE does not offer advice on which of the many methods might be used. However, the methods for achieving consensus should be recorded in the minutes of the meeting and a clear statement made about the factors that have been considered. This should also be documented in the guideline methods, ensuring the process is as transparent as possible.

The views of all committee members should be considered, irrespective of the method used to reach consensus.

Formal consensus outside the group

In certain cases, for example, if the literature search has found no evidence that addresses the review question, the committee may wish to identify wider views on best practice by using formal consensus methods (such as the Delphi technique or the nominal-group technique) outside of the group. The use of these methods and the constituency of the wider group should be discussed on a case‑by‑case basis with members of NICE staff with responsibility for guideline quality assurance, and the NICE people and communities team lead. The final decision on whether these methods are warranted is made by NICE staff with responsibility for quality assurance. If it is decided that such methods may be used, the planning and methods will be clearly documented and the methods described in the guideline. In all cases the approach used should be documented.