The NICE public health guidance development process (third edition)

5.2.1 Role of the PHAC Chairs

The PHAC Chairs guide each PHAC in developing the guidance, focusing on the referral, scope and timescale. Chairs also ensure that the perspectives of all members are listened to, and that each member has an equal voice in the process of guidance development. It is important to check that all members understand all the terminology used.

Chairs ensure that a range of possible approaches to the development of the guidance is considered, and checks that all the members agree to endorse any recommendations.

PHAC Chairs are experts in public health but may not have expertise in individual guidance topic areas. The Centre for Public Health Excellence (CPHE) associate director is the NICE lead for the guidance, and works with the CPHE project team (see chapter 7) and the PHAC to provide topic support and advise the Chairs on issues of process and method.

5.2.2 Role of the core PHAC members

Some core PHAC members will have been involved in commissioning or implementing public health interventions 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.

Community members are expected to ensure that the committee's recommendations are relevant to specific groups of people, or to the general public. They also help to identify where the guidance should acknowledge general or specific preferences and choice.

5.2.3 Topic expert members

When a new guidance topic is allocated to one of NICE's PHACs, it is complemented by a number of topic expert members. The topic expert members are usually recruited for a specific guidance topic, but may be appointed for up to 3 years so that they can work on subsequent guidance. They are recruited through a competitive process, following relevant NICE recruitment policy (see section 7.4). The process of appointing or allocating topic expert PHAC members is completed at least 6 weeks before the first committee meeting on that topic. Topic expert members are part of the committee, join in discussion and contribute to the formulation of recommendations. They have full member status, including voting rights, and count towards the quorum.

5.2.4 Co-opted members

If required, additional members may be co-opted to the PHAC for 1 or more specific meetings. The process of identifying and co-opting PHAC members is agreed with the Chairs and completed at least 6 weeks before a committee meeting. Co-opted members are part of the committee, join in discussion and contribute to the formulation of recommendations, however they are not full members, do not have voting rights and do not count towards the quorum.

5.2.5 Invited experts and observers

Each PHAC may also invite external experts to help in its consideration and interpretation of the evidence. Experts may be drawn from a wide range of areas as appropriate, including government and policy, research, practice, or the community and voluntary sector. They are invited to present their evidence in the form of expert testimony at a PHAC meeting as a presentation based on a written paper, and to answer questions from members of the committee. The expert paper is made available on the NICE website with other sources of evidence when the guidance is published (see section 3.4 for further information about expert testimony). These experts are not members of the PHAC, and should not be involved in decision making, or take part in formulating recommendations.

Observers, including NICE staff, need permission from the PHAC Chairs to attend a PHAC meeting. An observer should sit apart from the committee and should not enter into the discussions unless invited to do so by the Chairs. Observers do not have voting rights.

5.2.6 Meetings in public

Members of the public may attend a PHAC meeting as public observers. They are not involved in the business of the meeting and cannot ask questions, take part in voting or put their views to the committee. Public observers must register for the meeting via the NICE website (see Meetings held in public). Registration opens 20 working days before the meeting, and closes 10 working days before the meeting. Up to 20 places are available. The meetings-in-public coordinator at NICE is responsible for coordinating and liaising with public observers.

Holding advisory body meetings in public 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.

PHAC meetings may be held entirely in public or split into 2 parts: part 1 with the public present and part 2 with the public excluded. A closed session or part 2 may be required if for example, expert evidence involves the disclosure of an individual's health problems, or the consideration of national public health policy that has not been agreed by ministers, or if the drafting of recommendations might affect commercial interests. On rare occasions a meeting may be entirely closed.

5.4.1 Declaring interests

Declarations of interests should be made by committee members and participants in line with NICE's policy (see Code of practice for declaring and dealing with conflicts of interest [2008] on the NICE website). Everyone participating in PHAC meetings, including standing and co-opted committee members, experts, evidence providers and members of the evidence review teams, should complete a declaration of interests form before the meeting takes place. Any potential conflicts are considered by the Chairs and the CPHE directors before the meeting; any decisions to exclude participants should be documented. Any relevant interests, or changes to interests, should also be declared publicly at the start of the meeting. Any changes to a member's declaration of interests should be recorded in the minutes of the meeting.

5.4.2 Confidentiality

All PHAC members – and all those who see the documents, or who are party to discussions before public consultation on the draft guidance – must sign a confidentiality agreement form before becoming involved in guidance development. The CPHE project team (see chapter 7) keeps copies of the signed forms.

5.5.1 Induction

On joining a PHAC or the topic expert pool, all new core and topic expert members attend an induction session organised by the CPHE project team (see chapter 7). At this meeting, the CPHE project team presents and discusses the process of guidance development and the development of recommendations, the role of evidence of effectiveness and cost effectiveness in decision making, how members contribute, and the role of the PHAC. Members are also informed of the principles outlined in the report Social value judgements: principles for the development of NICE guidance, and NICE's equality scheme.

Staff from the PPIP and other NICE teams may also explain other aspects of the guidance development process.

Before beginning their work in a PHAC, new topic expert members may also be invited to observe another PHAC meeting.

5.5.2 Before the first PHAC meeting

Core PHAC members and the Chairs may wish to be involved in preparing the scope, although the responsibility for this is with the associate director and the CPHE project team.

5.5.3 PHAC meetings

There are usually 8 PHAC meetings for guidance topics following a standard process, and 3 for those following a short process. PHAC meetings are generally held at intervals of 6 weeks. Meeting papers are usually sent to the PHAC members 8 working days before the meeting. PHAC meetings are held in public, although these meetings may be divided into 2 sections as described in section 5.2.6.

The quorum of the PHAC meeting is 50% of all members (including the Chair). Guidance recommendations cannot be developed if the meeting is not quorate. PHAC meetings are formally recorded and the minutes are approved at the next meeting. The agreed minutes are published on the NICE website.

A draft outline agenda for the meeting is posted on the website 20 working days before the committee meeting. The final agenda is posted 5 working days before the meeting.

5.5.4 The first PHAC meeting

At its first meeting, the PHAC will consider the background to the referral, the scope, and plans for the evidence reviews and economic analysis that will address the scope. Topic expert members may be invited to present on their area of work, practice or experience, in order to familiarise core members with key topic issues. If a contracted evidence review team are providing some or all of the evidence reviews, they will usually be invited to present their plans to the PHAC for comment.

The PHAC will be asked to consider and discuss whether the planned evidence reviews and economic analysis are likely to answer the key questions, and make suggestions for any amendments or improvements. They may also be asked to discuss any gaps in the scope and plans, to suggest potential areas for expert testimony, and experts to provide that testimony, and to discuss and consider evidence. Members of the evidence provider team normally attend the first PHAC meeting, but do not contribute to the development of any recommendations.

5.5.5 Development meetings: reviewing the evidence

Evidence is reviewed during the first 6 meetings for guidance following a standard process, or 2 meetings for guidance following a short process. The PHAC considers each evidence review, the economic appraisal, and any additional evidence, (for example, expert testimony, see section 3.4), discusses whether these answer the key questions in each review, and summarises each area of evidence.

Members of the review team normally attend the PHAC meetings at which the evidence reviews are considered. They do not contribute to the development of recommendations.

The role of the review team in the PHAC meetings is to:

5.5.6 Drafting recommendations

The PHAC produces draft recommendations that are informed by the evidence and economic analysis. They also suggest recommendations for research to address uncertainties and gaps in our understanding.

The CPHE project team drafts the guidance document (see section 5.5.6), including the recommendations, according to evidence presented at the PHAC meetings and decisions made by the PHAC. The PHAC then revises the draft, to produce the consultation version of the guidance.

The PHAC also considers the impact of potential recommendations on equity and the extent to which they promote equality and diversity, and ensures that they are in line with NICE's equality scheme.

5.5.7 Finalising recommendations

The PHAC holds a final meeting after the consultation on the draft guidance (see section 3.5). At this meeting, the PHAC amends the recommendations in light of the consultation responses and the results of any fieldwork (to test recommendations against the experience of practitioners). For more information on the PHAC's role in drafting the recommendations see Methods for the development of NICE public health guidance – third edition (2012).

5.5.8 Revising the guidance

After the final PHAC meeting, the CPHE project team revises the guidance document, including the revised recommendations, according to the decisions made by the PHAC. The final guidance document includes:

5.5.9 Finalising the guidance

When the Chairs, associate directors and CPHE director have approved the final guidance, it is submitted for sign off by the NICE Guidance Executive (see chapter 10).

5.5.10 Implementation

The Chairs and designated members of the PHAC may work with the CPHE project team and the implementation lead to develop and approve tools to support implementation of the guidance (see section 3.7).