NICE process and methods

4 The role of stakeholders in the guidance development process

4 The role of stakeholders in the guidance development process

Stakeholder organisations have an essential role in the development of public health guidance. This chapter describes how potential stakeholders are identified and encouraged to contribute.

The process is managed by the Centre for Public Health Excellence (CPHE) project team (see chapter 7) in conjunction with the Patient and Public Involvement Programme (PPIP). Stakeholders comment on:

  • the draft scope

  • the draft guidance and the evidence.

These consultation documents are available on the NICE website.

Stakeholders in relevant areas may also be invited to contribute to Topic Advisory Workshops (TAWs) (see chapter 2).

4.1 Who are stakeholders?

For the purposes of NICE's public health guidance development process, stakeholders are:

  • national patient, carer, voluntary organisations or charities that directly or indirectly represent the public health interest, or disease prevention, relating to people covered by the guidance in England

  • national organisations representing public health, healthcare and other professionals who provide the activities and services covered by the guidance in England

  • local authorities, and representative bodies of local government

  • public and private utilities in England

  • providers and commissioners of public health, health and social care in England

  • commercial industries which are relevant to the public health arena, whose interests may be affected by the guidance

  • The Department of Health and other relevant Government departments and agencies

  • statutory organisations including Care Quality Commission, Ofsted, National Screening Committee, Joint Committee on Vaccination and Immunisation, and Local Government Association

  • Government or national statutory organisations in Wales, Northern Ireland and Scotland, including NHS Health Scotland, the Welsh Assembly Government

  • research organisations and academic institutions across the UK

  • overseas agencies that have a remit covering England, including the World Health Organisation, European Centre for Disease Prevention and Control

  • Equalities groups.

A 'national' organisation is defined as one that covers England. NICE public health guidance applies to England only, although other parts of the United Kingdom may choose to review and adapt it to their own circumstances.

Registered stakeholders for each guidance topic are listed on the NICE website.

4.1.1 People not considered as stakeholders

For practical reasons, individuals cannot usually register as stakeholders. However, they can participate by expressing their views to a registered stakeholder, such as their national professional body or organisation.

4.2 Stakeholder registration

To participate in the early stages of the guidance development process, potential stakeholders are advised to register as soon as possible, ideally within 6 weeks of the announcement of a new topic on the NICE website. However, they can register at any time.

4.2.1 How NICE alerts potential stakeholders

To publicise new topics for guidance development, NICE:

  • posts the topics on its website, with details on how to register as a stakeholder

  • contacts stakeholder organisations that registered for previous relevant guidance

  • writes to relevant stakeholders of previous guidance that will be updated by the new guidance

  • writes to community and professional organisations that may have an interest in the new topic.

4.2.2 How to register an interest

Stakeholders register an interest by completing the stakeholder registration form for public health guidance. This form is available on the NICE website on the relevant guidance topic page.

Forms can be completed online, emailed to phguidance@nice.org.uk or returned to NICE by mail.

4.3 Stakeholders' input to the scope

The scope is drafted by the CPHE project team (see section 3.3 and chapter 7).

The draft scope is published on the NICE website for a 4-week consultation period. Registered stakeholders are sent a copy, and are asked to submit their comments (see section 4.3.2).

4.3.1 Stakeholder meeting

By exception, where a referral in a new area has been received, or where a guidance topic or an area of practice has unique complexities, a stakeholder meeting may be held. All registered stakeholder organisations are invited to a stakeholder meeting, during the scope consultation. Presentations are given by key staff from the CPHE project team (see chapter 7) and the PPIP. The purpose of the meeting is to:

  • provide an overview of NICE

  • provide an overview of the public health guidance development process

  • describe the opportunities for stakeholders to contribute throughout the guidance development process

  • discuss the scope and hear stakeholders' views

  • discuss the role of the PPIP and opportunities for community stakeholders

  • discuss how the Public Health Advisory Committee (PHAC) is recruited, and how it functions.

All stakeholders registered for the topic are invited to attend the meeting. Organisations are allowed to send a maximum of 2 people.

A stakeholder meeting does not replace the formal process of submitting comments via the official email address for the project.

4.3.2 Commenting on the scope

All stakeholders are invited to comment on the scope during the consultation. Stakeholders are asked to bear in mind the following points when commenting on the scope:

  • NICE public health guidance applies to a wide audience including the NHS and people working in local government, education, public utilities, the private sector, the voluntary sector and central government developing public and social policy.

  • Guidance is published within 2 years of the development process starting (see chapter 3), so that information is up to date at the point of publication. If the scope is too wide it will not be possible to complete the work in time, so the scope must be restricted to what can be realistically covered.

  • The scope may specify or exclude certain groups. It is helpful if stakeholders can comment on whether such inclusions or exclusions discriminate on the grounds of race, disability, age, gender, sexual orientation and gender reassignment, pregnancy and maternity, religion or belief, or socioeconomic status.

Box 2. A guide to commenting on drafts of the scope and guidance

When the draft scope or guidance arrives, stakeholders should:

  • nominate a coordinating contact within their organisation

  • circulate the draft within the organisation, making it clear that it is for consultation and asking recipients to respond to the organisation's stakeholder contact (rather than directly to NICE)

  • submit the comments by the closing date for the consultation

  • send comments to the dedicated email address for the topic, including the stakeholder organisation's name in the subject box.

Stakeholders are asked to bear in mind that:

  • NICE will accept only one response from each stakeholder organisation; NICE does not have the resources to respond to individuals within registered stakeholder organisations

  • all comments received from stakeholders will be made public on
    the website

  • comments will not be considered if they are not on the correct form or if they are received after the deadline

  • NICE reserves the right not to respond to stakeholder comments if they could be considered offensive or are promoting particular services or products; such comments will not be made public on the NICE website

  • submissions of evidence are not invited at the draft scope consultation stage.

4.3.3 Finalising the scope

Once the consultation has closed, the CPHE project team (see chapter 7) produces a final version of the scope, taking into account the stakeholder comments received and the referral from the Department of Health for the guidance. The final scope is signed off by the centre director for the CPHE. All stakeholder comments – and the response to each comment – are published on the NICE website when the scope is finalised. All the responses are sent to stakeholders 5 days before publication to check that all their comments have been included and have been correctly understood.

4.4 Stakeholders' role in providing evidence

Once the scope has been agreed, the review team starts by developing the review and search protocols, then searching for evidence to answer the research questions.

In some topic areas or for some research questions the CPHE project team (see chapter 7), the evidence provider, or the advisory committee may believe that there is relevant evidence in addition to that identified by the search. In these situations, the CPHE project team may invite stakeholders to submit evidence.

A call for evidence specifies the research question being addressed and the type of evidence sought. It may be made at any point during the development of public health guidance, although usually occurs in the earlier stages of development, and stakeholders are generally given 4 weeks to respond.

For copyright reasons, NICE cannot accept copies of full papers – in electronic or hard copy form – in response to a call to evidence. Stakeholders are asked to submit references or links only, or details of contacts for unpublished research. Once all responses from stakeholders have been received, the CPHE project team then follow up all responses and obtain the relevant papers or reports.

Box 3. Types of information not eligible for consideration in a call for evidence

Promotional material.

Unsubstantiated or non-evidence-based assertions of effectiveness.

Opinion pieces.

Potentially unlawful or other inappropriate information.

The call for evidence may request relevant published or unpublished data or studies. Any confidential material should be clearly marked as such in the submission.

4.4.1 Confidential information

Box 4 explains what types of information may be considered confidential and NICE's approach to handing confidential information. When submitting evidence that contains confidential data, stakeholders should indicate which sections are confidential, for example by using the highlighter function in Microsoft Word.

When documents are prepared for consultation, any information that is still confidential will be removed, and a note added to explain what has been done. However, as a minimum, a summary or abstract of the study or economic model must be publicly available by the time the draft guidance is published for consultation. NICE needs to be able to justify the recommendations in public health guidance on the basis of the evidence considered by the PHAC. NICE and the evidence provider work with the data owners to agree a compromise between confidentiality and transparency.

Box 4. Information on data that may be considered confidential

Information that may influence share price values ('commercial in confidence') or is deemed intellectual property (that is, awaiting publication) is deemed confidential.

The relevant part of a sentence, a particular result from a table or a section of code is deemed confidential (that is, information deemed confidential should be kept to an absolute minimum).

NICE will not agree to a whole study being designated confidential. At a minimum, a structured abstract of the study or economic model must be made available for public disclosure during consultation on the guidance.

Results derived from calculations using confidential data are not considered confidential unless releasing those results would enable back-calculation to the original data.

4.5 Stakeholders' input to draft guidance

Registered stakeholders are informed via email and the NICE website when the draft guidance (containing the draft recommendations and supporting information) and the evidence reviews are available for consultation. They are given 6 weeks to comment.

Stakeholders are asked to submit comments on the form provided via the dedicated email address for the guidance. The scope should be considered when commenting on the guidance. Stakeholders may wish to include issues for consideration by the CPHE project team (see chapter 7) and the PHAC, such as:

  • a general view (either positive or negative) of the quality and content of the guidance

  • points or areas that seem to fall within the scope but are not covered by the guidance

  • potential inconsistencies in the interpretation of the evidence

  • disagreement with the interpretation of the evidence

  • the practical value of the guidance

  • issues relating to equality, diversity and potential discrimination

  • wording (for example, the clarity of the recommendations and definitions)

  • observations on the resource implications of the guidance or specific recommendations

  • suggestions for new guidance topics that arise from the draft guidance.

All the responses are sent to stakeholders on the day of publication for 5 days to check that all their comments have been included and understood. Stakeholder comments and the responses to them are then posted on the website once the guidance has been published. Stakeholders are not invited to check the guidance again before publication.

Comments received from non-registered stakeholders, and comments received after the deadline, are not considered or responded to; such comments are returned to the sender, with an explanation.

4.6 Keeping up to date with guidance topics

NICE produces a monthly e-newsletter, which gives details of forthcoming guidance, consultations on guidance in development, and future events. It also provides an e-alert facility. Both are available on the NICE website.

NICE emails reminders of consultation periods and other dates for a specific topic to all registered stakeholders. Stakeholders can also keep up to date with the progress of a project via the NICE website.

4.7 Patient and Public Involvement Programme

The main role of the PPIP is to work with the NICE project team and the PHACs to develop and support opportunities for people to be involved in developing NICE guidance (see section 9.5.4). This includes the public, members of a relevant organisation or support group and people, including carers, who will be affected by the guidance ('community members').