Process and methods
Stakeholders play an integral role in developing good practice guidance (GPG) and are encouraged to get involved at all stages. Organisations representing the NHS, social care, patient and carer representative bodies, as well as government organisations and private sector organisations with an interest in a particular topic, can register as stakeholders for a particular GPG topic. Registered stakeholder organisations can comment on the draft GPG during consultation (see section 13).
The following organisations can register as stakeholders for NICE GPG:
national patient and carer organisations that directly or indirectly represent the interests of people whose care will be covered by the GPG
local patient and carer organisations, but only if there is no relevant national organisation (see section 5.1.2)
national organisations that represent the health and social care professionals who provide the services described in the GPG
companies that manufacture the medicines or devices used in the area covered by the guidance and whose interests may be significantly affected by the GPG
providers and commissioners of health and social care services in England, Wales and Northern Ireland
statutory organisations including the Department of Health, NHS England, the Welsh Government, Healthcare Improvement Scotland and the Care Quality Commission
research organisations that have carried out nationally recognised research in the area.
NICE GPG is produced for the NHS in England and Wales. Therefore, a 'national' organisation is defined as one that represents England or Wales has a commercial interest in England or Wales.
For reasons of capacity, local patient and carer and professional groups cannot register as stakeholders unless there is no national organisation representing the group's specific interests.
Individual people cannot register as stakeholders. However, anyone with an interest in the topic is encouraged to participate by contacting a registered stakeholder and expressing their views to them. Additionally, external expert advisers may be identified by the NICE project team (see section 5.5).
Once new topics for the GPG are agreed after the topic selection process (see section 2), they are listed on the NICE website along with details of how to register as a stakeholder.
At the start of the development process for new GPG topics, an email is sent to potential stakeholders to alert them to the topic and the stakeholder registration process. The alert is sent to:
people signed up to receive NICE's medicines and prescribing email alerts
a list of organisations identified by the NICE project team that may have an interest in the GPG topic, which may include:
patient and carer organisations
local authority organisations
industry representative organisations
organisations that registered as stakeholders for previous GPG or other relevant NICE guidance/standards.
Delegates of any possible scoping workshop are also encouraged to identify potential stakeholders who are not registered.
The NICE project team cannot guarantee that all organisations that may have an interest in a particular GPG topic will be notified about the topic. Potential stakeholders are encouraged to visit the website regularly to check the list of GPG topics in development and register if appropriate.
Stakeholder organisations are encouraged to register their interest in a particular piece of GPG as soon as possible after the topic is announced (see section 2). This enables them to participate in the early stages of guidance development (including development of the scope as appropriate). However, organisations may register as stakeholders at any time in the development process and can be involved in the remaining stages of guidance development.
To register an organisation as a stakeholder, registration details (name of organisation, name of contact and email address) should be entered using the stakeholder registration page on the website. Organisations can register for any currently selected GPG topic. Organisations receive an automated response once the registration process is completed. Stakeholder applications are reviewed and organisations are contacted if additional information is needed or they are not eligible to be a stakeholder.
The current list of registered stakeholders for each GPG topic is published on the website at the time of consultation and updated when the GPG is published.
Stakeholders can be involved in different ways throughout the process and this varies depending on the needs of the specific topic. Stakeholders may, where appropriate for the GPG being developed:
All registered stakeholders are notified when the GPG is available for consultation and when the final GPG is published.
Although NICE does not routinely commission peer review from external experts, the NICE project team may occasionally consider arranging additional external expert review of specific sections or the full content of the GPG. These experts may include health and social care professionals, people with a patient and carer perspective, or those commissioning care.
The expert review may take place during GPG development or at the consultation stage. If the review occurs during development, the process and comments remain confidential, but the adviser(s) is named in the final GPG. Comments from external expert advisers during the development of the GPG are discussed by the GDG.
If external advisers comment during consultation, their comments are responded to in the same way as comments from registered stakeholders and are published in the GPG consultation comments table on the NICE website under 'expert advisers'. All expert advisers are required to complete a declaration of interests form.