Process and methods
11 The consultation process and dealing with stakeholder comments
Consultation with stakeholders, which lasts 6 weeks for standard social care guidance, is an integral part of the NICE guidance development process. Comments received from stakeholders are a vital part of the quality-assurance and peer-review processes, and it is important that they are addressed appropriately. This section describes the principles of responding to stakeholder comments following consultation.
This section also includes information on what to expect during the consultation process, and the circumstances in which a second consultation may be needed.
This section describes what to expect during the consultation phase.
The draft version of the guidance is published on the NICE website for consultation. Registered stakeholders are informed by NICE that it is available.
NICE does not routinely commission peer review from external experts, but occasionally additional external review of part or all of a social care guidance topic may be arranged. Experts may include social care practitioners, those commissioning care, healthcare professionals or people who can represent the perspective of service users and carers. These external reviewers should be named in the final guidance.
External expert review may take place during guidance development or at the consultation stage. If it occurs during development, the process and comments remain confidential with only the list of experts published in the final guidance. Comments from external expert witnesses during guidance development should be discussed by the whole Guidance Development Group (GDG).
If external expert witnesses comment during consultation, their comments are responded to in the same way as comments from registered stakeholders and are published in the guidance consultation table on the NICE website under 'external expert witnesses'. All external expert witnesses are required to complete a declaration of interests form (see section 3.2.1).
NICE staff also comment on the consultation draft of the guidance, before and during the consultation. These staff include NICE's Public Involvement Programme lead, implementation adviser and the lead editor for the guidance, as well as technical advisers, the programme manager and the Health and Social Care Directorate lead for the guidance.
This section describes how to respond to comments received from stakeholders about the draft guidance. The same principles apply when responding to comments on the draft scope (see section 2.6.1).
Most comments are received from registered stakeholders. These comments, and the responses to them, are sent to stakeholders with the advance copy of the guidance, and are posted on the NICE website when the guidance is published (see section 12.1).
Comments received from non-registered stakeholders, and comments received after the deadline for submission, are not considered and are not responded to; such comments will be returned to the sender.
The following key points should be taken into account when responding to comments from stakeholders:
Each comment must be acknowledged and answered as fully and as factually as possible.
If changes are made to the scope or guidance as a result of the comment, this must be made clear in the response. If no changes have been made, it should be made clear why not.
For draft guidance, responses to comments and changes to the guidance must be agreed with the GDG before publication.
In exceptional circumstances, the Health and Social Care Directorate director may consider the need for a further 4-week stakeholder consultation after the standard consultation. This additional consultation may be needed if either:
information or data that would significantly alter the guidance were omitted from the first draft, or
evidence was misinterpreted in the draft and the amended interpretation significantly alters the guidance.
NICE makes the final decision on whether to hold a second consultation.