Process and methods

13 The consultation process

When consultation begins, NICE publishes the consultation document for comment on its website for 4 weeks. It also informs, by email, everyone who registered an interest that consultation has begun. During consultation, anyone may submit comments via NICE's website using a structured web form, or by email, fax or post. NICE only accepts comments submitted as part of the consultation process. It does not accept comments that are posted by third parties on other organisations' websites as consultation responses.

No person or organisation may submit comments of more than 20 pages, although this may be waived in exceptional circumstances at NICE's discretion. If a submission is longer than 10 pages, it should contain an executive summary of no more than 1 side of A4.

NICE is committed to promoting the values of equality and diversity through its guidance, and to eliminating discrimination. NICE encourages comments on its draft guidance from all sections of the community. Consultees are asked to highlight any ways in which draft guidance fails to promote equality or avoid discrimination, and how it might be improved.

Late comments received after the 4‑week deadline are shown to the Committee only at the discretion of the Chair, on the advice of the programme team. Late comments are usually considered if they highlight substantial new information, or are sent by ratified specialist advisers or professional organisations directly involved in patient care. The programme is not obliged to accept or note comments unless they are formally made during the consultation period.

It is up to consultees what they include in their response to consultation. However, the Committee particularly welcomes the following:

  • comments on the draft recommendation(s)

  • the identification of possible factual inaccuracies

  • additional relevant evidence, with bibliographic references where possible.

All consultation responses are potentially important to, and potentially influence, the development of the guidance, including those that are entirely supportive of the proposed guidance.

During consultation, stakeholders submitting consultation comments are invited to complete a confidentiality statement enabling them to be involved in the programme's resolution process (see section 15).

13.1 Patient organisations and members of the public

For each procedure considered by the Committee, the public involvement programme (PIP) contacts national patient organisations, if they exist, that represent the interests of patients affected by the condition(s) relevant to the procedure, including those that have a specialist interest in issues relating to equalities. The patient organisations are asked if they would like to contribute to the consultation process. Anyone wishing to receive alerts about the progress of a procedure can register as a stakeholder with the programme. Stakeholders (groups and individuals) are alerted at the start of the consultation process.

NICE only seeks expressions of interest proactively from national patient organisations. However, local branches of patient organisations and individual patients and carers are also encouraged to contribute to the consultation. Anyone interested in contributing from a patient or carer perspective can contact the PIP during the consultation if they need help to participate in the process.

NICE encourages consultees to include the following in their responses:

  • views on the draft recommendations

  • views on how well the procedure works, including benefits or drawbacks to the patient that have been overlooked

  • views on how safe (or unsafe) the procedure is, including any pain, side effects or complications.

13.2 Medical device companies

NICE encourages companies with products that are used to do the procedure to respond to the draft guidance.

NICE supplies the Association of British Healthcare Industries (ABHI) with a list of procedures that have briefs approved, and a list of procedures before public consultation. The ABHI alerts the companies whose devices it knows to be involved in doing a procedure to inform them of relevant consultations, giving them the opportunity to make consultation comments, directly to NICE.

13.3 Professional organisations

NICE encourages professional organisations to register an interest in the procedures done by their members in order to be alerted to consultation. Before consultation opens, NICE also alerts the relevant specialist advisers, their professional organisations and those with members who refer patients for the procedure, as listed in the brief.

13.4 Other stakeholders

NICE informs the person or organisation that notified the procedure of the forthcoming consultation.

NICE also informs any person it recognises to be closely involved in a procedure's development. For example, if a procedure is named after the person who developed it, they are invited to comment on the draft recommendations. This includes developers who live outside the UK.

13.5 Stakeholders who register an interest

Clinicians, patients and any other people or groups who have registered an interest in the procedure via NICE's website are alerted when consultation opens.