Developing NICE guidelines: the manual

General

1. The committee will operate as an advisory committee to NICE's Board.

2. The committee will advise NICE on:

3. The committee will throughout guideline development:

4. Individual committee members will:

Membership

5. Committee members will be appointed by the developer, and committee membership will reflect both the spread of interests and expertise required for the business of the committee and NICE's values of equality and diversity.

6. The chair and members of the committee will be appointed in accordance with NICE's appointments to advisory bodies policy and procedure.

7. Committee members will be drawn from the NHS, local government, the academic community and other areas, as appropriate, as agreed by the developer and NICE staff with responsibility for guideline quality assurance. They will include practitioners, commissioners and providers, people using services, their family members and carers, and advocates.

8. The committee will have a minimum of 7 voting members with additional members agreed on a topic-by-topic basis according to need. Each committee will have a chair. Topic-specific committees may have a topic adviser, and will include professional and practitioner members, and at least 2 lay members. Standing committees will have core members and topic expert members. All committee members are selected for their expertise and not as representatives of their organisations.

9. Co-opted members may be included as additional members of a committee for 1 or more specific meetings. Co-opted members are part of the committee, join in discussion and contribute to formulating the recommendations. However, they are not full members, do not have voting rights and do not count towards the quorum.

10. Expert witnesses may be invited to attend and advise the committee on specific topics and can be drawn from a wide range of areas as appropriate. They are invited to present evidence (either as appraisable data, or as expert testimony). For more information see the appendix on call for evidence and expert witnesses. They also help the committee to consider and interpret the evidence, but they are not members of the committee so they should not be involved in the final decisions or influence the wording of the recommendations. Expert witnesses have no voting rights and do not count towards the quorum.

General

11. These Standing Orders describe the procedural rules for managing the work of the committee as agreed by NICE. The committee will act as an advisory body to NICE. Nothing in these Standing Orders shall limit compliance with NICE's Standing Orders so far as they are applicable to these Bodies.

12. The appointment of advisory committees is at the discretion of the Board subject to any direction as may be given by the Secretary of State.

13. Members of the committee shall be bound by these Standing Orders and will be expected to abide by the 7 principles for the conduct of public life as recommended by the Nolan Committee, which are:

14. Other members who may be co-opted to the committee from time to time at the discretion of the committee shall be subject to the same principles.

15. Behaviour by committee members and attendees at committee meetings such as bullying, harassment and victimisation is unacceptable to NICE. NICE is committed to taking the necessary action to ensure that such behaviour does not occur, and to taking the appropriate action in the event that it does occur.

16. For topic-specific committees, the chair and members of the committee will either be appointed for the duration of the development of the guideline or for up to 3 years to work on multiple guidelines within a topic area. This may be extended by mutual agreement to a further term of up to 3 years and up to a maximum term of office of 10 years.

17. For standing committees, the chair and core members will be appointed for an initial period of up to 3 years. This may be extended by mutual agreement to a further term of up to 3 years and up to a maximum term of office of 10 years.

18. For standing committees, when a committee member is appointed chair of the committee of which they are a member, the new position will count against the 10-year total.

19. For standing committees, the topic expert members are usually recruited for a specific guideline, but may be appointed for up to 3 years so that they can work on subsequent guidelines. They are recruited in accordance with NICE's appointments to advisory bodies policy and procedure.

20. The removal or substitution of committee members and the general constitution of an advisory committee shall be at the discretion of NICE.

21. All reasonable facilities shall be provided for members to ensure that they have the opportunity to participate fully and equitably in the business of committees.

Interpretation

22. During the course of a committee meeting, the chair of the committee can suspend the meeting to seek advice from senior members of NICE with responsibility for guideline quality assurance on the final interpretation of the Standing Orders.

23. Statements of committee members made at meetings shall be relevant to the matter under discussion at the time and the decision of the chair on questions of order, relevancy and interpretation (including conflicts of interest) shall be final.

Chairs and vice-chairs

24. Meetings will be conducted by the chair or in their absence, an officially appointed vice-chair or a nominated deputy.

25. The vice-chair will be appointed in accordance with NICE's appointments to advisory bodies policy and procedure.

26. The vice-chair's appointment will be for the duration of guideline development for topic-specific committees, or for a 3-year term for standing committees with an option to re-appoint.

27. In standing committees, if a committee member has been appointed to vice–chair from within the committee, the new term will count against the 10-year total. For example, if a member serves one 3-year term and is then appointed to vice-chair for another 3-year term, this will be regarded as having served 6 years as a member of the committee.

28. The chair, or the vice-chair or deputy nominated by the chair in the chair's absence, may take action on behalf of the committee outside of scheduled committee meetings when urgent decisions are required and it is impracticable to convene a special meeting of the committee.

29. In committee meetings, the chair:

30. The chair must ensure that NICE's equality policy and key principles that are universal to all guidance and standards are adhered to. The chair approves the equality impact assessment at scoping and final guideline stages.

31. The chair approves the draft guideline before sign-off by NICE, and advises the developer on responses to stakeholder comments as appropriate.

Voting

32. The decisions of the committee will normally be arrived at by a consensus of committee members present. Voting will only be used for decision-making in exceptional circumstances. Before a decision to move to a vote is made, the chair will, in all cases, consider whether continuing the discussion at a subsequent meeting is likely to lead to consensus.

33. Voting will be anonymous and decisions determined by a simple majority of non-conflicted committee members present at a quorate meeting.

34. The chair of the committee will be included in the vote, and in the event of there being an equality of votes the chair will have a second, casting vote.

35. Only committee members present at the meeting will be eligible to vote. There will be no proxy voting.

36. Co-opted members, expert witnesses, developer staff, NICE staff and observers will not be eligible to vote.

Quorum

37. The quorum is set at 50% of the full membership of the committee, in accordance with paragraph 3 in the membership section of these terms of reference, and includes both core and topic expert members and the chair (but excludes co-opted members, expert witnesses, developer staff, NICE staff and observers). The quorum should be rounded up to the next whole number when there is an odd number of committee members.

38. No recommendations should be confirmed unless the meeting is quorate. This provision also applies if a member is excluded because of a conflict of interest and as a result membership falls below the quorum. At the discretion of the chair on advice from a senior member of NICE staff, a meeting may proceed if it is not quorate on the basis that any recommendations formulated or decisions made are considered draft and are shared with the full committee for comment and approval.

39. The balance of the committee are such that even if the meeting is quorate, an appropriate spread of members' interests should be represented at each meeting. It is also important that for standing committees the mix of core and topic expert members is appropriate, and topic expert members are not in a majority. If, in the view of the chair, the spread of interests is insufficient for the business under consideration, the meeting or part of the meeting may be suspended or adjourned until a later date.

Collective responsibility

40. All members of the committee shall abide by the principle of collective responsibility, stand by the recommendations of the committee and not speak against them in public.

41. Members of the committee are not permitted to submit comments as stakeholders during the consultation on the draft guideline (see the chapter on the validation process for draft guidelines, and dealing with stakeholder comments in the manual). If a committee member is involved with a registered stakeholder organisation, they should not submit comments during the consultation on behalf of that organisation – someone else in the organisation should draft and submit the comments.

Confidentiality

42. On appointment, committee members (including co-opted members) will be required to sign a confidentiality agreement with NICE relating to any information designated confidential by NICE such as draft recommendations, committee discussions, academic or commercial-in-confidence material or sensitive personal data.

43. Confidential papers and confidential information disclosed in committee deliberations should not be discussed with colleagues who are not members of the committee, with other organisations, the media, or members of the committee who are excluded from discussions because of a conflict of interest.

44. If committee members are asked by external parties – including stakeholders or their professional organisation – to provide information about the work of the committee, they should discuss the request with the developer. They should also declare this at the next committee meeting. Any enquiries from the media should be directed immediately to NICE's enquiry handling team (nice@nice.org.uk) and the developer.

45. Co-opted members, expert witnesses and observers invited by the committee will sign a confidentiality form if confidential information is included in meeting papers, or if attending part of a meeting where confidential information is being discussed.

Arrangements for meetings

46. NICE will ensure that face-to-face committee meetings take place in venues that are accessible to, and have facilities for, disabled people.

47. Meetings of the Committee shall be held at such times and places as are deemed necessary to facilitate the conduct of its business.

48. Committee members may also be required to attend a working group that may be associated with the committee and will be expected to contribute to virtual discussions and occasional teleconferences as appropriate.

49. Developers shall determine which aspects shall appear on every agenda in advance of each meeting.

50. Any other business shall be discussed at the discretion of the chair.

51. Meetings will normally begin at 10:00 am and finish no later than 5:00 pm unless otherwise advised.

52. Committee members will be expected to attend for the full day unless agreed in advance with the chair or unless they have declared a conflict of interest to 1 or more discussions.

53. Laptops and other devices are to be used in a committee meeting by members solely to conduct the business of the meeting.

54. The developer will make all reasonable attempts to agree each meeting date well in advance and committee members are expected to keep proposed dates free until they are confirmed.

Access by members of the public

55. When committee meetings are open to the public, the following provisions will apply.

56. Public access will be enabled to meetings of standing committees; topic-specific committees will be held in private.

57. If considered necessary because of the confidential nature of the business to be transacted, the agenda for meetings held in public will be divided into 2 parts. Part 1 will be open to the public and part 2 will be closed to the public to enable the committee to discuss confidential information whereupon Standing Orders 61 and 65 will apply.

58. Only members of the committee and NICE staff, co-opted members, observers invited by NICE, and the developer will be present for part 2 of the meeting. However, at the discretion of the chair, experts such as practitioners, people using services, their family members or carers, and manufacturers may be invited to remain in order to discuss confidential or personal medical information that was not discussed in part 1. Once the information concerned has been discussed, the experts will leave the meeting and will take no further part in its deliberations.

59. Usually 20 working days before each committee meeting held in public, a public notice of the time and place of the meeting, along with the public part of the agenda, shall be displayed on NICE's website. The final agenda will be displayed on the NICE website usually 5 working days before the meeting.

60. The public and representatives of the press shall be allowed access to observe all formal meetings of the committee for part 1 of the agenda but shall not be entitled to ask questions or otherwise engage in the business of the committee.

61. The public and representatives of the press shall be excluded from part 2 of the committee meeting upon the chair moving the following motion:

'That representatives of the press and other members of the public be excluded from the remainder of this meeting having regard to the confidential nature of the business to be transacted, publicity in which would be prejudicial to the public interest' [section 1(2) Public Bodies (Admissions to Meetings) Act 1960].

62. Notwithstanding the above, the chair will have the discretion to adjourn the meeting at any time if the presence of the public or representatives of the press is considered prejudicial to the effective conduct of the business of the meeting upon moving the following motion:

'That in the interests of public order the meeting adjourn for (the period to be specified by the chair) to enable the Committee to complete business without the presence of the public' [section 1(8) Public Bodies (Admission to Meetings) Act 1960].

Other observers

63. NICE staff and invited guests (for example, visiting academics) may attend committee meetings as observers, with the permission of the chair.

64. Observers do not need to register via NICE's website. Observers should not sit with members of the public and should not enter into committee discussions unless invited to do so by the chair.

65. Observers can attend part 2 of meetings held in public if the chair and centre director agree. Observers who are not NICE or developer staff or are not commissioned to provide a service to NICE should sign a confidentiality agreement if they wish to attend a topic-specific committee meeting or part 2 of a meeting held in public.

Minutes

66. The draft minutes of the committee meetings shall be drawn up and submitted to the next meeting for approval by the committee. The minutes of the final committee meeting will be circulated and approved by email.

67. The approved minutes will be published on NICE's website subject to the redaction of any confidential or otherwise exempt material within 20 working days of approval.

Declarations of interest

68. Anybody applying to be a member of a NICE advisory committee must declare any interests as part of the application process, in line with the declaration of interests policy for NICE advisory committees.

69. All standing committee members must make an annual declaration of interests in line with the declaration of interests policy for NICE advisory committees.

70. All committee members must declare in writing before – and orally at the start of – each committee meeting any interests that are relevant, or could be perceived to be relevant, to the work of the committee. Declarations of interest will be recorded in the minutes and published on the NICE website.

71. During the course of the meeting, if a conflict of interest arises with matters under consideration, the member concerned must withdraw from the meeting, or part thereof, as appropriate.

72. Experts invited to provide expert testimony, and co-opted members will make a declaration of interest before committee meetings and in accordance with declaration of interests policy for NICE advisory committees. This declaration will be reaffirmed again at the start of each meeting. These will be recorded in the minutes and published on the NICE website.

73. Co-opted members will not be able to take part in a meeting if they have a conflict of interests. Expert witnesses may still be asked to give their evidence if they have a conflict of interest, but this will be at the discretion of the developer and NICE staff with a responsibility for quality assurance.

Suspension of Standing Orders

74. Except where this would contravene any statutory provision, any 1 or more of the Standing Orders may be suspended at any meeting. This should be agreed with the developer and NICE staff with responsibility for quality assurance, and a simple majority of those present and eligible to participate should vote in favour of the suspension.

75. Any decision to suspend Standing Orders shall be recorded in the minutes of the meeting.

76. No formal business may be transacted while Standing Orders are suspended.

77. NICE's Audit Committee shall review all decisions to suspend Standing Orders.

Petitions

78. Petitions from the public will not be received directly by or responded to by the committee. Anyone wishing to present a petition will be directed to NICE staff with responsibility for guideline quality assurance.

Recording of meetings

79. The recording of proceedings or the taking of pictures at committee meetings by public attendees is not allowed.

80. The recording of meetings is permitted by the developer where agreed by the committee, and for the purposes of facilitating guideline development or promoting transparency. Recordings will be deleted on approval of the meeting minutes.

Record of attendance

81. A record will be kept of committee members' attendance at committee meetings via the minutes.

82. Members of standing committees are expected:

83. Members of topic-specific committees are expected:

84. If committee members are unable to attend a committee meeting, deputies are not permitted.

85. Members who are unable to meet either of these expectations may be asked to stand down from the committee in accordance with Standing Order 20.

86. If a committee member is unable to fulfil their duties (for example, because of illness), another recruitment process may be considered to replace that person.

Terms of Reference

87. Committee members must comply with the Terms of Reference that set out the scope of the committee's work and its authority.

Review of Terms of Reference and Standing Orders

88. These Terms of Reference and Standing Orders will be reviewed every 3 years.