10 WHO guidelines are recommendations intended to inform decisions made by policy-makers, programme managers, providers and recipients of health care and other stakeholders. Recommendations may be for clinical interventions, public health activities or government policies.
20 A guideline is any publication containing recommendations and may include reports of meetings of WHO expert groups (WHO expert committees, scientific groups or study groups). All WHO guidelines are covered by the provisions of this section of the WHO eManual, irrespective of their dissemination format (e.g. print, web, etc.).
30 Such publications may also be called protocols, best practice algorithms, consensus statements or integrated care pathways, depending on their purpose. Notwithstanding the title, the provisions of this section of the WHO eManual apply to all publications containing or implying recommendations; the title of the publication is irrelevant. In case of doubt as to whether a publication is considered as a guideline, the Guidelines Review Committee (GRC) Secretariat should be consulted.
40 Publications such as job aids or implementation manuals should be based on – and refer directly to – a source guideline that has been developed and published in compliance with the provisions of this section of the WHO eManual.
50 Publications that are not considered as guidelines include:
- temporary recommendations issued by the Director-General under the International Health Regulations;
- publications that describe standards for manufacture of foods, pharmaceuticals or other similar materials, operating procedures and protocols for research.
60 When a technical unit decides to develop a guideline, the planning proposal must be approved by the GRC (see section VIII.1.3, paragraphs 40 to 50). The process for this approval is outlined in the WHO handbook for guideline development and incorporated in the planning clearance process for publications (see section VIII.1.4, paragraphs 10 to 50). The GRC may approve the proposal, approve it with recommendations for revision, or return it for revision. Proposals that are approved by the GRC are cleared by the assistant director-general, executive director or regional director concerned, and the Chief Scientist, through the planning clearance process (see section VIII.1.4, paragraphs 10 to 50).
70 When a technical unit has completed the development of a guideline, including the editing, the final version of the guideline must be approved by the GRC. The process for this approval is outlined in the WHO handbook for guideline development and incorporated in the executive clearance process for publications (see section VIII.1.4, paragraphs 60 to 85). The GRC may approve the guideline, approve it with recommendations for revision, or return it for revision. Guidelines that are approved by the GRC are cleared by the assistant director-general, executive director or regional director concerned, and the Chief Scientist, through the executive clearance process (see section VIII.1.4, paragraphs 60 to 85).
Guidelines developed in collaboration with external entities
80 Guidelines may be developed jointly with one or more external entities involved from the beginning, subject to prior approval of the proposed engagement by the Department of Compliance and Risk Management and Ethics (CRE) in line with the Framework of Engagement with Non-State Actors (FENSA; see section XVIII.1.1) ), as well as approval by the GRC, and the assistant director-general, executive director or regional director concerned, and the Chief Scientist, at the planning clearance stage (see section VIII.1.4, paragraphs 10 to 50). In such cases, the joint guidelines should be developed according to the standards for WHO guidelines. There should be agreement between the entities involved from the beginning about the methods and processes to be used (see section VIII.6.2).
Adaptation or endorsement of guidelines developed by an external entity
90 WHO may consider adapting or endorsing a guideline developed by an external entity when there is no current WHO guidance on the topic, subject to approval by the GRC and the assistant director-general, executive director or regional director concerned, and the Chief Scientist, at the planning clearance stage (see section VIII.1.4, paragraphs 10 to 50). The minimum standards for WHO guidelines should be met, as described in the WHO handbook for guideline development, including those concerning no funding from commercial entities (see paragraphs 170 to 180) and the declaration and reporting of any potential conflicts of interest (see paragraphs 100 to 160). The approach for reviewing and summarizing the evidence should be consistent with that required for WHO guidelines. There should be global representation of experts in the development of the recommendations and the recommendations should be appropriate for a global audience.
Declarations of interest
100 Any external person invited to participate in any capacity in the development of a guideline must complete a Declaration of Interests (WHO experts) form (see sections III.16.2 and VIII.7.1), and must agree to the public disclosure and publication of declared interests in the final guideline. Participants from commercial entities do not need to complete a Declaration of Interests form, for the reasons outlined in paragraph 180.
110 No external person may contribute to the development of a guideline until his or her Declaration of Interests form has been submitted to, and assessed by, WHO.
120 If a proposed participant in a guideline development group declares on the Declaration of Interests form that he or she has no relevant interests, the person may begin to contribute. If any potential conflict of interest is declared, the Declaration of Interests form must be reviewed, in accordance with the Guidelines for declaration of interests (WHO experts), by the technical unit concerned, in consultation with CRE.
130 CRE may, inter alia, advise that:
- the conflict of interest is considered insignificant, but must nonetheless be reported in the final guideline;
- the conflict of interest is considered potentially significant, but relates only to some areas of the guideline development group’s work; or
- the conflict of interest is such as to entirely preclude participation of the external person in the guideline development group.
140 In cases where a conflict of interest is related only to some areas of the guideline development group’s work, the participant will be absent when the group considers these areas, and will not have access to the relevant documents.
150 A summary of any declared interests of participants in a guideline development group should be provided to all other participants.
160 The text of any disclosures of information from the Declaration of Interest form that is to be included in a guideline shall take into account guidance provided in the Guidelines for declaration of interests (WHO experts). In case of doubt, CRE should be consulted.
Participation of commercial entities
170 Financing, direct or indirect, may not be accepted from commercial entities for activities leading to the production of WHO guidelines or recommendations (see section VIII.6.2, paragraph 20).
180 Representatives and employees of commercial entities with an interest in the guidelines may not contribute to the development of WHO guidelines, except where information from, or the opinions of, those entities are essential to a valid guideline. In such cases:
- all interested commercial entities, or their umbrella organizations, should be given an equal opportunity to contribute;
- their participation should be confined strictly to those parts of the guideline development process where their contribution is indispensable;
- their participation must be reported explicitly;
- they should have no access to documents and discussions not related to parts of the guideline where their participation is essential, and must under no circumstances attend guideline group meetings or committee meetings dealing with the decision as to final recommendations;
- they do not need to complete a Declaration of Interests form, as they are not providing advice in a personal and individual capacity but rather as representatives of the commercial entity concerned.
