XV.5.2 General rules

 

Definition of a WHO collaborating centre

10 A WHO collaborating centre (WHO CC) is an institution, or a part of an institution, designated by the Director-General to form part of an international collaborative network carrying out activities in support of the Organization's programmes at all levels.

Eligibility

20 The following are eligible for designation as WHO CCs:

• Formally recognized ministries, academies, universities, established research institutes or hospitals, or a part thereof (e.g. a department or laboratory -Academies  universities, established research institutes and hospitals are considered “ academic institutions” under the Framework of engagement with non-State actors (FENSA). These are defined as entities engaged in the pursuit and dissemination of knowledge, through research, education and training.-); or
  
• A group of facilities for reference, research or training belonging to different institutions as defined above, with one institution acting for them in their relations with WHO. This applies in the case of a laboratory or other technical facility which is owned by several institutions and which does not have its own legal personality.

30 Eligible institutions can be State actors or non-State actors. However, the institution should not be primarily of a commercial or profit-making nature, and the conditions stated in section XV.5.7 should be fulfilled. In the case of a non-State actor, due diligence and risk assessment in accordance with the Framework of engagement with non-State actors (FENSA) must be conducted.

40 The following are not eligible for designation as WHO CCs:

• Networks, working groups, partnerships and programmes;
• International and national nongovernmental organizations and similar bodies with a membership structure, including professional associations, philanthropic foundations and private sector entities as defined in FENSA - (for collaboration with non-State actors and definitions, please refer to the WHO Framework of Engagement with non-State actors (FENSA) and see Part XVIII.1.1);
• International intergovernmental organizations - (this takes into account, inter alia, that the mechanism of WHO CCs was designed for national institutions and the rules for designation provide for consultation with the national authorities concerned and, in the case of international intergovernmental organizations, such national authorities do not exist).　

50 In cases where the eligibility of an institution proposed for designation as a WHO CC is unclear, the final decision will be made by the Office of the Director-General (DGO), in consultation, as appropriate, with the Office of the Legal Counsel (LEG), the Due Diligence and non-State actors unit (DAN)  and the Global Focal Point for WHO CCs.

 "Multi-centres" and "joint centres"

60 "Joint centres" (i.e. two or more institutions, or two or more parts of an institution, sharing a single designation as a WHO CC) and "multi-centres" (i.e. an institution with "branches" or various offices in different locations sharing a single designation as a WHO CC) are not accepted. There must be one designation per institution, or per part of an institution (see paragarph 70-80 below). Different designations of different parts of the same institution are permitted, provided that these parts do not overlap in any way.

Specificity

70 Designations should be as specific as possible. Therefore, in principle, only the part of the institution (e.g. a department, division, unit, laboratory) directly working with WHO, and not the whole institution, should be designated as a WHO CC.

80 The designation of the entire institution may be justified only in cases where the entire research institute or hospital is specialized in a single field, with the entity as a whole working with WHO.

Criteria for designation

90 In order to be considered for designation, eligible institutions (see paragraph 20 above) must fulfil all the following criteria:

• high scientific and technical standing of the institution concerned at the national and international levels;
• prominent place of the institution in the country's health, scientific or educational structures;
• high quality of its scientific and technical leadership, and sufficient number and high-level qualifications of its staff;
• stability in terms of personnel, activity and funding;
• strong working relationship with other institutions in the country, as well as at the intercountry, regional and global levels;
• clear ability, capacity and readiness to contribute, individually and within networks, to WHO programme activities, whether in support of country programmes or by participating in international cooperative activities;
• clear technical and geographical relevance of the institution and its activities to WHO's programme priorities; and
• successful completion by the institution of at least two years of collaboration with WHO in carrying out jointly planned activities.

100 While all the criteria for designation should be fulfilled by all prospective institutions, the interpretation of the criteria should be made in such a way that institutions in developing countries are not disadvantaged.

110 In addition to the above criteria, the conditions contained in section XV.5.7 apply; and, in the case of non-State actors, any proposal for designation of an entity as a WHO cc is subject to the satisfactory outcomes of due diligence and risk assessment.  

Functions of WHO CCs

120 The functions of WHO CCs include the following:

• collection, collation and dissemination of information;
• standardization of terminology and nomenclature of technology, of diagnostic, therapeutic and prophylactic substances, and of methods and procedures;
• development of evidence-based technical guidance tools and resource materials on various topics;
• development and application of appropriate technology;
• provision of reference substances and other services;
• participation in collaborative research developed under WHO's leadership, including the planning, conduct, monitoring and evaluation of research, evaluation of WHO interventions in countries, as well as promotion of the application of the results of research;
• training, including research training;
• coordination of activities carried out by several institutions on a given subject;
• capacity-building work at country level; and
• provision of monitoring, preparedness and response services to deal with disease outbreaks and public health emergencies.

130 Certain activities are excluded from the functions of the WHO CCs. A non-exhaustive list of excluded activities is:

• Qualifying diplomas (such as PhD, MSc, certificate, etc.): delivery or endorsement of education or training activities leading to academic qualifications or degrees (e.g. Bachelor's degrees, graduate certificates, graduate diplomas, Master's degrees, Doctorates) are excluded from the functions of WHO CCs. While training activities are typical functions of WHO CCs, development and issuance of qualifying degrees and diplomas should not be listed as such in the workplan. WHO's name and logo must not be used for the promotion of the above-mentioned degrees nor on any diplomas or certificates of attendance awarded for other training activities.
• Clinical trials: a WHO CC should not undertake clinical trials on its own accord as part of its workplan (see paragraph 140 below).
• Establishment of separate entities (e.g. a research institute, a fundraising body, etc);
• Performing WHO core functions such as provision of advice to Member States on policy and legislative matters;
• Issuance of national guidelines: normally, the issuance of national guidelines is not part of WHO's mandate and therefore beyond the functional scope of WHO CCs. In exceptional cases activities relating to the development of national guidelines can be part of the workplan of a WHO CC, if the development of the guideline in question is explicitly included as a WHO task in WHO operational plans. If such national guidelines developed with the support of WHO CCs are to be officially endorsed by WHO, or WHO's involvement in the development of the national guideline is to be publicly acknowledged (e.g. the WHO emblem or name is to be used), they must conform with the requirements set forth in the WHO Guidelines Review Committee (GRC) policies, rules and procedures;
• HR related activities for which WHO has specific frameworks such as secondments, volunteers, interns, fellowships, etc.;
• Having any representative or managerial/executive responsibility on behalf of WHO;
• Participation in technical advisory groups of WHO.

135 Activities already included, or to be included, in another contractual arrangement with the proposed institution (e.g. MOU, collaboration agreement, APW, TSA, letter of agreement, etc) should not be included in the workplan of the WHO CC.

Research conducted by WHO CCs under a joint workplan

138 WHO defines research as the development of knowledge with the aim of understanding health challenges and mounting an improved response to them. This definition covers the full spectrum of activities WHO undertakes to support research. A cornerstone of WHO's work, research activities, due to their sensitivity and visibility, may constitute a serious risk to the Organization if WHO's standards of scientific quality and ethical integrity are compromised. To address this, WHO has developed a Code of Conduct for Responsible Research that articulates WHO's requirements vis à vis its research partner institutions, including WHO collaborating centres. This Code provides a standard to guide individuals working on all research associated with WHO , including non clinical research. The Code provides general principles and standards for good practice in the conduct of research, applicable to all individuals engaged in research associated with WHO. Institutions designated as a WHO CC are required to adhere to the WHO Code of Conduct for Responsible Research, or have their own Codes of Conduct that uphold principles in line with the WHO Code of Conduct for Responsible Research. WHO responsible officers are invited to carefully read the WHO Policy on Misconduct in Research to understand their own obligations vis-à-vis the research activities included in the agreed joint workplan, and contact the Office of Compliance, Risk Management and Ethics/Ethics Unit (CRE/Ethics Unit), the departement of the Prevention & Response to Sexual Misconduct (PRS), the Office for Internal Oversight (IOS) and/or the Office of the Legal Counsel (LEG) if they require any clarification.  

140 The terms of reference or workplan of a WHO CC should not include research involving human participants, including clinical trials, conducted by the WHO CC of its own accord. Instead, the terms of reference or workplan could provide that the centre will "participate in collaborative research under WHO’s leadership". Such activities will be conducted as WHO research, following WHO procedures and rules.

150 In order to fulfil WHO’s responsibilities and oversee its involvement in research involving human participants, WHO has established a WHO Research Ethics Review Committee (ERC) to provide ethical review of research involving human participants funded or otherwise supported by WHO. As a result, in addition to the approval required for the designation or redesignation of a WHO CC, any research activity involving human participants included in the terms of reference or workplan of the WHO CC may require the approval of the WHO ERC. The WHO responsible officer will seek such approval/s, if necessary. Approval by an ethics body other than the WHO ERC does not exempt a research activity from WHO ERC review. The decision whether or not a particular activity involving human participants requires WHO ERC review and approval is made by the WHO ERC.

160 All research involving human participants for which WHO ERC approval is required, must conform to the requirements set forth in section XV.3.

170 It is furthermore the responsibility of the WHO CC to safeguard the rights and welfare of human participants involved in research performed as part of the terms of reference or workplan, in accordance with the appropriate national code of ethics or legislation, if any, and, the Helsinki Declaration and any subsequent amendments. Research may only be undertaken where: (a) the rights and welfare of the research participants are adequately protected; (b) freely given informed consent has been obtained; (c) the balance between risk and potential benefits involved has been assessed and deemed acceptable by a panel of independent experts appointed by the institution; and (d) any special national requirements have been met.

180 It is moreover the responsibility of the institution to comply with the relevant national regulations pertaining to research involving human participants.

190 Without prejudice to obligations under applicable laws, the WHO CC is required to make appropriate arrangements to eliminate or mitigate the negative consequences to research participants, or their families in the case of death, injury or illness resulting from the conduct of the research. Such arrangements shall, to the extent feasible, include medical treatment and financial relief. The WHO CC should furthermore undertake to protect the confidentiality of the information relating to the possible identification of participants involved in such research.

200 The WHO CC should ensure that living animals, required for use as laboratory animals in research undertaken by the WHO CC, shall be handled in accordance with generally accepted principles for the humane treatment of such animals and the avoidance of unnecessary suffering.

Guidelines development

210 A WHO Guideline is a health information product containing recommendations. All WHO guideline development activities with any technical input provided by a WHO CC as part of the agreed terms of reference and/or workplan must conform to the requirements set forth in the WHO Guidelines Review Committee (GRC) rules and procedures, unless the WHO guideline in question has previously been adjudicated by WHO as being exempt from GRC review.  

215 Any technical collaboration must be in the interest of WHO, and, in the case of non-State actors, managed in accordance with FENSA to protect WHO, and, in particular, its normative work, from any undue influence or conflict of interest and to ensure there is no interference with WHO’s advisory function to Member States. 

Dissemination of results through WHO media

220 If any of the proposed activities provides that the results will be published by WHO, or disseminated through the WHO web site or through any other WHO media, or agreed channels, the material to be published or otherwise disseminated will be subject to specific WHO clearance processes.

Title

230 After designation, an institution is known by the official title of "WHO Collaborating Centre", these words being followed by a concise indication of the sphere of activity covered by the Centre (e.g. "WHO Collaborating Centre for Research on…", "…for Reference on…", "…for Standardization of Procedures on…"), as decided by WHO. The title should be neither too specific nor include geographical references.

Length of the period of designation and redesignation

240 The initial period of designation of an institution as a WHO CC is four years. The designation may be renewed for the same or shorter periods provided that: redesignation is warranted by WHO programme requirements; the collaboration between the designated institution and WHO has been successful; and the redesignation procedure has been properly followed by the Centre and relevant WHO departments (see section XV.5.4 paragraphs 100-160 for procedures on redesignation).

250 The period of designation for a new designation starts on the date of the official letter of designation, and ends exactly four years later.

Transfers and changes of title, terms of reference or workplan

260 It is not possible to transfer a designation from one institution to another, nor from one part of an institution to another. For instance, in cases where the staff members of a WHO CC move to a different institution, the designation remains with the institution originally designated. It may be necessary to terminate the designation of the former institution and to start a new procedure of designation for the new institution (provided that the criteria for designation is fully met by the new institution and WHO decides to proceed with a new designation).

270 As a general rule, the terms of reference and workplan of a centre may not be modified during the period of designation. However, minor updates to the workplan (e.g. new activities at the request of WHO falling under the agreed terms of reference) during the period of designation could be considered  provided that the responsible officer, the technical counterpart and the institution concerned agree and due diligence and risk assessment are conducted in case the WHO CC is a non-State actor. These minor updates are not reflected in the designation agreement but can be reported in the annual reports. Major changes may require a new designation. In case of doubt LEG, the Office of Compliance, Risk Management and Ethics/Due Diligence and Non-State actors (CRE/DAN unit) may be consulted through the Global Focal Point for WHO CCs.

280 It is possible to change the address, telephone number and name of the head of the WHO CC at any time, by using the form available for that purpose in the eCC electronic system available at http://intranet.who.int/bpm/  .

Spontaneous applications

290 Spontaneous applications for designations coming from outside the WHO Secretariat are not encouraged. When they are received by WHO, they are directed to the relevant WHO department for consideration and appropriate action. WHO does not have any obligation to favourably consider spontaneous applications, however, as a matter of courtesy, the relevant WHO department should reply to the interested institution appropriately.

Records management

300 Records regarding WHO relations with WHO CCs have long-term legal, administrative and historical value. These records document key WHO relationships and activities and must be retained permanently in the WHO Archives.

310 The eCC system captures the majority of records relating to the processes of designation, redesignation and discontinuation of WHO CCs. Any records created or received outside the eCC system, such as substantive e-mails or other correspondence must be forwarded to the Global Focal Point for WHO CCs by the responsible officer(s) for inclusion in electronic or paper files. These files (paper and electronic) will be periodically transferred to Records and Archives (RAS) for permanent retention, usually at the end of the four-year cycle.