WHO Conflict of Interest Guidelines

WHO has kindly made available its conflict of interest guidelines. Apparently they are not available from the public web page. Attached are two documents:

A few of the many interesting provisions follow:

I. MEANING OF “CONFLICT OF INTEREST”

1. Paragraph 4.6 of the Regulations for Expert Advisory Panels and Committees states that “In the exercise of their functions, the members of expert advisory panels and committees shall act as international experts serving the Organization exclusively … they shall disclose all circumstances that could give rise to a potential conflict of interest as a result of their membership of an expert committee, in accordance with the mechanisms established by the Director-General for that purpose.” This basic principle about the integrity of service provided to WHO as an international organization constitutes the legal basis for the mechanism described in these Guidelines and for the use of the DOI Form, including for experts providing advice in other forms than membership in expert advisory panels and committees.

2. In the context of these Guidelines, the term “conflict of interest” means any interest declared by an expert that may affect or reasonably perceived to affect the expert’s objectivity and independence in providing advice to WHO.

3. WHO’s conflict of interest rules are designed to avoid potentially compromising situations that could undermine or otherwise affect the work of the expert, the committee or activity in which the expert is involved or WHO as a whole. Consequently, the scope of the inquiry is any interest that could reasonably be perceived to affect the functions that the expert is performing.

III. WHEN IS A DECLARATION OF INTERESTS NOT REQUIRED?

Representatives of industry and other interest groups

1. Representatives of industry, trade associations or other interest groups who are invited to an advisory committee or other meeting are not required to complete a DOI Form. Such persons are normally invited to exchange information or present views as an industry spokesperson, not to make an assessment or to give advice as an independent expert.

STEP 1: The Initial Review: Relevance and Significance of the Interest

1. Upon receipt of a completed DOI Form from an expert, an Initial Review is conducted by the Coordinator or Director of the technical unit or programme responsible for the meeting or the activity in which the expert is involved, to determine whether an interest has been declared, and if so, whether it is insignificant or whether it is potentially significant. The Coordinator or Director will normally delegate the task of the Initial Review to the person responsible for the meeting or contract (“Responsible Officer”).

STEP 2: The Conflict of Interest Assessment: Factors to Consider

1. The purpose of this assessment is to determine whether the expert may participate in the activity at all or whether the expert may do so only under certain conditions. The following actions should be undertaken to ensure that an appropriate and robust assessment takes place:

. . .

c. In general, only experts without declared interests should be selected as Chairs of scientific or technical advisory meetings.
. . .

e. To the extent feasible, Responsible Officers, Directors and Coordinators should demonstrate a good faith effort to find individuals who do not have interests that may give rise to a real or perceived conflict of interest to serve as experts in scientific or technical advisory meetings.

STEP 3: The Conflict of Interest Assessment: The Balancing Test

1. A conflict of interest assessment essentially involves carrying out a “balancing test”. In carrying out such a balancing test, the Secretariat, while fully considering the contribution, tasks and function of the expert as well as the availability of alternative experts with the required expertise, must weigh:

the nature, type and magnitude of the expert’s interest and therefore the degree to which the interest may be reasonably expected to influence the expert’s judgment

against

the adequacy of measures/options available to protect the independence and integrity of the decision-making process.

STEP 4: The Conflict of Interest Assessment: Possible Options

1. If it is concluded that a declared interest is potentially significant, one of the following three options, or a combination of those options, may be considered to determine under what conditions, if any, the expert may participate in the activity or meeting.

2. The Responsible Officer and/or Director or Coordinator should always consult the Chair of the meeting prior to making a public disclosure of an expert’s interest to other meeting participants or considering any of the measures described below.

(i) Conditional Participation: Under this option, the Responsible Officer would decide to continue the expert’s involvement in the meeting or work and publicly disclose the expert’s interest at the start of the meeting to all meeting participants and in the report of the meeting and/or relevant publications or work products. This approach is especially appropriate where the expert’s interest is relatively minor.

(ii) Partial Exclusion: In this alternative, the Responsible Officer would limit the expert’s involvement, either (a) by excluding the expert from that portion of the meeting or work where a conflict of interest has been identified and/or (b) excluding the expert from participating in the decision making process relating to the development of, for example, guidelines or recommendations. In both cases, and after consulting the Chair of the meeting (if applicable), the reported interest must also be publicly disclosed to other meeting participants and must be recorded and disclosed in the report of the meeting and/or relevant publications or work products. Partial exclusion must be carefully monitored. It may only be used to enable other members to listen to the results of research or views held by the best-qualified experts, while bearing in mind the expert’s potential bias.

(iii) Total Exclusion. Here, the expert is excluded from the meeting or work altogether, where the nature of the conflict of interest is too significant vis-à-vis the overall objective, or where limiting the expert’s involvement to only a portion of the meeting or work is not feasible (because, for example, the expert’s participation in the remainder of the meeting would have little or no value). A decision to exclude an expert should always be taken in consultation with the relevant Assistant-Director General or Director of Programme Management (DPM) if in a regional or country office setting.

3. As a general matter, a useful approach is to assess the situation through the eyes of a hypothetical “reasonable person on the street”. If an appropriately well informed person might reasonably conclude that the work or proceedings as a whole were tainted, or were unfair or were unduly influenced by the expert’s interest in the outcome, then the expert’s involvement should be excluded or limited (rather than merely disclosed).

4. If the Responsible Officer, after meeting with the Director or Coordinator, is unable to determine which action should be taken in an individual case, the DOI responses should be reviewed with LEG and PUN.

5. It is recommended that the Secretariat also personally contact the expert whenever considering partial or full exclusion, both as a courtesy towards the expert and in order to confirm its understanding of the interests declared as such an exchange may yield additional information that may be pertinent to a conflict of interest analysis.

(There is additional emphasis, including underlining, in the original.)

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