Disclosure or discovery

To be managed, a COI must be identified. This can be done by either the individual (self‐disclosure) or by a third party (discovery). Although considered by some to be critically important to managing COI, there is limited evidence regarding the effect of COI disclosure. Research suggests that disclosure can have “perverse effects” or, at least, is not the panacea it is often perceived to be. These perverse effects include unwarranted immunity of the individual declaring the COI from criticism or censure for their role in developing an AES. Disclosure could have the unintended result of enabling or permitting a COI without preventing the effect of the COI.

Recusal or removal

Those with a COI are expected to recuse themselves from (ie, abstain from) decisions where such a conflict exists. It may be sufficient to recuse an individual regarding discussions and decisions of a specific topic, or it may be more appropriate for an affected party to be fully excused from participating in the AES. The obligation to recuse depends on: 1) the potentially conflicted individual identifying (ie, being aware of) and disclosing the potential COI, and 2) the individual recusing themselves (as opposed to a neutral party removing them from the situation). It could be appropriate for a neutral adjudicator to assess the potential COI and to decide on whether to retain or remove the individual in question.

Proposed process for identifying, considering and addressing potential or real conflicts of interest (based on those of the Endocrine Society

Optimally, AES panels would only include members who are free of COIs relevant to the topic of the statement. However, this will not always be feasible or possible, and processes must be in place to identify and manage COI. Transparency is key, and privacy concerns can be addressed by having the process widely acknowledged with details of the specific COI and management being private until publication of the statement, when COIs and management should be disclosed.

Processes for identification and management of COIs relative to the development of AES are summarized as follows:

1. To be considered for membership on an AES panel, nominees are required to disclose all relationships that could affect or be perceived to affect the AES (and those of immediate family members) for the 12‐month period before the formation of the panel and any relationships that are entered into during development of the statement.

2. Potential COIs that should be declared include all relationships with commercial, noncommercial, institutional, and patient or public organizations. These include employment, consultancy, interests in start‐up companies and those in which stock is not publicly traded, ownership interests (eg, stock options) in publicly‐traded companies (excluding indirect investments through vehicles such as mutual funds), research funding directly paid to the individual, research funding paid to an employer, organization or other research institution with whom the individual is involved, serving as a principal investigator, honoraria, royalties, paid or unpaid expert testimony, speaking engagements, speaker bureaus, and other relevant relationships. Leadership positions and memberships of other entities (paid and unpaid) including nonprofit or for‐profit advisory boards and committees must also be disclosed.

3. It is critical that the panel Chair (and Co‐Chair or Assistant Chair) is free from COIs or potential COIs because they are responsible for managing potential COIs for the entire panel. For consensus statements using a Delphi process, it is more important for the organizing panel members to be free from COIs than for the other expert participants.

4. Review of COI information is conducted as follows:

   1. Panel Chairs and panel members: The ERC, the ACVIM Chief Executive Officer and the ACVIM President will review all COI information and determine whether any relationship represents a potentially relevant COI. The final recommendations on management of the COI are provided to the ACVIM BoR for information, endorsement and approval.

      1. The Chair and Assistant Chair of the panel must be free of any COI or other biases that could undermine the integrity or credibility of the work.

      2. A majority (>50%) of the panel members and participants in Delphi processes must be free of relevant COI.

   2. Panel members with relevant potential COIs are required to declare the situation, and the ERC, Chief Executive Officer and President must determine whether the relationship represents a relevant COI and whether or not and how that COI should be managed. Management may include recusal from participation in all or part of the AES development process, including participation in relevant discussions, votes, and drafting recommendations.

   3. Panel members are prohibited from adding new relationships that create COIs throughout the AES development process, until publication. If a new relationship is added, the ERC, Chief Executive Officer and ACVIM President must determine whether the relationship represents a relevant COI and whether or not and how that COI should be managed.

5. If a relevant COI exists, it will be managed as follows:

   1. Disclosure and Review:

      1. The Chair of the ERC, with the assistance of the methodologist who is managing the AES, should interview the panel Chair and all proposed participants before initiating panel activities and ask the potential participants to disclose relationships that have the potential to create COIs.

      2. If a panel member is aware that another participant might have a COI and has not declared it for some reason, they are obliged to bring this concern to the panel Chair's attention.

      3. All potential COIs should be reviewed by the ERC, Chief Executive Officer and ACVIM President and any that require a management plan should be discussed with the affected participant.

   2. Recusal:

      1. Affected participants may be asked to recuse themselves from activities related to development of the AES for any part or all of the topics. Recused participants are prohibited from participating in developing or drafting guidelines sections that are directly related to their COI.

      2. Recused participants are prohibited from determining the strength and direction of a recommendation directly related to their COI.

      3. Recused participants are prohibited from voting on matters directly related to their COI.

   3. Divestment:

      1. Affected participants may alternatively choose to divest themselves of direct financial investments with entities that may have a potential financial interest in the contents of the guidelines or to otherwise alter or end relationships that are of a nonfinancial nature.

      2. Panel members must also refrain from participating in the marketing activities or advisory boards of such entities.

   4. Transparency:

      1. The ACVIM will report details of all COIs that are identified as such by the ERC, Chief Executive Officer and ACVIM President in a detailed table that is included in the draft document reviewed by ACVIM members and in published guidelines.

      2. More detailed COI documentation and management plans will be made available as needed in the form of published supplemental materials (to be available online).