Ecc conflict of Interest–Related Issues to Consider




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ECC Conflict of Interest–Related Issues to Consider

The American Heart Association has comprehensive policies and standards for the management of conflict of interest among volunteers, liaisons, staff, and others involved in AHA work. To operationalize these policies, the AHA ECC Committee recommends following the ECC Conflict of Interest Procedures below. The following issues are presented to assist individuals in their consideration.


Issues


  1. COI procedures apply to the ECC Committee and all subcommittees, work groups, task forces, evidence process panels, and writing panels. They also apply to all volunteers, committee attendees, liaisons, writers, and staff at both the national and regional levels.




  1. All covered individuals must adhere strictly to all AHA COI policies and standards, including




  1. Providing a detailed annual written disclosure of all potential conflicts of interest on AHA forms

  2. Providing an updated annual disclosure whenever material changes occur in the individual’s status

  3. Formal abstention from all votes and actions in which the individual has a potential conflict and recording of the abstention by the volunteer completing the AHA Record of Abstention Form. Discussion of a topic is not considered an “action” and is covered below.




  1. When a topic is under discussion during a meeting or presentation, before speaking on the topic, each individual must disclose the nature and extent of any relationships or interests in activities that pose an actual or reasonably perceived conflict of interest as defined in the AHA policy and AHA disclosure forms. This need only occur once during a meeting or presentation session. In small committee meetings this individual disclosure may be handled during introductions. (See note 1.)




  1. Individuals who have a direct or indirect conflict of interest in a particular area or topic and who are selected for a leadership role with oversight or responsibility for that area or topic will be the subject of heightened scrutiny regarding conflict of interest. These situations must be reviewed on a case-by-case basis as noted in the procedures below. The AHA may decide that the risk to the AHA from the individual’s relationship is not significant and that the individual still represents the best choice for the AHA, taking into account the risks and benefits. If an individual already playing a leadership role develops or is discovered to have a sufficiently significant conflict of interest that poses a significant risk to the integrity or credibility of the ECC process, then another qualified person without such a potential conflict should replace the individual. Such a substitution shall not imply any impropriety on the part of any person but rather indicates a preventive step taken to avoid any real or perceived conflict of interest from endangering the integrity of the process. A position of leadership can include the chair or vice chair of any committee, subcommittee, task force, working group, ad hoc group assigned to work on an issue, evidence panel, or evidence collection process. The fact that such perceived conflicts of interest are usually without any improper intent does not protect the individual, the AHA, and its work from the potential consequences of inadequate management of such a situation.




  1. In addition to financial relationships, other bases of potential conflicts of interest must be considered, such as in-kind support, intellectual collaboration or intellectual investment in one’s own ideas, or a long-term research agenda in which an investigator has invested substantial time. Although these situations will be considered on an ad hoc basis, financial relationships are more likely to adversely affect the credibility of the AHA and the integrity of its process and products.




  1. The AHA ECC Program must exercise care in providing representatives to industry-sponsored conferences. It may be in the interests of the AHA for an AHA representative to attend such conferences to clarify AHA policy and rationales. It is always preferable for such conferences to be sponsored by a noncommercial entity or a consortium of multiple companies. If the AHA chooses to send a representative to any industry-sponsored conference, it must be prepared to send a representative to many conferences sponsored by similar companies. In selecting the conferences at which the AHA will be represented, it is appropriate to consider the benefit to be gained or the impact from attending, the costs to the AHA of attending, including underwriting by sponsors, and the availability of appropriate resources.


Notes
Note 1: AHA policy and disclosure forms imply that a volunteer is precluded from even discussing an issue on which that person has a potential financial conflict. That AHA policy, however, is more oriented toward ensuring that the individual will not influence whether the AHA will conduct business with an outside entity than by concern that the AHA may endorse a product, drug, or training model. If the ECC Program were to follow the AHA guideline of precluding volunteers with potential conflicts from participating in discussions, the AHA would jeopardize the thoroughness of the evidence-based ECC guideline process. The integrity of the AHA ECC process can be adequately protected if individuals follow the disclosure, abstention, and leadership rules listed above. David Livingston, AHA general counsel, agrees with this interpretation.

AHA Conflict of Interest Policy: ECC Procedures

Procedures for all ECC volunteers, liaisons, and conference attendees:




  1. Follow all AHA COI policies.

  2. Complete and submit the annual COI Disclosure Questionnaire. Update the form if there is any substantive change.

  3. At the meetings disclose all relationships that could pose a direct or indirect conflict of interest. For committee meetings this can be done during introductions. The AHA will keep written records of these disclosures.

  4. Abstain from any vote in which the individual has a relationship that could pose a direct or indirect conflict of interest. Complete and submit the AHA Record of Abstention when such abstention occurs.

  5. Bring COI issues to the chair of the committee/group in which the issue arises. If the issue involves the chair, bring the issue to the ECC Committee chair.

Procedures for AHA




  1. The AHA ECC staff scientist will review all annual COI Disclosure Questionnaires and Records of Abstention. If significant issues are found, he/she will discuss them with the chair and vice chair of the ECC Committee to decide if any action is needed in addition to the disclosures.

  2. The chair and vice chair of the ECC Committee will review the disclosures of chairs and topic leaders to ensure that relationships are understood and potential conflicts are limited and manageable.

  3. Any issues raised either by members or through the review of chairs and topic leaders will be reviewed by the chair and vice chair of the ECC Committee, the AHA vice president for ECC, the AHA ECC staff scientist, the ECC representative to the AHA Scientific Council on Cardiopulmonary and Critical Care, and the AHA general counsel for final resolution and actions if needed.

Endorsed by the AHA General Counsel and ECC Committee, April 2002



Send comments to John Billi at jbilli@umich.edu.


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