COC Guidelines for Volunteers

Updated:Feb 22,2013

AMERICAN HEART ASSOCIATION
CONFLICT OF INTEREST POLICY

The American Heart Association, its affiliates and components, and all officers, directors, delegates, council and committee members scrupulously shall avoid any conflict between their own respective personal, professional or business interests and the interests of the association, in any and all actions taken by them on behalf of the association in their respective capacities.

In the event that any Officer, Director, Delegate, Council or Committee member of the Association shall have any direct or indirect interest in, or relationship with, any individual or organization which proposes to enter into any transaction with the Association, including but not limited to transactions involving:
a.     the sale, purchase, lease or rental of any property or other asset;
b.     employment, or rendition of services, personal or otherwise;
c.     the award of any grant, contract, or subcontract;
d.     the investment or deposit of any funds of the Association;

such person shall give notice of such interest or relationship and shall thereafter refrain from discussing or voting on the particular transaction in which he has an interest, or otherwise attempting to exert any influence on the Association, or its components to affect a decision to participate or not participate in such transaction. (See 2010-2011 Relationship Disclosure Questionnaire.)
The AHA Inclusiveness policy states that the existence of an inclusive group of volunteers and staff is essential to the mission of the Association, and that the Association must continue to broaden its constituencies to become genuinely representative of the community.  The AHA Ethics policy is to support a culture of openness, trust, and integrity in all American Heart Association management and business practices with the support of every AHA volunteer and staff.  The Association adopted these Core Values: integrity, excellence, vision, dedication, inclusiveness, sensitivity, and equality. 

The American Heart Association has the highest standards for all of its activities. To maintain the integrity of our processes, we ask all volunteers and writing group members to disclose all relationships that they have with industry.

Writing Groups
(See MOC Policies and Procedures Regarding Relationships
With Industry for Writing Group Members)

Recently, the topic of conflicts of interest has become a very important part of the AHA Guidelines Process for obvious reasons.  Unfortunately, the AHA has received some very bad press lately.  Some outsiders (media and/or public) have the perception that writing committee authors may be conflicted based on income received from industry or government grants, participation as consultants or on advisory boards, honoraria from speakers’ bureaus, etc. In the future, this will have to be watched very carefully, not only for the protection of the reputation of the writers, but also to protect the AHA’s reputation. 

As you know, the AHA is considered a valuable resource for unbiased information, and because of that public perception, we must be very careful.  This subject will be belabored by the Science and Medicine Advisor (SMA) and Manager during the course of the writing process of any paper because the Manuscript Oversight Committee (MOC) and the Science Advisory and Coordinating Committee (SACC) are now charged with looking very carefully at how balanced the group is as far as conflicts of interest.  It is crucial and critical that the conflicts of interest be updated regularly during the writing process. 

The AHA makes every effort to avoid any actual or potential conflicts of interest that might arise as a result of an outside relationship or personal interest of a member of the writing panel.  Specifically, all members of the writing panel are asked to provide disclosure statements of all such relationships that might be perceived as real or potential conflicts of interest to inform the writing effort.  These statements are reviewed by the parent task force, reported orally to all members of the writing panel at the first meeting, and updated as changes occur.  Peer reviewers are also asked to report any potential conflicts. The relationships with industry information for writing committee members and peer reviewers is published in the appendices of each scientific statement or guideline.

 

Each author is required to identify all relationships within the last 12 months that are relevant to the topic of the manuscript. A person has a relevant relationship with a company or other entity IF:
1.   The relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document.
2.   The company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document.
3.   The person or a member of the person’s household has/have a reasonable potential for financial, professional or other personal gain or loss as a result of the issues/content addressed in the document.

As previously noted, conflict of Interest tables are published with all of our scientific statements and guidelines. Recent scrutiny of RWI tables by the media drew attention to potential conflicts that members had and detracted from our message. For that reason, we strive to maintain a balance of writing group members, with at least 51% of the group having NO relationships with industry, throughout the process. Grants from government or nonprofit organizations are listed but do not count in the calculation of percentages. Only industry conflicts are considered in our percentage counts.

Other specific conflicts of interest questions/clarifications: 

  • DSMBs – Even though a DSMB does not pose a conflict, it should be listed under “Other” on the disclosure table.  Even though most people serving on DSMBs are very unconflicted because they have to be, these activities should still be listed on the table.  Sometimes, an honorarium is received for DSMB work, but it usually falls under the modest category in terms of income.  Even a DSMB that is not related to cardiovascular or stroke should be listed.  
  • NIH Grants or Funding – Although the grant or funding itself may not pose a conflict of interest, due to the climate change regarding conflicts of interest, relevant NIH Grants have to be disclosed also.  Basically, the author needs to disclose what type or kind of study the grant covers and what the author’s role is in that study.  Whether industry-sponsored or NIH, there are perceptions, and although we cannot guard ourselves against the perceptions, we can anticipate what those perceptions might be in the future.  In the past, authors have felt that since NIH grants are “government money” that this would not or should not be perceived as a conflict, but it is now very important to disclose them in the interest of full transparency.  This issue has come up recently, and we have to look at all NIH studies.    Everyone has their passion, and the question is whether an author can put aside any bias, even though it is NIH-funded, as these papers/guidelines are guiding clinical practice. 
  • Local PI’s and Co-Investigators on Industry-Funded Trials (this falls under the “research grant” category of the disclosure table) – If an author receives any funding or income for any related study, it must be disclosed.  When participating in a clinical trial, you are at the cutting edge, but the media and public do not quite understand that.  This issue will be sorted out over many months, and the answer is not final, but an evolution over time.  For now, the idea is to be completely transparent and to anticipate any problems in the future, especially before it gets to SACC.  SACC will now scrupulously be looking at this.  All relevant research – industry and government – must be disclosed.  
  • Expert Testimony/Legal Consultations – This information should be disclosed and listed under “Other” on the disclosure table.  Additionally, the author may provide a more detailed description in e-mail form so that AHA will have the opportunity to review it. 
  • Grant Reviews – It is not necessary to list grant reviews as a potential conflict of interest.
  • Timeframe for Disclosures – All relevant relationships that a potential writing group member has had for the 12 months preceding their nomination should be disclosed.
  • Recusal from Discussion – On some rare occasions, a writing group member may have to recuse himself/herself from discussions on a particular section of a paper due to significant conflicts of interest. 

Listing conflicts will not necessarily disqualify an author from participating in a writing group, but all conflicts must be disclosed, along with the extent of the conflict (i.e., monetary interest – significant or modest). For information purposes, a relationship is considered to be “significant” if (a) the author receives $10,000 or more during any 12-month period, or it constitutes 5% or more of the author’s gross income; or (b) the author owns 5% or more of the voting stock or share of the entity, or owns $10,000 or more of the fair market value of the entity.  A relationship is considered to be “modest” if it is less than “significant” under the preceding definition.
Each writing group member is encouraged not to enter into any new relationships with industry during the development of a paper and is responsible for notifying AHA staff of any new relevant relationships that he/she does enter into.