January 29, 2016
The American College of Cardiology (ACC) and American Heart Association (AHA) are committed to the highest ethical standards in developing trustworthy guidelines, performance measures, and data standards. To fulfill this responsibility, policies and procedures preclude influence of industry or other relevant entities upon the scientific or clinical content of these documents. The leaders of both organizations recognize that including among the members of writing committees experts who in some cases have relationships with industry or other entities (RWI), when properly managed and disclosed, can enhance the value of published documents.
The following statement outlines the ACC/AHA policy and methods used to ensure that the document development process is free of bias or improper influence. While these policies apply generally to all clinical practice guidelines, more stringent restrictions may apply to certain documents. This is the case for the suite of cardiovascular disease prevention guidelines that specifically address cardiovascular risk assessment, hypertension, hyperlipidemia, obesity, and lifestyle modification. Because of the large portion of the population potentially affected by these guidelines, a more restrictive policy requires that no writing committee members have relevant relationships with industry or other entities (see Section 2.1.1 below).
The ACC/AHA requires that those involved in writing efforts (authors, external peer reviewers, and members of the Task Forces overseeing document development disclose all RWI (defined in Section 2.1.2) pertaining to production, marketing, distribution or reselling of healthcare goods, services, advice or information for patients, investors or physicians. This includes relationships with government entities, not-for-profit institutions, and organizations (see category definitions for detail). All relationships must be declared, regardless of perceived relevance to the topic of the document. These disclosure statements are reviewed to ascertain the candidate’s RWI status, and assess eligibility to serve in various capacities in the production of ACC/AHA guidelines, data standards and/or performance measures. Employees of industry, part-time or full-time, are prohibited from serving on guideline writing committees.
1.2.1. Relationships with Industry and Other Entities versus Conflict of Interest
The term Relationships with Industry and Other Entities (RWI) is preferred over Conflict of Interest (COI) as the intent is not to imply conflict or bias. When all relationships are disclosed with detail regarding category and amount and managed appropriately when building consensus and voting, potential bias can be avoided or minimized while assuring that the final, published document reflects the necessary expertise.
In addition to managing RWI, the ACC/AHA, through the respective Task Forces, monitors for and manages other potential sources of bias pertinent to the writing effort, beginning with selection of writing committee members to assure an array of perspectives, including those of academic and nonacademic healthcare providers, diversity of race, ethnicity, gender, geography and setting, and a broad range of intellectual positions.
1.3. Organizational Structure: Task Forces and Writing Committees
1.3.1. The Task Force on Clinical Practice Guidelines
The Task Force on Clinical Practice Guidelines (TFPG) oversees development of guidelines and establishes policies and procedures governing these documents. The TFPG prioritizes and coordinates topic selection, writing committee formation, document development methodology, and procedures for evidence review, peer review, document approval and publication.
1.3.2. The Task Force on Performance Measures
The Task Force on Performance Measures (TFPM) oversees development of performance measures and establishes policies and procedures governing documents of this type. The TFPM prioritizes topics and performance items, writing committee formation, methodology, document development, and procedures for peer review, document approval, publication and implementation.
1.3.3. The Task Force on Clinical Data Standards
The Task Force on Clinical Data Standards (TFDS) oversees establishment of data standards, setting the policies for promulgation of these standards. The TFDS determines the scope, topics, and metrics for this purpose, assembles writing committees, and defines the methodology for document development, peer review, approval, publication and implementation of these standards.
1.3.4. Writing Committees
Writing Committees commissioned by the TFPG, TFPM, and TFDS are charged with developing guidelines, performance measures, or data standards documents on assigned topics for publication in the appropriate journals of the two organizations. ACC/AHA policy is defined by clinical practice guidelines, but the restrictions on RWI apply to performance measures and data standards as well.
1.3.5. Chair, Co-Chairs, Vice Chairs
Chairs and Co-Chairs of writing committees must have no relevant RWI. Co-Chairs are individuals who share equally the responsibility for leading the writing committee to develop the document. The term Vice Chair refers to an individual who is subordinate to the Chair but assists with document development. Unlike Chairs and Co-Chairs, Vice Chairs may have RWI relevant to the topic of the document.
2.0. General Principles for Managing RWI
2.1. Collecting RWI Information
The ACC/AHA collects the following information to evaluate and manage RWI during document development and to report these relationships in the published document.
2.1.1. Reporting Timeframe
ACC/AHA requires disclosure of all RWI for the 12-month period prior to writing committee initiation, consistent with the reporting timeframe for the National Institutes of Health and the Food and Drug Administration. In addition, authors must refrain from adding new RWI throughout the writing effort until the date of publication. Writing committee members are encouraged to maintain their current RWI status for a period after publication to allow participation in focused updates; RWI will be re-assessed to determine continued eligibility when a writing initiative is re-commissioned. Changes to RWI must be verbally disclosed by each member of the writing committee at the beginning of all conference calls and meetings and reflected in the author disclosure table.
2.1.2. Relationship Type
The following definitions describe the categories or types of relationships used for RWI reporting:
Relationships for which honoraria are allocated or received from private sector payers, pharmaceutical, device, or other mission-related companies, gifts or other consideration, or ‘in kind’ compensation, including fees donated to nonprofit organizations, whether for consulting, lecturing, traveling, service on advisory boards, or similar activities in the reporting period (generally 12 months prior to the date of disclosure). This includes consulting or advisory activities for Federal, state, or local government agencies such as CMS or the FDA. Since the Federal government maintains procedures to assure freedom from bias, consulting for its agencies is generally not classified as relevant to ACC/AHA document development.
Speaker or Member of Speakers’ Bureau
Honoraria or fees received directly from industry for lecturing. Compensation received through contracts with industry or other entities for membership on or participation in speaker’s bureaus.
Accredited continuing medical education (CME) programs organized through certified educational organizations need not be disclosed, since this designation requires that program content be developed without industry influence.
Stock holdings*, stock options*, ownership, partnership, membership or other equity positions, regardless of the form of the entity, or options or rights to acquire such positions, rights and/or royalties in patents or other intellectual property.
Ownership of interests in diversified mutual funds is excluded from this designation and need not be reported.
Roles as principal investigator (PI), co-PI or investigator at a local, national or international level, steering committee member or consultant for grants pending, awarded or received (including commercially-funded, NIH or other Federal agency-funded, and university-managed grants and data monitoring committee [DMC; DSMB], clinical event adjudication committee [CEAC; CEC] activities and other operational activities related to research). This category includes receipt of drugs, supplies, equipment or other support when the individual has direct decision-making responsibility for allocated resources or proceeds. This type of relationship should be reported by the individual even when funds are budgeted to an institution. For investigators, sub-investigators† or co-investigators† (as defined below), affirmative responses to any question in the definition indicates responsibility to report.
Research activity funded by the NIH or other Federal agency should be reported but is generally not classified as relevant to ACC/AHA document development.
Full or partial funding for support of salary, position or program.
Institutional or Organizational (including but not limited to research)
This category refers to relationships between industry and an institution or organization with which the individual is affiliated when the individual is involved in the relationship. The individual should report RWI when funds provided to an academic institution or organization are designated for the use of the individual, rather than awarded or paid directly to the individual. An individual participating as a co-investigator or subsidiary investigator in a study for which another individual is designated as the grant awardee or funded PI is an example of this type of relationship, which should be disclosed.
When industry funds an institution for other purposes (e.g., to support a program or fellowship), the determining consideration is whether the reporting individual has decision-making responsibility over the funds. Examples of RWI that should be reported include (1) serving as an investigator, sub-investigator† or co-investigator† (as defined below) when the individual engages in or oversees recruitment of subjects to participate in a clinical trial; (2) a Department Chair or Division Chief with fiscal authority or decision-making responsibility over funds received from extramural sources for research, fellowships, educational conferences, institutional supplies, etc.; (3) funds provided by a commercial entity to an institution with which the individual has a professional or personal affiliation (e.g., faculty of a medical school) when the funds provide full or partial salary support of the individual or staff under the direction of the individual.
These relationships may be considered relevant to the writing effort (see Section 2.1.5), whereas research or clinical funding obtained from Federal sources (e.g., grant support from NIH or other government agency) is not considered relevant, even when the government has received support from industry for the project.
Other relationships that should be reported include leadership or governance responsibilities or roles (e.g., officer, director, trustee or other fiduciary role, editor, etc.) in professional or nonprofit organizations, whether or not remunerated, that may involve interests potentially competitive with the ACC or AHA or cooperative or competitive with entities having business interests in the guideline topic.
Legal proceedings in which the individual served as a consultant, expert or deposed witness, whether compensated or uncompensated, should be disclosed, reporting the year of involvement, alignment with the plaintiff or defendant, and the topic of the case/testimony, whether or not the matter proceeded to trial. Disclosure should be consistent with applicable legal requirements and restrictions, such as HIPAA or confidentiality agreements.
*Divesting of stock or stock options nullifies the specific relationship and in such cases the 12 month rule does not apply.
†Sub-investigators or co-investigators are defined here as individuals who have signed FDA Form 1572 or an Investigator Agreement in roles other than primary or co-author of data analyses, abstracts, or manuscripts, who do not have oversight of the research, report data, or receive compensation from the sponsor (including direct salary support or salary support for staff, shared staff or overhead charges), and do not receive funds for travel or accommodation to attend investigator meetings hosted by the sponsor.
Sub-investigators or co-investigators should answer 3 questions: (1) Have you signed a FDA Form 1572 or an Investigator Agreement? (2) Do you have oversight of the research or data reporting? (3) Did you receive funds or compensation to attend investigator meetings? If the answer to any of these is affirmative, the relationship should be disclosed under the personal research category; if all answers are negative, the relationship should be disclosed under the institutional category.
184.108.40.206. Data Monitoring Activities for Clinical Trials
Membership on Data Monitoring Committees ([DMCs] or Data Safety Monitoring Boards [DSMBs]) and Clinical Event Adjudication Committees [(CEACs] or Endpoint Committees [CECs]), whether commercially-funded or government- or university-managed, are not classified as relevant relationships when the committee is independent of industry influence, as recommended by the FDA. The ACC/AHA recognizes that the main responsibility of the DMC is to assure the safety of trial participants and the scientific integrity of the study in the interest of advancing clinical research. DMC membership should be reported on the member’s comprehensive disclosure. The oversight Task Force will review the DMC Charter to assure compliance with FDA regulations regarding independence from influence by a commercial sponsor, in which case the relationship will not be considered relevant to the document under development.
2.1.3. Writing Committee Balance (bias)
Chair/Co-Chairs: The Chair or Co-Chairs should have no relevant RWI.* The writing committee chair is selected mainly on the basis of competency to effectively manage the writing group and develop consensus on the text and recommendations. A general knowledge of the topic of the document is also necessary, but the chair need not have expertise in the topic. The chair must be free of relationships or other biases that could undermine the integrity or credibility of the work.
Vice Chair: A vice chair may be appointed to add content expertise. Vice chairs may have relevant RWI but may not have a significant relationship in the ownership category as defined above.
Committee: The Chair and at least half the writing committee members must be free of relevant RWI*. The TFPG/TFPM/TFDS monitor writing committee composition for RWI and other potential sources of bias, such as intellectual perspectives or organizational relationships, and approve each writing committee before document development commences. Once chosen, authors are requested to avoid relevant RWI throughout the writing effort until publication.
*In conjunction with the writing committee Chair, the TFPG/TFDS/TFPM may prospectively define relevance to the topic when the content addressed in the document is non-clinical or non-prescriptive in nature and, therefore, where disease- or procedure-based definitions do not apply. Based upon the agreed-upon definitions, certain relationships may be deemed irrelevant to the document. These may include, but are not limited to, specified institutional/organizational and government/nonprofit relationships. Such special determinations must be approved by the organizational leadership of the ACC/AHA.
2.1.4. Financial Value or Level of Relationship
Financial relationships should be classified as significant, modest, or not monetary. A significant interest in a business reflects ownership of 5% or more of the voting stock or share of the entity, ownership of $5,000 or more of the fair market value of the entity, or funds received from the entity exceeding 5% of the individual's gross annual income for the reporting period. A relationship is modest if less than significant under the preceding definition. No financial relationship pertains to relationships for which the individual receives no financial compensation. However, if an individual directs where financial compensation goes, e.g., donates to charity, faith-based, educational, or other tax-exempt organization, such funds are reported as a financial relationship.
2.1.5. Relevance to Document Topic
Authors must report all RWI, and all relationships are evaluated for relevancy by the respective oversight committee to determine eligibility of the individual to serve as a member of a writing committee. A person has a relevant relationship when:
- The relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or
- The company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, makes a drug or device that competes for use with a product addressed in the document; or
- The person or a member of the person’s household has a reasonable possibility of financial, professional or other personal gain or loss as a result of the issues or content addressed in the document.
For determining eligibility to draft text or vote on recommendations, the following considerations apply to relevant RWI of members of the writing committee:
- If the individual has relevant RWI regarding a product or competing product, and the section of the document pertains to the specific product or competing product, the member is permitted to participate in discussions but is not permitted to draft recommendations or corresponding text or vote on recommendations to which the relationship applies.
- If the individual has relevant RWI regarding a product or competing product, and the section of the document is not related to the specific product or a competing product and the company does not manufacture or market a relevant product or service or competing product or service, the member is permitted to participate in the discussion and is permitted to draft recommendations and/or corresponding text and vote on recommendations to which the relationship applies.
- If the individual has relevant RWI regarding a product or competing product, and the section of the document relates to the company that manufactures or markets the product or service or a competing product or service but not the specific product or class of products involved in the relationship, then the member is permitted to participate in the discussion but is not permitted to draft recommendations and/or corresponding text and is not permitted to vote on recommendations to which the relationship applies.
2.1.6. Timing of Disclosures
Relationships extant during the prior 12 months are disclosed in writing and/or online during formation of the writing committee to determine eligibility. New relationships should be avoided during the writing process, and those that develop or arise must be reported to the chair of the writing group immediately to ensure transparency throughout the writing, voting, and document approval processes. In cases where the relationship disturbs the requisite balance or more rigorous criteria restricting membership on the writing committee of persons with RWI, the individual may be required to resign from the writing committee. Such circumstances, hopefully rare, will be reported in the published document.
2.2. RWI Management
2.2.1. Consensus Development
The ACC/AHA values the expertise of its writing committee members and encourages full discussion to inform deliberation on document content. All writing committee members are therefore free to discuss all aspects of the document within the confidentiality bounds that apply to the document development process, including those topic areas to which relevant RWI may apply. If, in the judgment of the chair, one or more members seem to exert undue influence or otherwise risk biasing the outcome of the discussion, whether or not they have RWI relevant to the topic under discussion or other bias, the individual(s) may be asked to leave the room or conference call during all or part of the discussion to assure that the work of the writing committee can proceed unfettered.
2.2.2. Voting on Recommendations
In general, all committee members, even those with relevant RWI, may participate in the discussions of all topics covered by the writing committee. Individual members may not draft or vote on recommendations and/or text when they have relevant relationships, as defined in Section 2.1.4 above. For the purpose of tracking adherence to this policy, a confidential written vote is taken for every formal recommendation prior to external peer review and then again when recommendations are revised in response to peer review prior to submission of the final document for review and approval by the ACC Board of Trustees (BOT) and AHA Scientific Advisory and Coordinating Committee (SACC). The writing committee chair reviews the votes to ensure appropriate recusal of writing committee members with RWI and, in the interest of transparency, the record of recusals is published in the document by author and section.
2.2.3. External Peer Review
There are no RWI restrictions upon participation in the external peer review process, but reviewers must disclose all RWI related to the topic. The relevant relationships are published in an appendix to the document. This policy provides opportunity for comment from a variety of constituencies and assures that those with diverse viewpoints inform the content of the document.
2.2.4. ACC Board of Trustees and AHA Science Advisory and Coordinating Committee and ACC and AHA Executive Committees Review and Approval
Documents are approved as ACC and AHA policy by a majority vote of BOT and SACC and Executive Committee members who have no relevant RWI related to the document under consideration. BOT and SACC members with relevant RWI may comment but may not vote on clinical documents at the time of board review and approval.
2.2.5. Public Disclosure of RWI
The ACC/AHA disclosure policy is cited in the published document and relevant RWI of authors and peer reviewers is published in the document appendix. In addition, to ensure transparency, a hyperlink to the updated comprehensive RWI of each author (in effect at the time of the writing effort) and TFPG/TFDS/TFPM member is included in the document. This information resides on www.acc.org and on myamericanheart.org.
ACCF BOT approved 12/7/09; EC approved revisions 5/17/10; EC approved revised DSMB policy 7/10/15; AHA approved updated/clarified policy 1/29/16