May 17, 2010
ACCF Relationship With Industry and Other Entities: Policies and Procedures for the Development of Guidelines and Other Clinical Documents
The American College of Cardiology Foundation (ACCF) is committed to the very highest ethical standards in all its activities, including development of clinical policy. The College considers clinical document development as core to its missions and accepts no industry funding for development. The College has always taken a stringent approach to ensuring responsible, transparent relationships, in which industry support and other relevant entities have no influence on scientific content. The College believes that including experts who have relationships with industry and other relevant entities on writing committees, when transparent and properly managed, strengthens the writing effort and final published document. However, part- or full-time employees of industry are prohibited from serving as members of clinical document writing committees. The following policy outlines the College’s methodology for ensuring a document development process without improper bias or influence.
For those involved in the writing effort (i.e., authors, external peer reviewers, and document oversight group members), the ACCF requires the disclosure of all relationships with industry and other entities (as defined in Section 2.1.2.) involved in the production, marketing, distribution or reselling of healthcare goods, services, advice or information consumed by patients, investors and/or physicians. This may include relationships with government entities as well as not-for-profit institutions and organizations (see Clinical Statement Definitions for detail).
1.2.1. Relationships with Industry (RWI) Versus Conflict of Interest (COI)
The ACCF prefers the term Relationships with Industry and Other Entities (RWI) as opposed to the term Conflict of Interest (COI). RWI, by definition, does NOT necessarily imply a conflict. When all relationships are disclosed with the appropriate detail regarding category and amount, and managed appropriately for building consensus and voting, the College believes that potential bias can be avoided and the final published document is strengthened since the necessary expertise is accessible.
In addition to managing RWI, the College monitors and manages other potential biases that may be relevant to the writing effort including the views of academic versus nonacademic physicians, as well as other potential biases that may stem from race, gender, geographic location, or intellectual position on a particular issue.
1.2.2. Document Oversight Groups
Document Oversight Groups oversee the development of a particular document type, such as practice guidelines, performance measures, data standards, appropriate use criteria, expert consensus documents, clinical competence and training or health policy statements. These groups coordinate: topic selection and prioritization, writing committee formation, document development methodology and procedures, external peer review, document approval and publication.
1.2.3. Writing Committees
Writing Committees are commissioned by their respective Document Oversight Group and charged with developing a document on an assigned topic for publication in the College’s journal which reflects ACCF policy.
1.2.4. Chair, Co-Chairs, Vice Chairs
The term Co-Chair refers to two or more chairs who share equal responsibility. Co-Chairs (as for Chairs) may have no relevant RWI. The term Vice Chair refers to an individual who serves in conjunction with a Chair but is subordinate to that Chair. Unlike Chairs and Co-Chairs, Vice Chairs may have relevant RWI.
2. General Principles for Managing RWI
2.1. Collecting RWI
Listed below is the information the College collects for the purposes of managing RWI for clinical document development.
2.1.1. Reporting Timeframe
The ACCF requires the disclosure of all RWI for the past 12 months, consistent with the reporting timeframe for the National Institutes of Health and the Food and Drug Administration. In addition, authors are discouraged from adding new RWI during the writing effort; however, if relevant relationships are added, this information must be verbally disclosed during any conference calls or meetings, as well as added to the author disclosure table.
2.1.2. Relationship Type
Seven categories are defined for reporting RWI:
- Speakers' Bureau
- Personal Research
- Institutional or Organizational
- Expert Witness
View definitions of RWI categories.
2.1.3. Financial Value/Level of Relationship
Financial disclosures should be classified as significant, modest, or no financial relationship. A person is deemed to have a significant interest in a business if the interest represents ownership of 5% or more of the voting stock or share of the business entity, or ownership of $10,000 or more of the fair market value of the business entity, or if funds received by the person from the business entity exceed 5% of the person’s gross income for the previous year. A relationship is considered to be modest if it is less than significant under the preceding definition. No financial relationship pertains to relationships for which you receive no monetary reimbursement.
2.1.4. Relevance to Document/Topic
Authors must report all relevant RWI.
For determining eligibility to serve on a writing committee, all relationships are evaluated by the respective oversight committee for relevance. A person has a relevant relationship IF:
- 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, or makes a competing drug or device addressed in the document; or
- The person or a member of the person’s household, has a reasonable potential for financial, professional or other personal gain or loss as a result of the issues/content addressed in the document.
For determining eligibility to vote on and draft recommendations and text, a person has a relevant relationship:
- If a member of a writing committee has a relevant RWI regarding a product or competing product, and the section of the document relates to the specific or competing product, then the member is permitted to participate in the discussions but is not permitted to draft or vote on a recommendation or corresponding text.
If a member of a writing committee has a relevant RWI regarding a product or competing product, and the section of the document is not related to the specific or competing product, and the company does not manufacture or sponsor any relevant product/service or competing product/service, then the member is permitted to participate in the discussions and is permitted to draft and vote on the recommendation and/or corresponding text.
If a member of a writing committee has a relevant RWI regarding a product or competing product, and the section of the document relates to the company that manufactures or sponsors the product/service or competing product/service but not the specific product or class of products involved in their relationship, then the member is permitted to participate in the discussions but is not permitted to draft or vote on the recommendation and/or corresponding text.
2.1.5. Disclosure Timing
Relationships are disclosed 1) in writing or online in advance of the writing effort to determine eligibility of members to serve on a writing committee and 2) throughout the document development process to ensure complete transparency in the writing and sign-off processes. Relationships that develop during the writing process must be reported to the writing group chair immediately.
2.2. RWI Management
2.2.1. Writing Committee Balance (bias)
Chair/Co-Chairs: The Chair or Co-Chairs may have no relevant RWI.* The writing group chair is selected primarily for the competency of effectively managing the writing group. A general working knowledge and competency in the writing topic is also necessary, but the chairperson does not have to be a leading expert in that topic. The chairperson must be selected to avoid relationships that could undermine the credibility of the writing group or its work product.
Vice Chair: A vice chair may be added to the writing effort if needed for content expertise. Vice chairs may have relevant RWI but may not have a significant relationship in the ownership category as defined above.
Committee: A majority of writing committee members must be free of relevant RWI.* At least 50% of writing committee members, plus the Chair, may have no relevant RWI. The Document Oversight Group monitors writing committee composition for RWI, as well as other potential areas of bias, such as intellectual bias/perspectives or organizational relationships potentially competitive with the College, and must approve each writing committee before work begins. Once chosen, authors are requested to withhold from forming any new relevant RWI during the writing effort in order to maintain the RWI balance of the writing committee.
Of note, the Document Oversight Group also reviews writing committee balance for other issues such as specialty, geographic location, private practice (versus academic setting/practice), gender, race, and appropriate organizational/content expertise.
2.2.2. Consensus Development
All writing committee members are invited to discuss all aspects of the document, including those for which they have relevant RWI. The College values the expertise of all writing committee members and allows open discussion to inform the writing committee’s final deliberation on document content. However, if one or more individuals appear to be unduly influencing the outcome of the discussion, whether they have a relevant relationship with industry to the topic under discussion, a relevant relationship with another (nonindustry) entity to the topic (see above definition), or other bias related to the discussion, the individual may be asked to leave the room or conference call during a portion or all of the discussion at the discretion of the Chair.
2.2.3. Voting on Recommendations
In general, all committee members, even those with relevant RWI, may participate in all discussions. However, writing committee members may not draft or vote on recommendations and/or text if they have a relevant relationship 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 document recommendation prior to external peer review and then again on recommendations that change as a result of peer review following the finalization of the draft prior to the Board review/approval process.† The writing committee chair must review all votes to ensure accurate recusal by all writing committee members. Recusals from voting are published in the document by author and section for the purpose of transparency.
2.2.4. External Peer Review
There are no RWI restrictions for participation in the external peer review process of a document; however all reviewers must disclose all relevant RWI to the topic for publication in an appendix of the document. This promotes the opportunity for comment on the document from a variety of constituencies/viewpoints to inform final document content.
2.2.5. ACCF Board Review and Approval
Board members may comment but should not vote on clinical documents at the time of board review and approval if they have relevant RWI. Documents are approved as College policy by a majority vote of board members who have no relevant RWI to the document under consideration.
2.2.6. Public Disclosure of RWI
The College’s disclosure policy is cited in the published document and relevant RWI of authors and peer reviewers are published in a document appendix. In addition, to ensure complete transparency, a hyperlink to the comprehensive RWI of each author (in effect at the time of the writing effort) and Document Oversight Group member (updated in real time) is included in the document. This information resides on www.cardiosource.org.
*At the discretion of the Document Oversight Group, certain disclosed relationships of the chair, co-chair or writing committee member levels including participation in government-sponsored or university-managed Data Safety Monitoring Boards or research, as well as certain institutional/organizational relationships and government/nonprofit relationships may be considered as NOT relevant to the writing of the document. A standard exemption is extended to Appropriate Use Criteria writing committees which do not make recommendations but rather prepare background materials and typical clinical scenarios/indications (Delphi Method Step 1) that an independent technical panel then uses to set recommendations through a review and rating process (Delphi Method Step 2). See Section 2.2.3. for details.
†Appropriate Use Criteria (AUC) documents utilize a modified Delphi consensus method as outlined by RAND in their Appropriateness Criteria Method document and ACCF AUC Methodology paper. This method utilizes a two-step process: Delphi Method Step 1) writing committee develops a list of typical clinical scenarios/indications; Delphi Method Step 2) technical panel members review and rate the individual clinical scenarios. The RAND Delphi method allows the contribution of a wide range of viewpoints while minimizing and controlling bias through an independent rating/recommendation panel, a review of score dispersion, use of the median rating to determine final recommendations, and a highly structured process for determining recommendations (see methodology manual for details). As such, all technical panel members, even those with RWI, will be allowed to rate as a part of the technical panel modified Delphi process.
ACCF Board of Trustees approved December 7, 2009; Revisions ACCF Executive Committee approved May 17, 2010