American College of Cardiology

Disclosure Toolkit

POLICIES & PROCEDURES REGARDING ACC/ACCF
DISCLOSURES OF FINANCIAL RELATIONSHIPS AND COMPETING INTERESTS
WITH INDUSTRY AND OTHERS

I.          Introduction and Summary

The American College of Cardiology Foundation and the American College of Cardiology (“College”) are committed to ensuring balance, independence, objectivity, and scientific rigor in their governance, programmatic, educational, chapter, and other activities.  Fulfilling this commitment depends in large measure on ensuring member and public confidence in the College’s integrity.  The College recognizes that the expertise and involvement of College members in their practice, research, and other volunteer and private activities, unavoidably will lead to the development of interests and the formation of relationships that could be adverse to or inconsistent with certain College interests.  Therefore, the College has sought to define an appropriate and workable policy and process to identify and address such competing interests and relationships of members involved in activities of the College with other outside interests and entities.

Trustees and members must disclose all financial, personal, volunteer and professional interests and relationships with industry, individuals, and other organizations (including those of spouses, business partners , and immediate family members) within the last 12 months (1 year) that actually or potentially could predispose or bias the individual to a particular decision, view, or goal in connection with the College activity in which he or she is engaged.   

The presence of a competing interest or relationship does not necessarily result in ineligibility to serve, but rather that participation in some matters may need to be modified or avoided as determined by disinterested members of the College.  The responsibility for identifying a potential issue in any given activity or situation is that of the member.  If you have a question as to whether or not there is an issue, you should discuss the matter with the Chair of your committee, board, or task force. 

All Trustees and members involved in College governance, such as committees and task forces, programmatic, educational, chapter, and other activities must provide complete, timely, accurate, and signed disclosure statements. Compliance with this process is mandatory for participation in College activities.  The names and information regarding disclosures will be retained by the College.  Disclosures for ACC writing committee members and ACCF accredited activities shall be included in the agenda of committee meetings and/or conference calls.  

The information will be kept within the College and may be shared with other committee chairs and staff, as well as the College leadership and the editors of the College journals.  Disclosures for ACC writing committee members and peer reviewers shall be published in both the Journal of the American College of Cardiology and Circulation, as well as posted on www.acc.org and www.americanheart.org web sites.  Disclosures for accredited activities will be shared with the activity audience.

II.        Accredited Educational Activities
In addition to the foregoing, there are certain specific disclosure requirements in connection with ACCF’s position as a continuing medical education provider accredited by the Accreditation Council for Continuing Medical Education (“ACCME”) and a provider of continuing nurse education accredited by the American Nurses Credentialing Center (“ANCC”). 

Please see the attached ADDENDUM for the ACCF’s “Disclosure (Vested Interest) Policy/Procedures for Accredited Educational Activities.” This addendum includes the additional policy and procedures specific to accredited activities including the ACCF’s mechanisms to identify and resolve conflicts of interest.

ADDENDUM
American College of Cardiology Foundation
Disclosure (Vested Interest*) Policy and Procedures for Accredited Educational Activities
(Effective May 31, 2005)

*Note: The term “disclosure” is used throughout this statement, but all policies and procedures included herein also apply to the vested interest declarations required by the American Nurses Credentialing Center’s Commission on Accreditation.

Policy statement For Accredited Activities
It is the policy of the American College of Cardiology that audiences for any ACCF programs, products, policies, services and scientific publications (“activities”) must be informed, prior to their participation, of ACCF’s and individual ACCF contributors’ relevant relationships with commercial interests in any proprietary entity producing health care goods or services (with the exception of nonprofit or government organizations and non-health care related companies).  Contributors will include directors, planners, reviewers, moderators, speakers, faculty and authors and editors of programs, products, services and publications. All such contributors must disclose relevant relationships to ACCF annually in accordance with the policies and procedures described in this statement.  ACCF will identify and resolve all conflicts of interest prior to a contributor’s participation in the program, product, policy, service and/or scientific publication. 

ACCF’s policy also incorporates adherence to the following guidance:

• American Medical Association’s (AMA) Opinion 8.061, “Gifts to Physicians from Industry” (adopted December 1990) and Opinion 9.011, “Ethical Issues on CME” (adopted by the AMA in December 1993 and updated June 1996).
• Accreditation Council for Continuing Medical Education’s (ACCME) “Standards for Commercial Support.”
• Accreditation Council for Graduate Medical Education’s (ACGME) “Principles to Guide the Relationship Between Graduate Medical Education and Industry.”
• American Nurses Credentialing Center’s Commission on Accreditation, “Unit Operations Criterion.”

Individual Disclosure
All contributors to accredited activities will be asked to disclose:

• Financial relationships related to the content of the activity
• Nothing to Disclose
• Unlabeled or investigational uses of product

The need to disclose specific financial involvement only applies if it is germane to the content or is related to the commercial supporters of the activity.  Disclosure must never include the use of a trade name or product-group message. For a contributor with no relevant financial relationships, the audience must be informed that no relevant financial relationships exist. 

Relevant financial relationships should be described according to the following levels of support
and categories described on the accompanying Disclosure Form:  
                        Levels of Support:

• None
• Modest: up to $10,000
• Significant: greater than $10,000

           
Any relevant financial relationship may constitute a conflict of interest with respect to the contributor’s ACCF activities and should be disclosed and reviewed consistent with the procedures described in this statement.  Significant cumulative levels of personal relationship will signal a potential conflict of interest to be further reviewed.  As a condition of participation, each contributor must attest that his/her presentations and/or writings are based on the best available scientific evidence and will not promote the interests of any commercial interest. Specific procedures for managing conflict of interest are discussed elsewhere in this statement.

ACCF financial relationships
Any relevant ACCF organizational financial relationships will also be acknowledged before or as an integral part of the activity by indicating the corporate name of the support and, in some instances, the level of financial support.

Unlabeled (off-label) or investigational use disclosure
ACCF requests that all contributors disclose discussion of unlabeled (off-label) use of approved products or experimental or investigational use of unapproved products referenced in his or her presentation or publication. 

PROCEDURES RELATING TO DISCLOSURE OF CONFLICT OF INTEREST FOR ACCREDITED ACTITIVES

Collection and review of disclosure information for educational activities
ACCF will obtain disclosure information from potential contributors prior to final confirmation of committee or task force appointments and/or final contributor selection.  All disclosure information will be reviewed by the group and/or individual(s) selecting the contributors, and conflicts of interest will be addressed and managed consistent with the procedures described in this statement.  It is the responsibility of each contributor to notify the ACCF of any changes to his or her annual financial disclosures.  The ACCF will re-confirm disclosure information as part of the contributor selection process.

Disclosure of financial relationships to audiences
All audience members and readers will be informed, prior to the activity, whether each contributor has any relationship or no relationship to disclose as described in this statement.  The committee agenda, activity syllabus and/or handout will be used to disclose financial relationships for planners, presenters and reviewers of live activities; disclosure will also be required via an opening slide.. 

In rare emergency situations where a last minute speaker substitute is required, and advance disclosure analysis is not possible, the ACCF will assign an appropriate person (e.g., moderator) to request this information at the time of the presentation, and document that the relevant information was disclosed.  The resulting verification documentation must be on file with ACCF within one month of the activity and must reflect that:
a) verbal disclosure occurred; and
b) itemize the disclosed information, including disclosure of no relevant relationships.

Mechanisms to identify and resolve conflicts of interest
Disclosure information from all contributors with relevant financial relationships will be reviewed prior to final confirmation/selection.  Particular attention will be given to contributors with single or multiple financial relationships at a significant level.   The disclosure review process and resolution method must be documented by the reviewer.   In instances where the reviewer(s) determine that a financial relationship constitutes an irresolvable conflict, the individual will not be selected as a contributor.  If a perceived conflict of interest is deemed resolvable,  the nature of the contribution will be carefully delineated to resolve the conflict.  Resolution mechanisms may include advance peer review of slides (which must also be documented), re-assignment of lecture, limitation of discussion (e.g. no recommendations), speaker attestation of a balanced presentation based on best available evidence, etc.

All activities must offer a balanced view of therapeutic options.  Use of generic names will contribute to impartiality.  If the activity must include references to trade names, where available, trade names of products from several companies should be referenced instead of trade names from a single company. 

CONSEQUENCES OF NONCOMPLIANCE
Any individual refusing to provide adequate disclosure consistent with this policy will be prohibited from participation in any future ACCF education activities.   Violations may also be reported to the individual’s academic institution or entity with whom he or she is professionally affiliated.  The ACC/ACCF Ethics and Discipline Committee will serve as the final review and adjudicating body for noncompliance with these policies.

AUDIT PROCESS
Audience members will be asked to evaluate the activity for bias.    If more than 3 percent of the participants report perceived bias, a review committee will convene to recommend mechanisms for eliminating the perception of bias in the future.  A contributor’s failure to resolve the perception of bias will result in disqualification from future participation.

ACCF may conduct random post meeting audits, by topic, to ensure presentations were balanced and on site verbal disclosures did not create a perception of bias or a conflict of interest.

Glossary of ACCME Terms

Commercial Interest
Any proprietary entity producing health care goods or services, with the exemption of nonprofit or government organizations and non-health care related companies.

Commercial support
Financial or in-kind contributions given by a commercial interest that is used to pay all or part of the costs of a CME activity.

Conflict of Interest
When an individual has an opportunity to affect CME content about products or services of a commercial interest with which he/she has a financial relationship.

Financial relationships
Financial relationships are those relationships in which the individual benefits by receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds), or other financial benefit.  Financial benefits are usually associated with roles such as employment, management position, independent contractor (including contracted research), consulting, speaking and teaching, membership on advisory committees or review panels, board membership, and other activities from which remuneration is received, or expected.  ACCME considers relationships of the person involved in the CME activity to include financial relationships of a spouse or partner.

Relevant financial relationships 
The ACCME defines “ ‘relevant’ financial relationships” as financial relationships in any amount occurring within the past 12 months that create a conflict of interest.

ACCF Frequently Asked Questions

Who should disclose?
Anyone with an opportunity to affect/control content.  Includes individual ACCF contributors (including directors, planners, reviewers, moderators, speakers, faculty, and authors and editors of programs, products, services and publications).

What should be disclosed?

• Relevant financial relationships with a commercial interest related to the content of the activity *
• Category and Level of Support (but not the amount)*
• If there is nothing to disclose
• Unlabeled or investigational uses of products

*See Disclosure Form for levels and categories of support to disclose
  Note:  ACCF to disclose organizational financial relationship

When will disclosure information be required?
The ACCF will obtain disclosure information from potential contributors prior to confirming any committee or task force appointments and/or final selection as a contributor. 

Who reviews the disclosure information?
All disclosure information will be reviewed by the group and/or individual(s) selecting the contributors, and conflicts of interest will be managed in accord with the procedures described in this statement.  

What if a financial relationship is deemed an irresolvable conflict?
In instances where the reviewer(s) determine that a financial relationship constitutes an irresolvable conflict, the individual will not be selected as a contributor or the nature of the contribution will be carefully delineated to resolve the conflict of interest

How will disclosure of financial relationships be made to audiences?
The committee agenda, activity syllabus and/or a slide will be used to disclose financial relationships for planners, presenters, and reviewers of live activities.  If this information has not been provided in advance, it is the responsibility of the moderator to request this information at the time of the presentation and to document that the relevant information is disclosed.