n Purpose
n Scope
n Definitions
n Types of Conflict that Must Be Disclosed
n Classification of Relationships
n Persons with Interest Requiring Dislcosure
n Process for Disclosure
n DISCLOSURE FORM
n Speakers Faculty and Moderators
n Board Members
n Committee and Task Force Members
n Process for Review of Disclosures
n Process for Monitoring Compliance
n Sanctions for Violations
n References
Quick Link
n Download NASS DISCLOSURE FORM
Purpose
The mission of the North American Spine Society is to advance quality spine care through education, research and advocacy. We strive for the highest standards of academic rigor, intellectual veracity and professionalism. To maintain the integrity of professional judgment of our members, volunteers and leaders, and to maintain public confidence, the society hereby adopts the following policy for the disclosure and management of financial conflicts of interest.
The society recognizes that professional relationships with industry are essential for development of new spinal technologies and medical advancement. These relationships do not in any way reflect negatively on the character of an individual. The goal of this policy is to establish uniform mechanisms for transparently disclosing these relationships so that the possibility for confusion or misrepresentation is minimized.
As professionals, we rely on the honor of our colleagues in matters of trust and disclosure. It is not the threat of intentional misrepresentation which is at the heart of the issue. With regard to our professional obligations, even the appearance to the public that any member, volunteer or leader has allowed a financial consideration to influence his or her professional behavior is damaging. Accordingly, the intent of this policy is to encourage disclosure of situations in which there is even the potential for bias, without any implications regarding actual bias. The establishment of uniform disclosure requirements frees individuals from having to decide which relationships might influence his or her decision-making and which are irrelevant; transparent disclosure allows the audience to participate in the interpretation of significance.
Scope
The focus of this policy is disclosure of financial conflicts of interest. The society recognizes that other types of conflicts also exist, such as motivations for professional advancement through academic achievements. Indeed, many such conflicts of interest are an inescapable component of human endeavors. We focus on financial conflicts because they are measurable, and money raised for one purpose can easily be used for another.
This disclosure policy applies to all participants in NASS activities. Although NASS encourages medical organizations to adopt uniform disclosure policies and terminology, this policy does not apply to the National Association of Spine Specialists, the World Spine Society or The Spine Journal, which are governed independently of NASS.
Definitions
We apply the definition of a conflict of interest as a set of conditions in which professional judgment concerning a primary interest (such as the health of patients, the integrity of research, and the education of students) has the potential to be unduly influenced by a secondary interest (such as financial gain). (1)
For this policy, company is defined as “a corporation… that carries on a commercial or industrial enterprise.”2 Company is further defined herein as an entity that produces or sells products or services to the spine market. We include in this definition companies that are in a development stage, that is, a company that devotes substantially all of its efforts to establishing a new business in which the principal operations either have not yet begun or have begun but without significant revenue.
Product is defined as “something that is distributed commercially for use or consumption.” It is usually (1) tangible personal property; (2) the result of fabrication or processing; and (3) time that has passed through a chain of approval and commercial distribution before ultimate use or consumption.
Stock/security indicate an interest based on an investment in a common enterprise and include any interest or instrument relating to finances, including a note, stock, treasury stock, bond, debenture, evidence of indebtedness, certificate of interest or participation in a profit sharing agreement.
Types of Conflict that Must be Disclosed
Required elements of disclosure include any remuneration from a company (stock ownership, stock options, stock warrants, royalties, consulting fees, loans from the sponsor, speaking arrangements), receiving gifts from a company (endowments, equipment, biomaterials, discretionary funds, support of office or research staff, support of training such as fellowships, sponsorship of trips, other sponsorships) and holding office in a company (board of directors, scientific advisory board, other office in the company).
Classification of Relationships
Financial relationships will be categorized as none, minor or major, ie:
None: valued less than $250 annually.
Minor: valued at $250 to $10,000 or up to 5% ownership of a company if value of ownership is less than $10,000.
Major: valued more than $10,000 annually or more than 5% ownership of a company.
Relationships still in the negotiation phase will be classified with the same terminology on the basis of estimated potential future value. NASS participants are required to disclose all relationships with industry, including relationships in negotiation.
Persons with Interest Requiring Disclosure
The object of this policy is complete disclosure of financial arrangements between a company and participants in NASS activities. Participants in NASS activities are individuals presenting at NASS meetings and courses, NASS office bearers and individuals officially appointed to NASS committees and task forces. The relationships requiring disclosure include but are not limited to those involving the participants, their spouses, de facto spouses, dependent children, adult children, siblings, parents, known holdings of all other family members, trusts, organizations or other related enterprises over which the individual exercises a controlling interest.
Process for Disclosure
Disclosure is provided through completion of a Financial Conflicts Disclosure Form. Completion of this form will be required as part of acceptance of speaking engagements, abstracts or NASS official appointments to office, committee, board or other positions. Each author on a scientific presentation will be required to submit an individual disclosure form. NASS office holders, committee members and board members will submit a disclosure form annually by the end of January. Additional disclosure by these individuals is required when substantive changes occur in their relationships in the interim.
Process for Reporting Disclosed Information
- Speakers, Faculty and Moderators. Disclosure will be acknowledged at the beginning of each presentation (invited presentation, abstract presentation, symposium, course or other speaking engagement) in both verbal form and on a slide immediately following the title slide. The disclosure for each author and speaker will be listed in the program materials (handouts, final program, web content and other published materials).
- Board Members. Each board member will complete and sign a new Financial Conflicts Disclosure Form prior to each meeting of the board. The completed form for each board member will be included in the first tab of the board book. Individuals with a financial conflict relative to the subject matter about to be discussed will be asked to immediately recuse themselves from the deliberation unless they have special information of a technical nature that will help the board better understand the issue. In that case the individual will be allowed to supply such information and then recuse herself or himself from the deliberations. Recusal means leaving the room in which the discussion is taking place, or disconnecting from the phone in the case of a telephone or video conference, for the portion of time during which the issue is discussed. These individuals will not vote or otherwise influence a decision in any matter related to the issue, and they may not witness the vote or be privy to the vote attribution. After the vote is recorded, the individual may be invited back into the room or call and will be apprised of only the final vote tallies. These individuals may then comment on the matter, but they may not alter the decision or request reconsideration.
- Committee and Task Force Members. Each member will complete and sign a new Financial Conflicts Disclosure Form upon acceptance of appointment. The completed form will be made available to the chair of each committee or task force. Prior to discussions at this level, disclosure will be updated by each individual relative to the topic being discussed, whether in person, via e-mail or on a conference call. The recusal process shall be the same as in the board protocol outlined above.
Process for Review of Disclosures
NASS will establish a committee to manage financial conflicts of interest. This committee will review disclosures of financial conflicts and establish policies for managing these conflicts. The committee will provide guidance for disclosure when requested for specific unclear situations, adjudicate complaints related to incomplete disclosure and set constraints for NASS office bearers regarding specific types of relationships.
In some cases it may be difficult to assess a financial relationship and its concomitant potential conflicts. If an individual does not feel that they can adequately characterize the relationship, they will be directed to discuss the matter with the chair or other senior member of the Disclosure Committee for guidance. If the issue remains unresolved, the individual will be asked to provide written details and the Disclosure Committee will review and render an opinion. If the individual disagrees with this decision, the issue may be referred to the Professional Conduct & Ethics Committee for adjudication, with the Chair of the Disclosure Committee serving as witness.
Process for Monitoring Compliance
The membership of NASS is bound by the bylaws of the association. Members are expected to adhere to all codes and guidelines, including the rules set forth in the NASS Code of Ethics and this Policy on Disclosure of Financial Conflicts. If a member fails to live up to the obligations therein, it is incumbent upon the society and other society members to hold that individual accountable. In cases where an individual fails to disclose a significant relationship, it is an obligation of those members aware of the relationship to remind the forgetful individual of the obligation to disclose. If the failure persists, these members are obligated to report this failure to the Professional Conduct & Ethics Committee. The Professional Conduct & Ethics Committee may investigate the allegation, with the complainant automatically defaulting to the secretary of the society as per current committee procedure. The committee will follow normal due process in its inquiry into the matter as outlined in the document “Procedural Guidelines of the Professional Conduct & Ethics Committee of the North American Spine Society.”
Sanctions for Violations
The Professional Conduct and Ethics Committee will establish procedures for the processing of complaints in determining sanctions for failures to disclose financial conflicts.
References
1. Thompson DF. Understanding financial conflicts of interest. N Engl J Med. 1993;329:573-576.
2. Garner BA (ed). Black’s Law Dictionary, 8th ed. Eagan, MN: West Publishing; 2004.
Adopted by the NASS Board of Directors, January 13, 2006.