Where do I submit/update my disclosure?
When did NASS adopt the Disclosure Policy?
NASS originally adopted its disclosure policy in January 2006. Significant revisions were made in October 2008 requiring disclosure of dollar amounts and establishing sanctions for non-compliance. It was not until NASS began its widespread implementation of the policy, in conjunction with annual committee appointments and abstract submissions for the 2009 Annual Meeting, that members started to use the new online disclosure module (accessed at http://disclosure.spine.org), resulting in questions about some of the practicalities of disclosure. Appropriate revisions to the disclosure policy were made by the Board of Directors, at the recommendation of the NASS Committee on Ethics & Professionalism (previously called the Ethics Committee), at their February 2009 meeting. These changes were not substantive and dealt, rather, with practicalities of implementation and compliance. NASS recognizes that there are confidentiality agreements, legal issues, and practical barriers that might impact disclosure of more detailed information.
What were the February 2009 changes?
The revised NASS disclosure policy can be viewed in its entirety here.
Modifications to the NASS disclosure process should not be viewed as a change in its overall disclosure policy, but as a means of making the disclosure process easier for its membership and presenters/authors. NASS remains committed to leadership in the field of transparency in professional medical associations, and in formulating disclosure policies and procedures that allow for full transparency of physician-industry relationships.
The basic changes made in February 2009 are outlined below:
- A change in wording from "actual dollar amounts" to "estimated dollar amounts," in order to make the process easier to comply with for those who may not have received all of their tax documents yet when completing the module
- The universal deadline to comply was moved to later in the year (May 1) to coincide with receipt of tax information. However, as stated in the policy, if an abstract deadline comes first, you must adhere to the earlier deadline
- Assertions of online security were added, as was the requirement that staff who handle disclosure information must sign Confidentiality Agreements about that information.
- The requirement for dollar amounts did not change: NASS participants in meetings, committees, etc still give NASS their information in dollar amounts, but staff will then convert those amounts into ranges for disclosure to attendees at meetings (for those disclosing relative to a CME event) and by other committee/task force members (for those disclosing relative to NASS volunteer positions).
- The NASS Board will disclose their relationships both on the member section of the NASS website and (along with the Program Chairs) in the Final Program for the Annual Meeting.
Who should disclose?
The NASS disclosure policy applies to all participants in all NASS activities, including those who serve in committee and leadership positions within the society, speakers and others participating in a CME activity, and authors on NASS publications including but not limited to The Spine Journal (TSJ), SpineLine, Contemporary Concepts and Clinical Guidelines. The relationships requiring disclosure include but are not limited to those involving these 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.
If I am a member, but do not participate in NASS activities, do I have to disclose?
Compliance with the policy is not a requirement for membership. If you are a member but you are not serving in a volunteer role, nor presenting at a NASS CME activity, you are not required to disclose. You may attend NASS CME activities without disclosing, but you may not present without disclosing. If you attend a NASS CME event and you wish to ask a question/make a comment during a Q&A period (during a symposium, for instance), however, you will be asked to verbally disclose relationships which are relevant to the topic at hand (this truncated disclosure is allowed in this situation due to time constraints). Though disclosure is not required merely as a function of membership, the availability of the disclosure module is a member benefit of which any member may take advantage, if one wishes to have a definitive disclosure available online.
What should be disclosed?
The NASS disclosure policy requires participants in NASS activities to disclose estimated dollar amounts to the nearest $1000 for activities taking place in the prior calendar year (i.e., January 1 to December 31 of the previous year). Financial disclosures in the Final Program, Proceedings supplement, and on disclosure slides (where applicable) will be shown in ranges of estimated dollar amounts. NASS will translate estimated amounts submitted by presenters into ranges for presentation in these forums. NASS respects that there are confidentiality agreements, legal issues, and practical barriers that might prevent public disclosure of more detailed information.
The disclosure format retains the intent of the policy: to disclose any and all participant relationships and to allow attendees and other learners to judge whether or not a relationship constitutes a conflict of interest or source of bias with respect to information that is presented in an educational setting in accordance with Accreditation Council for Continuing Medical Education (ACCME) regulations. NASS participants are required to disclose all relationships with industry, including relationships in negotiation. Relationships still in the negotiation phase will be classified with the same terminology on the basis of estimated potential future value. For further guidance and explanation regarding this policy and ramifications of policy violations, please refer to the full accompanying document, the NASS Disclosure Policy (revised February 22, 2009).
Is NASS Leadership required to disclose?
Yes. The relationships held by potential candidates for leadership positions are vetted by the Conflict of Interest Review Panel (COIRP) and are bound by adherence to the NASS Policy on COI in Leadership Positions. The Board of Directors disclose to each other in printed and verbal form at the beginning of every Board of Directors meeting, and their disclosures will also be included (along with those of the Program Committee) in the front of the Annual Meeting Final Program.
Are members who serve on committees and task forces required to disclose?
NASS member volunteers have their disclosure information, in ranges, disclosed to other members of the committees and task forces on which they serve.
What is the COIRP?
The COI Review Panel (COIRP) reviews financial interest disclosures, leadership positions in other societies, and other non-financial disclosures submitted by the membership and renders reasonable decisions as to whether these financial or management interests could directly and significantly affect the involved party's ability to maintain unbiased, ethical interactions. If a conflict is deemed to exist, the Panel will work with the party to manage, minimize or eliminate any actual COI. All committee/task force appointments are considered contingent upon COIRP review; an invitation to serve may be revoked as a result of COI disclosure at the discretion of the COIRP in concert with the Committee/Task Force Chair and Council Director overseeing the position in question. The COI Review Panel consists of seven members with various specialty backgrounds, who have agreed to review these issues and to abide by NASS' Fiduciary Responsibility Rules. They will have been vetted at the time of appointment by the NASS Executive Committee. COIRP members are classified as Level 1 in the NASS Policy on Leadership COI. The disclosures submitted by COIRP members will be a matter of record, available for review by any NASS member serving as a complainant or respondent to a case brought before the Panel. All decisions and recommendations by the COIRP will be by a majority vote of those COIRP members who participated in that particular review. Five members of the Panel will constitute a quorum. The protocol document for the COIRP can be viewed here.
How do I submit a question to the COIRP?
To solicit the advice of the COIRP, please send an e-mail (subject line: "COIRP Review") to Julie Randolph, Manager of Ethics & Section Development . Your e-mail should include your question in its entirety, including, if applicable, the exact nature of the relationship in question and the NASS activity for which you are disclosing.
How do I complete my disclosure using the online module?
The user-friendly module will walk you through the process. Just visit http://disclosure.spine.org. You will need your member ID and password. If you don't have this information, you can retrieve it via the disclosure module log-in page or by contacting the Membership Department. The online module was implemented to provide ample space for the relay of contextual information and to eliminate the need for filling out forms that were repetitive in nature. Your disclosure information is now submitted ONCE per year (barring any changes in your relationships that might cause you to update your information more frequently than that, or additional activities participated in that may have different deadlines) and stored on our secure server, accessed only by staff who have signed confidentiality agreements and who have a reason to see it, based on their interaction with your NASS activities.
How do I get my disclosure information to the staff member or committee that needs to see it?
At the end of the module (accessed at http://disclosure.spine.org), after you hit "submit form," you will be presented with options for distribution. You may send the form to yourself, and then forward it to whomever you wish. There is also a drop-down list from which you can choose the NASS department that needs to see your form: "Education" if you are a moderator, for instance; or "Research Department" if you are being invited to serve on a research committee. When in doubt, send it to yourself and then forward it to the correct party. Please only send the information to the staff member who needs it.
What if I am submitting an article for The Spine Journal (TSJ)?
TSJ authors MUST send their completed disclosure to the corresponding author for their submission, rather than directly to TSJ (accessed at http://disclosure.spine.org/Tsj.aspx). You may either send the disclosure to yourself (at the end of the module) and then forward it to your corresponding author, or you may choose "TSJ corresponding author" from the drop-down list at the end of the module and hit "send" and the module will give you a blank text box where you can enter the e-mail address for the corresponding author. If you are the corresponding author, send the disclosure information to yourself and compile the other authors' disclosures before submitting to TSJ. If you have questions about this process, it is further explained on the TSJ submission page, or you may contact TSJ Managing Editor, Robin Campbell, who can answer your questions regarding this process.
How do I make updates to my form?
You may update your form at any time, and should do so at a minimum of once a year. You will receive an email with instructions from staff reminding you to update your form when it is necessary (if you are participating in an activity that requires it). To update your form, return to the online disclosure module (accessed at http://disclosure.spine.org). You will be given a choice whether to "create new" (which will give you a blank form so you can start over from scratch), or "Recall saved form" (which will pull up the most recent version of your information so that you may review and make modifications only where things have changed). Please use caution: once you choose "Create New" you are given a blank form and you may not go back and recall saved information. Please use caution: once you choose "Create New" you are given a blank form and you may not go back and recall saved information.
What is the deadline for disclosure?
You will be given individual disclosure deadlines each year based on the activities in which you are involved. The default disclosure deadline is May 1.
Who will see my disclosed information?
Information supplied to NASS through the disclosure module in estimated dollar amounts will be viewed only by a limited number of NASS staff in the Education, Membership, and Ethics departments, who have signed Confidentiality Agreements regarding such information. As stated in the revised Disclosure Policy, the information is stored on a password-protected, secure server. Once your information has been translated into ranges by staff, your disclosure in range format will may be made available to the following parties: either to the audience of the CME activity at which you are presenting, or to the Committee/Task Force Chair (and appropriate Council Chair to which it reports) for the committee/task force on which you have volunteered to serve. In the case of questions regarding a volunteer or presenter's disclosure, the information may also be viewed by members of the Professional Conduct & Ethics Committee, the COI Review Panel, and/or the NASS Executive Committee.
Will the general public have access to the information I submit?
Yes, in an annual index of disclosures for all NASS activities that will be published for the first time in August 2013 (approximately). NOTE: Due to a recent Board of Directors ruling in October 2011, disclosure information—in range format-- will begin to be made available to the general public beginning in early to mid 2013. This will include any disclosure information that is provided to NASS after February 2012.
Can I "opt out" of having my disclosed information—in range form—made publically available?
No. This is required of participants in all NASS activities.
If a member of the press or general public calls the NASS office to request my disclosure information, will you release it?
We will only release the information that is publically accessible on our website—that is, the annual index of disclosures in range format. We will not release your detailed disclosure information with dollar amounts, nor your contact information, to the press or to anyone else.
Will NASS release disclosure information to my patients?
Disclosure to patients is not the function of the current disclosure policy. We encourage our members—and all medical providers—to talk openly with their patients about the nature of their conflicts. Most patients feel that their doctors' collaboration with industry is crucial to scientific advancement, and is important work that should continue. NASS is working on developing tools to help guide the spine care provider in disclosing COI appropriately to patients. Patients will, however, be able to view their doctors' range-format disclosures in the annual index.
May I refuse to disclose my information to NASS and still participate?
No. As with ACCME policies which do not allow presenters to refuse to disclose, the NASS disclosure policy is mandatory. Disclosure according to the NASS policy is a requirement of participation in both NASS CME activities and as a NASS volunteer. Those who do not wish to disclose according to the NASS policy may not submit abstracts for
NASS meetings or volunteer to serve on committees/task forces.
What about context? All this financial information is useless without knowing more about the nature of the relationship.
We agree that context is essential to the learners'/audience's comprehension and judgment of the nature of a conflict. The NASS online disclosure module provides the ability to define the context of each relationship, both with categories such as "consulting," "grants," and "royalties," as well as with text boxes which allow for clarification in the individual's own words. The module is organized by categories of types of relationships. To view the online disclosure module and complete your own disclosure, visit http://disclosure.spine.org. In some cases, however, lengthy disclosures may be edited by staff for length, making every effort to retain the spirit of the disclosure (presenters are always given the chance to review their disclosure in final form prior to publication)
How do I provide a dollar value for stocks/options?
The information requested in the disclosure module (accessed at http://disclosure.spine.org) for stocks does not include a dollar value. NASS is aware that values fluctuate, or that there may be no value to options, etc. Information requested includes "number of shares" and "percentage of company" ONLY.
If I am aware that a NASS volunteer or a presenter at a NASS meeting has inadequately or inaccurately disclosed their relationships, and I want to issue a complaint, what do I do?
When submitting a complaint, you should send your letter to the address below. In your letter, be sure to mention specifically what part of the disclosure policy you feel the member/participant/author in question has violated, and include what evidence you have that contradicts their submitted disclosure.
Todd Wetzel, MD, Chair—COI Review Panel
c/o Julie Randolph, Manager of Ethics & Section Development
7075 Veterans Blvd
Burr Ridge, IL 60527
(Phone number if required for shipping purposes: (630) 230-3600)
What disclosure information will attendees at the NASS Annual Meeting see?
Financial disclosure in the Final Program, Proceedings supplement, and on disclosure slides (where applicable) will be shown in ranges of estimated dollar amounts. This disclosure format retains the intent of the policy: To disclose any and all participant relationships, and to allow attendees and other learners to judge whether or not a relationship constitutes a conflict of interest or source of bias with respect to information that is presented in an educational setting in accordance with Accreditation Council for Continuing Medical Education (ACCME) policies.
Can I give NASS my financial information in ranges?
No. The policy requires that you submit estimated dollar amounts. The presenter will provide estimated dollar amounts as indicated above, through the NASS on-line disclosure module. NASS will then translate that information into dollar ranges for viewing at the meeting. It should be noted that these ranges will not be "Major" and "Minor" as in years past, but ranges that give more accurate and useful information to the attendee/learner.
What are the ranges?
Level A. $100 to $1000
Level B. $1,001 to $10,000
Level C. $10,001 to $25,000
Level D. $25,001 to $50,000
Level E. $50,001 to $100,000
Level F. $100,001 to $500,000
Level G. $500,001 to $1M
Level H. $1,000,001 to $2.5M
Level I. Greater than $2.5M
Will I still have to disclose verbally?
Yes. ACCME policies require verbal disclosure by the moderator or presenter. This verbal disclosure may reference the slide and indicate that more detailed information is available in the program.
How will my information be listed in Annual Meeting program materials?
Information included in the Final Program and Proceedings will be similar to that provided in prior years, in the format Name: Company - Relationship, followed by a letter representing the appropriate dollar range. Both publications will contain a key indicating the values that correspond to these ranges.
A sample listing would be:
Last Name, First Name: Company-Royalties, Level B; Company-Consulting, Level A
How can I be sure the "estimated dollar amount" information that I input into your system is secure?
Information submitted via the online disclosure module (accessed at http://disclosure.spine.org) will be collected and stored on a password-protected secure server. All NASS staff who interact with disclosed information are required to sign Confidentiality Agreements prior to viewing such information.
Who do I contact if I have a question not covered in this FAQ, or if I need help with the disclosure module?
If you have any further questions, please feel free to contact the staff liaison in charge of the disclosure program: Julie Randolph, Manager of Ethics & Section Development through e-mail or (630) 230-3686.