Volume 9, Number 1, March 2019 • COMMENTARY
What is Considered a Conflict of Interest or What to Disclose in Lectures and Publications?
Keywords: conflict; interest; lectures; publications
Level of Evidence: AAOS Therapeutic Level IV
Recently our Journal was criticized for allowing a co-author to submit and publish a technical paper when said surgeon is involved in a litigation matter. “I am very surprised indeed that you do not consider being a defendant in legal action concerning the very practice being defended in an article amounts to a conflict of interest.”
This made me think it might be an appropriate time to revisit this issue. I think it is important to understand some of the history regarding disclosure and conflict of interest.
What should a conflict of interest policy include when it comes to Continuing Medical Education (CME)? One might think this is an easy question but I have been involved with this question since the 1990s and find that it is one of the more difficult areas of debate. 
A policy on conflict of interest (COI) should require those with a conflict (or who think they may have a conflict) to disclose the conflict or potential conflict.
CME in the United States clearly dates back to the formation of the American Medical Association (AMA) in 1873 with publication of its first publication in 1883 Journal of the American Medical Association (JAMA).
This issue of COI has been much discussed and debated over the years and the topic of FDA investigation back in 1991and 1992 resulting in a 1995 publication The Statutory Basis for FDA Regulation of Scientific and Educational Information. 
The Accreditation Council for Continuing Medical Education (ACCME) intervened in 1992 and was successful in pointing out to the FDA that a governing body was already in place concerning CME activities. However, the FDA did instruct the ACCME that if they changed their guidelines concerning commercial support of CME activities to standards they would basically back off from official involvement. As a result ACCME in 1992 adopted new standards for all ACCME accredited sponsors.
These 1992 standards have been the foundation for many organizations in establishing their own guidelines and standards for educational activities into publications. The ACCME has updated their Standards in 2004, 2005 and more recently in 2014. 
1992 ACCME Standards
1. General Responsibilities of Accredited Sponsors – The accredited sponsors are responsible for the content, quality, and scientific integrity of all CME activities certified for credit. Identification of continuing medical education needs, determination of educational objectives, and selection of content, faculty, educational methods and materials is the responsibility of the accredited sponsor. Similarly, evaluation must be designed and performed by the accredited sponsor.
2. Enduring Materials – The accredited sponsors are responsible for the quality, content, and use of enduring materials for purposes of CME credit.
3. Identifying Products, Reporting on Research and Discussing Un-Labeled Use of Products – Presentations must give a balanced view of options. Faculty use of generic names will contribute to the impartiality. If trade names are used, those of several companies should be used rather than only that of a single supporting company. Reporting scientific research offered by a commercial entity to provide a presentation reporting the results of scientific research shall be accompanied by a detailed outline in the presentation, which shall be used by the accredited sponsor to confirm the scientific objectivity of the presentation. Concerning unlabeled uses of products or an investigational use not yet approved for any purpose is discussed during the educational activity, the accredited sponsor shall require the speaker to disclose that the product is not labeled for the use under discussion or that the product is still investigational.
4. Exhibits and Other Commercial Activities – When commercial exhibits are part of the overall program, arrangements for these should not influence planning or interfere with presentation of CME activities. Exhibit placement should not be a condition of support for CME activity. No commercial, promotional material shall be displayed or distributed in the same room immediately before, during, or immediately after an educational activity certified for credit. Representatives of commercial supporters may attend an educational activity but not engage in sales activities while in the room where the activity takes place.
5. Management of Funds from Commercial Sources – The ultimate decision regarding funding arrangements for CME activities must be the responsibility of the accredited sponsor. Funds from a commercial source should be in the form of an educational grant made payable to the accredited sponsor for the support of programming. The terms, conditions, and purposes of such grants must be documented by a single agreement between the commercial supporter and the accredited sponsor. No other funds from a chimerical source shall be paid to the director of the selectivity. Payment of reasonable honoraria and reimbursement of out of pocket expenses for faculty is customary and proper. Commercial support must be acknowledged in printed announcements and brochures. However, reference must not be made to specific products.
6. Commercially Supported Social Event – Should not compete with nor take precedence over the educational events.
7. Policy On Disclosure of Faculty and Sponsor Relationships – An accredited sponsor shall have a policy disclosure of the existence of any significant financial interest or other relationship a faculty member or a sponsor has with the manufacturer of any commercial products discussed in an educational presentation.
8. Financial Support for Participants in Educational Activities – In connection with an educational activity offered by an accredited sponsor, the sponsor may not use funds originating from a commercial source to pay travel, lodging, registration fees, honoraria, or personal expenses for non-faculty attendees. Scholarships or other special funding to permit medical Students, residents, or fellows to attend selected educational conferences may be provided as long as the selection of students, residents or fellows who will receive the funds is made either by the academic or training institution or by the accredited sponsor with the full concurrence of the academic or training institution.
Conclusion: There is no question that commercial support can contribute significantly to the quality of CME activities. However, there have been abuses in the past and the ACCME new standards will help to assure scientific integrity of all CME activities that receive certification for credit.
The standards have evolved and I would suggest anyone that publishes and or lectures at CME activities should know the Standards because most lectures that I have observed do not comply with the requirements.
In my opinion, although medical journals have lagged behind ACCME standards with regards to conflict of interest, they have established their own policies on the matter. Almost all medical journals now require authors to disclose COI, however the same standards have not been employed for editors and reviewers. 
Haque et al, looked at 703 editors and COI policies at 60 medical journals. 57% of the journals had policies in place governing COI for editors, but only 21% publicly reported the disclosures. 
Journals and CME activities have focused on financial conflict of interest (FCOI) but is that sufficient? Certainly there can be other factors that can influence the behavior and actions of persons in a position of authority. A 2004 study, argued that “…the automatic nature of self-interest gives it a primal power to influence judgment and makes it difficult for people to understand its influence on their judgment, let alone eradicate its influence.” 
There have been published examples of overtly biased actions by editors. “For example, an orthopedic surgeon, during his tenure as an editor published many studies in his journal favoring products from a company, which paid him millions of dollars in patent royalties.” 
What about the potential issues of editors and or reviewers trying to gain favor by approving manuscripts submitted by key surgeons who influence appointments to key memberships in professional societies and committees. I suggest that we have to understand better what motivates behavior and what is the level of trust in a given professional standard of behavior.
In 2007 The American Academy of Orthopaedic Surgeons (AAOS) adopted Standards of Professionalism on Orthopaedic-Industry Conflicts of Interest that require orthopaedic surgeon members to identify and disclose potential conflicts of interest to their patients. 
JISRF created a web page that deals with Patient-Physician Guide, Patient Disclosure Letter, Patient Disclosure Poster, and AAOS Patient-Physician Communications. This page is not intended to be and end all result on the subject but a convenient resource page. We recommend that you also check with your individual professional societies for their policies on disclosure. 
All Policy and Procedures can be Viewed on Reconstructive Review Website. 
The following highlights some of our policies that pertain to COI.
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The issue of conflict of interest and what and how to disclose will be an ongoing area of concern and debate for years to come.
The following quote from Phyllis Pettit Nassi clearly states the challenge. “When you talk about trust you have to know the way a group thinks, how they interact, how they communicate, how they educate. You have to know what their roles and relationships are. What are their values? Their practices? What are the expected behaviors?”
Members of JISRF and Reconstructive Review will stay diligent with regard to COI and disclosure issues and from time to time will update our policies and procedures. We welcome comments on this subject and look forward to addressing concerns within a common sense approach.
- McTighe T, Vise G.T., Bechtol C.O., CME Conflict of Interest, AAOS Scientific Exhibit 1993 San Francisco, CA.
- Boulding M, The Statutory Basis for FDA Regulation of Scientific and Educational Information. Journal of Pharmacy and Law, Vol. 4, No. 2, pages 123-142 (1995)
- Standards for Commercial Support: Standards to Ensure the Independence of CME ActivitiesSM
- Haque W, Minhajuddin A, Gupta A, Agrawal D, Conflicts of interest of editors of medical journals. Published: May 18, 2018. doi: 10.1371/journal.pone.0197141
- Moore DA L. Self-Interest, Automaticity, and the Psychology of Conflict of Interest. Social Justice Research. 2004;17:189.
- Journal-Sentinel M. Journal editor gets royalties as articles favor devices Dec 2009 [07/28/16]. Available from: .
- Patient Discussion Guide AAOS.
Submitted: March 6, 2019
Reviewed: March 10, 2019
Accepted: March 11, 2019
Published: March 31, 2019
1 Timothy McTighe, Dr HS (hc); Joint Implant Surgery & Research Foundation, 46 Chagrin Shopping Plaza, #117, Chagrin Falls, OH 44022 US
(Direct reprint requests to Timothy McTighe, email@example.com)
The authors declare that there are no disclosures regarding the publication of this paper.
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