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Published 2/1/2010
Richard N. Peterson, JD

AAOS strengthens disclosure policy

New easy-to-use disclosure database, clear guidelines

In response to increasing public and governmental scrutiny of the relationships between orthopaedic surgeons and industry, the AAOS is establishing a new disclosure database, which will be rolled out at the 2010 Annual Meeting in New Orleans. The new database is easy to use and incorporates clear definitions of what must be disclosed.

The new disclosure database is the result of recommendations made by a special conflict of interest project team and adopted at the December 2009 meeting of the AAOS Board of Directors.

“The AAOS feels strongly that we have a responsibility to be completely transparent with respect to disclosure and potential conflicts of interest at all levels of the organization, starting with the Board of Directors,” stated AAOS President Joseph D. Zuckerman, MD. “This includes all governance units, committees, subcommittees, practice guideline and technology overview workgroups, contributors to continuing medical education (CME) courses and materials, and editorial boards. In short, everyone involved in AAOS activities.”

The project team was chaired by former AAOS President Tony Rankin, MD, and included Michael F. Schafer, MD; Paul Tornetta III, MD; Kristy L. Weber, MD; and Murray J. Goodman, MD.

“Our team reviewed a wealth of material provided by the AAOS General Counsel and his staff, including the Institute of Medicine’s Conflict of Interest in Medical Research, Education, and Practice and a draft report from the Council of Medical Specialty Societies,” said Dr. Rankin. “We had very thorough discussions with a diversity of opinions, ultimately achieving consensus on our recommendations to the Board.” (See “AAOS Board Directives on Disclosure”)

Open to the public
In a significant departure from the current disclosure program, the AAOS will provide public access to the information contained in the new AAOS Orthopaedic Surgeons Mandatory Disclosure Database. The AAOS conflict of interest policies will also be posted on the Web site, in the “About AAOS” section.

“The AAOS Board clearly recognizes the importance of proper disclosure so that conflicts of interest can be identified and managed,” Dr. Zuckerman observed. “We also recognize that disclosure is an evolving issue and that the rules in 2009 are different than they were in 2007.” The shift toward more public access is one example of the evolving standard.

Another example is the establishment of a new section on the Web site on “Industry Relations.” This area will identify commercial supporters of AAOS programs, including in-kind support such as donations of equipment for surgical skills courses. A new Committee on Outside Interests (COI), reporting directly to the AAOS Board of Directors, is being established to oversee the program as well as to address conflict of interest questions posed by AAOS committees and members.

Additionally, the AAOS Nominating Committee and the Nominating Committees for the Board of Councilors (BOC) and Board of Specialty Societies (BOS) will be required to ask candidates for positions on the AAOS Board of Directors about income sources other than from professional patient care, such as from healthcare facilities or consulting arrangements, and how such candidates plan to manage those potential conflicts if elected.

Mandated and voluntary participation
Participation in the new disclosure database is mandatory for orthopaedic surgeons involved in all AAOS organizational governance (including members of the BOC and BOS), as well as for CME faculty, authors of enduring materials, and participants in guidelines development. Members of the AAOS Board of Directors, Guideline Development Workgroups—and, beginning in 2010, the editors-in-chief and deputy editors of the Journal of the AAOS, Orthopaedic Knowledge Online, Your Orthopaedic Connection and AAOS Now—will also be required to disclose certain financial information associated with relationships that may create potential conflicts of interest.

Participation in the disclosure program is not required to become an AAOS Fellow. Voluntary participation by all orthopaedic surgeons in the disclosure program is, however, encouraged. Likewise, use of the disclosure database by ortho-paedic specialty societies and state orthopaedic societies is also encouraged.

Clear guidelines, easy-to-use
The new database has been redesigned to make it easier to use, and clarifying language has been added to ensure that participants understand the precise meaning of terms such as “immediate family,” “royalties,” and “principle investigator.”

A “yes” to any of the 11 questions will trigger a detailed information page pop-up when the participant clicks the “submit” button. At that point, the participant can choose from a series of options or enter specific information.

Under clarified guidelines from the Accreditation Council on Continuing Medical Education (ACCME), faculty, authors, program developers, and CME planners must list any conflict regardless of the content of the activity. Industry support for institutions or departmental research, however, must only be reported if the participant is the “principle investigator.” This clarified policy will alleviate many concerns expressed about the current disclosure system.

Done, and done well
“The project team was quite pleased with the outcome of our work and the subsequent approval by the Board,” Dr. Rankin reported. “We believe the adoption of the recommendations places the AAOS in a leadership position among medical organizations regarding conflict of interest principles.”

Dr. Zuckerman agrees. “Under Dr. Rankin’s outstanding leadership, the project team provided the Board with a comprehensive set of recommendations that addressed all aspects of disclosure throughout the AAOS. It was no surprise that the Board adopted with only minor amendments the entire set of recommendations. The work of the project team has made us an even better organization and at the forefront of disclosure policies.”

View the Academy’s mandatory disclosure policy

Richard N. Peterson, JD, is general counsel for the AAOS. He can be reached at peterson@aaos.org

Try it out!
Visit the Disclosure Database Assistance Booth in Lobby B of the Morial Convention Center during the 2010 AAOS Annual Meeting to find out more about the new disclosure database and policies. Fill out your new disclosures on-site! Staff will be on hand to answer questions.