Ethical Rules of Disclosure

A symposium was held on June on 27, 2008 at the University of California, Irvine School of Medicine, co-sponsored by the Association for Ethics in Spine Surgery, for the purpose of addressing a perceived lack of disclosure in medicine. Specifically, the symposium addressed the precise amounts of money being given by medical companies to the physicians who are influencing medicine with their research and opinions. In addition, those holding certain positions in medicine should be expected to have limited or no financial interests. Explicit transparency is sorely lacking and strongly warranted for the sake of patient care, which should be held as the highest single priority.

As a result of the symposium, a group of like-minded physicians created the Association for Medical Ethics along with a set of rules to address these deficiencies.

A. Principles

  1. Good medicine and science depend on minimizing bias.
  2. Financial ties and financial incentives present compelling interests that may result in unintentional bias and potentially intentional bias.
  3. Even where financial conflicts do not result in bias, the integrity of science and medicine is at risk because of the potential perception that bias may have occurred.
  4. Because of the risks of real or perceived bias, transparency regarding financial interests is critical for clinicians, scientists, and the public to weigh the validity of research findings, policy decisions, and practice guidelines developed by professional medical societies.
  5. Academicians with or without tenure, editorial board members, and medical society officers are looked to by the public, academics, and fellow physicians as a source of unbiased scientific data and education. Therefore, they should have no Substantive Financial Interest (defined below) that creates unacceptable conflicts.
  6. All scientists and clinicians should publicly disclose in all publications and presentations the precise nature and amount of any financial conflicting interest exceeding $500 per calendar year.

B. Definitions

  1. Financial Interests: Financial interests consist of anything of monetary value, including but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights) received within the preceding three calendar years.
  2. Substantive Financial Interest: Although any amount of money may induce bias, a “substantive financial interest” will be considered an amount that most reasonable persons would regard as unequivocally creating a significant risk of bias. Various existing guidelines set differing thresholds, but “substantive financial interest” will be defined here to be the direct or indirect (e.g., via a foundation)  receipt from industry of greater than $50,000 in personal compensation in any form.
  3. Incomplete Disclosure: Negligence in reporting disclosures exceeding current market value of greater than $10,000 for any of the preceding three calendar years.
  4. Disclosing Parties:
    1. Academicians: Physician or academic authors of papers who present or publish evaluations of product for clinical implantation or procedural use.
    2. Editorial board members: Editors and members of editorial review board of peer-reviewed medical journals who are in a position to accept or reject publication of research or options about any product for clinical implantation or procedural use. [Note: Although for-profit publishing companies are primarily organized for the stated and fiduciary obligation of enhancing revenue, it is the purpose of the editorial board to ensure unbiased and objective evaluation of the flow of medical information. Though often blinded, manuscript evaluation cannot be accomplished without financial bias if evaluators and editors have substantive financial interests.]
    3. Medical Society Officers: Those in governance positions of societies representing their specialty who exert critical influence over opinions of the public and physicians by dissemination of information and sponsorship of meetings involving products for clinical implantation or procedural use. [Note: Their role is objective education and research via evidence-based medicine without financial considerations. Their significant influence over the practice of medicine in this country by the issuance of professional practice guidelines is great, and needs to lack financial bias.]

C. Disclosure of Financial Interests

  1. Location of Disclosure
    1. Program insert for presented papers.
    2. Title page footnote for published papers.
    3. Medical society website for medical society officers.
  2. Items and format for Disclosure
    1. Form and value of monetary compensation:
      1. Cash
      2. Stock or options – current market value to be cited
    2. Entity receiving compensation:
      1. Personal and family members
      2. Practice corporation, research group, department, or institution
      3. Foundation with beneficiaries cited
    3. Purpose of Compensation
      1. Product development
      2. Product support and education
      3. Royalties, intellectual property
      4. Study grant – specify restrictions or not
      5. Honoraria – amount per event
      6. Specific products or procedures to be cited whenever involved

D. Incomplete Disclosure of Financial Interests

  1. Recommend penalties for incomplete disclosure
    1. Publication of journal errata for notification with complete disclosure for published papers. [Note: If complete disclosure is not released by author(s), then the notification includes prohibition of further publication until so accomplished.]
    2. Medical society member communication errata with complete disclosure for presented papers. [Note: If complete disclosure is not released by presenter(s), then the notification includes prohibition of further presentations until so accomplished.]
    3. Loss of academic appointment whether tenured or not.
    4. Suspension of editorial board activity.
    5. Medical society officer impeachment .
  2. Monitoring and reporting of incomplete disclosure
    1. Compliance with AME – UCI Ethical Rules of Disclosure will warrant recognition by AME as meeting the highest standards of unbiased medical ethics, education and research, and as such, be valued publicly in their opinions and policy. Such recognition of compliance will apply to medical societies, peer-reviewed publications, medical and scientific meetings, papers and presentations.
    2. AME will function as watchdog group. Alleged violations will be investigated, and, if accurate, reported on AME website and reported to appropriate society or publication.

Elimination of Substantive Financial Interests

  1. Academicians
    1. Salaried faculty, with or without tenure, doing publishable clinical research should eliminate substantive personal financial interests, if present, prior to engaging in such research. Grants from industry may be directed, but should be unrestricted and departmental.
    2. Non-salaried faculty should not represent published clinical research as university-based if substantive financial interests are present.
  2. Editorial Boards Members
    1. Editorial board members should eliminate substantive financial interests, if present, prior to serving on the board, by divestiture.
  3. Medical Society Officers
    1. Officers should eliminate substantive financial interests if present, prior to taking office, by divestiture.
    2. Disclosures using guidelines as noted above for three preceding calendar years should be made available on society website.
    3. No arrangements or financial transactions during their term of appointment that involve delayed future compensation should occur. This includes the sale or purchase of the stock, in any form, of a company involved in medical care unless part of a regulated mutual fund.