November 1999
Volume 40, Issue 12
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Editorial  |   November 1999
ARVO Commercial Relationships Policy: Financial Disclosure in ARVO Presentations and Publications
Investigative Ophthalmology & Visual Science November 1999, Vol.40, 2765-2766. doi:
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      Gary D. Novack; ARVO Commercial Relationships Policy: Financial Disclosure in ARVO Presentations and Publications. Invest. Ophthalmol. Vis. Sci. 1999;40(12):2765-2766.

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ARVO has a financial disclosure policy that has been in place for several years. This policy is presented in detail in the author instructions for Investigative Ophthalmology and Visual Science (see www.arvo.org/arvo/commerci) and, for presentations at the annual meeting, in the abstract submission forms. Simply stated, the policy asks authors to disclose whether they have any financial interest in the research presented or in that of a competitor. To quote from the policy: “The ARVO Board of Trustees believes that financial interests should not restrict presentation or publication but that the audience should be aware that such interests exist.” 
ARVO is not alone in its concern about financial disclosure. In 1991, Hillman et al. 1 discussed the types of biases that may occur because of the behavior of the scientist/clinician, the sponsoring firm, or both. They pointed out that bias is especially possible in studies that have an economic impact and propose a standard for improving the quality of economic analyses. In the past decade, scientists in fields as diverse as neurology, nutrition, psychiatry, internal medicine, epidemiology, and veterinary science have highlighted financial disclosure issues in their publications. 2 3 4 5 6 7 8 There is even a proposal in the journal Neurology that sets a finite financial limit, beyond which individuals with substantial investments recuse themselves from reviewing manuscripts. 9  
What constitutes a “financial interest”? If you have received any compensation (funds, services, or goods) beyond a meal, then you have a financial interest. If you have the future possibility of financial gain through patent ownership, etc., then you have a financial interest. ARVO asks for the nature (although not the magnitude) of this financial interest to be stated. 
There are some obvious examples of having a “financial interest” in your ARVO presentation or IOVS manuscript. For example:
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    Did a pharmaceutical firm give you a grant (restricted or unrestricted) to conduct the studies you are presenting?
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    Did a firm provide biostatistical or other such support for data analysis?
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    Did you conduct this research as a contractor to a firm?
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    Do you own a patent for, or are you an inventor of, the product described?
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    Do you own stock in a firm that owns the product or process you are describing?
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    Do you have stock options in a competitor’s firm?
There are also some less obvious examples of having a financial interest:
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    Did a firm whose product, device, or process you evaluated pay your travel expenses to talk about the product, device, or process at a meeting?
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    Did a firm handle logistics and expenses for a practical course you taught on the product, device, or process?
As listed in ARVO’s Commercial Relationships Policy statement, there are different codes for each of these types of financial relationships. The abbreviation “P,” for example, stands for the“ Product” category where there is a financial interest in the“ equipment, process, or product presented.” Likewise, there are categories for Investor, Employee, or Consultant. Subcategories further define the type of compensation or support received. This use of codes differs from the American Academy of Ophthalmology (AAO) policy in which any financial relationship beyond the “free lunch” is combined into the same category of financial relationships. 
The ARVO Commercial Relationships Policy also states, “Bias in research presentation and publication can arise from various forms of self-interest.” Thus, the “intellectual bias” that any scientists may exhibit can also be of concern. 10 If you have spent years of your scientific career in quest of a particular goal, and when the results are obtained, there is no difference between your new treatment and the standard of care, it may be difficult to give up the theory. One could posit that there is no one with a greater proprietary interest than the principal investigator presenting his or her data at the ARVO meeting in May whose grant is up for renewal. It is probably sufficient disclosure for such an investigator to cite the source of funds in the appropriate section of the abstract form. 
In the area of clinical trials, where outcomes are most immediately felt in the financial marketplace, one could argue that double-masking of clinical trials would minimize bias. Even here, intellectual bias rather than sponsor-induced (financial) bias could skew the results. Of course, such intellectual bias is not technically covered by the ARVO guidelines but must be guarded against. 
Yet another area of concern is that of “proprietary” methods. Scientists are taught that the methods section of a paper should be complete enough to allow another scientist to understand their work and to be able to replicate it fully. In 1996, a scientist published a clinical pharmacokinetic paper and footnoted a bioanalytical method. Upon request of a colleague, the author refused to supply the method, as it was “proprietary.” The Editor, who had assumed that details would be made available to interested colleagues, then stated that he would not accept such papers in the future. 11 The view of ARVO and IOVS is that, if one part of a scientific study is not disclosable, then none of it can be presented. Again, this is not technically covered by the ARVO guidelines but is certainly an area in which full and open disclosure is demanded. There is the special case where an investigator conducts an experiment using an instrument with a proprietary technology (e.g., a visual field analyzer with a special program). If the brand name and program name is cited, then I believe that this would be adequate. 
Finally, let me give you a personal example. As a consultant to pharmaceutical firms, my compensation is typically provided as a fixed hourly rate. I am happy when a regulatory filing for a client is successful, and they can begin to market their product. If the firm believes that I helped them in this regard, it will be more likely to use me in the future and to recommend me to other firms. However, my relationship is not a proprietary one since my compensation is not directly related to the financial success of a product. If, on the other hand, my compensation is in the form of stock or stock options, and then, if the stock price increases at approval, my interest becomes proprietary. 
Once an author discloses a financial relationship, what happens? ARVO’s Commercial Relationships Committee (CRC) believes that the audience or reader will take this relationship into account as appropriate in interpreting the research. For example, should the stated conclusion of the author be that a new treatment for a disease will instantly supplant all other treatments and the author is the owner of the patent and receives a royalty from the manufacturer, the reader might be circumspect. If there are two possible analyses of a study, intent-to-treat and per-protocol, if the one favoring the new therapy is overly highlighted, and again, if there is a proprietary relationship for the authors, the reader might also be concerned. However, in both of these extreme cases, self-reporting protects the author from major criticism. For most properly self-reporting, peer-reviewed research, it is the science and/or clinical outcome that is of paramount importance; neither the scientist nor the sponsor dictates the relevance and importance of the work. 12 Thus, proper self-reporting can only enhance the credibility of the research report and, to the discerning reader, should not be viewed as a detriment or liability. 
Therefore, ARVO scientists are asked to self-report financial relationships in IOVS submissions. Likewise, for ARVO meeting presentations, this is easily done by providing a short statement on a poster or on a slide used during an oral presentation. For occasions when a financial interest has not been disclosed, the CRC serves as a site where a member can report an alleged act of nondisclosure. Given the relative infrequence of these reports to date, it has not been necessary to establish a formal policy on how to deal with them – specifically, to take punitive measures against nonreporters. It is incumbent on each scientist to be knowledgeable about the Commercial Relationships Policy and to be forthright about disclosure of financial and proprietary relationships regarding the work being described. We can all agree that self-reporting among colleagues is preferable to any type of centrally mandated system. 
Financial Disclosure: The author serves as a consultant to many firms developing and marketing ophthalmic pharmaceuticals. He has stock or stock options in two firms, neither of which is mentioned in this article. 
Editorial Note: At the time of writing this article, Dr. Novack was Chairman of the CRC. The present chair is Kenneth P. K. Trevett, JD, COO and General Counsel of the Schepens Eye Research Institute, Boston, Mass. 
Hillman AL, Eisenberg JM, Pauly MV, et al. Avoiding bias in the conduct and reporting of cost-effectiveness research sponsored by pharmaceutical companies. N Engl J Med. 1991;324:1362–1365. [CrossRef] [PubMed]
Rock CL. Conflict of interest: an important issue in nutrition research and communications [comment]. J Am Diet Assoc. 1999;99:31–32. [CrossRef] [PubMed]
Garry RF. Beyond conflict of interest. BMJ’s editors should publish their own conflicts of interests regularly [letter]. BMJ. 1999;318:464–465.
Krimsky S, Rothenberg LS, Stott P, Kyle G. Scientific journals and their authors’ financial interests: a pilot study. Psychother Psychosom. 1998;67:194–201. [CrossRef] [PubMed]
Krimsky S, Rothenberg LS. Financial interest and its disclosure in scientific publications. Epidemiology. 1998;280:225–226.
Marshall DF. All scientific content of the BMJ should declare authors’ conflicts of interest [letter]. BMJ. 1998;317:351.
Schulman K, Sulmasy DP, Roney D. Ethics, economics, and the publication policies of major medical journals. Epidemiology. 1994;272:154–156.
Wahlbeck K, Adams C. Beyond conflict of interest. Sponsored drug trials show more-favourable outcomes [letter]. BMJ. 1999;318:465.
Kieburtz K. Avoiding conflicts of interest: responsibilities of authors, reviewers, and editors [editorial; comment]. Neurology. 1998;51:1527–1528. [CrossRef] [PubMed]
Horrobin DF. Beyond conflict of interest. Non-financial conflicts of interest are moreserious than financial conflicts [letter]. BMJ. 1999;318:466. [CrossRef]
Reidenberg MM. Publication and proprietary information. Clin Pharmacol Ther. 1996;59:367–368. [CrossRef] [PubMed]
Welch SJ. Conflict of interest and financial disclosure: judge the science, not the author [editorial]. Chest. 1997;112:865–867. [PubMed]
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