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MEDICAL Ethics: Conflict of Interest
By: Lindsay A. Hampson, MD; Raj S. Pruthi, MD, MHA, FACS | Posted on: 01 May 2021
The ethics column seeks to introduce readers of AUANews to a wide range of contemporary ethical issues faced by practicing urologists.
Case: A urologist serves on the operating room governance committee of her health care system. The committee is deciding to upgrade its current robotic system with the purchase of 4 new robotic machines from Acme Surgical. The total expense will exceed $10 million in initial payment in addition to the annual service costs. Of note, the urologist’s husband owns 10,000 shares of Acme Surgical which he purchased in 2009 at $31/share (current value=$752/share).
Does her spouse’s stock ownership pose a conflict of interest (COI) for the urologist? If so, what are some options for her and her health care system?
Academic–industry collaborations are vital in urology, where innovative research influences device manufacturing and advancing therapeutics. However, such collaborations also raise the possibility for undue influence—the risk that industry financial ties could have an impact on clinical care and research. Fears over COIs have manifested in urology in various ways: financial incentives for the use of luteinizing hormone-releasing hormone agonists for prostate cancer, self-referral related to the purchase of intensity-modulated radiation therapy machines by physician groups, and physician ownership of lithotripsy and surgical centers.1,2 So what exactly is a COI, and how do we manage it?
A COI exists when an individual’s judgment related to their primary professional interest is unduly influenced, potentially influenced or perceived to be influenced by secondary interest, whether personal or professional.3 Importantly, a professional’s judgment does not have to be biased to have a COI; merely the appearance or potential of bias is important to recognize.
Financial COIs have been the main focus of reporting and accountability in medicine. Common financial ties include receipt of stock options, research grants, small value gifts, consulting fees, honoraria and speaker’s bureau. As a result of concerns about COIs in medicine, the Sunshine Act was passed by Congress requiring pharmaceutical and medical device companies to record physician payments worth more than $10 and to make these payments publicly available through the Open Payments Database (https://www.cms.gov/OpenPayments).4,5
A 2009 report released by the Institute of Medicine provided recommendations for managing COIs between individuals and institutions with industry.6 Institutions, funding agencies, medical societies, pharmaceutical and medical device associations, and journals have adopted and refined COI policies to help manage the potential for bias provided by these financial relationships. In nearly all cases, COI policies require disclosure of financial ties related to an individual’s professional responsibilities with strategies for mitigating any undue influence. In some cases, these policies prohibit certain transfers of value from industry to physicians or require physicians to divest certain relationships to participate in certain activities or take on certain leadership roles within an institution or professional organization. In essence, physicians and researchers are guided not only by their own integrity but also by detailed policies based on the institution at which they practice, the source of their research funding and the forum where they present their recommendations and data.
In regard to our case study, the urologist’s husband’s ownership stake in Acme Surgical stock poses a potential COI, given the potential of this financial interest to influence the urologist’s decision making or even provide the appearance of bias to others. Notably, the urologist herself is not the purchaser of the stock. In most situations, if a spouse, partner or any dependent family member(s) owns stock or stock options in pharmaceutical or device companies or other health care commercial interests, unless the stocks are contained in mutual funds, retirement accounts or trusts, this is still considered a potential COI for the related individual. In this case, the urologist would be guided by her own institution’s COI policy. Options for managing this COI could be recusal from the governance committee, exclusion from discussion related to robotic machines with inability to vote on the topic or at the least disclosure of the conflict to the committee. Ideally, institutions will have robust COI policies that define policies and procedures for handling conflicts such as these. Often, institutions will have a COI committee that helps to be an independent arbiter in cases such as these.
Ultimately, we must rely on our institutions and associations to develop robust COI policies and a forum in which to make COIs publicly accessible and on individuals to report COIs, whether or not they believe their ties actually have an influence on them. Finally, responsibility lies with each of us to evaluate individual’s COI for one’s self when interpreting data or recommendations.
- Goldberg C: Hormones seen as risky regimen for prostate cancer. The Boston Globe. October 26, 2006.
- Saul S: Profit and questions on prostate cancer therapy. The New York Times. December 1, 2006.
- Hampson LA and Montie JE: Conflict of interest in urology. J Urol 2012; 187: 1971.
- Agrawal S, Brennan N and Budetti P: The Sunshine Act—effects on physicians. N Engl J Med 2013; 368: 2054.
- Centers for Medicare and Medicaid Services: Medicare, Medicaid, Children’s Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests. Federal Register 2013. Available at https://www.federalregister.gov/documents/2013/02/08/2013-02572/medicare-medicaid-childrens-health-insurance-programs-transparency-reports-and-reporting-of. Accessed March 11, 2021.
- Institute of Medicine Committee on Conflict of Interest in Medical Research, Education, and Practice: Conflict of Interest in Medical Research, Education, and Practice. Eds. Lo B and Field MJ. National Academies Press 2009. Available at http://www.ncbi.nlm.nih.gov/books/NBK22942/. Accessed March 11, 2021.
- Lo B, Wolf LE and Berkeley A: Conflict-of-interest policies for investigators in clinical trials. N Engl J Med 2000; 343: 1616.