Conflicts of Interest in Clinical Care Policy

Overview

Conflicts of interest are common and practically unavoidable in the modern research university and teaching hospital. At Stanford University, conflicts of interest can arise out of the fact that a mission of the University is to promote public good by fostering the transfer of knowledge gained through University research and scholarship to the private sector. Stanford University School of Medicine is committed to excellence in research, patient care, and teaching and promotes transparency in the professional activities and financial interests of our faculty to ensure this. Stanford physicians are committed to avoiding conflicts of interest, or the appearance of conflicts of interest, between their personal financial interests and the best interests of their patients. Because we recognize that Stanford physicians have a unique opportunity to improve and advance patient care through collaboration with industry, it is critical that these interactions take place in an atmosphere of high integrity and transparency.

This policy is established to further promote physician integrity and objectivity, such that collaborations with industry can optimally benefit patients and improve human health and well-being.  Accordingly, our policy seeks to ensure full disclosure of financial relationships, as defined below between Stanford physicians (defined as Stanford UTL, MCL and CE faculty) and Commercial companies that produce, manufacture, distribute, or otherwise provide medical devices, implants, pharmaceuticals, biologics, diagnostics, or other medical care related products that may be used in the care of their patients [hereafter referred to as ‘product’].  Stanford University School of Medicine considers a conflict of interest to exist when a Stanford treating physician has a personal financial relationship with a commercial company, and that physician’s financial interest/relationship could specifically influence his/her clinical decision-making or affect a patient’s decision and/or consent to the use of that commercial company’s product. Physicians should conduct their affairs so as to avoid or minimize conflicts of interest and must respond appropriately when conflicts of interest arise. Every Stanford physician has an obligation to become familiar with, and abide by, the provisions of this policy. In addition, Stanford physicians are required to abide by the Stanford Industry Interactions Policy (SIIP), including its prohibitions against accepting personal gifts, including drug samples, and actively participating in clinically-related educational activities that are promotional in nature, and/or where the physician is not responsible for the selection of topic, and/or the content and educational materials used in the presentation.

Policy

Stanford University School of Medicine recognizes that its physicians are often the best qualified clinicians to provide commercial companies with innovative ideas and product feedback, to conduct clinical research, to serve on advisory boards, and to teach the use of new technologies. In addition, Stanford physicians often rely on commercial companies to bring their creative ideas to fruition. These collaborative relationships with industry are vital to advancing and improving patient care, diagnosis and treatment. It is also recognized that it is appropriate for physicians to receive reasonable compensation for the services they provide to these commercial companies, and for technologies they have invented. However, Stanford physicians acknowledge that these relationships must also be carefully scrutinized to avoid improper inducements, whether real or perceived, and that patients be advised of these relationships where that information is pertinent to their treatment or informed consent.

  1. Acceptable Payments
    1. Physicians who provide services to commercial companies should receive reasonable compensation for their services. However, to avoid the appearance of an improper inducement, Stanford physicians who consult for, or otherwise provide services to, commercial companies shall ensure that compensation is based on the provision of tangible services and not on the decision to use a specific product in a patient.
  2. Unacceptable Payments
    1. Payments for all services should be reasonable and customary and not based on use of a specific product.
    2. Payments for activities that serve clinically-related promotional or marketing purposes.
  3. University Disclosure
    Stanford physicians will disclose any personal financial relationships with commercial companies that relate to their clinical care activities through their disclosures on the Annual Outside Professional Activities Certification System (OPACS). These disclosures will be reviewed by the Conflict of Interest Review Program (COIRP), and when appropriate, additional discussion and/or management may occur. The COIRP will review these disclosures to assess the breadth and scope of the relationship, the dollar values of the financial relationships or financial interests, the actual usage of this company’s product or products and the justification for any predominant usage, as well as off-label usage of a company’s products.
    1.  All consulting relationships that involve payment greater than $5,000, royalties greater than $5,000, equity greater than $5,000 in a publicly traded company, or equity of any amount in a privately held company will be disclosed in the physician’s Community Academic Profile (CAP).
  4. Patient Disclosure
    1. Certain significant financial relationships with commercial companies may also warrant disclosure to a patient before a Stanford physician recommends, prescribes, or uses that company’s product in his/her patients.  Financial relationships disclosed that are deemed significant will be reviewed on an ad hoc basis by the Senior Associate Deans for Clinical Care, in consultation with the Dean. After review, if it is deemed necessary to provide a disclosure to the patient, or the patient’s family, such disclosure must be documented in the patient’s medical record.
    2. All consulting relationships that involve payments greater than $5,000, royalties greater than $5,000, equity greater than $5,000 in a publicly traded company, or equity of any amount in a privately held company will be disclosed in the physician’s Community Academic Profile (CAP), which is available to Stanford patients and the public on the web.
  5. Definitions
    1. Financial Relationship: For purposes of this policy, a financial relationship is any relationship that a Stanford physician (or his/her spouse/domestic partner or dependent children) has involving cash or something of value (including, but not limited to, consulting fees, advisory board payments, service on a Board of Directors, product evaluation payments, royalties, intellectual property rights, honoraria, ownership interests e.g. stocks, stock options, or other ownership interests, excluding stock in a diversified mutual fund not under the control of the physician) from a commercial company that produces, manufactures, or distributes a medical care related product that is recommended to, prescribed for, or used in, patients under the care of Stanford physicians.
    2. Commercial Companies: For purposes of this policy, commercial companies are any entities involved in producing, manufacturing, or distributing a medical care related product.
  6. Management
    Stanford physicians are expected to provide full disclosure of all financial relationships related to the medical care of their patients to the University. Violation of any part of this Policy may cause a faculty member to be subject to sanctions as described in the Statement on Faculty Discipline. In addition, management activities may include:
    1. Transfer of clinical care activities to an alternate clinician;
    2. Reduction or elimination of the financial conflict;
    3. Other actions as appropriate.

Stanford Medicine Resources:

Footer Links: