Financial Disclosure and Conflict of Interest
“Conflict of Interest” is an evolving factor affecting human research. Research investigators have many obligations to carry out the clinical trial according to the protocol. “Altruism”, or the unselfish interest in the well being of the patient, should always be the primary obligation that guides medical decisions. A conflict of interest arises if professional judgment involving a primary interest, such as the patient, is compromised by a secondary interest, such as financial, academic, or publicity gain. Additional conflicting interests may include the academic pressure to publish research or enroll patients in a trial, and could in rare instances, compromise the integrity of the trial.
It is important to note that many physicians are expected to have secondary interests, as they are an important way for physicians to engage in research and developments in their field. For example, it is common for physicians to serve as a referral source, grant recipient, peer reviewer, author, or pharmaceutical consultant, to name just a few of their roles. These potential conflicts or interest are ethical if they are fully disclosed and do not influence medical decisions. Conflict of interest is a condition, not a behavior. However, to sway medical judgment for a self-serving secondary gain is clearly a conflict or interest that is unethical behavior. As fewer research trials are conducted by non-profit organizations and more are directly funded by the pharmaceutical industry, the arena of financial conflicts of interest will become more common. To further protect patients from potential financial conflicts of interest, the Institutional Review Boards (IRB - also known as the Ethics Review Board or Committee) have pro-active policies and financial disclosure requirements to examine secondary interests and prevent potential conflicts from becoming unethical behaviors.
Additionally, The National Institutes of Health (NIH), Food and Drug Administration (FDA), and American Society of Clinical Oncology (ASCO) each have conflict of interest policies and financial disclosure requirements. The strictest of these is the American Society of Clinical Oncology’s (ASCO) recently updated rules (effective April 2004, www.asco.org) for all its members and/or authors submitting to the Journal of Clinical Oncology or ASCO Annual Meeting Abstracts. Physicians must disclose all stock ownership (except money in a diversified mutual fund that the investigator does not control), all compensation as an employee, advisor, expert testimonials, leadership positions, honoraria, and research funding. Additionally, all trips, travel, and gifts more than $100 must be also disclosed. Trial leaders, such as the lead investigator, members of executive committees, and members of Data Safety Monitoring Boards (DSMB) are subject to stricter requirements and must not be in a position to benefit from the trial. These trial leaders may not own stock or equity interest in a trial sponsor (pharmaceutical company), or receive royalties or licensing fees, or hold patents for the drug under investigation. Further, they are unable to serve as an officer, member of the board of directors, or employee of the sponsor. Research related payments cannot exceed the actual cost of the trial, and no honoraria or gifts are permitted. The direct research-related costs of time, effort, equipment, staff and travel to investigator meetings are the only payments allowed from the sponsor to the investigator.
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