Case Three: It Slipped My Mind…

RCR Casebook: Conflicts of Interest

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William is a Professor of Cardiology who has found evidence in his practice that, Dilox, an approved drug used to treat erectile dysfunction appears to be effective in lowering cholesterol. He decides to conduct a randomized controlled clinical trial to determine how effective Dilox (being used off-label) is for lowering cholesterol compared to currently used statins. William submits his research protocol to the IRB and receives approval; however, the study is subject to an annual IRB audit.

As the research gets underway, the drug-maker of Dilox, Restall, learns of William’s study and offers to provide him with financial support to complete the study more quickly. Restall says it will pay William $200 per participant recruited into the study; it will also pay for the Dilox, key personnel, and any study-related procedures required to evaluate the drug’s effectiveness. William agrees to accept the conditions proposed by the company, including sharing the results of the study with Restall prior to publishing.

Since the collaboration with Restall happened after the IRB approved the protocol, William makes a mental note to submit a disclosure to them and the institution soon. The trial progresses so rapidly, enrolling participants and easily meeting recruitment deadlines that combined with his busy clinical schedule, it slips his mind that he didn’t fill out the financial disclosure form regarding his relationship with Restall. 

A serious adverse event: “any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, results in congenital anomalies/birth defects, or in the opinion of the investigators represents other significant hazards or potentially serious harm to research subjects or others. A serious adverse event is considered unexpected if it is not described in the Package Insert or in the Investigator’s Brochure (for FDA investigational agents), in the protocol, or in the informed consent document.”

-Office of Human Subjects ResearchAdverse Event Reports

Before he knows it, the first annual audit takes place. The IRB chair has reviewed all documents related to the study. Thus far, it has a total of 120 participants: 60 in each study arm. There is no financial disclosure form. However, a research nurse coordinator who works for William at the university called the IRB office, worried that some participants may have been enrolled in studies who do not meet inclusion criteria as indicated by certain lab values and previous procedures. She refused to identify herself and hung up before sharing anything more. The IRB chair also notes that nearly a dozen participants were withdrawn from the study by the Principal Investigator in the last two months but no rationale was provided. In addition, he notices that some side effects identified as adverse events seem to meet the criteria for serious adverse events related to the research. In fact, there are only 10 serious adverse events listed while there are about 80 adverse events listed. Yet the IRB was only made aware of half (5) of the serious adverse events listed.

As the one conducting the annual audit, the IRB chair decides more information is needed to examine if the trial is being conducted ethically. William is asked to explain how the study staff is categorizing side effects as well as the reporting of adverse events.


What should the IRB Chair do?

Discussion Questions for the Facilitator

  • What is meant by a conflict of interest in this situation?
  • Can the conflict of interest be managed? If so, how? *
  • How can you determine if a conflict of interest is negatively affecting the conduct of the trial—e.g., the recruitment of participants or the reporting of serious adverse events?
  • How might other university offices involved in research administration affect this project and potentially identify the financial entanglements before the audit occurred (e.g., human resources and sponsored programs/grants & contracts)?
  • What experience have you had with “conflicts of interest”—your own, your colleagues’, or your institutions’? Do you think they affected the performance of research? Positively or negatively? How were they addressed?

Source URL: https://ori.hhs.gov/case-three-it-slipped-my-mind…