Types of Financial Conflicts of Interests (FCOIs)
Financial conflicts of interest (FCOIs) can take many forms and include
- income from external activities over $5,000
- includes conducting research external to University of Iowa
- publicly traded stocks ("ownership") valued over $5,000
- a combination of the above, when added together, are valued at over $5,000
- royalties received from licensed inventions
- any ownership in a private company
- "faculty startup"
- a role with fiduciary duties (e.g. board of directors, officer role, employment, etc.)
The two of the most common FCOIs are income from consulting and ownership in a faculty startup company.
The primary tool of managing financial conflicts of interest in research is transparency. Therefore, management plans will often contain conditions requiring the conflicted investigator to disclose the interest to certain populations:
- Informed consent documents when human subjects are involved
- Disclosure to students on the study team in order to protect their academic careers
- Informing all members of the study team in order to protect the integrity of the research
- Disclosures to conference audiences and journal editors when the research is reported
Anne Marks, Assistant Professor in the Department of Biology, is a named inventor on a patented resin developed in their lab. With the assistance of the UI Research Foundation, they started a company, TDM Industries, which has licensed the intellectual property. Dr. Marks holds 100% of the company’s equity. They have received no personal compensation from the company.
TDM Industries has been awarded a Phase I Small Business Innovation Research (SBIR) grant from the Department of Defense to research and explore applications for military materials. TDM Industries will sub-contract to The University of Iowa for some of the research. Dr. Marks will involve a doctoral student, Mike Strand, in the portion of the project that the University will conduct. Although this specific project is not the central theme of the student's dissertation, the data from the research may be used as part of their dissertation or they may co-author a publication of the study results. Dr. Marks is the chair of Mr. Strand's dissertation committee.
Dr. Marks disclosed the interest in the company to the university and has now submitted a routing form for the University’s sub-contract with TDM Industries. The Conflict of Interest in Research Office has reviewed the interest and the project and has determined the existence of, or the appearance of, a financial conflict of interest. The Conflict of Interest in Research Committee has reviewed the disclosure form, and they have recommended the following management plan:
- Whenever Dr. Marks is an author on any manuscript covering this research study, they are required to disclose to the journal that they have equity in the sponsor of the study, TDM Industries. In the case of a presentation related to this research study, they are required to disclose the interest to the audience and organizers of the meeting.
- The student involved in the project, Mike Strand, will be informed by the Conflict of Interest in Research Office that Dr. Marks has equity in the sponsor of this study, TDM Industries. The notice will include the name of an independent third party to be contacted in the event that the student has questions or concerns about the financial interest. The student will be asked to respond to the notice from the COIR Office as an acknowledgement of receiving the notice.
- Dr. Marks is required to update their disclosure in the eCOI system within 30 days of any changes.
Frank Michaels, Professor of Anesthesia, has discovered a new local anesthetic agent that seems to be superior to existing agents. Based on animal studies, he hypothesizes that the compound creates excellent local anesthesia without some of the typical cardiovascular adverse effects of other anesthetic agents. A patent has been filed by the University, but it has not been issued yet. The University has licensed the intellectual property to NeuroBlock -- a small, publicly traded pharmaceutical company. The company now intends to sponsor a clinical trial to evaluate the drug in human subjects. Dr. Michaels proposes to be the Principal Investigator of a safety study in a small group of patients undergoing minor surgical procedures.
Last year Dr. Michaels entered into a consulting agreement with NeuroBlock, and he also serves on its Scientific Advisory board.
Dr. Michaels has disclosed the financial interest in NeuroBlock the the university.
University policy, which aligns with the recommendations of the Association of Academic Medical Centers, prohibits participation of an investigator who has a financial conflict of interest in a clinical trial unless there are compelling circumstances to allow him to participate. The Conflict of Interest in Research Office has asked Dr. Michaels to provide a memorandum of compelling justification outlining the following:
- their specific role in the study (recruiting/consenting subjects, performing procedures, data analysis, etc.)
- why they are uniquely qualified to conduct this research
- why they believe that the research cannot otherwise be conducted without his involvement
The Conflict of Interest in Research Committee reviewed Dr. Michaels' disclosure form and memorandum. The Committee members decided that they could not develop a plan that would reduce or eliminate the conflict of interest and that, because Dr. Michaels is not uniquely qualified to administer the investigational anesthetic, his participation in this clinical trial is not justified. The Committee concluded that, although Dr. Michaels would have to forgo participation in the clinical trial, another anesthesiologist could be identified to serve as the Principal Investigator.
Jamie Richards, a Research Engineer in the College of Engineering, has developed copyrighted software that allows health care providers to directly access electronic medical records from a variety of personal digital assistants (PDAs), regardless of the manufacturer of the device. In collaboration with a colleague in his department, he has formed a start-up company, Top Pocket Technologies, Inc., which is focusing on the commercialization of his technology. Dr. Richards holds 25% equity in Top Pocket Technologies. The University of Iowa Research Foundation has licensed the software to Top Pocket Technologies.
Dr. Richards has disclosed his interest in Top Pocket Technologies the eCOI system.
The company has received a Phase II Small Business Technology Transfer Research (STTR) award from the NIH, and the company is issuing a subcontract to the University for some research to further develop the software program. Although he does not propose to be the Principal Investigator of the research, Dr. Richards will be involved as part of the study team. The Conflict of Interest in Research Committee has reviewed the interest and the proposed research, and recommended the following plan:
- Whenever Dr. Richards is an author on any manuscript covering this research study, they are required to disclose to the journal that they have equity in the sponsor of the study, Top Pocket Technologies. In the case of a presentation related to this research study, they are required to disclose the interest to the audience and organizers of the meeting.
- Dr. Richards is required to update his disclosure in the eCOI system within 30 days of any changes.
Dr. Wilma Gilbert, Professor of Internal Medicine specializing in oncology, will be conducting a human subjects research study in which they will be comparing a new combination of chemotherapy agents in subjects with non-Hodgkin’s Lymphoma. In the study, she will examine the efficacy of adding the drug Apix, a drug previously approved for use in a different form of cancer, to the standard treatment for lymphoma. The study will be funded under Dr. Gilbert’s grant from the National Cancer Institute, but the company that manufactures Apix, Welkers Pharma-A, will be providing it.
Dr. Gilbert has a long-standing consulting agreement with Welkers, a global pharmaceutical company, for serving as a scientific advisor.
Dr. Gilbert has disclosed the interest with Welkers to the university. On the disclosure form, they indicated that last year they received $8,000 in personal compensation from the company. In the current year, they expect to receive $11,500. In addition, they reported that the company paid for travel to Boston, Copenhagen, and Washington, D.C., at an estimated expense of $6,000.
Since Dr. Gilbert’s research involves the use of human subjects, she has been asked to provide a memorandum that outlines a compelling justification for her participation in this research. She has provided the following information:
- their unique qualifications by virtue of expertise with and experience with treating patients who have lymphoma
- their knowledge of the safety profile of the study medication, Apix, since they have prescribed the medication in other patient populations
- their specific role in the study which is assessment of medication side effects, analyzing data, and reporting study results.
- a research nurse will evaluate potential research subjects for eligibility to participate in the study, obtain informed consent of the subjects, and coordinate the collection of clinical data.
The Conflict of Interest in Research Committee determined that, although Dr. Gilbert presented a compelling justification for remaining a member of the study team, the following management plan should be implemented:
- Whenever Dr. Gilbert is an author on any manuscript covering this research study, they are required to disclose to the journal that they have received personal compensation from the manufacturer of the study drug for serving as a scientific advisor. In the case of a presentation related to this research study, they are required to disclose the interest to the audience and organizers of the meeting.
- Dr. Gilbert shall nominate, for review and approval by the Conflict of Interest in Research Officer, a non-subordinate individual who has no significant financial interest related to the project to:
- assess whether the data were appropriately analyzed (in terms of basic theory, applicable models, and/or statistical methods, as appropriate)
- determine whether the study conclusions are supported by the data
- report the results of this data evaluation and conclusions to the Conflict of Interest in Research Office
- Dr. Gilbert shall not be involved in the following study activities:
- recruiting or consenting human subjects
- assessing adverse events
- Dr. Gilbert is required to disclose that they have received personal compensation from the manufacturer of the study drug for serving as a scientific advisor in the human subjects consent documents.
- Dr. Gilbert is required to update their disclosure in the eCOI system within 30 days of any changes.
Asa Gustafson is a faculty member in the Rhetoric department, College of Liberal Arts and Sciences. Their academic focus is on storytelling, particularly in how it can impact trauma healing. In previous research, Dr. Gustafson has realized positive result in groups within the LGBTQIA+ community. Now they would like to test their theory on a prison population. Dr. Gustafson hypothesizes that if incarcerated populations could develop guided, structured and applicable storytelling skills, they can tell their stories of trauma and crime and thus reduce recidivism.
Gustafson has designed a specific 12 week curriculum for use with the subject population. A national nonprofit organization that works with prison populations is interested in the curriculum and would like to sponsor the research. They have also hired Dr. Gustafson as a consultant and are paying them $12,000 annually for this activity. The consulting agreement has received approval from the department.
Asa discloses the new consulting agreement to the university. The Conflict of Interest in Research Committee has reviewed the interest and the proposed research, and recommended the following plan:
- Whenever Dr. Gustafson is an author on any manuscript covering this research study, they are required to disclose to the journal that they have a consulting relationship with the sponsor, The Fortune Society. In the case of a presentation related to this research study, they are required to disclose the interest to the audience and organizers of the meeting.
- Dr. Gustafson is required to disclose to the other study team members, Drs. Richards, Leon and Willow, that they have a consulting relationship with the sponsor, The Fortune Society.
- Dr. Gustafson is required to disclose in the informed consent documents that they have a consulting relationship with the sponsor, The Fortune Society.
- Dr. Gustafson is required to update his disclosure in the eCOI system within 30 days of any changes.
For additional scenarios and management plans, see Appendix B of the AAMC/AAU manual, Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research.