Below are some fictional scenarios which illustrate financial conflict of interest in research situations.
Scenario One -- Dr. Anne Marks
Dr. Anne Marks, Assistant Professor in the Department of Biology, is a named inventor on a patented resin developed in her lab. With the assistance of the UI Research Foundation, she started a company, TDM Industries, which has licensed the intellectual property. Dr. Marks holds 100% of the company’s equity. She has received no personal compensation from the company.
TDM Industries has applied for, and 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 his dissertation or he may co-author a publication of the study results. Dr. Marks is the chair of Mr. Strand's dissertation committee.
Dr. Marks had disclosed the interest in the company in the eCOI system 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 her disclosure form, and they have recommended the following management plan:
- Whenever Dr. Marks is an author on any manuscript covering this research study, she is required to disclose to the journal that she has equity in the sponsor of the study, TDM Industries. In the case of a presentation related to this research study, she is 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 her disclosure in the eCOI system within 30 days of any changes.
Scenario Two -- Dr. Frank Michaels
Dr. 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 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 his financial interest in NeuroBlock in the eCOI system.
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:
- his specific role in the study (recruiting/consenting subjects, performing procedures, etc.)
- why he is uniquely qualified to conduct this research
- why he believes 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.
Scenario Three -- Dr. Jamie Richards
Dr. 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, 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, he is required to disclose to the journal that he has equity in the sponsor of the study, Top Pocket Technologies. In the case of a presentation related to this research study, he is 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.
Scenario Four -- Dr. Wilma Gilbert
Dr. Wilma Gilbert, Professor of Internal Medicine specializing in oncology, will be conducting a human subjects research study in which she 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 her interest with Welkers in the eCOI system. On her disclosure form, she indicated that last year she received $8,000 in personal compensation from the company. In the current year, she expects to receive $9,000. In addition, she reported that the company paid for her 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:
- her unique qualifications by virtue of expertise with and experience with treating patients who have lymphoma
- her knowledge of the safety profile of the study medication, Apix, since she has prescribed the medication in other patient populations
- her 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, she is required to disclose to the journal that she has 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, she is 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 she has 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 her disclosure in the eCOI system within 30 days of any changes.