COI Case Studies
Case Study #1 - The Researcher
ABC Pharmaceuticals has agreed to sponsor Dr. C's proposed human subjects' research project to be conducted at the Medical Center. The study involves research on using antiemetics to reduce the side effects caused by chemotherapy. In 2008, ABC Pharmaceuticals gave Dr. C $8,000 in honoraria for speaking about their products and he expects to receive approximately the same amount in 2009.
Dr. C also participates in the Scientific Advisory Board (SAB) of Combat Chemo, Inc. who recently started exploring new methods of minimizing the side effects of chemotherapy to become a more formidable competitor in the pharmaceutical market. Dr. C expects to receive $25K-30K in 2009 for his service on the SAB, but has not received any compensation to date.
Test your knowledge of conflict matters by working through the following questions. Click on the question to see the explanation.
Yes, Dr. C's financial interests create more than one potential conflict because he receives honoraria from the sponsor of his proposed research study and he also receives consulting compensation from a direct competitor of the sponsor. While the former conflict does not present a Significant Financial Interest since it's less than $10,000, his financial interest with Combat Chemo, Inc., is of greater concern because the amount of money he expects to receive from his service on the SAB.
Dr. C's financial interest with ABC Pharmaceuticals is not significant and would generally be permitted, but would require a conflict management plan is implemented by the Research Conflict of Interest Committee (RCOIC). However, the RCOIC would review this Significant Financial Interest to determine if Compelling Circumstances exist to merit an exception to the general policy. The RCOIC would consider the following list of factors in evaluating whether Compelling Circumstances exist:
A. whether basic academic values are upheld, an open academic environment is maintained, the research is appropriate to the mission of the Medical Center, and the research is of a fundamental or basic nature;
B. the nature and amount of the disclosed interest, how closely the interest is related to the research, the control or influence such relationship or interest might have over the Research Sponsor's or Financially-Interested Company's decisions, and the extent to which the research results could be influenced by the financial interest;
C. whether the research is essential to maintain the continuity of a research effort related to NYU's rights in intellectual property covering a product or process to be used in the research;
D. the potential gains to patients and the community in the immediate and long-term future in the event the research is successful;
E. any unique expertise of the Investigator (e.g. inventorship, experience, special insights, knowledge, perseverance, laboratory resources or a need for a special patient population) that may make his or her involvement essential, including the degree to which the safety or effectiveness of the research might be compromised without that individual;
F. restrictions, if any, on publications, presentations or other disseminations related to or referencing the research or the research results;
G. whether the risks to Human Subjects Research are sufficiently low and disposition may be similar to or identical with disposition for a Non-Human Subjects Research project;
H. the steps proposed by the Investigator for effective oversight and management of the financial interests;
I. what role students, trainees, and junior faculty and staff will play and whether such role is appropriate and free from exploitation; and
J. (for Institutional Financial Interests in Human Subjects Research only) whether the Medical Center is uniquely qualified (by special facilities or equipment, unique patient population, qualifications of its investigators, etc.) to conduct the research and safeguard the human subjects in the Research.
