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Dr. Bill Inventor has stock in the CancerCure company that has licensed a product from Case where the value of the stock exceeds $10,000. This product is the focus of an NIH grant to examine its effectiveness in treating cancer in an animal model. Dr. Inventor is the principal investigator for this project. Is this a conflict of interest; if so, why; and what if anything should Case do about it?
Salary or other payments for services , e.g., consulting fees or honoraria expected to exceed $10,000 in the next twelve months (when aggregated for you, your spouse and dependent children);
Equity interest , e.g., stock, stock options, etc., with a fair market value over $10,000 or which represents more than a 5% ownership in any single publicly-held entity (when aggregated for you, your spouse, and dependent children);
Any equity interest , e.g., stock, stock options, etc., in a privately-held entity (when aggregated for you, your spouse, and dependent children);
Officer in a company , e.g., CEO, board of directors, chief scientific officer
Intellectual property rights (e.g., patents, copyrights and royalties from the rights)
“ An institutional financial conflict of interest may occur when the institution, any of its senior management or trustees, or a department, school or other sub-unit, or an affiliated foundation or organization, has an external relationship or financial interest in a company that itself has a financial interest in a faculty research project”
AAU Report on Individual and Institutional Financial Conflict of Interest, Oct. 2001
Situations that can create an institutional conflict of interest
Institution is entitled to receive royalties from sale of product that is the subject of the research
Institution has an equity interest in research sponsor or licensee of technology that is the subject of the research
Institutional official holds significant financial interest in a research sponsor or licensee of technology that is the subject of the research
Institution receives gift from research sponsor or licensee of technology that is the subject of the research
Major procurement or purchasing decisions involving research sponsor made by investigator, research administrator, or institutional official with research oversight authority
Case has licensed sensor technology invented by Professor Mary Nobel to a company called Remote Sensors, Inc. Remote Sensors would like to fund research at Case to further develop the technology. Is this a conflict of interest? If so, why; and what if anything should Case do about it? Would the situation change if the company was founded by Dr. Nobel and she had equity in the company? Would the situation change if Case had equity in the company?
University-generated patent applications have increased from 250 per year prior to 1980 to more then 7,900 in 2003
In Fiscal Year 2003, U.S. universities executed 4,516 technology licenses and options, received $1.310 billion in gross license income, and held equity in 251, or 67 percent, of the 374 start-up companies that were formed around university-licensed technology.
Publicity surrounding perceived abuses at research institutions
Dr. Smith is a consultant to several drug companies and is compensated quite well for this (>$10,000 per year per company). He is the principal investigator on an NIH sponsored multi-center clinical trial that is testing the efficacy of several drugs including one from a company that he serves as a consultant. Is this a conflict of interest? If so, what should be done to address it?
Professor Morley has developed a device that could potentially restore function to certain areas of the brain in stroke patients. Professor Morley is both a neurosurgeon and biomedical engineer. He has patented this technology through Case and it has been licensed to a small start-up company in which both Case and Professor Morley have equity. Professor Morley has received funding from NIH to conduct a feasibility study of the device in humans at University Hospitals. This feasibility study will be done in a small number of subjects and the device will not need to be implanted (no invasive surgery required). Is this a conflict of interest, and if so, what can be done to address it?
Report on Individual and Institutional Conflict of Interest, Association of American Universities; Oct. 2001
HHS Direction Needed to Address Financial Conflicts of Interest, US General Accounting Office; Nov. 2001
Policy and Guidelines for the Oversight of Individual Financial Interests in Human Subjects Research; Association of American Medical Colleges; Dec. 2001
Protecting Subjects, Preserving Trust, Promoting Progress II: Principles and Recommendations for Oversight of an Institution’s Financial Interests in Human Subjects Research; Association of American Medical Colleges, October 2002
University Research: Most Federal Agencies Need to Better Protect against Financial Conflicts of Interest; US General Accounting Office, November 2003
Summary of Recommendations from Recent Reports/Guidelines
Expand definition of significant financial interest
Treat research consistently, regardless of funding source
Disclosures should be made by more than just faculty
Research involving human subjects requires special scrutiny
Disclosures should be made to various constituencies, as needed
Significant financial interests are defined by PHS regulation and incorporate recent recommendations from AAMC/AAU . These interests are disclosed by all investigators annually, with each sponsored project and IRB application, and as financial interests change.
No sponsored project account or change to an existing account will be processed unless annual COI disclosure form has been received for all key personnel Faculty reappointment can also be delayed.
Disclosures reviewed initially by COI Administrator and then by COI Committee. COI Committee composed of faculty and administrators from Case and affiliated hospitals.
COI Committee identifies individuals who need to be interviewed about their COI in order to collect additional information and to jointly develop a COI management plan.
Management plan approved by COI Committee and signed by investigator.
COI administrator follows up at least annually on high-risk management plans and a sample of others to ensure that the plans are being followed.
Case COI Procedures for Sponsored Research - Management
- Accept sponsored project w/o any restrictions
- Accept with certain conditions:
1. Public disclosure
2. Adopt special review procedures
3. Monitor project by independent reviewers
4. Modify research plan
5. Withdraw all or part of the project affected by COI
Two Case professors have recently, with the help of the Case Tech Transfer Office, received a patent on intellectual property related to treating kidney stones. They have formed a company that has licensed this technology from Case. The company plans to conduct a clinical trial at University Hospitals (UH) with start-up money it has received from a venture capital firm. The company plans to enter into a clinical trial agreement with UH. One of the Case professors will be the principal investigator for this study. Is there any conflict of interest issues in this arrangement? If so, what are they and how can they be resolved, if at all?
How can we make sure that those who need to disclose are doing so and that their disclosure is complete?
Can or should conflict of interest (either individual or institutional) be eliminated? If so, when?
What is an acceptable conflict of interest management plan for investigators with financial conflicts of interest who are conducting human subjects research? How should the plan change if there is also institutional conflict of interest?
How does one coordinate the activities of the Conflict of Interest Committee with the IRB, IACUC, and sponsored project office?
What is a reasonable and effective approach to monitoring conflict of interest management plans? How often? What is monitored and how?