Conflict of Interests Andrew Gelasco, Ph.D. Vice-Chair, Research Conflict of Interests Committee Press Titles Surgeon's Royalties Bring Heat to a Medical School With a Strict Ethics Policy (U. Wisconsin SOM) вЂ“ $19.4 Mil over 4 yrs) Emory U. Psychiatrist Failed to Report Income From Drug Makers ($3.9 Mil Consulting on a 3 M NIH Trial of 5 Co. Products) How a Cancer Trial Ended in Betrayal With Millions at Stake, University Research became partners in Commerce вЂ“ and Medicine Pays a Price (UAB Patient report on worthless drug and physicians ties) Doctors Face Pressure to Disclose all Side Pay (Medical industry pays $20 Bil/Yr in payments and gifts) Harvard Medical School in Ethics Quandary (Professor promoted cholesterol drug product in class) Press Titles (Cont.) U.S. Probes Emory DoctorвЂ™s Glaxo Ties Grassley, Kohl seek information about money going from medical device makers to doctors Introduced S.2029, the Physician Payments Sunshine Act, Require companies that make pharmaceuticals, medical device and biologics to disclose payments they make to physicians. The information would be made publicly available online by the U.S. Department of Health and Human Services. Stanford medical school to provide online disclosure of faculty's consulting activities. Glaxo Expands List of Public Payments to Doctors Cap of 150 K per yr Doctors Urged End to Corporate Ties Industry Support of Medical School Departments 28% 20% 14% 14% Types of Funding (Survey Reponses) Research Support Technology Transfer Funds Research Equipment Support for students and postdocs Declaration of Financial Interests вЂў PHS and NSF enacted regulations (1995). вЂў Investigators must disclose any significant financial interests to the institution that would reasonably appear to be affected by the proposed research. вЂў Significant financial interests are defined as anything of monetary value, including but not limited to, salary or other payments of services (e.g., consulting fees, honoraria); equity interests (stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights) when aggregated for the investigator and the investigatorвЂ™s spouse and dependent children, are greater than, or equal to, $10,000 in value and 5% ownership interest in any single entity. вЂў Institutions determine whether or not these interest could directly or significantly affect the design, conduct or reporting of research вЂ¦ and how to proceed (eliminate, reduce, or manage the conflict). FASEB COI Toolkit 3 Guiding Principles* вЂў Conduct research activities objectively вЂў Operate with transparency вЂў Be accountable * Based on FASEB Guiding Principles Conduct Research Activities Objectively вЂў How to maintain objectivity? вЂ“ Intellectual honesty in proposing and conducting research вЂ“ Report research results to public and scientific community вЂ“ Lack of influence by competing interests, primarily $ вЂў Equity position, officer of company, family member involvement, purchasing, etc. Case Study 1 вЂў Dr. Doe receives a consulting fee of $8,000 in return for technical advice to ABC Pharmaceuticals. вЂў Dr. Doe also receives a sponsored clinical trial contract from ABC to test the efficacy of their pharmaceutical XXX. вЂў What are the major issues? Operate with Transparency вЂў What is Transparency? вЂ“ Openness and willingness to accept scrutiny вЂў Are you Transparent with your research? вЂў How can you be more transparent? вЂ“ Regular internal reporting вЂ“ External disclosure вЂ“ Perception is reality Case Study 2 вЂў Dr Doe receives an additional $8,000 from ABC for speaking about pharmaceutical XXX. This had not been disclosed by the investigator. вЂў Dr. Doe also received a second award for fundamental bench research from ABC on pharmaceutical YYY. вЂў What conflict issues are there now? Be Accountable вЂў What is Accountability? вЂ“ Obligation to take responsibility for oneвЂ™s actions вЂў Who are you accountable to? вЂ“ State or Federal sponsors вЂ“ All sponsors вЂ“ Human Subjects in Clinical Trials вЂў How do you handle accountability with different roles? вЂ“ Mentee vs. Mentor (PI) Case Study 3 вЂў Being creative, Dr. Doe has a really novel, patentable pharmaceutical, ZZZ, and his Chair and Dean have formed a company, XYZ Pharmaceuticals, to license/make/market this new product through RDF. All three are officers in the company as is Dr. DoeвЂ™s wife. вЂў XYZ contracts Dr. Doe to conduct bench research. вЂў XYZ, being a virtual company with only employees, also requests that XYZ employees assist in the research conducted in university facilities. вЂў What are some of the new issues? Other Conflict of Interests Issues Others than research-related, individual COI issues вЂў Institutional Conflict of Interests. вЂ“ University owns an equity position, so what? вЂ“ University officers own an equity position (i.e., shareholder)? вЂў Clinical Activities and Conflict of Interests. вЂ“ Prescribing Pattern вЂ“ Implant and Equipment Selection вЂ“ Paid Speaker for Drug Companies вЂў Acceptance of gifts. вЂ“ Meals including pharmaceutical lunches вЂ“ Entertainment, travel, etc. вЂў Misuse of Confidential Information. вЂ“ HIPAA, Trade secrets вЂ“ Relationship to Vendors вЂў New Programs e.g., CTSA, CoEE, provide more issues regarding COI The Conflict of Interests (COI) Committee вЂў The COI Committee determines if a conflict exists, not the investigator. вЂў There is no real difference between a вЂњrealвЂќ and a вЂњperceivedвЂќ COI; they are treated equally. вЂў Encourage investigators to submit a conflict of interests statement even if there is uncertainty of whether or not a conflict exists. вЂ“ transfer of liability is the real issue; why you should disclose вЂў Significant financial interests are reviewed as per federal guidelines. вЂ“ monetary value, including salary or other payments of services, equity interests, and intellectual property rights вЂ“ the investigator and family members have an interest of в‰Ґ $10,000 and в‰Ґ 5% (significant) ownership interest. вЂў If a COI is determined, then it must have an acceptable вЂњmanagement planвЂќ. Conflict of Interests (COI) Education Module The Institution recognizes that selected individuals are required to have interactions with government agencies, business, and industry, as important components in executing their assigned duties. Unfortunately, many of these interactions with the private sector bring an increased potential for personal financial opportunities that may compromise or influence institutional duties. It is the responsibility of our institution to acknowledge real and potential conflicts of interest, and to provide administrative oversight to managing these interactions such that the integrity of our public institution is not questioned. The disclosure process that follows should begin to lay the foundation for transparency of potential conflicts of interest between employees of the Institution (and our affiliates) and business organizations which interact directly and indirectly with our institution. Conflict of Interests (COI) Education Module Conflicts of Interest (COI) have taken an increasingly prominent role nationally in politics, businesses and clinical settings. High-profile examples of undisclosed or incompletely reported financial conflicts of interest have been well publicized with a strong sentiment for transparency in acknowledging potential COI. In responding to this concern, our Board of Trustees has adopted a COI Policy which is the basis for this training module and the survey questions that follow. A COI may arise when an employee of the MUSC enterprise has a job position that presents an opportunity for him or her to personally gain financially from an outside professional and/or financial relationship with a company in such a manner that the relationship could potentially interfere with his or her obligations to our institution. Conflict of Interests (COI) Education Module Family member: The Board of TrusteesвЂ™ COI Policy defines вЂњfamily memberвЂќ to include the employee's parents, spouse, siblings, children, stepchildren, and grandchildren. In responding to the survey questions, вЂњyouвЂќ and вЂњyour familyвЂќ include both you individually and your family as defined above. Financial Interest: A financial interest is defined as anything of monetary value either directly to you as the employee or to a family member from any company. Do not report: Any salary, royalties, stipends, honoraria, reimbursement for expenses or any other remuneration from the MUSC enterprise. Interest income, investment income, or other personal income that is not related to your sanctioned activities. Annual Conflict of Interests Disclosure Survey Part A Answer the following questions to the best of your knowledge. If you or a family member has a material role, or a financial interest in a company that does business with the MUSC enterprise: A-1. Are you involved in purchasing or procurement decisions that involve this company? Yes No A-2. Do you prescribe, use or implant products, e.g., drugs or devices, made by this company? Yes No A-3. Have you received a 2008 IRS Form 1099, W-2 or K-1 from this company? Yes No A-4. Do you have a role in any regulatory activities of the MUSC enterprise that involve this company? Yes No Continue Annual Conflict of Interests Disclosure Survey Part A If you or a family member has a material role, or a financial interest in a company that may or may not do business with the MUSC enterprise: A-5. Do you have intellectual property rights, e.g., patents or trademarks, that are held, licensed or optioned to this company? Yes No A-6. Do you serve as a compensated consultant for this company or in any other way advise investors with respect to research outcomes of clinical trials involving drugs or medical devices? Yes No A-7. Does this company sponsor or in any way support research activities in which you are identified as an investigator? Yes No View Response Continue Questions?