1. Disclosure Reporting for Conflicts of Interest and Commitment Conflict of Interest Program UTMB Research Services

2. Public Expectations
The growth of the biotechnology industry is a celebrated accomplishment of the U.S. economy, and together with the information technology industry has spurred public perception of research universities as engines of economic development and social betterment
But at the same time, the public insists that universities remain unblemished by financial self-interest and continue to serve society as trusted and impartial arbiters of knowledge
This “conflict of public expectations” is nowhere more intense than in academic medicine and research
AAMC: “Protecting Subjects, Preserving Trust, Promoting Progress”

3. University Expectations
UTMB recognizes that faculty and employee participation in activities with outside organizations (e.g., industry, agencies, private institutions, professional associations) often serves the academic interests of the institution and contributes to the diversity of the academic community
These activities include consultation, lectures, speakers bureaus, research, laboratory testing, teaching, writing, peer review panels, membership on advisory councils
Disclosure and review of such activities is required in order to meet public expectations, university policies, and regulatory requirements

4. Regulatory Requirements and Other Guidance

5. Regulatory Requirements
Public Health Services (PHS)
42 CFR 50, Subpart F, Sections to
Includes required notification to sponsor regarding conflicts of interest prior to expenditure of funds
National Science Foundation (NSF)
Includes required notification to sponsor if an institution determines that it is unable to manage, reduce, or eliminate a conflict of interest
Food and Drug Administration (FDA)
21 CFR 54

6. AAMC Guidance
Association of American Medical Colleges (AAMC) provides guidance through task force reports:
“Protecting Subjects, Preserving Trust, Promoting Progress: Policy and Guidelines for the Oversight of Individual Financial Interests in Human Subjects Research” (December, 2001)
“Protecting Subjects, Preserving Trust, Promoting Progress II: Principles and Recommendations for Oversight of an Institution’s Financial Interests in Human Subjects Research” (October, 2002)
“Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research (February, 2008)

7. Texas Law Governing Standards of Conduct
Texas Government Code relates to standards of conduct for, and conflicts of interest of, state employees:
A state employee should not accept other employment or compensation that could reasonably be expected to impair the employee’s independence of judgment in the performance of the employee’s official duties
A state employee should not make personal investments that could reasonably be expected to create a substantial conflict between the employee’s private interest and the public interest

8. UTMB Policy and Procedure Guidance
UTMB’s Conflict of Interest and Commitment Policy for Research and Education (IHOP ) provides guidelines for faculty and employees in their relationships with outside entities
The UTMB Conflict of Interest Manual provides guidance for disclosure requirements and procedures:
Additional educational resources issues are available at:

9. Individuals Covered by the Policy
Covered Individuals who must complete a disclosure:
All faculty and all A&P personnel
All non-teaching medical/research professionals
Individuals on research review-related committees
Employees who negotiate research agreements
All individuals involved in research
Covered Individuals must disclose applicable activities of family members:
Spouse
Dependent children and step-children

10. Conflicts of Interest

11. Conflict of Interest – Here is the Problem
A conflict of interest is a situation in which a financial or other personal consideration may directly and significantly affect, or have the appearance of directly or significantly affecting, a Covered Individual’s professional judgment in exercising any UTMB duty or responsibility
The danger of a conflict of interest is that it represents an incentive for bias which influences decision making based on one’s personal interest as opposed to the most objective decision

12. Financially Interested Entities (FIEs)
Covered Individuals must report activities and financial interests of any value with all financially interested entities (FIEs)
For purposes of these reporting requirements, an FIE is defined as an entity that interacts with UTMB in the areas of research or education; for example:
A pharmaceutical company that sponsors research at the university
An organization that donates to the university
A medical device company that licenses technology either from or to the university

13. Review of Overlapping Activities and Financial Interests
When a Covered Individual reports an activity or financial interest with an FIE, the university is required to review that relationship
The Covered Individual’s personal relationship with the FIE is reviewed for:
The nature of the relationship
The amount of compensation or value involved
The potential influence the relationship may have on any UTMB activity sponsored by the FIE in which the Covered Individual is involved

14. F.I.E.
UTMB ?
Covered
Individual

15. Relationships with FIEs that Represent Potential Individual Conflicts of Interest
An investigator’s consulting relationship with the organization sponsoring the investigator’s research
A management role or equity holdings in an outside entity that is sponsoring research or selling goods or services to the university
Ownership interest in technology that is the subject of the research
Dual supervisory roles (a faculty mentor supervises students in a UTMB activity and as employees of his/her company)

16. Significant Interests
If a Covered Individual or family member has a relationship with an FIE that sponsors a UTMB activity in which the Covered Individual is involved, the relationship is reviewed to determine if it is “significant”
UTMB utilizes 42 CFR and the AAMC task force reports as guidance to define “significant” interests
If the personal relationship with the FIE is not significant at the time of review, as a general statement of policy the situation would not represent a conflict, and participation in the UTMB activity (e.g., sponsored research) would be permitted

17. Significant Interests
Compensation, consulting fees, honoraria, intellectual property rights, gifts, or in-kind compensation received from an FIE that in the reporting period met or exceeded $10,000 or is expected to meet or exceed that amount in the next 12 months
Equity interests such as stocks, stock options, business ownership of any amount in a non-publicly traded FIE
Equity interests in a publicly-traded FIE of either $10,000 or 5% equity ownership, whichever is less
Royalty income of any amount, or the right to receive future royalties under a patent license or copyright, where the research is directly related to the licensed technology

18. General Guidelines Regarding Conflicts of Interest
Research: A Covered Individual with a significant interest in an FIE may participate in research or other activity at UTMB that is sponsored by the FIE only if the relationship has been disclosed and the activity is managed in accordance with an institutionally approved conflict management plan
Instructional Media: A Covered Individual should not require the use of his or her own or family member’s instructional media (e.g., textbooks, tests, software programs) unless in accordance with a conflict management plan or other authorization of the Conflict of Interest and Commitment Committee

19. Institutional Conflicts of Interest

20. Institutional Conflicts
All Institutional Officials are required to avoid institutional conflicts of interest with outside organizations in the areas of research and education, unless the conflict has been disclosed and managed in accordance with an institutionally approved conflict management plan
Institutional Officials by nature of their position act on behalf of UTMB through their authority over personnel and institutional resources
Institutional Officials are those individuals holding positions such as Division Chiefs, Center Directors, Institute Directors, Department Chairs, and higher

21. Relationships with FIEs that Represent Potential Institutional Conflicts of Interest
A Department Chair’s consulting relationship with a pharmaceutical company that sponsors research in his/her department
Stock owned by a Department Administrator in a medical device company that is a vendor of goods or services utilized within his/her department
A university resource (e.g., a grant award) proposes to purchase goods or services from a startup company in which UTMB holds an equity position

22. Outside Commitments

23. Conflicts of Commitment - Compensation
External compensation received from all FIEs as a result of activities such as lectures, speakers bureaus, consultation, board membership, advisory councils, etc. must be reported on the Conflict of Interest Disclosure Form (Parts 1-5)
A Covered Individual shall not receive excessive compensation in relation to his or her UTMB base salary
External compensation received from FIEs should not exceed 25% of the individual’s annual institutional base salary

24. Conflicts of Commitment - Time
All time spent on outside commitments must be reported on the Conflict of Interest Disclosure Form (Part 7), whether or not external compensation has been received
Activities that are a normal part of the individual’s UTMB duties (e.g., scientific or professional meetings, conferences, UTMB business meetings) are not included in this reporting requirement
A Covered Individual shall not devote excessive time to outside activities
Time spent on outside commitments, which is compatible with fulfilling the primary responsibility to UTMB, should not exceed 26 work days per academic/fiscal year

25. Disclosure Process

26. UTMB’s On-Line Disclosure Process
Covered Individuals are required to submit a disclosure:
At the time of employment;
Annually; and
Within 30 days after a change has occurred in the current disclosure situation (e.g., a new relationship, a change to an existing relationship, the termination of a relationship)
The on-line form is located at:
Instructions to assist employees in the completion of the on-line form:

27. Activities and Financial Interests That Do Not Require Disclosure
Salary or other compensation received from UTMB
Mutual funds in which the individual has no control over the selection of holdings (e.g., UTMB-provided TRS benefits, UTMB optional retirement plans)
Compensation from occasional activities with public agencies or non-profit organizations, involving activities such as lectures, advisory committees, and NIH review panels

28. Reporting Activities/Interests on Disclosure Form
Examples of activities and financial interests with FIEs that require reporting:
Lectures
Speakers bureaus
Consulting services (copy of agreement required)
Scientific advisory councils
Board membership
Executive positions (copy of contract required)
Compensation from licensing technology
Honoraria/payments for publications
Stocks, stock options
Business ownership, partnership interests

29. Reporting Activities/Interests on Disclosure Form
Covered Individuals report how the FIE relates to their UTMB duties:
The FIE sponsors research in which the Covered Individual participates
The FIE does not sponsor any research or other UTMB activity in which the Covered Individual is involved
The FIE interacts with UTMB in a department or other area in which the Covered Individual supervises personnel, selects or evaluates goods or services, and/or makes referrals

30. Reporting Activities/Interests on Disclosure Form
Covered Individuals report activities and financial interests of any value with FIEs
A list of FIEs is available within the disclosure form
The reporting period is calendar year 2008
An estimate of anticipated activities and financial interests for 2009 is also required
Copies of consulting agreements or contracts for services must be provided to the Conflict of Interest Program Office (mail route 0156)

31. Reporting Activities/Interests on Disclosure Form
Report any trainees involved in a UTMB activity that is sponsored by the same FIE with which the faculty member has a personal relationship
Report activities and financial interests with FIEs that do business with UTMB in a department or area in which the Covered Individual supervises or selects goods or services
Report instructional media created that is used within a UTMB instructional program
Report all time spent on outside commitments regardless of whether external compensation was received

32. Disclosure Review Process

33. UTMB Conflict of Interest and Commitment Committee
Chair, Conflict of Interest Official
Office of Research Subject Protection
Four Clinical Faculty Members
Basic Science Faculty Member
Two Faculty Members At-Large
Legal Affairs
Purchasing
Department Administrator
Center for Technology Development
Dean’s Office, School of Medicine
Two Community Representatives
Research Services (Ex-Officio)
Institutional Compliance (Ex-Officio)

34. Committee Review Process
The Conflict of Interest and Commitment Committee is appointed by the President and meets regularly to review disclosures and other issues brought to its attention
The Conflict of Interest Official may perform administrative reviews of disclosures, such as those that do not involve significant interests
Disclosures that involve human subjects research as the UTMB activity or potential institutional conflicts are reviewed by the Committee

35. Transactional Disclosure Reviews
In addition to the submission of annual disclosures, a Covered Individual who proposes to serve as Principal Investigator on a new research protocol or research contract provides information to update his/her disclosure
The updated disclosure situation is reviewed for potential conflict related to the specific proposed research
Contract negotiation and other reviews continue as usual
Final approvals may take place only if it has been verified that either no conflict exists, or if an identified conflict has been disclosed, an approved conflict management plan is in place

36. Standards Used to Review Significant Interests
If the UTMB activity does not involve human subjects research, the Committee applies the “reasonable circumstances” standard
If the UTMB activity involves human subjects research, the Committee applies the “compelling circumstances” standard:
There is not a significant likelihood that subjects will be harmed by the involvement of the investigator;
Financial incentives for bias have been appropriately mitigated;
The investigator is uniquely qualified to perform the research;
Research cannot be practically conducted without the researcher;
The significance of the research justifies the exception.

37. Committee Actions
When a disclosure review is completed, possible Committee actions include:
Determination that no individual or institutional conflict exists at this time
Action is deferred for more information, either from the Covered Individual or from other university areas, such as the Institutional Review Board or the Center for Technology Development
Identification of a conflict and the development of a management plan

38. Management Plans

39. Management Plans
Management plans identify the steps necessary to manage, reduce, or eliminate an identified conflict
Possible action steps of a management plan:
Deny the UTMB activity
Permit the research but limit the investigator’s role to consulting or advising on technical or safety issues
Require an independent review of the research and/or publications
Require monitoring of trainee/student activities
Require prior notification of all future proposals to conduct research with the entity

40. Management Plans
Covered Individuals (and the appropriate Chair, Dean) receive written notification of the Committee’s review and the actions to be taken by the individual
Acknowledgment of the management plan and acceptance of required actions and time frames must be signed by the individual and approved by the appropriate Chair and Dean
Some management plans that involve intellectual property must receive approval from the U.T. System prior to the research project taking place

41. For additional information, contact: Cary W. Cooper, Ph. D
For additional information, contact: Cary W. Cooper, Ph.D. Vice President and Dean, Graduate School of Biomedical Sciences Conflict of Interest Official (409) Jennifer Parker. Manager, Conflict of Interest (409)