Disclosure Reporting for Conflicts of Interestand Commitment

Conflict of Interest ProgramUTMB Research Services

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”

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

Regulatory Requirementsand Other Guidance

Regulatory Requirements

• Public Health Services (PHS) 42 CFR 50, Subpart F, Sections 50.601 to 50.607

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

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)

Texas Law Governing Standards of Conduct

• Texas Government Code 572.051 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

UTMB Policy and Procedure Guidance

• UTMB’s Conflict of Interest and Commitment Policy for Research and Education (IHOP 6.1.12) 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: http://rsdev.utmb.edu/new/comp-coi/files/UTMBCOIManual.doc

• Additional educational resources issues are available at: http://rsdev.utmb.edu/new/comp-coi/default.shtm

Individuals Covered by the Policy

• Covered Individuals who must complete a disclosure:All faculty and all A&P personnelAll non-teaching medical/research professionals Individuals on research review-related committeesEmployees who negotiate research agreements All individuals involved in research

• Covered Individuals must disclose applicable activities of family members:SpouseDependent children and step-children

Conflicts of Interest

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

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 universityA medical device company that licenses technology

either from or to the university

Review of OverlappingActivities 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

Relationships with FIEs that RepresentPotential 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)

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 50.603 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

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

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

Institutional Conflicts of Interest

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

Relationships with FIEs that RepresentPotential 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

Outside Commitments

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

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

Disclosure Process

UTMB’s On-Line Disclosure Process

• Covered Individuals are required to submit a disclosure:At the time of employment; Annually; andWithin 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: http://embweb2.utmb.edu/

• Instructions to assist employees in the completion of the on-line form: http://rsdev.utmb.edu/New/comp-coi/forms.shtm

Activities and Financial InterestsThat 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

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

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

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)

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

Disclosure Review Process

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)

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

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

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.

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

Management Plans

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

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

For additional information, contact:

Cary W. Cooper, Ph.D.Vice President and Dean,

Graduate School of Biomedical SciencesConflict of Interest Official

(409) 772-2665

Jennifer Parker.Manager, Conflict of Interest

(409) 266-9447