Transcript Document

Disclosure Reporting for
Conflicts of Interest
and Commitment
Conflict of Interest Program
UTMB 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 Requirements
and 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 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
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 university
 A medical device company that licenses technology
either from or to the university
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
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)
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 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
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; 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:
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 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
Reporting Activities/Interests on Disclosure Form
• Examples of activities and financial interests with FIEs
that require reporting:
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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 Sciences
Conflict of Interest Official
(409) 772-2665
Jennifer Parker.
Manager, Conflict of Interest
(409) 266-9447