University at Buffalo
Investigator
Disclosure Policy
I. Introduction
The University
at Buffalo (UB) as a community and as a public institution of higher
learning is committed to performing the highest quality research
and creative activity. In meeting this commitment, the University
encourages interaction of its faculty, administrators, students,
staff and fellows with the public and private sectors as an important
component of its educational, research and public service missions.
External funding through grants, contracts and gifts from public
and private sources is necessary to provide essential support for
University activities.
Professional
interactions with public agencies, private businesses, non-profit
organizations and individuals advance the University's ability to
provide research and educational opportunities for our students,
to contribute to the economic well being of our community, and to
add to our store of knowledge and understanding. Similarly, technology
transfer in the form of patents, licensing agreements, and consulting
opportunities for University members are important means of meeting
the needs of society and fostering the welfare of the citizens of
the State of New York.
II.
Policy
Members
of the University community, in pursuing UB educational, research
and public service missions, must meet high ethical standards and
minimize the risks of conflict between private interests and the
public interests the University serves.
The responsibilities
and obligations of Investigators to the University must be clearly
separated from their personal financial interests and their personal
obligations to others. Prudent stewardship of public resources requires
protecting University research, educational and public service missions
from being compromised by conflicts of interest and the appearance
of conflict of interest.
To meet
these objectives and to ensure compliance with federal and state
regulations, the University at Buffalo requires an Investigator
to disclose his/her financial interests and non-university obligations
and the financial interests and non-university obligations of his/her
spouse and dependent children by completing and submitting Form
SUNY-2-UB 1.
This
Policy sets forth requirements and guidelines for:
- disclosure of outside
financial interests and obligations by Investigators at the
University at Buffalo who engage in University activities funded
by any external entity and funded internally through specified
internal programs;
- review of Investigator
disclosures by designated University officials; and
- identifying, reporting and resolving
conflicts of interest.
This
Policy applies to all external and specified internal support for
University programs, projects, activities and services, solicited
and unsolicited, including gifts and donations with the exceptions
noted below.
- Internal Support
- This Policy applies only to those internal programs which
require formal application in response to a request for proposals
(for example, the UB Multidisciplinary Pilot Project Program
or the UB Invention Commercialization Enhancement Program).
- Gifts and Donations
- This Policy applies to all gifts and donations made to support
the activities of named individuals at UB. It does not apply
to unrestricted gifts and donations to support the activities
of administrative units (e.g., decanal, departmental or other
organized units) where individuals at UB are not named.
III. Definitions
-
Conflict of Interest:
A
conflict of interest exists when a designated official at UB
reasonably determines that a significant financial interest2
of an Investigator or a significant external obligation
of an Investigator could directly and significantly affect the
design, conduct, or reporting of research or creative activity.
A
conflict of interest in the conduct of externally and selected
internally supported activities may take several forms, but
typically arises when an Investigator at the University is,
or may be, in a position to influence activities or University
decisions in ways that could lead to personal gain for the Investigator
or the Investigator's immediate family (spouse and dependent
children), or give an improper advantage to third parties in
their dealings with the University or the State. Conflicts may
also arise when Investigators have outside obligations of any
kind which are in substantial conflict with the Investigator's
University responsibilities or the public interest. The potential
for conflicts of interest may arise from specific actions taken
by Investigators, or by the nature of positions they hold in
and outside the University, or by the financial interests they
or their immediate family hold.
For
example, a conflict of interest can result when:
- A significant
financial interest of an Investigator would reasonably be
expected to be affected by the design, conduct or reporting
by the Investigator of a University research, educational
or public service activity;
- An Investigator
has a significant non-University obligation to an individual
or entity that provides support for a University research,
educational or public service activity involving the Investigator;
or
- An Investigator
has a non-University obligation to an individual or an entity
to which the University provides support through an agreement
to perform a program project, activity or service involving
the Investigator.
Protecting against conflicts of interest requires careful review
of the following types of situations, among others:
- Consulting arrangements
or agreements between an Investigator and a business enterprise
that supports or is supported by University programs involving
the Investigator;
- Consulting arrangements
between an Investigator and a business enterprise that is
licensed to commercialize University technologies invented
by the Investigator;
- Significant financial
interests of an Investigator in a business enterprise that
supports or is supported by the Investigator's University
research;
- A position held
by an Investigator as consultant, officer, director, trustee
or owner of a non-University business enterprise that supports
or is supported by the Investigator's University research;
- Significant financial
interests of an Investigator in a business enterprise that
owns or has applied for the patent, manufacturing or marketing
rights to a drug, device or procedure that is a subject
of, or will predictably result from, the Investigator's
University research;
- Significant financial
interests of an Investigator in a business enterprise that
is known by the Investigator to own or have applied for
patent, manufacturing or marketing rights that can reasonably
be expected to compete with a device, product or procedure
that will predictably result from the Investigator's University
research.
-
Investigator:
Any person who holds a University
at Buffalo appointment and who is a principal Investigator,
co-principal Investigator or who is responsible for the design,
conduct, or reporting of University programs, projects, activities
or services described in an application or prospective application
for external and/or selected internal support, or in an award
made to the University without application.
-
Significant
Financial Interest:
Anything of monetary value to the Investigator or the
Investigator's spouse and/or dependent children that would reasonably
appear to be affected by work externally funded or proposed
for external funding or selected types of internal funding,
including but not limited to:
- salary, royalties
or other payments for services (e.g., consulting fees or
honoraria) that, when aggregated for the Investigator and
the Investigator's spouse and dependent children over the
next twelve months, are expected to equal or exceed $10,000;
- equity interests
(e.g., stocks, stock options, warrants or other ownership
interests) that meet both of the following criteria: equals
or exceeds $10,000 in value as determined through reference
to public prices or other reasonable measures of fair market
value and represents more than a 5% ownership interest in
the single entity; and
- intellectual
property rights (e.g., patents, copyrights and royalties
from such rights).
Examples
of significant financial interests include ownership of stock,
stock options, or any equity, debt, security, capital holding,
salary or other remuneration, or financial consideration, or
thing of value for services as an employee, consultant, officer,
or board member in:
- the entity to
which the application will be submitted;
- any entity that
owns or has applied for the patent manufacturing or marketing
rights to a product or procedure involved in, or which will
predictably result from, the work described in the application;
- any entity that
is known by the Investigator to own or have applied for
such rights in any product that can reasonably be expected
to compete with the product or procedure that will predictably
result from the work described in the application; or
- any entity that
will be a sub-recipient from the University of funding resulting
from the application.
Significant
financial interests do not include the following:
- salary, royalties
or other remuneration paid to an Investigator by the University;
- income from seminars,
lectures, or teaching engagements sponsored by public or
nonprofit entities;
- income from service
on advisory committees or review panels for public or nonprofit
entities;
-
Significant
Obligation: Significant obligations include positions
held by the Investigator (or the Investigator's spouse and dependent
children) as an officer, trustee, director, employee or consultant
of an entity whether the entity is for profit or not-for-profit
and whether the position is paid or unpaid, that would reasonably
appear to be affected by the work funded or proposed by the
University for all external and selected types of internal funding.
IV.
Disclosure and Review of Disclosures
- The Form
SUNY-2-UB will serve as the mechanism
for disclosing financial interests and obligations by all Investigators
at the University.
- Disclosure statements
(Form
SUNY-2-UB) must be submitted to the cognizant dean(s)
or cognizant vice president(s) not later than the time applications
for external and selected types of internal support are submitted
by the University, or prior to acceptance of an award made without
prior submission of a proposal. Disclosure statements may also
be submitted at any other time, but must be updated whenever
significant financial interests or obligations change during
the period of the proposal and the performance period of the
award.
- To ensure compliance
with this policy, each proposal for external or selected types
of internal support must be accompanied by a list of all Investigators.
- The cognizant dean(s)
or cognizant vice president(s) shall be the University's designated
officials responsible for reviewing Investigator financial disclosure
statements in the context of each proposal and/or award and
for determining whether a conflict of interest or appearance
of conflict of interest exists, and shall determine what conditions
or restrictions, if any, should be imposed by the institution
to manage, reduce or eliminate such conflicts. Cognizant deans
and cognizant vice presidents have primary responsibility for
assisting investigators to identify areas of potential concern
and, whenever possible, for instituting remedies that permit
affected research, creative activity or public service activity
to proceed. Remedies instituted by cognizant deans and cognizant
vice presidents to manage, reduce or eliminate conflicts of
interest shall be in writing, signed by all affected parties,
and a copy shall be forwarded to the Vice President for Research.
- All applications
for external support submitted by the University and for selected
types of internal support must be accompanied by written certification
by the cognizant dean or cognizant vice president that the appropriate
disclosure form has been submitted. Applications for support
of a University program, project, activity or service will not
be submitted to an outside party, unsolicited support will not
be accepted by the University and selected University internal
support will not be awarded unless accompanied by the cognizant
dean or cognizant vice president's certification that the appropriate
disclosures have been made.
- In instances where
a cognizant dean or cognizant vice president is an Investigator
on an application for external or selected types of internal
support, the Vice President for Research shall be responsible
for reviewing financial disclosure statements, determining whether
a conflict of interest exists, and shall determine what conditions
or restrictions, if any, should be imposed by the University
to manage, reduce or eliminate such conflicts.
- On receipt of a grant
award, the Office of Sponsored Programs Administration shall
request that the cognizant dean's or cognizant vice president's
office (or their delegate) certify that no conflict of interest
or conflict of obligation exists, or that any such conflict
has been resolved. No funds for externally or selected types
of internally funded projects may be expended until all conflicts
of interest have been managed, reduced or eliminated.
- The Vice President
for Research (VPR) shall report to the appropriate funding source
any instance where an Investigator participating in funded research
or creative activity has not complied with the this Policy,
and the specific corrective measures taken by the University.
- The review of financial
disclosure forms requires all participants to exercise the utmost
discretion. To the maximum extent permitted by federal and state
law and by University policy, all elements of this process are
to be treated as strictly confidential. The purpose of confidentiality
is to assure that the integrity of the research and the privacy
of the Investigator as well as the interests of the University
are protected at all times.
- When and as required
by an external sponsor and prior to the expenditure of any funds,
the Vice President for Research will report to the sponsor the
existence of a conflict of interest (but not the nature of the
interest or any other details) and provide assurance that the
conflict has been managed, reduced, or eliminated, and if a
conflict is identified subsequent to receiving an award, a report
to the sponsor will be made and the conflicting interest will
be managed, reduced or eliminated, at least on an interim basis,
within sixty (60) days of identification.
- The Vice President
for Research shall inform all sponsoring entities of cases in
which the University is unable to satisfactorily manage a conflict
of interest.
- The University will
maintain all disclosures and records of actions taken to resolve
conflicts of interest for three (3) years after the termination
or completion of the award to which they relate, or until after
the resolution of any state or federal government action involving
those records whichever is later. Maintenance of these materials
will be the responsibility of the cognizant deans and cognizant
vice presidents.
V.
Remedies
Any or all of the following
conditions or restrictions may be applied to manage, reduce or eliminate
actual or potential conflicts of interest:
- Public disclosure of
significant financial interests;
- Monitoring of the project
or activity by independent reviewers;
- Modification of the
project or activity plan;
- Disqualification from
participation in the portion of the externally funded project
or activity that would be affected by the significant financial
interests or significant obligations;
- Divesture of significant
financial interests;
- Severance of relationships
or significant obligations that create actual or potential conflicts.
If the University is
unable to resolve a conflict of interest, it may decline to perform
the activity in question.
VI.
Waivers
With
the exception of activities sponsored by the United States Public
Health Service (PHS), the cognizant dean or cognizant vice president
may recommend in writing to the Vice President for Research that
an activity go forward without imposing conditions or restrictions
if the dean or vice president determines that imposing such conditions
or restrictions would be ineffective and that the potential negative
impacts that may arise from a significant financial interest are
outweighed by interests of scientific progress, technology transfer,
or the public health and welfare. Research, training or educational
activity in question may not commence until a final decision has
been made in writing by the VPR.
VII.
Appeal
Should
an Investigator disagree with the cognizant dean's finding in determining
that an actual or potential conflict of interest exists, or disagree
with the proposed remedy, the investigator may appeal to the Associate
Vice President for Research (AVPR) within ten (10) working days3
of the dean's or vice president's decision. The AVPR will review
the case, seek the advice of the Advisory Panel on Responsible Conduct4,
and render a judgment within ten (10) working days of receipt of
the appeal. No expenditures for external and selected types of internal
support of a program, project, activity or service may be made by
the University until a final decision has been made.
When
a cognizant vice president serves as the reviewer of a disclosure
statement, the appeal shall be to the Vice President for Research.
When the Vice President for Research serves as the reviewer of a
disclosure statement (see IV, F), the appeal shall be to the Provost.
VIII.
Compliance
The VPR
shall report promptly in writing to the Provost all cases in which
an Investigator has failed to comply with the University's Investigator
Disclosure Policy or the means determined to resolve a conflict
of interest. In such cases, the Provost shall, at the direction
of the President, institute disciplinary proceedings against an
Investigator who has failed to comply with the disclosure policy.
- Disciplinary sanctions
may include termination or alteration of the employment or academic
status of persons against whom charges have been substantiated,
and must be consistent with established UB and State University
of New York Board of Trustees policies, and applicable collective
bargaining agreements. Article 19 of the UUP Agreement shall
be the sole source of University discipline for members of the
UUP-represented unit.
- Upon completion of
disciplinary proceedings, the Provost or appropriate vice president
shall report to the appropriate University officers or bodies,
to cognizant federal agencies when federal funds are involved,
and to other parties as necessary.
- The University shall
require the Investigator to include a notice, with each public
presentation of research and creative activity, of conflicts
of interest that were not disclosed or resolved prior to the
expenditure of funds or which arose during the course of the
activity.
-
IX. Program to Inform
the University Community
All persons
subject to this Policy shall be informed of its contents as well
as understand the meaning of conflict of interest. To those ends,
the Vice President for Research will ensure that all unit heads
receive a copy of this Policy with instructions that copies be made
available to all its members (faculty, administrators, students,
staff and fellows). Each unit head shall make his or her members
aware of the Investigator Disclosure Policy on a annual basis and
provide a copy of the Policy to new members as soon as possible
after the start of their association with the unit. The VPR shall
determine whether there are members of the University who would
not be covered by such a distribution procedure and ensure that
those individuals also receive a copy of the Policy. Any failure
of this distribution process should not be construed as relieving
any individual member of the University of obligations under this
Policy for Investigator Disclosure.
X.
Review and Evaluation
This Policy shall be periodically reviewed by the University to
determine if it is working as intended and if any modifications
are needed. This review and evaluation should occur every two (2)
years, unless circumstances warrant review in a shorter period of
time.
1See
Section IV, page 5 and Appendix A.
2Italicized items are defined in 2, 3, and 4 below on this
section.
3"Working days" shall mean days on which University offices
are open.
4The Advisory Panel on Responsible Conduct serves in an
advisory capacity to the Vice President for Research on allegations
of misconduct and issues arising from the Investigator Disclosure
Policy. The Panel consists of one faculty member from each decanal
unit, one member from the University Libraries, one member nominated
by the chair of the Faculty Senate, and the VPR who also serves as
Chair of the Panel. (see Policy on Responsible Conduct in
Intellectual and Creative Activity). |