Faculty Senate Resolution #09-50
Approved
by the Faculty Senate: December 1, 2009
Approved
by the Chancellor: pending
Approved
by the Board of Trustees: pending
Proposed revision to
the ECU Faculty Manual,
Proposed
revisions are noted in bold print and deletions are noted in strikethrough.
APPENDIX I
EAST CAROLINA UNIVERSITY POLICY ON
CONFLICTS OF INTEREST AND COMMITMENT AND
EXTERNAL ACTIVITIES OF FACULTY AND OTHER PROFESSIONAL STAFF
CONTENTS
II. The Concepts at Issue Definitions
III. Policies
A.
Conflict of Interest
B.
Conflict of Commitment
C. External Professional Activities of Faculty and Other
Professional Staff
IV. Categories and Examples of Potential
Conflicts
V. Conflict
of Interest Procedures
V. Submission of
Conflict Evaluation Forms (Disclosures)
VI. Review and Approval of Activities and
Plans for Eliminating or Managing Conflicts
VII. Institutional Conflict of Interest
VIII. External
Professional Activity for Pay Procedures
VIII. Enforcement of the
Policies
IX. Definitions Enforcement of Policies
Example Forms:
A. Annual Faculty/Professional Staff Disclosure
Form of Potential Conflict of
Commitment
or Interest Activities or Relationships.
B. Report of Activities and
Relationships with Enterprises Sponsoring University Activities or Doing
Business with the University.
C. Report of Potential
Conflicts of Interest Related to Students’ Activities with External Enterprises.
D. Report of Potential
Conflicts of Interest Related to Teaching and Ownership of Intellectual
Property.
E. Notice of Intent to
Engage in External Professional Activities for Pay.
Effective July 1, 1995, aAll EPA faculty members and other
professional Non faculty EPA staff of East Carolina University are subject
to revised policies concerning conflicts of interest and conflicts of
commitment affecting University employment and external professional
activities. This policy covers full-time faculty and EPA non-faculty employees,
part-time faculty and EPA non-faculty employees, (those UNC employees who are not subject to the State Personnel Act –
hereinafter referred to as ‘EPA employees’). insofar as their University
responsibilities are concerned, and faculty and EPA non-faculty employees who
are on leave if the leave is funded at least partially from University sources.
The revised ECU policies are This
policy is based on policies and guidelines adopted by the UNC system Board
of Governors, federal and state law,
and federal agency sponsor requirements.
Any questions regarding these procedures or the Board of Governors' policies
upon which they are based should be directed to the appropriate divisional
vice chancellor ECU Office of
Research Compliance Administration.
The distinction between conflicts of interest and commitment is
not always clear. In general, conflict of commitment relates to allocation of
time and should become apparent in the annual review process conducted by the
administrative superior. Conflict of interest involves matters which might
unduly influence employee judgment in the conduct of employee affairs, such
that personal financial advantage is or might be unduly gained.
More specifically, conflict of interest occurs when related
personal considerations, e.g., employment of a spouse, potentially compromise the faculty or
professional staff member's objectivity in fulfilling University duties or
responsibilities, including research activities. Conflict of commitment occurs
when the pursuit of outside activities involves an expenditure of time that
potentially interferes with the faculty or professional staff member's
obligations to students, to colleagues, and/or to the missions of the
University.
A.
Business
means any corporation, partnership, sole proprietorship, firm, franchise, association, organization,
holding company, joint stock company, receivership, business or real estate
trust, or any other legal entity
organized for profit, not-for-profit, or charitable purposes.
"Business" excludes University-related entities, which is inclusive
of the University, and any private medical practice or any other entity
controlled by, controlling, or under common control with the University or with
which the University has a contractual relationship for the purpose of
providing patient care.
B.
Conflict
of commitment relates to an individual’s distribution
of effort between obligations to his or her University employment and
participation in activities outside of University employment. The latter may include such generally
encouraged extensions of professional expertise as professional consulting. A conflict of commitment occurs when the
pursuit of such outside activities involves an inordinate investment of time
that interferes with the EPA employee’s obligations to students, to colleagues,
and/or to missions of the University
C. Conflict of
interest relates to situations in
which financial or other personal considerations may compromise, may involve
the potential for compromising, or may have the appearance of compromising an
EPA employee’s objectivity in fulfilling University duties or responsibilities,
including research activities.
D.
Executive Position" refers to any position that
includes responsibilities for a material segment of the operation or management
of a business, including Board membership.
E.
External
professional activities for pay means any activity that 1) is not
included within one’s University employment responsibilities; 2) is performed
for any entity, public or private, other than the University employer; 3) is
undertaken for compensation; and 4) is based upon the professional knowledge,
experience and abilities of the EPA employee.
Activities for pay not involving such professional knowledge, experience
and abilities are not subject to advance disclosure and approval requirements
of this Policy, although they are subject to the basic requirement that outside
activities of any type not result in neglect of primary University duties,
conflicts of interest, inappropriate uses of the University name or resources,
or claims of University responsibility for the activity.
F.
Department means an academic department, a
professional school without formally established departments, or any other
administrative unit designated by the chancellor of an institution or by the
president for the office of General Administration, for the purposes of
implementing this policy.
G.
The "Immediate
Family" of a faculty or EPA non-faculty employee includes his or her
spouse, dependent children and/or other dependent(s) as defined in the Internal
Revenue Code.
H.
Inappropriate
use or exploitation of University resources means using any services, facilities,
equipment, supplies, or personnel that members of the general public may not
freely use. A person engaged in
professional activities for pay may use, in that connection, his or her office
and publicly accessible facilities such as University libraries; however, an
office shall not be used as the site for compensated appointments with clients,
e.g., for counseling or instruction.
Under no circumstances may a supervisory employee use the services of a
supervised employee during University employment time to advance the
supervisor’s external professional activities for pay.
I.
"Participate"
means to be part of the described activity in any capacity, including but not
limited to serving as the principal investigator, co-investigator, research
collaborator or provider of direct patient care. The term is not intended to
apply to individuals who provide primarily technical support or who are purely
advisory, with no direct access to the data (e.g., control over its collection
or analysis) or, in the case of clinical research, to the trial participants,
unless they are in a position to influence the study's results or have
privileged information as to the outcome.
J.
Significant
Financial Interest has the same meaning as in 42 C.F.R. 50.603 as it
currently exists and as it may later be amended. This provision of the Code of Federal
Regulations defines a Significant Financial Interest to mean: anything of
monetary value, including, but not limited to, salary or other payments for
services (e.g., consulting fees or honoraria); equity interests (e.g., stocks,
stock options or other ownership interests); and intellectual property rights
(e.g., patents, copyrights and royalties from such rights). The term does not include:
1. Salary, royalties, or other remuneration from the applicant
institution;
2. Any ownership interests in the institution, if the
institution is an applicant under the Small Business Innovation Research
Program (SBIR);
3. Income from seminars, lectures, or teaching engagements
sponsored by public or nonprofit entities;
4. Income from service
on advisory committees or review panels for public or nonprofit entities;
5. An equity interest that when aggregated for the Investigator
and the Investigator’s spouse and dependent children, meets both of the
following tests: Does not exceed $10,000 in value as determined through
reference to public prices or other reasonable measures of fair market value,
and does not represent more than a five percent ownership interest in any
single entity; or
6. Salary, royalties or other payments that when aggregated for
the Investigator and the Investigator’s spouse and dependent children over the
next twelve months, are not expected to exceed $10,000.
K.
"Sponsored Programs" means research,
public service, training and instructional projects involving funds, materials,
or other compensation from outside sources under grants, contracts, or
cooperative agreements.
L.
"Technology" means any process,
method, product, compound, drug, device, or any diagnostic, medical, or
surgical procedure developed using University time, facilities, equipment, or
funds whether intended for commercial use or not.
M.
University employment responsibilities include both “primary duties” and “secondary duties.” Primary duties consist of assigned teaching,
scholarship, research, institutional service requirements, and other assigned
EPA employment duties. Secondary duties
consist of professional affiliations and activities undertaken by EPA employees
outside of the immediate University employment context that redound to the benefit
of the profession and to higher education in general. Such endeavors, which may or may not entail
the receipt of honoraria (See also UNC Policy Manual 300.2.2.2[R]) or the
reimbursement of expenses, include membership in and service to professional associations
and learned societies; membership on professional review or advisory panels;
presentation of lectures, papers, concerts or exhibits; participation in
seminars and conferences; reviewing or editing scholarly publications and
books; and service to accreditation bodies.
Such integral manifestations of one’s membership in a profession are
encouraged, as extensions of University employment, so long as they do not
interfere with the timely and effective performance of the individual’s primary
University duties.
The
goal of this policy is to ensure that all potential conflicts of
interest or commitment are disclosed so that appropriate administrative
interventions may eliminate, avoid, or manage them. These policies, however, are not intended to
limit responsible external activities.
A.
Conflict of Interest
It
is the policy of the University that faculty and EPA non-faculty Employees shall avoid conflicts of
interest that have the potential to affect adversely the University's interests,
to compromise objectivity in carrying out University responsibilities, or
otherwise to compromise the performance of University responsibilities. Compromise, may involve the potential for
compromising, or may have the appearance of compromising the EPA employee’s
objectivity in fulfilling University responsibilities, including research
activities. Accordingly, outside
activities and financial interests must be disclosed by EPA employees on an annual basis. Disclosures must be updated
when new external interests develop. This
notwithstanding, EPA employees have a continuing obligation to timely update
these disclosures as new external interests develop. Outside activities and financial
interests should be arranged to avoid such conflicts. Related policies are
also discussed in the ECU Faculty Manual, Part VII. Research Information.
B.
Conflict of Commitment
It is the policy of the University that faculty and EPA non-faculty eEmployees shall devote their primary
professional loyalty, time, and energy to their teaching, research, service,
and, where applicable, patient care at the University employment responsibilities, including research activities.
Accordingly, outside activities and financial interests must be arranged to
avoid interference with the primacy of these commitments. Policies and Procedures for those potential
conflicts of commitment situations that do not involve conflict of interest are
discussed in the ECU Faculty Manual, Part VI, General Personnel Information.
The policy on External Professional Activities of Faculty and Other
Professional Staff should be used for these potential conflicts of commitment situations. Accordingly, EPA Employees shall not engage in activities outside of
their employment that involves an inordinate investment of time that interferes
with the EPA employee’s obligations to students, to colleagues, and/or to
missions of the University. Such
activities are unacceptable outside activities.
Conflicts of commitment may also arise in connection with non-compensated
activities and a conflict of commitment may exist notwithstanding that an EPA
employee received no economic benefit from the outside activity. The issue, in each case, is whether the
employee is meeting the requirements of the job (as such responsibilities and
requirements may be defined by applicable University policy and as may be
further described in an individual’s job description or appointment
letter).
The policy on External
Professional Activities of Faculty and Other Professional Staff should be used
for these potential conflicts of commitment situations.
Although full-time
faculty and other EPA employment is not amenable to precise, time-clock
analysis and monitoring, administrators at the department and school levels are
charged with the evaluation of the work of employees under their
supervision. The formal occasions for
determining whether an individual is devoting sufficient time and energy to
University employment include regular reviews in connection with annual salary
decisions and scheduled reviews incident to promotion, reappointment or tenure
decisions and reviews of Notices of Intent to Engage in External Professional
Activities for Pay.
Activities
that may involve conflicts of interest can
be categorized under four general headings: or commitment fall into
three general categories that differentiate relationships according to
potential for adverse impact.
Category
I: consists of activities that appear to
involve a conflict of interest but in, fact, do not. consists of
relationships that, while including some that are conflicts in a technical
sense, are allowable because they do not compromise the objectivity of research
results or other interests of the University, the sponsor, or the public. These
relationships are generally minimal in their personal financial impact, and
otherwise do not represent a potential source of bias.
Category
II: consist of activities that present
potential conflict of interest and must be reported, but that may be allowable
with administrative approval. consists of relationships that may be
permissible following disclosure and, where necessary, the initiation of
supervisory procedures designed to preclude bias or other inappropriate actions
and to ensure the maintenance of academic standards and institutional
integrity.
Category
III: consists of relationships that are
generally not allowable because they involve potential conflicts of interest or
they present obvious opportunities or inducements to favor personal interests
over institutional interests. Before proceeding with such an endeavor, the EPA
Employee must demonstrate that in fact
his or her objectivity would not be affected and University interests otherwise
would not be damaged. An approved
conflict of interest management plan must be in place before any activities
involving this category are initiated.
consists of relationships that
presumptively may be inappropriate for a faculty member or EPA non-faculty
employee. In such cases, the individual must demonstrate to the University's
satisfaction the compatibility of such practices with University policy prior
to going forward with the proposed activity.
Category IV: consists of activities that have the
potential for creating conflicts of interest that are prohibited by North
Carolina and/or federal law and, therefore, may not be undertaken.
Provided
below are representative, but not all-inclusive, examples of activities in each
of these three four categories.
Please refer to Section IX below above
for important definitions.
Category
I:
Activities allowable,
with no reporting required. The examples
cited below involve activities external to University employment, and thus may
present the appearance of a technical conflict, but they in fact do not have
the potential for affecting the objectivity of the EPA employee’s performance
of University responsibilities; at most, some such situations could prompt
questions about conflicts of commitment.
a) An EPA Employee receiving royalties
from the publication of scholarly works and other writings or for the licensure
of patented inventions pursuant to the University's Patent and Copyright
Policies (Faculty Manual, Part VII, Research Information).
b) An EPA employee receiving nominal
compensation, in the form of honoraria or expense reimbursement, in connection
with service to professional associations, service on review panels,
presentation of scholarly works, and participation in accreditation reviews.
Senior Academic and Administrative Officers may also be subject to special
regulations regarding honoraria which require leave to be taken when external
activities for pay will take place during the regular work week (UNC Policy
Manual, 300.2.2.2[R]).
c) An EPA Employee having an equity
interest in a corporation used solely for the individual's consulting
activities provided such consulting activities are appropriately reported and
approved in accordance with the policy on, External Professional Activities of
Faculty and Other Professional Staff and the corporation is not directly or
indirectly conducting any business or sponsoring any projects with the
University.
Category II:
Activities requiring
disclosure for administrative review.
a) An EPA employee accepting support for University research
under conditions that require research results to be held confidential,
unpublished, or inordinately delayed in publication. Research conducted by faculty or students
under any form of sponsorship must maintain the University’s open teaching and
research philosophy and must adhere to a policy that prohibits secrecy in
research. Such conditions on publication
must be in compliance with UNC Policy Manual, 500.1 and 500.2.
b) Related persons working on the same funded or unfunded
project.
2. External Activities
a)
An EPA
Employee serving on the board of directors or scientific advisory board of an
enterprise or business that provides financial support for University research,
and the employee or a member of his or her immediate family may receive such
financial support.
b) An EPA Employee serving in an executive position in a for
profit or not-for-profit business which conducts research or other activities
in an area related to the University duties of the employee.
3. Ownership
a)
An EPA
Employee having a financial interest or a significant financial interest in a
business that competes with the services provided by the University.
b) An EPA Employee having significant equity or a Significant
Financial Interest in a for-profit business which conducts research or other
activities in an area related to the employee’s University duties. An EPA Employee requiring students to
purchase the textbook or related instructional materials of the employee or
members of his or her immediate family, which produces compensation for the
employee or family member.
4. Other
a)
An EPA
employee receiving compensation or gratuities (other than occasional meals,
gifts or desk copies of textbooks, and the like) from any individual or entity
doing business with the University. This
notwithstanding, see Category IV example (f).
b) Engaging in any other activity that has the potential for
creating a conflict of interest or commitment as defined herein.
Category III:
Activities or
relationships that are generally not allowable.
1. Research Activities
a)
An EPA
Employee participating in University research involving a technology owned by
or contractually obligated (by license, option, or otherwise) to a business in
which the individual or an immediate family member has a consulting relationship,
has an ownership interest, or holds an executive position.
b) An EPA Employee participating in University research which
is funded by a grant or contract from a business in which the individual or
member of his or her immediate family has an ownership interest and/or
significant financial interest;
c) An EPA Employee assigning students, postdoctoral fellows or
other trainees to University research projects sponsored by a business in which
the individual or a member of his or her immediate family has an ownership
interest and/or significant financial interest.
2.
External Activities
a)
Assuming
an executive position in a not-for-profit business with which the University
has a contractual relationship known to the individual and which is engaged in
commercial or research activities in a field related to the individual's
University responsibilities.
b) An EPA Employee making referrals of University business to
an external business or company in which the individual or a member of his or
her immediate family has a financial interest, including a consulting
relationship.
c) An EPA Employee associating his or her own name with the
University in such way as to profit financially by trading on the reputation or
goodwill of the University. An example of a context in which such an
association might occur is external professional activity for pay. Mere
identification of the University as the employer of the individual and of the
individual's position at the University is permitted by this section, provided
that such identification is not used in a manner that implies sponsorship or
endorsement by the University.
d) An EPA Employee serving as an expert witness for pay in
litigation which requires the disclosure of research data in a manner that will
compromise the University’s or a student’s ability to publish.
3. Public Disclosure
a)
An EPA
Employee publishing or formally presenting University sponsored research
results, or providing expert commentary on a subject, with out simultaneously
disclosing any significant financial interest relating to such results or such
subject.
b) An EPA Employee making unauthorized use of privileged
information acquired in connection with one's University responsibilities. See also Category IV activities.
4. Administrative
Responsibilities
a)
An EPA
Employee taking administrative action in the course and scope of University
responsibilities that is beneficial to a business in which the individual or an
immediate family member has a significant financial interest, including a
significant consulting relationship. See
also Category IV activities.
b)
An EPA
Employee influencing the negotiation of contracts between the University and an
outside organization with which the individual or an immediate family member
has a significant financial interest, including a significant consulting
relationship. See also Category IV
activities.
5. Committee
Participation
a)
An EPA
Employee serving on a committee of a governmental agency or private entity
during the consideration by such a committee of the regulation or application
of a technology that is owned by or contractually obligated to a business in
which that individual or immediate family has a significant financial interest,
including a significant consulting relationship.
Category IV: Activities that have the potential for creating conflicts of
interest that are prohibited by North Carolina and federal law (including N.C.
Gen. Stat. 14-234 and 14-234.1 as they
currently exist and as may later be amended) and, therefore, may not be
undertaken.
(a)
N.C.G.S. (a1)(4)
defines “direct benefit from a contract” to mean where a state officer or
employee or his or her spouse: (i)
has more than a ten percent (10%) ownership or other interest in an entity that
is a party to contract with a state agency; (ii) derives any income or commission
directly from the contract with a state agency; (iii) acquires any property
under the contract with a state agency.
(b) N.C.G.S. 14-234 (a1)((2)
states that a public officer or employee is involved in administering a
contract if he or she oversees the performance of the contract or has authority
to make decisions regarding the contract or to interpret the contract.
(c)
N.C.G.S. 14-234 (a1)((3) states in part that a public
officer or employee is involved in making a contract if he or she participates
in the development of specifications or terms or in the preparation or award of
the contract.
(d) North Carolina law
prohibits a state officer or employee who is involved in making or
administering a contract on behalf of a state agency from deriving a direct
benefit from the contract (N.C.G.S. 14-234 (a)(1)).
(e)
North Carolina law prohibits a state officer or employee who
receives a direct benefit from a contract with the state agency he or she
serves, but who is not involved in making or administering the contract, from
attempting to influence any other person who is involved in making or
administering the contract. (N.C.G.S.
14-234 (a)(2))
(f)
North Carolina law prohibits a state officer or employee
from soliciting or receiving any gift, reward, or promise of reward in exchange
for recommending, influencing, or attempting to influence the award of a
contract by the state agency he or she serves. (N.C.G.S. 14-234 (a)(3))
(g)
Contracts made in violation of N.C.G.S. 14-234 are void as a matter of law and anyone violating this statute may be
prosecuted criminally.
(h)
N.C.G.S.
14-234.1 prohibits a State officer or employee from benefiting
financially, or helping someone else benefit, from non-public information
gained by the employee in his or her official capacity. Anyone
violating this statute may be prosecuted criminally.
(i)
Note that the North
Carolina Ethics Act (Ethics Act) also regulates Conflicts of Interest for
“Covered Persons”. Questions regarding
the Ethics Act should be directed to the University Attorney.
(j)
Medicare Anti-Kickback
Law. The Medicare Anti-Kickback
law (42 U.S.C. 1320a-7b(b)) prohibits
compensation from research sponsors that provide or supply healthcare services
or products to researcher-physicians or hospitals for their participation in
clinical research if such compensation is intended to induce physicians or
hospitals to purchase drugs or services of the research sponsor that will be
paid by Medicare or Medicaid.
(k)
False Claims Act. Researchers must certify in their grant
applications that they are in compliance with statutory and regulatory
requirements, including applicable statutes and regulations prohibiting
conflicts of interest. Falsely
certifying compliance could result in criminal prosecution and civil penalties
under the False Claims Act (31 U.S.C.
3729, et seq.),
Activities that are routinely allowable and are not required to be
disclosed pursuant to this policy.
d)
Receiving royalties for published
scholarly works and other writings or for inventions pursuant to the
University's Patent and Copyright Policies (Faculty Manual, Part VII, Research
Information).
e)
Membership in and service to
professional associations and learned societies; membership on professional
review or advisory panels; presentation of lectures, papers, concerts or exhibits;
participation in seminars and conferences; reviewing or editing scholarly
publications and books; and service to accreditation bodies are permitted under
the ECU Policy Statement on External Professional Activities of Faculty and
other Professional Staff (Faculty Manual, Part VI, General Personnel
Information) so long as they do not conflict or interfere with the timely
performance of primary University duties. These activities are permitted even
if they are performed for nominal honoraria or reimbursement of expenses,
provided that the receipt of nominal honoraria or reimbursement of expense is
not in conflict with any other applicable University, state, or federal policy,
rule or regulation. These activities are not required to be disclosed in this Policy's
Annual Faculty/Professional Staff Disclosure Form. However, a "Notice of
Intent to Engage in External Professional Activity" may be required
pursuant to ECU's policy (Faculty Manual, Part VI, General Personnel
Information).
f)
Ownership of or equity in a corporation
used solely for the individual's consulting activities provided such consulting
activities are appropriately reported and approved in accordance with Faculty
Manual, Part VI, General Personnel Information, External Professional Activities
of Faculty and Other Professional Staff.
Category II:
Activities that may be allowable following disclosure and, where
necessary, the implementation of monitoring procedures.
c)
Participating in University research
(basic, applied, and clinical) on a technology developed by that individual or
a member of his of her immediate family, unless the activity is specifically
disallowed under the guidelines of Category III.
d)
Participating in University research involving a technology
owned by or contractually obligated (by license, option or otherwise) to a
business in which the individual or immediate family has a consulting
relationship.
e)
Receiving through contract or gift University sponsored
research support (whether in dollars or in kind) for research from a business
in which the individual or immediate family has a consulting relationship.
2. External Activities
c)
Serving on the board of directors or
scientific advisory board of a business from which that individual or immediate
family receives University-sponsored research support or with which the
University has a substantial contractual relationship known to the individual,
unless the activity is specifically disallowed under the guidelines of Category
III.
d)
Assuming an executive position in a not-for-profit business
with which the University has a substantial contractual relationship known to
the individual and which is engaged in commercial or research activities in a
field related to the individual's University responsibilities, unless the activity
is specifically disallowed under the guidelines of Category III.
3. Ownership
c)
Possessing a significant financial
interest, including a significant consulting relationship, in a business that
competes with the services provided by the University as a part of their
academic, research, or service mission.
d)
Possessing a significant financial interest, including a
significant consulting relationship, in a business field related to the
individual's University responsibilities, unless the activity is specifically
disallowed under the guidelines of Category III.
e)
Requiring or recommending one's own textbook or other
teaching aids, materials, or equipment to be used in connection with University
programs or those of immediate family. Such a requirement or recommendation
must be preceded by disclosure and review according to this policy.
4. Other
c)
Acceptance by the University employee
or immediate family of other than nominal gratuities or special favors from one
whom the individual knows is doing business with or proposing to do business
with the University.
d)
Engaging in any other activity that has the potential for
creating a conflict of interest or commitment as defined herein.
Category III:
Activities that are presumptively not allowable. Many of the examples below may seem to
overlap examples in Category II above; however, the addition of ‘significant
financial interests’ in the activities below creates the presumption that these
activities are not allowable.
1. Research Activities
d)
Participating in University research
involving a technology owned by or contractually obligated (by license, option,
or otherwise) to a business in which the individual or immediate family holds
significant stock or similar significant ownership interest, or has any other
significant financial interest, other than a receipt of University-sponsored
research support, or receipt of royalties under University royalty sharing
policies.
e)
Receiving, through contract or grant, University sponsored
research support (whether in dollars or in kind) for research from a business
in which the individual or immediate family holds a significant stock or
similar significant ownership interest or has any other significant financial
interest.
f)
Assigning students, postdoctoral fellows or other trainees
to University projects sponsored by a for-profit or not-for-profit business in
which the individual or immediate family has a significant financial interest,
including a significant consulting relationship.
2. External Activities
e)
Assuming an executive position in a
not-for-profit business with which the University has a substantial contractual
relationship known to the individual and which is engaged in commercial or
research activities in a field related to the individual's University
responsibilities.
f)
Making referrals of University business to an external
business or professional office in which such individual or immediate family
has a significant financial interest, including a significant consulting
relationship.
g)
Associating one's name or one's work with an external
activity in such a way as to profit monetarily by trading on the reputation or
good will of the University or to imply sponsorship or endorsement by the
University. An example of a context in which such an association might occur is
external professional activity for pay. Mere identification of the University
as the employer of the individual and of the individual's position at the
University is permitted by this section, provided that such identification is
not used in a manner that implies sponsorship or endorsement by the University.
3. Public Disclosure
c)
Publishing or formally presenting
University sponsored research results, or providing expert commentary on a
subject, with out simultaneously disclosing any significant financial interest
relating to such results or such subject.
d)
Unauthorized use of privileged information acquired in
connection with one's University responsibilities to further one's own personal
interests.
4. Administrative Responsibilities
c)
Taking administrative action in the course
and scope of University responsibilities that is beneficial to a business in
which the individual or an immediate family member has a significant financial
interest, including a significant consulting relationship.
d)
Influencing the negotiation of contracts
between the University and an outside organization with which the individual or
an immediate family member has a significant financial interest, including a
significant consulting relationship.
5. Committee Participation
b)
Serving on a committee of a governmental
agency or private entity during the consideration by such a committee of the
regulation or application of a technology that is owned by or contractually
obligated to a business in which that individual or immediate family has a
significant financial interest, including a significant consulting
relationship.
V. Submission of Conflict Evaluation Forms
(Disclosures). COI Procedures
Policy: Effective July 1,
1995, eEach faculty member
and all other EPA eEmployees
will be required to disclose annually
relationships and circumstances that may raise questions about conflicts of
interest and conflicts of commitment relating to University employment
responsibilities, including, but for
both him/her selves and their immediate families (see definition in Section IX)
the extent of their relevant external activities and relationships and their
financial holdings that are related to the employee’s university
activities. These university activities
include but are not limited to sponsored research activities. These
external activities, relationships and financial holdings are described above
in Section IV under Categories II & III. All potential Category II, III, and III IV relationships or financial holdings
must be reported regardless of the dollar amounts involved. Category I activities and relationships are
not required to be disclosed under this policy; however, other university
reporting requirements may apply to these activities (see Section IV). Where there is some question whether an
activity should be considered a Category I or II activity as described above,
the faculty/EPA non-faculty eEmployee
should include the activity in the disclosure for consideration by his/her
supervisor.
All faculty and other EPA personnel are charged by the University
to provide a full good faith disclosure.
Failure to provide such a full disclosure may be considered a serious
breach of this policy and may be cause for disciplinary action (see Section
VIII).
Revisions
or updates of the yearly disclosures are required between yearly disclosures
whenever there is a significant change in the faculty member’s EPA employee’s or his/her immediate family’s affairs that may lead to or may be
perceived to lead to a conflict with the faculty member’s EPA employee’s university activities,
e.g., the faculty member’s spouse begins to receive consultant fees from a
company that currently contracts with university for research services from the
faculty member’s laboratory.
Procedures: To facilitate disclosure and to ensure appropriate
uniformity across the University, each individual will complete the
"Annual Faculty/Professional Staff Disclosure Form." Each unit
administrator will distribute this form annually to all faculty and
professional staff (EPA non faculty) under his or her supervision and assure
that completed forms are returned. Unit Administrators shall summarize the
disclosure completed by EPA employees to the Office of Research Compliance
Administration.
The
purpose of this form is to identify employees' activities that may lead to
actual or potential conflicts of commitment or interest so that appropriate
administrative intervention may address the problems. The employee and the
administrative superior are to complete and sign the annual disclosure form,
which implies that the administrative superior has reviewed the form. No
further action will be required if all questions are answered "no".
Further
disclosure and review are required if questions elicit any "yes"
responses on the Annual Faculty/Professional Staff Disclosure Form or on any
mid year revisions or updates of the annual form. The employee must then
complete and sign the appropriate additional forms. Suggested provisions or
plans for eliminating or managing conflicts should be included in these additional
forms where indicated. Examples of some (but not all) possible provisions for
conflict management plans are:
1.
Public disclosure of the significant financial interests or external
activities;
2.
Monitoring of activities by disinterested university officials to assure that
conflicts do not arise;
3.
Cessation of the pertinent outside activities;
4.
Divestiture of the pertinent financial interests; and
5.
Severance of the relationships that create actual or potential conflicts.
Since
these forms have direct bearing on the employment of individuals with the
University, all disclosure forms (the annual form and accompanying forms) and
associated documents will be maintained in the administrative office of the
employee's unit in his/her personnel folder for a period of at least three
years following termination of the pertinent activities.
VI. Review and Approval of Activities and Plans for Eliminating or
Managing Conflicts.
The
unit administrator (chair, dean, or the employee's supervisor in the case of a
senior administrator) has the initial responsibility to review and approve or
disapprove the disclosure forms filed with him or her by the EPA employees
within that unit. The review shall follow the provisions of this Policy. The Unit administrator should be familiar
with the definition of ‘Significant Financial Interest’ (See Section IX)
to differentiate between Category II and Category III activities and
relationships. Category III activities
are presumptively considered to be non-allowable.
The
unit administrator may refer any question regarding an annual disclosure form
to the next higher administrative level for review and decision and must refer
to the next higher level for review and approval all annual disclosures (and
updates/revisions) which require additional forms (as described in the annual
disclosure form) for EPA employees involvement in possible Category II and III
activities as described above.
If
a potential conflict is determined to exist, written plans for eliminating or
managing the conflict will be developed in consultations between the employee, the Office of Research Compliance
Administration, and his/her supervisors (up to and including deans of academic units as appropriate) and
presented to the Vice Chancellor of
Research and Graduate Studies of the appropriate division for
concurrence. For Category II through IV
Conflicts of Interest, the plan will also be submitted to the appropriate
division’s Vice Chancellor for informational review. It will then be
presented to the ECU Research Ethics Oversight Committee (see below) for final
approval. An adverse decision of the
Committee to a proposed management plan may be appealed to the Chancellor. The supervisor of the EPA employee
will be responsible for assuring the implementation and/or monitoring of the
conflict management plan.
Documentation
of all decisions on activities and associated conflict management plans will be
maintained in the employee's personnel folder.
In
order to fulfill the certification requirements of grant and contract funding
agencies (e.g., the NIH and NSF), each unit administrator shall also provide
annually to the Vice Chancellor for Research and Graduate Studies a list of all
faculty members and EPA staff in the administrator's unit who have submitted approved
current annual disclosure forms and, where needed, an indication when such
approval required development of an acceptable conflict management plan. This
list may be amended as needed during the year. The Vice Chancellor for Research
or his designee will use this information to report any perceived or potential COI to the sponsor or to certify
to potential funding agencies that this Institution has a conflict of interest
policy consistent with NIH and NSF guidelines and that to the best of our
knowledge all provisions of the policy have been followed with respect to
proposals submitted to the agencies by ECU faculty and staff.
If
after initial review of any disclosure by
the department head, dean, and vice chancellor, questions remain regarding
ethical issues or if disagreement exists between the EPA employee and the
administration regarding the permissibility of activities, or if the COI management involves more than disclosure and minor
oversight, the situation may be referred to a faculty/administrative
advisory committee for review of conflicts of interest and commitment. This
committee, the Research Ethics Oversight
Committee, will be chaired by the Vice Chancellor for Research &
Graduate Studies. Appropriate individuals will be appointed
members to the committee by the Vice Chancellor for Research and Graduate
Studies. and will have
representatives from the faculty senate as members. When the committee reviews conflict
management plans, a representative of university attorney's office shall be present. In addition, when a management plan
involves graduate students, a representative from the graduate council will
also be present. Other appropriate individuals will be appointed members to the
committee by the Vice Chancellor for Research & Graduate Studies. Decisions
by this committee will be presented to the Chancellor for his or her
concurrence and, if approved, will become the University's final position
subject only to appeal in accordance with Section 501C(4) of The Code of the
If
the activity at issue involves external support (grant, contract or cooperative
agreement), the vice chancellor for research Director of Sponsored Programs shall inform the sponsor in accordance to Sponsor policy and
guidelines of the COI. whenever
the University determines that it is unable to develop a satisfactory conflict
management plan for an actual or potential conflict of interest.
Whenever human subjects are involved in an activity
presented to the Research Ethics Oversight Committee University’s
Office of Research Compliance Administration (including approvals of
conflict management plans), the University & Medical Center Institutional
Review Board (UMCIRB) will be confidentially notified of the issue and the
Committee’s actions.
VII. Institutional Conflict of Interest
East Carolina University, from time to time, forms
relationships with profit-making entities (including the holding of equity
interests) for mutual benefit. However,
such relationships may put the University into actual or apparent conflict of
interest situations when accepting grants or contracts from the profit making
entities for research or other activities.
(See exclusion at the end of this section for certain types of
relationships.) To assure that these grants and contracts are performed with
the highest level of integrity by University employees and to assure that the
public maintains it trust in University activities, the following procedures
shall be followed:
1. At the
beginning of each calendar year, the Director, Office of Technology Transfer
shall prepare a disclosure listing all profit-making entities in which the
University has a significant financial interest (See Section IX.4). This
disclosure shall be updated during the year as new relations develop and old
ones terminate. This disclosure and its
updates will be submitted to the Vice Chancellor for Research and Graduate
Studies who shall distribute the disclosure to the Chancellor, the other Vice
Chancellors and Deans, and the Research Ethics Oversight Committee. Copies of
the disclosure and updates shall also be distributed to those university
administrative offices charged with approving and administering grants and
contracts and other regulatory committees human subjects research
protection (for example,
Office of Sponsored Programs, Office of Grants and Contracts Administration and
the UMCIRB).
2. Units
submitting proposals for external funding to commercial entities may not be
aware of possible institutional conflict of interest issues. Thus, the Office of Sponsored Programs shall
have the primary responsibility of notifying Office of Research Compliance
Administration, Vice Chancellor for Research and Graduate Studies and the
submitting unit of the University’s conflict of interest as part of its regular
procedures for the review and approval of such applications. The Office of Research Compliance
Administration or the Vice Chancellor or his designee shall then develop a
plan to manage the institutional conflict of interest after consultation with
the submitting unit and other relevant university offices. The conflict management plan shall be
submitted to the Research Ethics Oversight Committee for review. The Committee may approve the plan (with or
without mandatory changes) or disapprove the plan. University acceptance of grants and contracts
related to a management plan is contingent upon approval of the management plan
by the Committee. A negative decision of
the Committee may be appealed to the Chancellor. An institutional conflict management plan
may range from a simple disclosure of the University’s interest in publications
and reports emanating from the grant or contract to complete University
divestiture of the financial interest. The institutional conflict of management
plan shall be separate from and in addition to any conflict management plans
for conflicts of interests of individuals (e.g., the principal investigator)
involved in the grant or contract.
3. When
considering an institutional conflict of interest management plan, the Research
Ethics Oversight Committee shall a) include as voting members, one or more
individuals from the general public who have no direct or indirect relationship
with the University, i.e., the individuals and their spouses or other
dependents must not be current employees or students of the University; and b)
recuse from the deliberations of the Committee any ECU member of the Committee
who has been involved in the negotiation, approval, or implementation of the
relationship that is the basis of the actual or perceived conflict of
interest. The general public members of
the Committee should be individuals that have sufficient education or
experience to understand both the issues before the Committee and the possible
impacts of the Committee’s decisions on the general public.
4. Arrangements
for plan implementation and oversight shall explicitly be part of an
institutional conflict management plan.
Implementation and oversight will usually be the joint responsibility of
the submitting unit and the Office of the Vice Chancellor for Research and
Graduate Studies. However, other
arrangements shall be made for plan implementation and oversight if, in the
judgment of the Research Ethics Oversight Committee, such arrangements are
necessary for the effective management of the conflict.
Excluded Relationships: A relationship with a profit making
organization for the purposes of this institutional conflict of interest policy
shall not include ordinary investments of the university’s endowment that are
managed by the Board of Trustees of the Endowment Fund or ordinary
client-vender relationships where the University contracts for specific goods
or services from a profit-making organization.
VIII. External Professional Activity for Pay
Procedures
1.An EPA Employee who plans to engage in external professional activity
for pay shall complete the "Notice of Intent to Engage in External
Professional Activity for Pay" (hereinafter referred to as "Notice of
Intent") in a format as described in section 2 of this Part VIII. The Notice of Intent shall be filed with the
head of the department in which the individual is employed. A separate “Notice
of Intent" shall be filed for each such activity in which an employee
proposes to engage. Unless there are exceptional circumstances, the
"Notice of Intent" shall be filed not less than ten (10) calendar
days before the date the proposed external professional activity for pay is to
begin.
2.The Notice of Intent Format:
The format for giving notice of Intent should follow the sample notice
form.
NOTICE OF INTENT TO ENGAGE
IN EXTERNAL PROFESSIONAL ACTIVITIES FOR PAY
Date:
______________________
___________________________(Name)
intends to engage in external professional activity for pay under the following
conditions:
1.
Name and address of contracting organization;
2.
Nature of proposed activity;
3.
Beginning date and anticipated duration of activity;
4.
On average, how many hours per week will be devoted to this
activity?
a.
For twelve-month employees, for the anticipated duration of
the activity, within the current fiscal year ending June 30: ___,;
b.
For 9-month employees, for each component part of the
academic year, as applicable, within the current fiscal year ending June 30:
i.Second summer session (post
July 1) ____
ii.
Fall Semester ___
iii.
Spring Semester ___
iv.
First Summer Session (pre July 1) ___
5.
Total number of hours to be devoted to activity: ___
6.
Identify any classes, meetings, or other university duties
that will be missed because of involvement in the proposed activity (respond
separately for each applicable component part of the academic calendar if
9-month employee) and state what arrangements have been made to cover any such
duties;
Duties Missed Arrangements to Cover
____________ ____________________
____________ ____________________
7.
Use of University resources in connection with proposed
activity:
1.
Will the activity entail the use of any university
resources? (see Section II(G) above and UNC Policy Manual, 300.2.2, Section I,
Item G) ___ Yes ___ No
2.
If yes, describe what resources will be used; ____________________
8.
To your knowledge, does the contracting organization provide
funding which directly supports any of your University duties or activities?:
Yes() No()ITo be completed if the contracting organization is a private firm:
a. Do you or any member of your
immediate family own an equity interest in the contracting organization:
Yes() No ()
b. Do you hold an office in
the contracting organization? Yes() No ()
9.
Performance of the above described activity is consistent
with the Board of Governors Policy on Conflicts of Interest and Commitment and
External Professional Activities
Signatures follow..
10.
Each EPA faculty
and EPA non-faculty participating in external activity for pay must report the
activity during the past fiscal year.
Such reports (a sample form for reporting external activity for pay is
available at the Academic Affair’s webpage) will contain the following
information for each external professional activity for pay engaged in during
the last fiscal year preceding the date of filing of a "Notice of
Intent":
11.
Contracting organization;
12.
Beginning and ending date of activity (if completed): 3.
Average hours per week devoted to this activity;
13.
Total number of hours devoted to this activity;
14.
Nature of professional activity;
15.
Date Notice of Intent was filed; and
16.
Administrative Action on Notice of Intent which will have
the following signatures and information:
17.
Signature and date of unit head certifying activity
determined to be consistent with university policy;
18.
Other action (as required);
19.
Signature and date of Dean or Other Administrative Officer
(Approval by dean or next higher administrator is required if the contracting
organization is providing funding to the University or if a family member or
the EPA faculty or EPA non faculty owns equity or hold an office in the
contracting organization) if activity determined not to be consistent with
university policy;
20.
Action on appeal (if any) and date action taken;
21.
Signature and date of Dean or next higher administrator if
appealed; and
22.
Signature of Chancellor if appealed.
23.
Any administrative
action approving a "Notice of Intent” shall be effective only for the
remaining balance of the fiscal year (in the case of twelve-month employees) or
for the balance of the academic year (for nine-month employees).
3.Approval of a "Notice of Intent” may be granted for a
period not to exceed the balance of either 1) the fiscal year (in the case of
twelve-month employees and employees with contract service periods that include
the summer session) or 2) the academic year (in the case of nine (9) month
employees with no summer session contract period) remaining as of the date of
approval; if the approved activity will continue beyond the end of the relevant
fiscal or academic year in which it was begun, an additional "Notice of
Intent” must be filed at least ten days before engaging in such activity in the
succeeding relevant year.
4.Except as set out in paragraph 5 below, the “Notice of
Intent” shall be considered as follows: If, after a review of the “Notice of Intent"
and consultation with the EPA employee, the unit head determines that the
proposed activity is not consistent with this policy statement of the Board of
Governors and East Carolina University, the EPA Employee shall be notified of
that determination within ten (10) calendar days of the date the "Notice
of Intent" is filed. In the event of such notification by the unit head,
the EPA Employee shall not proceed with the proposed activity but may appeal
that decision to the next higher administrator and then to the Chancellor or
the Chancellor’s designee. A decision on any such appeal shall be given to the
EPA Employee within ten calendar days of the date on which the appeal is
received. The decision of the Chancellor is final. Appeals shall be made in writing
on the "Notice of Intent” form.
5.If question 8, question 9a, or question 9b on the Notice of
Intent, above, is answered in the affirmative the procedure set out in
paragraph 4 above shall be modified as follows: The decision of the unit head
to approve the activity shall be reviewed promptly and approved or disapproved
within ten (10) days of receipt by the next higher administrator, and appeal of
a disapproval by that officer shall be to the Chancellor or the Chancellor’s
designee. In addition, the Vice
Chancellor for Research and Graduate Studies must review the external activity
for management of any Conflicts of Interest and notify the University and
Medical Center Institutional Review Board if the EPA Employee is participating
in a protocol involving human subjects at ECU to ensure compliance with
applicable IRB laws and regulations.
6.Departmental summaries of all "Notices of Intent"
filed and of actions taken in response to such "Notices of Intent"
during the preceding fiscal year shall be submitted by unit heads to the
Chancellor each July. As initiated by
the UNC General Administration on or before September 1 of each year, the
Chancellor will provide an annual summary report to the President.
7.If the external professional activity for pay is wholly
performed and completed outside of the academic year by EPA employees serving
on academic year contracts, said EPA Employees do not need to file Notices of
Intent with their unit head provided that the activity does not conflict with
this policy statement of East Carolina University and of the Board of Governors
and is not conducted concurrently with a contract service period for teaching,
research, or other services to East Carolina University during a summer session
8.University employees not complying with these procedures
will be subject to disciplinary action. Unit heads are held responsible for
proper reporting.
III IX. Enforcement of the Policies
Faculty and non-faculty EPA
Employees staff are under a clear obligation to adhere to the ECU
policies and procedures to disclose and to remove or appropriately manage
conflicts of interest or commitment. Breaches of the policy/procedures will be
viewed as serious ethical violations by the persons involved. Possible breaches
of the policy/procedure include, but are not limited to:
1.
Furnishing false, misleading or
incomplete information on the disclosure forms;
2. Failure to
promptly update disclosure forms before the required annual update when a
significant change in a person's financial or fiduciary status places the
individual into an immediate potential conflict of interest or commitment
situation;
3. Failure to
comply with the procedures described above (e.g., refusal to respond to
inquiries, responding with incomplete or knowingly inaccurate information, or
otherwise);
4.
Failure to remedy conflicts as
determined by the Procedures; and
5.
Failure to comply with a prescribed
monitoring plan.
If
a possible breach in the policy/procedures occurs, the appropriate dean shall
consult with the faculty person and his chair. If no resolution is forthcoming,
the dean shall refer the case to the appropriate vice chancellor. The vice
chancellor shall consult with the vice chancellor for research and shall
initiate an investigation and/or hearing as prescribed in Faculty Manual, Part
VII and Appendix D and apply sanctions as determined by university policies.
Such sanctions may range from administrative intervention to dismissal from
employment, all in accordance with applicable university policies.
1. "Business" means any
corporation, partnership, sole proprietorship, firm, franchise, association,
organization, holding company, joint stock company, receivership, business or
real estate trust, or any other legal entity organized for profit or charitable
purposes. "Business" excludes University-related entities, which is
inclusive of the University, and any private medical practice or any other
entity controlled by, controlling, or under common control with the University
or with which the University has a contractual relationship for the purpose of
providing patient care.
2. "Executive Position" refers to any
position that includes responsibilities for a material segment of the operation
or management of a business, including Board membership.
3. The
" Immediate Family" of a faculty or EPA non-faculty employee includes
his or her spouse, dependent children and/or other dependent(s) as defined in
the Internal Revenue Code.
4.
"Significant Financial Interest" means anything of monetary value, including
but not limited to, salary or other payments for services (e.g., consulting
fees or honoraria); equity interests (e.g., stocks, stock options or other
ownership interests); and intellectual property rights (e.g., patents,
copyrights, license agreements, and royalties from such rights). The term does not include:
(1)
Salary, royalties, or other remuneration from East Carolina
University to its faculty or staff;
(2)
Income from seminars, lectures, or teaching engagements
sponsored by public or nonprofit entities;
(3)
Income from service on advisory committees or review panels
for public or nonprofit entities;
(4)
An equity interest that when aggregated for the
faculty/staff and the faculty/staff’s immediate family, meets both of the
following tests: Does not exceed $10,000 in value as determined through
reference to public prices or other reasonable measures of fair market value,
and does not represent more than a five percent ownership interest in any
single entity;
(5)
Salary, royalties or other payments that when aggregated for
the faculty/staff and the faculty/staff's immediate family over the next twelve
months, are not expected to exceed $10,000 from any one source.
(6)
Mutual, pension, investment or other funds over which the
employee or the University does not exercise direct control.
5. "Participate" means to be part of
the described activity in any capacity, including but not limited to serving as
the principal investigator, co-investigator, research collaborator or provider
of direct patient care. The term is not intended to apply to individuals who
provide primarily technical support or who are purely advisory, with no direct
access to the data (e.g., control over its collection or analysis) or, in the
case of clinical research, to the trial participants, unless they are in a
position to influence the study's results or have privileged information as to
the outcome.
6. "Sponsored
Programs" means research, public service, training and instructional
projects involving funds, materials, or other compensation from outside sources
under grants, contracts, or cooperative agreements.
7. "Technology" means any process,
method, product, compound, drug, device, or any diagnostic, medical, or
surgical procedure developed using University time, facilities, equipment, or funds
whether intended for commercial use or not.
Example Forms A-E are available online at
http://www.ecu.edu/cs-acad/fsonline/customcf/facultymanual/appendixi/appendixi.htm