4 February 2002 Graduate Assembly
22
September 2003 Graduate School Administrative Board, and
29
September 2003 Graduate Assembly
APPENDIX I
EAST
CONTENTS
I. Introduction
II. The Concepts
at Issue Definitions
III. Policies
A.
Conflict
of Interest
A.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 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 Compliance Officer.
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.
J.
"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.
K. "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.
L.
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, appers,
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 comproming, 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 activitives.
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 catorized 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
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
Universityduties 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
(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)
(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)
(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
(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.
a)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).
a)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).
a)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.
a)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.
b)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.
b)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
a)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.
b)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
a)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.
b)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.
b)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
a)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.
b)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
a)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.
b)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.
b)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
a)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.
b)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.
b)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
a)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.
b)d)
Unauthorized
use of privileged information acquired in connection with one's University
responsibilities to further one's own personal interests.
4. Administrative Responsibilities
a)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.
a)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
a)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
comflicts 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
dislosure 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
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
University Compliance Office, 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 and 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
Compliance Office (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
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).
1.2.
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
University Compliance Office, 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 University Compliance
Office 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.
1.3.
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.
1.4.
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, :
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, Office
of Research and Sponsored Programs, 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
(1)(2)
Income from
seminars, lectures, or teaching engagements sponsored by public or nonprofit
entities;
(1)(3)
Income from
service on advisory committees or review panels for public or nonprofit
entities;
(1)(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;
(1)(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.
(1)(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