The UNC Policy Manual
300.2.2[G]
Adopted 06/21/12
Various
federal regulations and state laws and policies specifically address conflict
of interest and conflict of commitment of personnel associated with UNC
Constituent Institutions. Several
prominent federal agencies have agency-specific policies regarding Conflict of
Interest, chiefly the Public Health Service (PHS) and the U.S. Department of
Health and Human Services, including the National Institutes of Health, and the
National Science Foundation. Further,
North Carolina General Statute 138A also addresses Conflict of Interest as it
applies to employees of the UNC Constituent Institutions.
The
purpose of these guidelines is to provide a framework for UNC Constituent
Institutions in the development, implementation, publicizing, training,
monitoring and enforcement of implementing institutional policies and
procedures for Conflict of Interest, Conflict of Commitment and External
Professional Activities for Pay. These
guidelines are organized to provide definitions, examples of conflicts of
interest within the context of the UNC Policy on Conflict of Interest and
Commitment (see UNC Policy Manual 300.2.2)
and agency-specific thresholds and requirements.
I. Categories of Potential Financial Conflicts of Interest
Activities
that may involve financial conflicts of interest may be categorized under four
general headings: first, those that are allowable and are disclosed; second,
those that are allowable with administrative approval and are disclosed; third,
those that generally are not allowable and require an approved conflict of
interest management plan; and fourth, those that are not allowable under any
circumstances. The following examples
are merely illustrative and do not purport to include all possible situations
within the four categories:
A.
Activities that are
allowable and are disclosed
The examples cited below involve
activities external to University employment, and thus may present the
appearance of a financial conflict of interest, but have little or no potential
for affecting the objectivity of the Covered Employee’s performance of
Institutional Employment Responsibilities; at most, some such situations could
prompt questions about conflicts of commitment.
1. A Covered Employee receiving royalties from the
publication of books or for the licensure
of patented inventions subject to the UNC Patent and Copyright Policies.
2. A
Covered Employee receiving 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.
B. Activities requiring disclosure for
further administrative review and analysis
The examples cited below suggest
a possibility of conflicting interests that can impair objectivity, but
disclosure and resulting analysis of relationships may render the activity
permissible and may result in the establishment of an approved management plan.
1.
A Covered 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.
2.
A Covered Employee
receiving compensation or gratuities from any individual or entity doing
business with the University. Note that no university employee may seek or
receive any gift, reward, or promise of reward for recommending, influencing,
or attempting to influence the award of a contract by his or her employer (See
G.S. 14-234 and G.S 138A).
3.
A Covered Employee
serving on the board of directors or scientific advisory board of an enterprise
that provides financial support for University research and the employee or a
member of his or her immediate family may receive such financial support.
4.
A covered employee or a
member of his /her immediate family having an equity or ownership interest in a
publicly or non-publicly-traded entity or enterprise.
5.
Covered 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, and with campus Intellectual Property policies.
C. Activities or
relationships that are generally not allowable or permitted unless an
approved Conflict of Interest Management Plan is in place
The examples cited below involve
situations that are not generally permissible, because they involve potential
financial conflicts of interest or they present obvious opportunities or inducements
to favor personal interests over institutional interests. Before
proceeding with such an endeavor, the Covered Employee would have to
demonstrate that in fact his or her objectivity would not be affected and
University interests otherwise would not be damaged and an approved Conflict of
Interest Management Plan is in place.
1.
A Covered Employee
participating in University research involving a technology owned by or
contractually obligated to (by license or an option to license, or otherwise)
an enterprise or entity in which the individual or a member of his or her
immediate family has a consulting relationship, has an equity or ownership
interest, or holds an executive position.
2.
A Covered Employee
participating in University research which is funded by a grant or contract
from an enterprise or entity in which the individual or a member of his or her
immediate family has an equity or ownership interest.
3.
A Covered Employee
assigning students, post-doctoral fellows or other trainees to University
research projects sponsored by an enterprise or entity in which the individual
or a member of his or her immediate family has an equity or ownership interest.
D. Activities
that are not allowable under any circumstances
1. A
Covered Employee making referrals of University business to an external
enterprise in which the individual or a member of his or her immediate family
has a financial interest.
2. A
Covered Employee associating his or her own name with the University in such a
way as to profit financially by trading on the reputation or goodwill of the
University.
3. A
Covered Employee making unauthorized use of privileged information acquired in
connection with one's University responsibilities.
4. A
Covered Employee signing agreements that assign Institution patent and other
intellectual property rights to third parties without prior Institutional
approval.
5. Any
activity otherwise prohibited by law or university policy.
II. Federal and State Regulations
The
following resources are established to provide guidance to UNC Constituent
Institutions in the establishment of implementing policies for the avoidance of
conflicts of interest and conflicts of commitment in the conduct on University
responsibilities including teaching, research and service. The Institution may have more stringent
financial disclosure requirements. Please refer to the Institution’s conflict of
interest policy and confer with the Institution’s designated official(s) to
determine the Institution’s disclosure requirements.
A.
Public Health Service/US Department of
Health and Human Services
The Public
Health Service (PHS) and the U.S. Department of Health and Human Services
issued revised regulations on the “Responsibility
of Applicants for Promoting Objectivity in Research for which PHS Funding is
Sought and Responsible Prospective Contractors” (commonly known
as the Financial Conflict of Interest (FCOI) regulations) on August 25,
2011. These regulations establish new
standards and clarify previously issued standards to be followed by
Institutions that apply for or receive research funding from PHS Awarding
Components, including the National Institutes of Health (NIH), for grants,
cooperative agreements, and research contracts.
The 2011 revised regulations were written to increase accountability,
add transparency, enhance regulatory compliance and effective Institutional
management of Investigator’s financial conflicts of interest, and strengthen
PHS’s compliance oversight. The primary
goal is to promote objectivity by establishing standards that provide a
reasonable expectation that the design, conduct, and reporting of research
funded under PHS grants, cooperative agreements, and research contracts will be
free from bias resulting from Investigator financial conflicts of interest.
Institutions
must maintain an up-to-date written Conflict of Interest policy, must ensure
the policy is enforced and make the policy available via a publically-available
website. The institution must inform investigators
of their responsibilities regarding disclosure of significant financial
interests and the applicable federal regulations.
The full regulatory citation for the
PHS policy is located at the following URL:
http://grants.nih.gov/grants/policy/coi/
1.
Required
Compliance/Implementation Date
An Institution applying for or receiving PHS funding
from a grant or cooperative agreement must be in compliance with all of the
revised regulatory requirements no later than 365 days after publication of the
regulation in the Federal Register, i.e., August 24, 2012, and immediately upon
making the Institution’s Financial Conflict of Interest policy publicly
accessible as described in 42 CFR part 50.604(a). When the Institution posts its Financial
Conflict of Interest policy (or, if the institution does not have a current
presence on a publicly accessible Web site, makes the policy publicly
accessible by written request), it signifies that the Institution applying for
or receiving PHS funding from a grant or cooperative agreement that is covered
by the 2011 revised regulation is in full compliance with all the regulatory
requirements. The Institution must be in
compliance with the 2011 revised regulation no later than August 24, 2012.
2.
Applicability of Revised
FCOI Regulations (Institutions)
The regulation is applicable to each Institution that
is applying for, or that receives, PHS research funding by means of a grant or
cooperative agreement. The revised
regulation will apply to each grant or cooperative agreement with an issue date
of the Notice of Award that is subsequent to the compliance dates of the final
rule (including noncompeting continuations) no later than August 24, 2012 and
immediately upon making its Financial Conflict of Interest policy publicly
accessible. Through their policies, however, Institutions may choose to
apply the revised regulations to all active PHS awards. The regulation
does not apply to Phase I Small Business Innovative Research (SBIR) Small
Business Technology Transfer Research (STTR) applications.
3.
Applicability of Revised
FCOI Regulations (Investigators)
The
regulation is applicable to each investigator, through implementation of the
regulation by the Institution, who is planning to participate in, or is
participating in PHS research funded by means of a grant or cooperative
agreement. The term investigator applies to the individual identified as
the project director or principal investigator and any other person, regardless
of title or position, who is responsible for the design, conduct, or reporting
of research funded by the PHS, or proposed for such funding and may apply to faculty, post-doctoral
fellows and graduate students. For purposes of financial disclosure only, the
regulation covers the Investigator’s spouse and dependent children. The
regulation also applies to those few cases where an individual, rather than an
Institution, is applying for or receives PHS research funding. However, in
those cases, the PHS will make case-by-case determinations on the steps an
Institution or an Investigator must take, consistent with the regulation, to
provide a reasonable expectation that the design, conduct, and reporting of the
research will be free from bias resulting from a Financial Conflict of Interest
of the individual.
4.
Applicability of Revised
FCOI Regulation (Subreceipients)
The revised regulation is applicable to each
Institution that applies for or receives PHS funding for research through
grants or cooperative agreements and, through the implementation of the
regulation by each Institution, to each Investigator planning to participate
in, or participating in, such research. A subrecipient relationship is
established when federal funds flow down from or through an awardee Institution
to another individual or entity and the subrecipient will be conducting a
substantive portion of the PHS-funded research project and is accountable to the
awardee institution for programmatic outcomes and compliance matters.
Accordingly, as a recipient of federal funds from an awardee Institution, the
Financial Conflict of Interest regulation applies to subrecipients (e.g.,
subcontractors or consortium members). See 42 CFR 50.604 (c). The awardee Institution must determine if the
Conflict of Interest policy of the awardee Institution or the Subrecipient will
apply to the Subrecipient’s investigator(s) and incorporate language into the
written agreement that designates the applicable Conflict of Interest policy.
5.
Organizational
Structure/Designated Official
An Institution may administer its policy through
whichever office or structure it chooses as long as the policy is applicable to
all Investigators and the policy meets all requirements of the regulation. Each
institution must designate official(s) to review all financial disclosures by
Investigators and determine whether any Significant Financial Interest is
related to a PHS-funded research and a Financial Conflict of Interests exists
by making a reasonable determination that the Significant Financial Interest
could be affected by the PHS-funded research or is in an entity whose financial
interest could be affected by the research.
6.
Required Training
Institutions are expected to develop and implement
their Financial Conflict of Interest policies during the 365-day implementation
period provided in the 2011 revised regulation. Once the Institution implements and posts
their Financial Conflict of Interest policy as required under the final rule,
Investigators are expected to then complete required training prior to engaging
in PHS-supported research or by the issue date of the Notice of Award issued
subsequent to the Institution’s implementation date. NIH has issued a Conflict of Interest tutorial
that can be incorporated into campus training programs, which can be accessed
from the URL cited at the beginning of section I of the Guidelines. Each Investigator (as defined by the
regulation), including subrecipient Investigator(s), must complete training
prior to engaging in PHS-funded research and at least every four years, and
immediately under specifically designated circumstances:
a.
Institutional Financial
Conflict of Interest policies change in a manner that affects Investigator
requirements
b.
An Investigator is new to
an Institution
c.
An Institution finds that
an Investigator is not in compliance with the Institution’s Financial Conflict
of Interest policy or management plan.
7.
Disclosure
a.
Institutional responsibilities:
1. Under the revised FCOI
regulation, Significant Financial Interests that are subject to
disclosure by an Investigator to an Institution are those that reasonably
appear to be related to the Investigator’s ‘‘Institutional responsibilities,”
as defined by the Institution. As a result, when read in conjunction with the
revised Investigator disclosure requirements under 42 CFR 50.604, the revised
Significant Financial Interest definition results in the disclosure by Investigators
to Institutions of a wider array of interests on a more frequent basis. In
addition to their own, Investigators are required to disclose the Significant
Financial Interests of his/her spouse and dependent children.
b. Monetary
threshold:
1. The
Significant Financial Interest de minimis threshold is $5,000 and, in some
circumstances monetary thresholds for disclosure may be $0.
2. The
definition also differentiates between remuneration to the Investigator (and
the Investigator’s spouse and dependent children) from a publicly traded entity
and remuneration from a non-publicly traded entity. With regard to a publicly traded entity, a
monetary threshold of $5,000 applies to the aggregated amount of any
remuneration received from the entity in the twelve months preceding disclosure
and the value of any equity interest as of the date of disclosure. With regard to a non-publicly traded entity, a
Significant Financial Interest exists if the value of any remuneration received
from the entity in the twelve months preceding the disclosure, when aggregated,
exceeds $5,000, or when the Investigator (or the Investigator’s spouse or
dependent children) holds any
equity interest (e.g., stock, stock option, or other ownership interest).
c. Timing:
1. The
revised Significant Financial Interest definition applies to any remuneration
received from an entity in the twelve months preceding the disclosure. Any
Investigator who is planning to participate in PHS-funded research must
disclose the Investigator’s Significant Financial Interests no later than the
time of application for PHS-funded research.
In addition, each such investigator must submit an updated disclosure or
Significant Financial Interests within thirty days of discovering or acquiring
(such as through purchase, marriage, or inheritance) a new Significant
Financial Interest.
d. Reimbursed
or Sponsored Travel:
1. Investigators
must disclose the occurrence of any reimbursed or sponsored travel (i.e., that
which is paid on behalf of the Investigator and not reimbursed to the
Investigator so that the exact monetary value may not be readily available),
related to the Investigator’s institutional responsibilities. However, the disclosure requirement does not
apply to travel that is reimbursed or sponsored by the following:
a. a federal, state, or local
government agency,
b. an
Institution of higher education as defined at 20 U.S.C. 1001(a),
c. an
academic teaching hospital,
d. a
medical center, or
e. a
research institute that is affiliated with an Institution of higher education.
e. Exclusions:
1. The
revised regulation modifies the types of interests that are specifically
excluded from the Significant Financial Interest definition.
The exclusions are:
a. salary,
royalties, or other remuneration paid by the Institution to the Investigator if
the Investigator is currently employed or otherwise appointed by the
Institution;
b. intellectual
property rights assigned to the Institution and agreements to share in
royalties related to such rights;
c. any
ownership interests in the Institution held by the Investigator, if the
Institution is a commercial or for-profit organization;
d. income
from investment vehicles, such as mutual funds and retirement accounts, as long
as the Investigator does not directly control the investment decisions made in
these vehicles;
e. income
from seminars, lectures, or teaching engagements sponsored by a federal, state,
or local government agency, an Institution of higher education as defined in 20
U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research
institute that is affiliated with an institution of higher education;
f. income
from service on advisory committees or review panels for a federal, state, or
local government agency, or an Institution of higher education as defined at 20
U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research
institute that is affiliated with an institution of higher education.
f. Paid Authorships:
1. Paid authorships are considered
payment for services under the revised regulations and must be disclosed.
8.
Consequences of
Investigator Non-Compliance
a. When
an Investigator fails to comply with the Institution’s Financial Conflict of
Interest policy or the management plan, the Institution shall within 120 days:
1. complete
a retrospective review of the Investigator’s activities and the PHS-funded
research project to determine any bias in the design, conduct or reporting of
research;
2. document
the retrospective review consistent with the regulation; and
3. document
the Institution’s determination as to whether any PHS-funded research, or
portion thereof, conducted during the period of time of the Investigator’s
non-compliance with the Institution’s Financial Conflict of Interest policy or
a Financial Conflict of Interest management plan, was biased in the design,
conduct, or reporting of such research.
4. If
bias is found, the Institution shall notify the PHS promptly and submit a
mitigation report to the PHS that shall address the following:
a. impact
of the bias on the research project, and
b. the
Institution’s plan of action or actions taken to eliminate or mitigate the
effect of the bias.
5. Thereafter,
the Institution shall submit FCOI reports annually, in accordance with the
regulation. Depending on the nature of the Financial Conflict of Interest, an
Institution may determine that additional interim measures are necessary with
regard to the Investigator’s participation in the PHS-funded research project
between the date that the Financial Conflict of Interest is identified and the
completion of the Institution’s independent retrospective review, in accordance
with 42 CFR 50.605(a)(3) and 42 CFR 50.605(b)(3).
9.
Clinical Research to
Evaluate the Safety or Effectiveness of Drug, Medical Device or Treatment
The revised regulations contain special provisions for
Clinical Research. If the HHS determines
that an PHS-funded project of clinical research whose purpose is to evaluate
the safety or effectiveness of a drug, medical device, or treatment has been
designed, conducted, or reported by an Investigator with a conflicting interest
that was not managed or reported by the Institution as required by the
regulation, the Institution must require the Investigator(s) involved to
disclose the Financial Conflict of Interest in each public presentation of the
results of the research and to request an addendum to previously published
presentations. Institution’s Financial Conflict of Interest policy may
have additional requirements.
10. Institutional Reporting of Identified Financial Conflicts
of Interest to PHS
Prior
to the institution’s expenditure of any funds under a PHS-funded research
project, the institution shall provide to the PHS awarding component any
Investigator’s significant financial interest found by the Institution to be
conflicting and ensure that the institution has implemented a management plan
in accordance with the revised regulations. Further, the Institution will
provide annual FCOI reports for the duration of the project period. Any FCOI report required under the revised
regulations shall include, at a minimum, the following information:
a.
PHS-Funded Research
Project Number
b.
Name of the Principal
Investigator
c.
Name of the Investigator
with the financial conflict of interest
d.
Name of the entity with
which the Investigator has a financial conflict of interest
e.
Nature of the financial
interest
f.
Value of the financial
interest, or a statement if the interest is one whose value cannot be readily
determined through to public prices or other reasonable measures of fair market
value
g.
Description of how the
financial interest relates to the PHS-funded research and the basis for the
Institution’s determination that the financial interest conflicts with the
research
h.
Description of key
elements of the Institution’s management plan, including:
1.
Role and principal duties
of the conflicted Investigator in the research project
2.
Conditions of the
management plan
3.
How the management plan is
designed to safeguard objectivity in the research project
4.
Confirmation of the
Investigator’s agreement to the management plan
5.
How the management plan
will be monitored
6.
Other information as
needed
11.
Public Accessibility of
Identified Financial Conflicts of Interest
Prior
to the expenditure of PHS funds on or after August 24, 2012, the institution
must ensure public accessibility (via publically-available
website or response to written request within five (5) business days of the
request) of information concerning significant financial interests disclosed to
the institution that are:
a.
Previously disclosed and
currently held by Investigators or Senior/Key Personnel;
b.
The significant financial
interest is related to PHS-funded research; and
c.
The institution has
determined the significant financial interest is a financial conflict of
interest
The information the Institution must make publically-available must be updated at least annually,
must be maintained for a period of three years from the last update, and must
include the following data elements at a minimum:
1.
Investigator Name
2.
Investigator Title
3.
Investigator role with
respect to the research project
4.
Name of the entity in
which the significant financial interest is held
5.
Nature of the significant
financial interest
6.
Approximate dollar value
of the significant financial interest, or a statement if the interest is one
whose value cannot be readily determined through to public prices or other
reasonable measures of fair market value.
B.
Definitions
See the notice announcing the availability of new
Frequently Asked Questions (FAQs) related to the 2011 revised regulations for a
list of definitions at http://grants.nih.gov/grants/policy/coi/.
Following are some key
definitions:
1.
Senior/Key Personnel means the Project Director/Principal Investigator
(PD/PI) and any other person identified as senior/key personnel by the
Institution in the grant application, progress report, or any other report
submitted to the PHS by the Institution under the regulation.
2. Investigator means the project
director or principal investigator and any other person, regardless of title or
position, who is responsible for the design, conduct, or reporting of research
funded by the PHS (e.g., NIH), or proposed for such funding, which may include,
for example, collaborators or consultants. Institutions should consider
the role, rather than the title, of those involved in research and the degree
of independence with which those individuals work. When the definition of
investigator is limited to titles or designations (e.g., to principal
investigators, key personnel, faculty) the risk increases that an unidentified
FCOI may comprise the research.
3. Institutional
responsibilities are defined by the 2011 revised regulation as an
Investigator’s professional responsibilities on behalf of the Institution, and
as defined by the Institution in its policy on Financial Conflict of Interest,
which may include, for example, activities such as research, research
consultation, teaching, professional practice, Institutional committee
memberships, and service on panels such as Institutional Review Boards or Data
and Safety Monitoring Boards. The Institution can include other professional
responsibilities within the definition, as appropriate.
4. A Financial Conflict of
Interest exists when the Institution, through its designated official(s),
reasonably determines that an Investigator’s Significant Financial Interest is
related to a PHS-funded research project and could directly and significantly
affect the design, conduct or reporting of the PHS-funded research.
5. Significant Financial
Interest is defined as follows:
a. A
financial interest consisting of one or more of the following interests of the
Investigator (and those of the Investigator’s spouse and dependent children)
that reasonably appears to be related to the Investigator’s institutional
responsibilities:
1. With
regard to any publicly traded entity, a significant financial interest exists
if the value of any remuneration received from the entity in the twelve months
preceding the disclosure and the value of any equity interest in the entity as
of the date of disclosure, when aggregated, exceeds $5,000. For purposes
of this definition, remuneration includes salary and any payment for services
not otherwise identified as salary (e.g., consulting fees, honoraria, paid
authorship); equity interest includes any stock, stock option, or other
ownership interest, as determined through reference to public prices or other
reasonable measures of fair market value;
2. With
regard to any non-publicly traded entity, a significant financial interest exists
if the value of any remuneration received from the entity in the twelve months
preceding the disclosure, when aggregated, exceeds $5,000, or when the
Investigator (or the Investigator’s spouse or dependent children) holds any
equity interest (e.g., stock, stock option, or other ownership interest); or
3. Intellectual
property rights and interests (e.g., patents, copyrights), upon receipt of
income related to such rights and interests.
b. Investigators
also must disclose the occurrence of any reimbursed or sponsored travel (i.e.,
that which is paid on behalf of the Investigator and not reimbursed to the
Investigator so that the exact monetary value may not be readily
available). See Section II, A, 6, (4)
above.
c. The
term significant financial interest does not include the following types
of financial interests: salary, royalties, or other remuneration paid by the
Institution to the Investigator if the Investigator is currently employed or
otherwise appointed by the Institution, including intellectual property rights
assigned to the Institution and agreements to share in royalties related to
such rights; any ownership interest in the Institution held by the
Investigator, if the Institution is a commercial or for-profit organization;
income from investment vehicles, such as mutual funds and retirement accounts,
as long as the Investigator does not directly control the investment decisions
made in these vehicles; income from seminars, lectures, or teaching engagements
sponsored by a federal, state, or local government agency, an Institution of
higher education as defined at 20 U.S.C. 1001(a), an academic teaching
hospital, a medical center, or a research institute that is affiliated with an
Institution of higher education; or income from service on advisory committees
or review panels for a federal, state, or local government agency, an
Institution of higher education as defined at 20 U.S.C. 1001(a), an academic
teaching hospital, a medical center, or a research institute that is affiliated
with an Institution of higher education.”
C. National Science
Foundation
The full regulatory citation for the
National Science Foundation is located at the following URL: http://www.nsf.gov/pubs/manuals/gpm05_131/gpm5.jsp#510
1.
NSF requires each grantee institution
employing more than fifty persons to maintain an
appropriate written and enforced policy on conflict of interest. Guidance for
such policies has been issued by university associations and scientific
societies.
2.
An institutional conflict of interest
policy should require that each investigator disclose to a responsible
representative of the institution all significant financial interests of the
investigator (including those of the investigator’s spouse and dependent
children) (i) that would reasonably appear to be
affected by the research or educational activities funded or proposed for
funding by NSF; or (ii) in entities whose financial interests would reasonably
appear to be affected by such activities.
3.
The term “investigator” means the
principal investigator, co-principal investigators, and any other person at the
institution who is responsible for the design, conduct, or reporting of
research or educational activities funded or proposed for funding by NSF.
4.
The term “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 interest (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:
a.
salary, royalties or other
remuneration from the applicant institution;
b.
any ownership interests in the
institution, if the institution is an applicant under the Small Business
Innovation Research Program or Small Business Technology Transfer Program;
c.
income from seminars, lectures, or
teaching engagements sponsored by public or non-profit entities;
d.
income from service on advisory
committees or review panels for public or nonprofit entities;
e.
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 5% ownership interest
in any single entity; or
f.
salary, royalties or other payments
that, when aggregated for the investigator and the investigator’s spouse and
dependent children, are not expected to exceed $10,000 during the twelve month
period.
5.
An institutional policy must ensure
that investigators have provided all required financial disclosures at the time
the proposal is submitted to NSF. It must also require that those financial
disclosures are updated during the period of the award, either on an annual
basis, or as new reportable significant financial interests are obtained.
6.
An institutional policy must designate
one or more persons to review financial disclosures, determine whether a
conflict of interest exists, and determine what conditions or restrictions, if
any, should be imposed by the institution to manage, reduce or eliminate such
conflict of interest. A conflict of interest exists when the reviewer(s)
reasonably determines that a significant financial interest could directly and
significantly affect the design, conduct, or reporting of NSF-funded research
or educational activities.
7.
Examples of conditions or restrictions
that might be imposed to manage, reduce or eliminate conflicts of interest
include, but are not limited to:
a.
public disclosure of significant
financial interests;
b.
monitoring of research by independent
reviewers;
c.
modification of the research plan;
d.
disqualification from participation in
the portion of the NSF-funded research that would be affected by significant
financial interests;
e.
divestiture of significant financial
interests; or
f.
severance of relationships that create
conflicts.
8.
If the reviewer(s) determines that
imposing conditions or restrictions would be either ineffective or inequitable,
and that the potential negative impacts that may arise from a significant
financial interest are outweighed by interests of scientific progress,
technology transfer, or the public health and welfare, then the reviewer(s) may
allow the research to go forward without imposing such conditions or
restrictions.
a.
The institutional policy must include
adequate enforcement mechanisms, and provide for sanctions where appropriate.
b.
The institutional policy must include
arrangements for keeping NSF’s Office of the General Counsel appropriately
informed if the institution finds that it is unable to satisfactorily manage a
conflict of interest.
c.
Institutions must maintain records of
all financial disclosures and of all actions taken to resolve conflicts of
interest for at least three years beyond the termination or completion of the
grant to which they relate, or until the resolution of any NSF action involving
those records, whichever is longer.
D.
North Carolina General Statute 138A “State Government Ethics Act”
The
purpose of the “State Government Ethics Act” is to ensure that elected and
appointed State agency officials exercise their authority honestly and fairly,
free from impropriety, threats, favoritism, and undue influence. To this end,
it is the intent of the General Assembly in this Chapter to ensure that
standards of ethical conduct and standards regarding conflicts of interest are
clearly established for elected and appointed State agency officials, that the
State continually educates these officials on matters of ethical conduct and
conflicts of interest, that potential and actual conflicts of interests are
identified and resolved, and that violations of standards of ethical conduct
and conflicts of interest are investigated and properly addressed. (2006‑201,
s. 1.)
The full general status is located at
the following URL:
http://www.ncga.state.nc.us/enactedlegislation/statutes/html/bychapter/chapter_138a.html
E. North Carolina General Statute 14-234
“Public Officers or Employees Benefiting from Public Contracts”
The purpose of
the Public Officers or Employees Benefiting from Public Contracts statute is to
ensure the making and administering of public contracts is free of bias, in
appropriate influence, conflict of interest and does not result in personal
benefit to the public officer or employee.
The full general status is located at the following URL: http://www.ncga.state.nc.us/EnactedLegislation/Statutes/HTML/BySection/Chapter_14/GS_14-234.html