PROCEDURES FOR
UNIVERSITY POLICY ON CONFLICTS OF INTEREST AND COMMITMENT 1Q9
Procedures governing the management of Southern Illinois University Edwardsville’s (SIUE’s)
Policy on Conflicts of Interest and Commitment 1Q9 pertaining to projects funded by any
sponsor that requires disclosure of FCOI, which includes all federal agencies, shall be managed
by The Graduate School in accordance with applicable federal regulations. These procedures
may be modified by The Graduate School as necessary to remain compliant with appropriate
rules and regulations with notification of changes sent to the Graduate Council and appropriate
other governing bodies.
Procedures
No activity can be conducted until the SIUE Financial Conflict of Interest (FCOI) Committee
grants approval. The FCOI Committee will be coordinated by the SIUE Graduate School.
Disclosure, Review and Monitoring Requirements
1. The Lead Investigator is responsible for assuring all investigators as defined in the FCOI
Policy have filed appropriate disclosure forms with the Graduate School.
2. An Investigator is responsible for submitting a completed SIUE Financial Conflict of
Interest Disclosure form to the Graduate School to disclose his or her significant
financial interests (SFIs) as well as those of the Investigator’s spouse and dependent
children that are related to the Investigator’s institutional responsibilities and that meet
or exceed the regulatory definition of SFI.
a. Investigators must submit the SIUE FCOI Disclosure form(s) no later than at the
time of application for projects funded by any sponsor that requires disclosure
of FCOI, which includes all federal agencies.
b. If the Investigator plans to work on existing projects funded by any sponsor that
requires disclosure of FCOI, which includes all federal agencies , the Investigator
must submit the SIUE FCOI Disclosure form(s) prior to beginning the work.
c. Disclosure forms must be updated at least annually during the period of the
award.
d. Investigators must file an updated SIUE FCOI Disclosure form within 30 days of
discovering or acquiring a new SFI. An SFI includes any reimbursed or
sponsored investigator travel related to his or her institutional responsibilities.
Reimbursed or sponsored travel includes travel which is paid on behalf of the
investigator but not reimbursed directly to the investigator.
3. The Graduate School’s FCOI Committee will determine whether an Investigator's SFI is
related to the funded project and, if so related, whether the SFI is an FCOI.
a. The FCOI Committee will consist of the members shown below. Members other
than ex officio members will be nominated by their deans and, subject to the
approval of the Associate Provost for Research and Graduate Dean, serve 3-year
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staggered terms. The FCOI Chair will be appointed by the Associate Provost for
Research and Graduate Dean.
i. Associate Dean of the Graduate School as ex officio, non-voting
ii. General Counsel as ex officio, voting
iii. tenured or tenure-track faculty member in the College of Arts and
Sciences (generally from the Department of Biological Sciences)
iv. tenured or tenure-track faculty member in the School of Business
v. tenured or tenure-track faculty member in the School of Dental
Medicine
vi. tenured or tenure-track faculty member in the School of Education
(generally from the Department of Kinesiology or Department of
Psychology)
vii. tenured or tenure-track faculty member in the School of Engineering
viii. tenured or tenure-track faculty member in the School of Pharmacy
ix. tenured or tenure-track faculty member in the School of Nursing
x. member of a university-wide research center (e.g., IERC, IUR, and
NCERC)
b. At the discretion of the Chair of the FCOI Committee, a member may send an
alternate if that member’s FCOI case is being reviewed.
c. All new members will undergo training in the policy and procedures prior to
reviewing disclosures.
4. The FCOI Committee may request additional information from the investigator(s).
5. The FCOI Committee, prior to SIUE’s expenditure of funds, will:
a. review all Investigator SFI disclosures within 60 days of their receipt in the
Graduate School
b. determine if a significant financial conflict of interest exists that could directly
and significantly affect the design, conduct, or reporting of the funded project
c. develop and implement management plans as needed to manage the FCOIs.
Examples of conditions and restrictions include:
 Public disclosure of financial conflicts of interests (e.g., when
presenting or publishing the research; to staff members working on
the project; to Institution’s Institutional Review Board(s);
 For projects involving human subjects research, disclosure of financial
conflicts of interest directly to participants;
 Appointment of an independent monitor capable of taking measures
to protect the design, conduct, and reporting of the project against
bias resulting from the Financial Conflict of Interest;
 Modification of the project plan;
 Change of personnel or personnel responsibilities, or disqualifications
of personnel from participation in all or a portion of the project;
 Reduction or elimination of the financial interest (e.g., sale of an
equity interest); or
 Severance of relationships that create financial conflicts
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6. The FCOI Committee will review disclosures of SFIs, make determination of FCOIs, and
implement a management plan within 60 days whenever an Institution identifies a SFI
that was not disclosed in a timely manner by an Investigator or not previously reviewed
by the Institution.
7. The FCOI Committee will take such actions as necessary to manage FCOIs, including any
financial conflicts of a subrecipient Investigator, if applicable, and monitor Investigator
compliance with management plans until completion of the project.
8. If the employee is dissatisfied with the decision of the FCOI Committee review, he/she
may appeal in writing disputing the recommendation by either stating the disagreement
or by recommending another plan to the Associate Provost for Research, then the
Provost, and then the Chancellor. The decision of the Chancellor will be final.
Reporting Requirements to the Sponsor
1. The Graduate School will report to any sponsor that requires disclosure of FCOI, which
includes all federal agencies, sufficient information to enable the sponsor to understand
the nature and extent of the FCOI and to assess the appropriateness of the Institution’s
management plan. The following key elements along with other pertinent information
will be included in the report:
a.
b.
c.
d.
e.
f.
g.
h.
Project number;
PD/PI or Contact PD/PI if a multiple PD/PI model is used;
Name of the Investigator with the Financial Conflict of Interest;
Name of the entity with which the Investigator has a Financial Conflict of Interest;
Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement,
honorarium);
Value of the financial interest (dollar ranges are permissible: $0-$4,999; $5,000$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of
$20,000; amounts above $100,000 by increments of $50,000), or a statement that
the interest is one whose value cannot be readily determined through reference
to public prices or other reasonable measures of fair market value;
A description of how the financial interest relates to the funded research and why
the Institution determined that the financial interest conflicts with such research;
A description of the key elements of the Institution’s management plan, including:
(A) Role and principal duties of the conflicted Investigator in the research project;
(B) Conditions of the management plan
(C) How the management plan is designed to safeguard objectivity in the research
project;
(D) Confirmation of the Investigator’s agreement to the management plan;
(E) How the management plan will be monitored to ensure Investigator
compliance; and
(F) Other information as needed.
2. The Graduate School will send initial, annual (i.e., ongoing) and revised FCOI reports,
including all reporting elements required by the regulation, to the sponsor for the
Institution and its subrecipients, if applicable, as required by the regulation:
a. prior to the expenditure of funds
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b. within 60 days of identification for an investigator who is newly participating in
the projects
c. within 60 days for new, or newly identified, FCOIs for existing Investigators
d. at least annually (at the same time as when the Institution is required to submit
the annual progress report, multi-year progress report, if applicable, or at time
of extension) to provide the status of the FCOI and any changes to the
management plan, if applicable, until the completion of the project
e. following a retrospective review to update a previously submitted report, if
appropriate.
3. The Graduate School will notify the sponsor promptly if bias is found with the design,
conduct or reporting of the project and will submit a Mitigation Report in accordance
with the regulation.
The policy and/or procedures will include all reporting elements as required by
the regulation.
4. The Graduate School will notify the sponsor promptly if an Investigator fails to comply
with the Institution’s FCOI policy or a FCOI management plan appears to have biased the
design, conduct, or reporting of the project.
Training Requirements
1. The Graduate School will inform Investigators of the SIUE policy, the investigator’s
disclosure responsibilities, and the federal regulations by:
a. maintaining a FCOI website
b. announcing the website and requirements to SIUE faculty and staff via methods
such as e-mail, the New Faculty Orientation, workshops, and personal contact
during assistance in proposal preparation.
2. Each Investigator is required to complete appropriate training, such as through the CITI
Program Financial Conflict of Interest (FCOI) online course, prior to engaging in activities
related to any grant from a sponsor requiring FCOI disclosure.
3. This training is required every 4 years or immediately for supported investigators if:
a. SIUE revises its FCOI policy that affects requirements of investigators
b. the Investigator is new to SIUE
c. the Investigator is not in compliance with the policy or management plan.
4. The Graduate School is responsible for tracking the FCOI training certificates of
completion.
Maintenance of Records
The Graduate School will maintain all FCOI-related records that meet or exceed the regulatory
requirements:
a. for at least 3 years from the date the final expenditures report is submitted to the
relevant sponsor
b. from other dates specified by the sponsor.
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Enforcement Mechanisms and Remedies and Noncompliance
1. Charges of violations of the FCOI policy shall be carefully examined. Charges shall be
processed in the normal reporting channels. Disciplinary sanctions may range from
reprimands to dismissal.
2. The FCOI Committee will document and require a complete retrospective review within
120 days of the Institution’s determination of noncompliance for SFIs not disclosed
timely manner or previously reviewed or whenever an FCOI is not identified or managed
in a timely manner and to document the reviews consistent with the regulation as
follows:
SIUE will document the retrospective review which must include at least the following
key elements:
a.
b.
c.
d.
e.
f.
g.
h.
i.
Project number;
Project title;
PD/PI or contact PD/PI if a multiple PD/PI model is used;
Name of the Investigator with the FCOI;
Name of the entity with which the Investigator has a financial conflict of interest
Reason(s) for the retrospective review;
Detailed methodology used for the retrospective review (e.g., methodology of the
review process, composition of the review panel, documents reviewed, etc.);
Findings of the review; and
Conclusions of the review.
3. The Graduate School will ensure that in any case in which a f clinical research project to
evaluate the safety or effectiveness of a drug, medical device, or treatment has been
designed, conducted, or reported by an Investigator with an FCOI that was not managed
or reported by SIUE as required by the regulation, SIUE shall require the Investigator
involved to:
a. disclose the FCOI in each public presentation of the results of the research
b. request an addendum to previously published presentations.
Subrecipient Requirements
The Graduate School will establish where applicable via a written agreement whether the
subrecipient will follow the FCOI policy of SIUE or the FCOI policy of the subrecipient.
If applicable, SIUE will obtain a certification from the subrecipient that its FCOI policy
complies with the regulation.
b. If applicable, SIUE will include in the written subrecipient agreement a requirement for
the subrecipient to report identified FCOIs for its Investigators in a time frame that
allows SIUE to report identified FCOIs to the sponsor as required.
a.
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c.
Alternatively, if applicable, SIUE will include in the written agreement a requirement to
solicit and review subrecipient Investigator disclosures that enable SIUE to identify,
manage and report identified FCOIs to the sponsor.
Public Accessibility Requirements
1. The Graduate School will post a link to the SIUE FCOI policy on the SIUE website.
2. The Graduate School will make available information concerning identified FCOIs held
by Investigators (as defined by the regulation) publicly accessible prior to the
expenditure of funds. The information will:
a. be made available within 5 calendar days of a written request. (The Institutions’
response must be postmarked or dated ((if replying by electronic means)) within
five business days of the receipt of the written request.
b. include the minimum elements as provided in the regulation:
i. investigator’s name
ii. title and role with respect to the research project
iii. name of the entity in which the SFI is held
iv. nature of the SFI
v. and the approximate dollar value of the SFI or a statement that the
interest is one whose value cannot be readily determined through
reference to public prices or other reasonable measures of fair market
value.
c. be updated annually and within 60 days of a newly identified FCOI
d. remain available for 3 years from the date the information was most recently
updated.
e. A request must be filed under the Freedom of Information Act by contacting the
SIUE Director of Administrative Services, Robert Vanzo.
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