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Following a federal mandate, The
University of Montana approved and implemented a Conflict
of Interest and Financial Disclosure Policy that follows the
minimum requirements as suggested by the proposed regulations
published in the Federal Register on June 28, 1994 for both the
National Science Foundation and Health & Human Services.
On July 11, 1995 , the final notice
for implementation of this policy was published in the Federal
Register. Working in tandem, both the NSF
and HHS notices have an effective
date of October 1, 1995.
I. Disclosure Requirements
This Policy uses disclosures as
the key mechanism to bring potential conflicts of interest to
light for evaluation and possible oversight. All full-time University
faculty and other employees must annually complete and submit
a Conflict of Interest Disclosure Statement and Certification
(“Disclosure
Form”) either to the UM President or the UM Vice President
of Research and Development, as noted below. Faculty members or
other employees working less than half-time are exempt from submitting
the annual Disclosure Form, but nonetheless are required to comply
with UM conflict of interest policies.
A. Executive Officers and Research
& Development Personnel
UM Executive Officers, as well
as other employees of the Office of Vice President for Research
and Development, the Office of Research and Sponsored Programs,
the Office of Environmental Health and Risk Assessment, and Laboratory
Animal Resources must submit the Disclosure Form directly to the
University President for review and development of a conflict
management plan when necessary. All personnel subject to presidential
review and approval shall be subject to the procedures set forth
herein.
B. UM Faculty and Other Employees
1. Disclosure Forms must be filed
at the beginning of the Fall Semester of each academic year
AND any time a new potential conflict of interest arises.
2. The employee’s signature
on the Disclosure Form certifies that the employee has read
and understands this policy; and that either 1) the employee
does not have a conflict of interest and is in compliance, or
2) that the employee has appropriately disclosed on this form,
any significant financial interest which could create a conflict
of interest, or a potential conflict of interest.
3. The Disclosure Form will
be submitted to the faculty member’s or other employee’s
academic dean or director. The academic deans or directors shall
review the forms and forward them to the Office of Vice President
of Research & Development for review and development of
a conflict management plan when necessary.
4. When making a conflict of
interest disclosure, an employee may, at the employee’s
option, include a proposed conflict management plan. A proposed
conflict management plan shall include the name and position
of the person responsible for plan oversight. The Vice President
for Research & Development’s Research Compliance Officer
shall be available to consult with any employee to help develop
an acceptable management plan.
5. Questions concerning activities
specified in UM Conflict of Interest Policy that raise the possibility
of a conflict of interest should be submitted to Claudia D.
Denker, UM Associate Legal Counsel /Research Compliance Officer,
ext. 4755.
C. Principal Investigators of Sponsored
Research
Before submitting a proposal for
funding, an investigator shall make any real or potential conflict
of interest known to UM by submitting a Disclosure Form to the
Office of Research and Sponsored Programs along with the Checklist
for Proposal Approval. A separate Disclosure Form as described
in this section is required for each activity that may create
an actual or apparent conflict of interest.
II. Review by President
or Vice President of Research & Development
A. The President or Vice President
for Research & Development shall review each Disclosure Form
to determine if a real or potential conflict of interest exists.
B. If the President or Vice President
determines that a conflict of interest exists, the President or
Vice President shall determine if any restrictions should be imposed
on the faculty member or other employee in order to manage, reduce,
or eliminate the conflict of interest. These conditions and restrictions
should be described in a Conflict Management Plan.
C. Examples of conditions or restrictions
that might be imposed to manage, reduce or eliminate actual or
potential conflicts of interest include but are not limited to:
1. public disclosure of significant
financial interests;
2. monitoring of research by
independent reviewers;
3. modification of the research,
educational, or public service activities plan;
4. disqualification from participation
in all or a portion of the research;
5. divestiture of significant
financial interests; or,
6. severance of relationships
that create potential conflicts of interest
D. The President or Vice President
of Research may waive the disclosed conflict and authorize the
investigator to proceed with the sponsored activity without a
Conflict Management Plan if the President or Vice President concludes
in writing that:
1. The conflict of interest is
so remote that there is no probability for bias in the overall
conduct of the sponsored activity, or
2. Any resolution of the conflicts
other than by disclosure and waiver would be ineffective or
inequitable, or
3. Any bias reasonably expected
is outweighed by the interests of scientific progress, technology
transfer or the public health or welfare.
III. Appeal/reconsideration
process
A. If an employee believes the
conditions or restrictions are inappropriate, the faculty member
or other employee may appeal or ask for the decision to be reconsidered.
The President or Vice President for Research will then refer the
appeal to a Conflicts of Interest Review Committee (CIRC) (see
Section VI below for membership and guidelines) to have the activity
reconsidered.
B. Upon completion of the review,
the President or Vice President for Research will consider the
CIRC recommendation(s), if any.
C. If an employee believes that
there exists cause for further review, the employee may appeal
to the UM President, who shall make the final campus decision
on appeal.
D. An employee who disagrees with
the President’s decision may appeal to the Montana Commissioner
of Higher Education and exercise any applicable rights permitted
by Article 19 of the UM University Faculty Association Collective
Bargaining Agreement or the Regents appeal policy and procedure.
No award will be accepted by UM while any appeal is pending.
IV. Reporting and Record
Retention
A. The President or Vice President
for Research will report to external sponsoring agencies as required
by the agencies 1) the existence of any conflict of interest found
by UM; and 2) actions taken to manage, reduce, or eliminate the
conflict.
B. The Vice President for Research
will maintain records of all Checklist for Proposal Approval forms,
Disclosure Forms, and all actions taken by UM, on an award-by-award
basis, for at least three (3) years beyond the termination of
the award or until resolution of any action by UM or governmental
agencies involving the records. All records will be maintained
in a manner to protect sensitive and confidential information
consistent with state and federal law.
C. To the extent required by law
or requested by the sponsor, the President or Vice President for
Research will also inform the Office of UM Legal Counsel of any
external sponsor of UM research activity whenever UM finds itself
unable to manage and satisfactorily resolve any conflict of interest
related to the sponsor’s UM activities.
V. Compliance
A. UM expects all employees to
comply fully and promptly with all requirements of this policy.
Breaches of this policy include, but are not limited to, intentionally
filing an incomplete, erroneous, or misleading Disclosure Form,
failing to provide additional information as required, or failure
to provide a Disclosure Form to the Vice President for Research
as required.
B. A violation of this policy may
be the basis for discipline of a faculty member or other employee.
If sanctions are necessary, they will be imposed in accordance
with applicable MUS policies and the UM University Faculty Association
Collective Bargaining provisions.
C. The potential sanctions may
include, but are not limited to, the following:
1. Letter of admonition;
2. Ineligibility of employee
to submit grant applications;
3. Withholding Institutional
Review Board (IRB) or Institutional Animal Care and Use Committee
(IACUC) approval, or supervision of graduate students;
4. Suspension;
5. Non-renewal of probationary
appointment;
6. Termination
VI. Conflict of Interest
Review Committees (CIRCs)
A. Formation and Membership
1. The President or Vice President
for Research will determine whether a CIRC should be organized
to assist in reviewing (or upon appeal by the employee) the
potential for conflicts of interest regarding research and gifts.
2. In consultation with Faculty
Senate and appropriate deans and other administrators, the President
or Vice President for Research will be responsible for appointing
committee members to one or more CIRCs.
3. A CIRC may be organized by
school (multiple departments) or for a particular department
if the number of such cases or their nature justifies a separate
committee.
4. Three-quarters of the voting
membership of each CIRC will be faculty member or other employees
from the area or department(s) to be served. The remaining one-quarter
of the voting members will include faculty from outside the
department(s).
5. At least one of the members
should be an individual who has participated or is currently
participating in approved external relationships.
6. Each CIRC will also include
non-voting representation by the Director of the Office of Technology
Transfer.
B. Guidelines
1. The principal objective for
the CIRC is to help guard UM employees and UM from engaging
in activities where the risk to integrity and reputation as
a result of an external relationship outweighs the value of
the activity to academic and societal goals.
2. Relevant factors to consider
are the nature of the financial interest, where and when the
relationship commenced, whether the conditions of the relationship
have changed during the past year, the likelihood of a conflict
of interest (will the results of the activity likely affect
or be affected by the significant financial or other interests),
mechanisms to ensure integrity (peer review, other independent
research sites, and independent monitors and controls), the
importance of the proposed activity, and the availability of
alternatives to avoid the conflict of interest.
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