UNIVERSITY OF MAINE
Policies
and Procedures
for
Financial Disclosures and Conflicts of Interest
in Extramurally Sponsored Activities
University of Maine
Office of Research and Sponsored Programs
Corbett Hall
Orono, ME 04469-5717
581-1498
Approved 8/95: Frederick E. Hutchinson, President
TABLE
OF CONTENTS
Declaration
of Policy
Applicability
Definitions
Obligation to Disclose Financial Interests
Financial Disclosure Statements
Review of Disclosures
Time Schedule
Reconsideration of Conflict Resolution Plans
Further Administrative Approval
Certification of Compliance
Updating Financial Disclosures
Record Keeping
Enforcement
Reporting
Appendix I: Significant Financial Interest Disclosure
Form and Policy Summary
Policies
and Procedures
for
Financial Disclosures and Conflicts of Interest
in Extramurally Sponsored Activities
Declaration of Policy:
To ensure continued confidence of the people
of Maine in the University, personnel engaged in extramurally funded work shall
act at all times in a manner consistent with their public responsibilities to
the University and shall exercise particular care that no detriment to the
University results from conflicts between their personal financial interests
and the interests of the University. Such conflicts can threaten -- or seem to
threaten -- the integrity of educational programs and research agendas, the
free dissemination of scholarship, and the appropriate use of public resources
for public benefit. Accordingly, investigators shall disclose all significant
financial interests they may have in extramurally funded work, and shall adhere
to any conditions or restrictions imposed by the University to manage,
eliminate, or reduce conflicts relating to those interests.
This policy outlines the obligations of
University personnel to disclose significant financial interests and the
responsibility of the University to review such information and take
appropriate steps to manage, reduce, or eliminate related conflicts. Certain
financial interests are inherent in the incentive structure of the academic enterprise.
Such incentives are not inherently bad and are indeed motivating forces for
diligence in research. It is not the intent of this policy to require
disclosure of interests in any indefinite prospective financial rewards
associated with career advancement. Nor is it the intent of this policy to
prohibit all extramurally sponsored activities in which investigators hold a
more easily defined significant financial interest; however, it is required
that these interests be disclosed and that the project be conducted in such a
way that such interests do not compromise, or appear to compromise, an
investigator's professional judgment in conducting projects or reporting
results.
Applicability:
This policy and the requirement for financial
disclosure take effect on October 1, 1995 and apply to all University employees
and students who serve as investigators in proposals submitted to external
sponsors on or after this date. Collaborators for other institutions must
either comply with this policy or provide certification that their institutions
are in compliance with Federal policies regarding disclosure of significant
financial interests and that their portion of the project is in compliance with
their institutional policies.
Definitions:
A Conflict of Interest is a divergence between an individual's private interests and his or her professional obligations to the University such that an independent observer might reasonably question whether the individual's professional actions or decisions are determined by considerations of personal gain, financial or otherwise.
Investigator refers to those individuals responsible for the
design, conduct, and reporting of activities funded or proposed for funding by
an external sponsor. This would normally include all individuals listed as
Principal Investigator/Project Director, Co-Investigator/Co-Director, and
others so responsible who are not supervised by any of the above.
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 ownership
interests); and intellectual property rights (e.g., patents, copyrights, and
royalties from such rights).
Specifically excluded
from the definition of Significant Financial Interest are:
1. Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities.`
2.
Income from service on advisory committees or review panels for public or
nonprofit entities.
3.
Investments in mutual funds or retirement programs if the investigator has no
practical control over the management of those investments.
4.
Royalties paid by the University.
5.
Regular salary, summer salary, or overload compensation paid by the University
when the rate of compensation is set by the University. (Note:
consulting fees or other forms of overload compensation paid by the University
at rates other than that established by the University are not necessarily
excluded from the definition of significant financial interest. See item 7.
below.)
6.
An equity interest that, when aggregated for the investigator and the
investigator's spouse and dependent children, satisfies both the following
conditions: (a) does not exceed $10,000 in value as determined through
reference to public prices or other measures of fair market value, and (b) does
not represents more than a 5% ownership interest in any single entity.
7.
Salary, consulting fees, royalties or other payments that, when aggregated for
the investigator and the investigator's spouse and dependent children over the
past twelve months have not exceeded $10,000, and over the next twelve months
are not expected to exceed $10,000.
Obligation to Disclose Financial
Interests:
Each University employee and student who
serves as an investigator in proposals submitted to
external sponsors must disclose for himself or herself, and for his or her
spouse and dependent children--
(a) all significant financial interests that would reasonably appear to be affected by the activities funded or proposed for funding, and
(b)
all significant financial interests in entities whose
financial position would reasonably appear to be affected by activities funded
or proposed for funding.
Regardless of the above minimum requirement,
an investigator in his or her own best interests may choose to disclose other
financial or related interests that could present, or be perceived to present,
a conflict of interest. Also, it is not possible to specify all the possible
personal relationships or business arrangements which might result in
significant financial interests for University personnel engaged in
extramurally sponsored activities. In filing a Financial Disclosure Statement,
however, University personnel are expected to follow the spirit of the policy
and disclose other financial interests that might be anticipated to threaten
the same harm. For example, the financial interests of a parent, a sibling, an
independent child, an unmarried domestic partner, or a close associate may be
perceived as grounds for the same kind of conflict of interest, and should be
reported if known. Similarly, the promise of future gifts, or the offer of a
loan on advantageous terms not available to the general public might represent
a disclosable significant financial interest.
Financial Disclosure Statements:
Each investigator shall specify on the
internal Proposal Transmittal Form ("Green Sheet") whether he or she
has a significant financial interest relating to the proposed activity. Each
investigator having such an interest shall also complete a Significant
Financial Interest Disclosure Form, and submit it along with the proposal and
Green Sheet to the Office of Research and Sponsored Programs following normal University
procedures. Supporting documentation that specifies all business enterprises or
entities involved and the nature and amount of each interest should be
submitted in a sealed envelope marked confidential and should accompany the
Disclosure Form and the Green Sheet. At the investigator's option, the
supporting documentation may also include a proposed Conflict of Interest
Resolution Plan.
All required financial disclosures must be on
file in the Office of Research and Sponsored Programs prior to the submission
of any proposal to an external sponsor.
Review of Disclosures:
A standing Financial Disclosure Review Committee (FDRC) shall be responsible for (a) reviewing financial disclosures, (b) developing or approving plans to manage, reduce, or eliminate conflicts of interest, and (c) educating the campus community about this policy. The Committee shall be comprised of the Vice President for Research (Chair), the Director of Research and Sponsored Programs (Secretary), the campus Patent and Licensing Officer, the Chair of the Research and Public Service Committee of the Faculty Senate, and one tenured faculty member from each College, appointed by their respective Deans to staggered three-year terms.
The Vice President for Research, in
consultation with the Director of Research and Sponsored Programs and the
campus Patent and Licensing Officer, shall conduct an initial review of all
financial disclosures to determine whether a conflict of interest exists. A
conflict of interest exists if a reasonable determination can be made that a
significant financial interest could directly and significantly affect the
design, schedule, conduct or reporting of the activities proposed for funding.
If the initial determination is made that there is a conflict of interest
covered by this policy, then the disclosure packet will be referred to the
FDRC.
Prior to consideration by the FDRC, the
investigator, in cooperation with the investigator's academic department or
unit, shall develop and submit to the FDRC a Conflict Resolution Plan that
details proposed steps that will be taken to manage, reduce, or eliminate any
conflict of interest presented by the investigator's financial interests.
The Chair will appoint a subcommittee of the
FDRC to review and act on each Conflict Resolution Plan. Normally a
subcommittee will be comprised of seven members; the four ex-officio members of
the Committee plus three tenured faculty members appointed by the Chair. In the
event members of the subcommittee are unable to serve in a timely manner, or
have a relationship to the individual making the disclosure which represents a
potential conflict of interest, or if in the judgment of the Chair, other
circumstances warrant restructuring the subcommittee, the Chair may appoint an
alternative subcommittee of no fewer than five members to act on behalf of the
full Committee.
The subcommittee shall review the Conflict
Resolution Plan and approve it, disapprove it, or require modifications,
conditions, or restrictions. Such conditions or restrictions may include,
without limitation: (a) public disclosure of significant financial interests,
(b) monitoring of the funded activities by independent reviewers, (c)
modification of the planned activities (which may be subject to sponsor
approval), (d) disqualification from participation in all or a portion of the
project, (e) divestiture of significant financial interests, or (f) severance
of relationships that create conflicts.
The subcommittee may, at its discretion,
invite individuals with special expertise, including legal counsel, to assist
the members in reviewing and resolving complex issues. These individuals may
not vote with the subcommittee. A subcommittee may also, at its discretion,
invite the person whose disclosure statement is under review to attend
meetings, participate in discussions, and/or provide supplementary or
clarifying information.
The subcommittee may designate an individual
or individuals responsible for monitoring compliance with its Conflict
Resolution Plans. When this option is exercised, the subcommittee shall also
specify the type and frequency of reporting required.
If the subcommittee 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, the subcommittee may allow the
research to go forward without imposing conditions or restrictions.
Time Schedule:
The Vice President for Research shall normally decide within ten (10) days whether a potential conflict of interest exists. If so, the investigator will be asked to prepare a proposed Conflict Resolution Plan, and the Financial Disclosure Review Subcommittee shall normally act on that plan within thirty (30) days of its receipt. The subcommittee may decide to extend the review period by up to an additional thirty (30) days when such a delay is warranted by the complexity of the circumstances.
Whereas investigators must disclose
significant financial interests before a proposal is submitted to an external
sponsor, the Conflict Resolution Plan, if any, does not need to be finalized
until just prior to acceptance of the award. The time duration between the
submission of a proposal and the offer of an award varies greatly, from a few
days in some instances to more than a year in others, and of course not all
proposals result in an award. In view of these circumstances, the principal
investigator or project director may request that the review of all disclosures
relating to the subject proposal be deferred until such time as an award is
offered. In that event, the time schedule outlined above will still apply; only
the starting point is delayed. If a delayed review is requested and the
proposal is not selected for funding, the sealed envelope(s) containing
confidential information about financial interests will be returned unopened.
Reconsideration of Conflict
Resolution Plans:
Final responsibility for the review of financial disclosures and approval of a Conflict Resolution Plan is vested with a Financial Disclosure Review Subcommittee. In the event that the resolution plan specified by the subcommittee is unacceptable to the investigator whose interests have been disclosed, he or she may request reconsideration, and may meet with the subcommittee to explain why the plan is unacceptable and to propose changes. The request for reconsideration shall be in writing and shall be submitted to the subcommittee via the Director of ORSP. Upon receipt of such a request, the subcommittee shall have thirty (30) days in which to consider changes proposed, or other modifications deemed appropriate, and to issue its final resolution plan.
There are no further provisions for
reconsideration or appeal within this policy. If the subcommittee's
requirements remain unacceptable to the Principal Investigator or Project
Director of a proposed project, the University shall decline the award. If the
subcommittee's requirements are unacceptable to another of the project's
investigators, the University shall seek sponsor approval to replace that
investigator.
Further Administrative Approval:
Conflict Resolution Plans approved by a Financial Disclosure Review Subcommittee may be disapproved, or approved with additional terms and conditions, by the President or by any other University officer designated by the President. However, no officer of the University may approve a Conflict Resolution Plan which does not include as a minimum all terms and conditions approved by the subcommittee.
Certification of Compliance:
Each person judged to have a conflict of interest must sign an agreement certifying that he or she will adhere to all conditions or restrictions imposed by the subcommittee and will cooperate fully with any individual(s) assigned responsibility for monitoring compliance. The University will not accept an award until the Director of Research and Sponsored Programs has received signed Certifications of Compliance for all project personnel judged to have a conflict of interest.
Updating Financial Disclosures:
Investigators are responsible for updating information on new reportable significant financial interests such that accurate and current information is on file with the University at all times. New reportable significant financial interests include financial interests that become reportable due to an increase in value that meets the reporting threshold, as well as the acquisition of new interests that are reportable. Updated financial disclosures must be submitted to the Director of Research and Sponsored Programs within fifteen (15) days of the reportability of such interests, either during the period of a funded project or during the period while a decision on a proposal is pending.
If an updated disclosure statement is
received by the University during the period of an ongoing project, the Vice
President for Research shall review the updated information within ten (10)
days of its receipt and decide whether it causes a conflict not already
satisfactorily managed, reduced, or eliminated. If it is so decided, the
investigator shall have ten (10) days to prepare and submit a new or revised
Conflict Resolution Plan, and a Financial Disclosure Review Subcommittee shall
have an additional thirty (30) days to act on it. The person making the updated
disclosure shall then have ten (10) days to (a) sign a certification to abide
by any new conditions or restrictions imposed by the subcommittee, (b) seek
reconsideration by the subcommittee, or (c) terminate participation in the
funded project.
If an updated disclosure statement is
received by the University while a decision on a proposal is pending, the
University shall defer acceptance of the related award until the Vice President
for Research, and if necessary, a Financial Disclosure Review Subcommittee has
reviewed and acted on the updated information and the investigator has
certified compliance with any new terms or conditions.
Individuals not listed as investigators in
proposals, but who later assume such roles through hiring, promotion or other
means, shall submit a Financial Disclosure Statement before beginning work on
the project as an investigator:
(a) If the individual (including the individual's spouse and dependent children) has no significant financial interests related to the project, work may begin immediately upon submitting written certification of that fact to the Director of Research and Sponsored Programs.
(b)
If significant financial interests exist, the individual shall delay work on
the project until the financial information is acted upon, and he or she has
certified compliance with the Conflict Resolution Plan, if any, as above.
Record Keeping:
Financial disclosures, and updates thereof,
shall be submitted to the Director of the Office of Research and Sponsored
Programs who shall be responsible for keeping records of all disclosures and
associated actions. No proposal may be submitted to an external sponsor on
behalf of the University until the Director or his designee has received all
Financial Disclosure Statements related to that proposal.
The Director of Research and Sponsored
Programs shall maintain all records of disclosures and related actions for a
minimum of three (3) years after the later of the termination or completion of
the corresponding funded project, or the resolution of any audit or legal
action involving the records.
Enforcement:
Whenever an investigator has violated this
policy or the terms of an approved Conflict Resolution Plan, the FDRC shall
recommend sanctions which may include disciplinary action ranging from a letter
of reprimand to termination of employment. If the violation results in a
collateral proceeding under the University policy for misconduct in research
and other scholarly activities, the FDRC shall defer its recommendation until
that collateral proceeding is completed. The FDRC shall present its
recommendations to the President who shall decide on sanctions and their
implementation.
Reporting:
The Financial Disclosure Review Committee
reports its actions to the President. The Director of Research and Sponsored
Programs will also report the existence of conflicting interests, financial disclosures,
and/or related Conflict Resolution Plans to the sponsor of the relevant
project, if (a) such reporting is required by the pertinent program regulations
or guidelines, (b) the University finds that it is unable to manage, reduce, or
eliminate a conflict of interest, or (c) the failure of an investigator to
comply with this policy has biased the design, conduct, or reporting of the
research. In the last case, report will also be made of corrective action taken
or to be taken.
APPENDIX
I:
Significant
Financial Interest Disclosure Form
and
Policy Summary
Investigator Financial Disclosure Policy
(Applicable to all Sponsored Project Proposals)
What is required?
Federal regulations require institutions to
have policies and procedures in place that ensure that Investigators disclose
any significant financial interest that may present a conflict of interest in
relationship to externally sponsored projects. Such disclosures must be made
prior to the submission of a proposal for funding,* and institutions must
develop specific mechanisms by which conflicts of interest will be
satisfactorily managed, reduced, or eliminated prior to award or acceptance of
an award.
* If a new reportable significant conflict of interest arises at any time during the period after the submission of the proposal through the period of the award, the filing of a disclosure is also required.
Who is covered?
"Investigator" means the principal
investigator/project director, co-principal investigators, and any other person
at the University who is responsible for the design, conduct, or reporting of
research, educational, or service activities funded, or proposed for funding,
by an external sponsor. In this context, the term "Investigator"
includes the investigator's spouse and dependent children.
What must be disclosed?
Each investigator shall disclose all significant
financial interests:
(1) that would reasonably appear to be
affected by the research, educational, or service activities funded, or
proposed for funding, by an external sponsor;
(2) in entities whose financial interests would reasonably appear to be
affected by such activities.
What is covered?
"Significant financial
interests" 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, and royalties from such rights). The term does
not include
(1) Income from seminars, lectures, or
teaching engagements sponsored by public or nonprofit entities.
(2) Income from service on advisory committees or review panels for public or
nonprofit entities.
(3) Investments in mutual funds or retirement programs if the investigator has
no practical control over management of those investments.
(4) Royalties paid by the University.
(5) Regular salary, summer salary, or overload compensation paid by the
University at rates set by the University.
(6) 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,
or, constitute more than a five percent ownership interest in any single
entity.
(7) Salary, consulting fees, royalties, or other payments that when aggregated
for the Investigator and the Investigator's spouse and dependent children over
the past twelve months have not exceeded $10,000, and over the next twelve
months are not expected to exceed $10,000.
Disclosure Procedures:
(1) All Investigators must disclose their
significant financial interests utilizing this form and attaching all required
supporting documentation. The completed form and packet must be submitted with
the proposal and Proposal Transmittal Form ("Green Sheet") to the
Office of Research and Sponsored Programs. Supporting documents should be
submitted in a sealed envelope marked Confidential.
(2) In accordance with Federal regulations, a complete disclosure must be made
by investigator(s) prior to submission of the proposal.
(3) Steps to manage or eliminate conflicts of interest will be incorporated in
a Conflict Resolution Plan approved by the Financial Disclosure Review
Committee. Each Investigator must certify that he or she will adhere to all
terms and conditions of a Conflict Resolution Plan prior to the University's
acceptance of an award.
These forms are available in the Office of Research and Sponsored Programs, Corbett Hall, 581-1498.
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