UNIVERSITY OF SOUTH FLORIDA
Policies and Procedures Manual
|
|
Subject of Policy Statement |
Effective Date |
Policy Number |
Conflicts
of Interest
|
New 8/30/96
|
0-309
|
I. INTRODUCTION (Purpose and Intent)
Federal regulations
require institutions to have in place policies and procedures that ensure
objectivity in research by requiring that investigators on federally-sponsored
research projects disclose any significant financial interests that may present
actual or potential conflicts of interest.
In addition, state
law provides that no employee of a state agency (including a state university)
“shall have any interest, financial or otherwise, direct or indirect; engage in
any business transaction or professional activity; or incur any obligation of
any nature which is in substantial conflict with the proper discharge of his or
her duties in the public interest.” §112.311,
The purpose of this
policy is to establish a process that will meet the requirements of state and
federal law for the disclosure and management of actual and apparent conflicts
of interest between investigators' sponsored research obligations and private
financial interests. This policy applies to all sponsored research conducted or
administered by the
II. STATEMENT OF POLICY
A
University employee who is responsible for the design, conduct, or reporting of
a sponsored research project under the auspices of the University must disclose
financial or other interests that are, or may be perceived to be, related to
the project. Existing or potential
conflicts of interest must be disclosed prior to the submission of a proposal
for funding. Actual or potential conflicts
of interest that develop during the conduct of a funded project must be
disclosed as soon as the conflicts occur.
If the University determines that such interests may affect the design,
conduct, or reporting of the project, steps will be taken to manage or
eliminate the conflict.
III. DEFINITIONS
Conflicts of
Interest Administrator (COI
Administrator) means the
administrative official responsible for:
initial review of Financial Interests Disclosure Forms; determination of
the existence of a conflict of interest requiring review by the Conflict of
Interest in Research Committee (CoIRC); preparation (if necessary) and
subsequent presentation to the CoIRC of a conflict of interest management plan
or other recommendation for resolution; and communication with the investigator
regarding the conflict of interest review process as described in this policy.
Conflict of
Interest in Research Committee (CoIRC) refers to the
committee within the Research Office that reviews conflicts of interests
relating to specific sponsored research proposals not involving human subjects
that are submitted to the Division of Research Grants
(DRG) pursuant to this policy.
The CoIRC is comprised of two representatives of the Research Council,
two representatives of the Graduate Council, the Director of the DRG or
designee, the COI Administrator (Chair), and an attorney from the Office of the
General Counsel.
Financial Interests Disclosure
Form refers to the “Financial
Relationships Disclosure Form for Individual Sponsored Research Proposal” available
through the DRG and on the USF Research Office web page at http://www.research.usf.edu/sr/FinancialRelationshipReportingForm.
HSC-Affiliated Individual means all
Interests means
anything of monetary value, including, but not limited to: salary or other payments for services;
consulting fees; honoraria; reimbursement of expenses; royalty payments;
dividends, or any other payments or consideration; equity interests (e.g.,
stocks, stock options, or other ownership interests); intellectual property
rights (e.g., patents, copyrights and royalties from such rights, trademarks,
and trade secrets); a position as director, officer, partner, trustee, or
member of board of directors; and other related interests or activities of the
investigator (and the investigator’s spouse and dependent children) that
possibly could affect, or be perceived to affect, the results of the research
or educational activities funded or proposed for funding. The investigator's interests are related to a
research project if the work to be performed on the project, or the results of
such work, can be expected to have an impact on the investigator's interests.
Exclusions
● Income received as salary or other remuneration from the
University.
● Income from seminars, lectures, or teaching engagements
sponsored by
public or nonprofit entities.
● Income from service on advisory committees or review panels for
public
or nonprofit entities.
● Stocks held in a
diversified mutual fund; or stocks that, when aggregated for
the investigator and investigator’s spouse and
dependent children,
do not exceed $10,000 in value and do
not represent more than a 5%
ownership interest in any single
entity.
Investigator means the principal investigator and any other
person at the University who is responsible for the design, conduct, or
reporting of the research.
Responsible Institutional Official for Health Sciences means the person within
the Health Sciences Center (HSC) who is responsible for overseeing the process
of review of Financial Interests Disclosure Forms of HSC-affiliated individuals
and for research projects involving human subjects pursuant to the HSC Policy on Conflict
Commitment and Conflict of Interest.
IV. DISCLOSURE REQUIREMENTS
Initial Submission of Research
Proposals. An investigator submitting a sponsored research
proposal to the DRG must complete the Conflict of Interest Certification
included in the Proposal Review and Certification Form (http://www.research.usf.edu/sr/InternalForm.doc). If the investigator has any interests to disclose, a Financial
Interests Disclosure Form (http://www.research.usf.edu/sr/FinancialRelationshipReportingForm)
must be completed, signed by the investigator’s supervisor or program leader,
and submitted to the DRG along with the research proposal. If the investigator is participating in
research supported by the National Institutes of Health (NIH) or National
Science Foundation (NSF), the investigator must complete the Financial
Interests Disclosure Form regardless of whether the investigator has any
interests to disclose.
Annual
Updates/Change in Status of Interests. During the course of their research, investigators
must provide updates on the status of their interests, annually or within sixty
(60) days of when new interests are acquired, by filing a new Financial
Interests Disclosure Form with the DRG for each sponsored research
project. Investigators who have
completed the Financial Interest Disclosure Form because the investigator is
participating in research supported by NIH or NSF must complete the Financial
Interest Disclosure Form annually regardless of whether the investigator has
any interests to disclose.
V. PROCESS
for REVIEW of FINANCIAL INTERESTS DISCLOSURES
Submission of Financial Interests Disclosure Form
to Supervisor. If the investigator has interests to disclose, the
investigator must submit a completed Financial Interests Disclosure Form to the
investigator’s supervisor or program leader (e.g., Department Chair) for review
and signature. (Investigators who must
complete a Financial Interest Disclosure Form only because the investigator is participating in an NIH or NSF
study do not need to obtain the signature of the supervisor or program leader
if the investigator has no interests to disclose.)
Submission of Financial Interests Disclosure Form
to DRG. Upon
obtaining the signature of the supervisor or program leader, the investigator
must submit the completed Financial Interests Disclosure Form to the DRG along
with the sponsored research proposal.
Investigators who have no interests to declare must complete the
Conflict of Interest Certification in the Proposal Review and Certification
Form but are not required to complete a Financial
Interests Disclosure Form.
DRG Distribution of Financial Interests Disclosure
Form. Financial
Interests Disclosure Forms for research projects involving human subjects or
submitted by HSC-Affiliated Individuals will be forwarded by DRG to the Responsible
Institutional Official for Health Sciences for review and final handling
pursuant to the HSC Policy on Conflict Commitment and Conflict of Interest. Financial
Interests Disclosure Forms submitted by investigators other than HSC-Affiliated
individuals, for research not involving human subjects, will be forwarded to
the COI Administrator for review.
COI Administrator Review of Financial Interests Disclosure Form.
The COI Administrator will review Financial Interests Disclosure Forms
forwarded by the DRG to determine, in consultation with the investigator if
necessary, whether the interests disclosed present a conflict of interest with
the investigator’s sponsored research proposal.
If the COI Administrator determines that no conflict of interest exists,
the COI Administrator will notify the DRG and return the Financial Interests
Disclosure Form to the DRG with the COI Administrator’s signature on the
internal tracking form. If the COI
Administrator determines that a conflict of interest exists, the COI
Administrator, in consultation with the investigator, will prepare a management
plan or a recommendation for other resolution to be presented at the next
meeting of the CoIRC.
CoIRC Meetings and Review of Conflict of Interest. The CoIRC will meet at intervals to be
determined by the COI Administrator based upon the volume of research proposals
received by the COI Administrator. At
each meeting of the CoIRC, the COI Administrator will present the management
plan or recommendation for resolution for each sponsored research proposal for
discussion and action by the CoIRC. The
CoIRC may provide for expedited review and approval of management plans or
recommendations for resolution by the COI Administrator under certain
conditions to be established by the CoIRC pursuant to CoIRC operating policies
and procedures.
Action by the CoIRC. When an
investigator has interests that would reasonably appear to be directly or
significantly affected by the research proposed for funding, the CoIRC has the
authority to rule that the project may not proceed. In situations where there is uncertainty about
the extent of a conflict of interest, conditions or restrictions such as the
following may be imposed:
1) Public disclosure of interests
2) Monitoring of the project by independent reviewers
3) Modification of the research or project plan
4) Disqualification from participation in all or a portion of
the
project
5) Divestiture of interests
6) Severance of relationships that create actual or potential
conflicts.
Notification to Investigator. The COI Administrator will notify the
investigator, in writing, of the actions taken by the CoIRC. The actions of the CoIRC are not
appealable.
Notification to DRG of Resolution. The COI Administrator or the Responsible
Institutional Official for Health Sciences will sign the internal tracking form
on behalf of the CoIRC and return the form to the DRG for filing, along with
all relevant documentation summarizing the resolution of the conflict of
interest. The DRG will not distribute
any funds awarded in connection with the research proposal until the fully
executed Financial Interests Disclosure Form has been submitted to the DRG with
all appropriate approvals.
VI. SANCTIONS
Failure to file a completed Financial Interests
Disclosure Form for a sponsored research project will be grounds for
disciplinary action under the provisions of any applicable University rule,
policy, or collective bargaining agreement.
In addition, failure to comply with requirements to file a complete and
accurate disclosure form may result in the termination of current awards and
the investigator becoming ineligible to receive future awards.
VII. REFERENCES
42
CFR Part 50, Subpart F, “Responsibility of Applicants for Promoting Objectivity
in Research for Which PHS Funding is Sought.”
45
CFR Part 94, “Responsible Prospective Contractors.”
NIH
Grants Policy Statement (Revised December 1, 2003),
NIH
Guide Notice: Publication of the Revised NIH Grants Policy Statement (Rev.
12/03): Policy Changes, Clarifications, and Enhancements, November 26, 2003.
NIH
Guide Notice: Publication of “Financial Conflict of Interest—Objectivity in
Research: Institutional Policy Review.” February 10, 2003.
NIH
Review of Financial Conflict of Interest Policies of Grantee Institutions
(07/18/2002) Information on NIH’s review of Financial Conflict of Interest:
Objectivity in Research Policies provided by 300 Institutions.
Association
of American Universities Task Force on Research Accountability: Report on
Individual and Institutional Financial Conflict of Interest, October 2001.
|
M. Ian Phillips |
|
Judy Genshaft |