COI Self-Guided Review

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Conflict of Interest
Faculty & Staff of Instruction or Research
Human Resources
2011
Outline
 Why Conflict of Interest Matters and Risks of
Non-Disclosure
 What is a Conflict of Interest?
 Clarkson’s Conflict of Interest Policy
 Types of Conflict
 Responsibilities
 Disclosure & Evaluation Process
 Potential Conflicts of Interest
 COI Resources
 Conclusion
Why Conflict of Interest
Disclosure Matters?
 Conflicts of Interest , especially those of a financial
nature, have the potential to threaten the integrity of a
university’s research, scholarship, instruction, evaluation,
and administrative functions.
 To ensure that Clarkson’s reputation and research
programs are not compromised by even an appearance
of inattention to this matter, Clarkson has put in place
policies consistent with federal guidelines that require the
reporting and management of the potential Conflicts of
Interest of its faculty, investigators, administrators, and
staff.
What is a Conflict of Interest?
 A Conflict of Interest arises when an individual's private
interests (such as outside professional or financial
relationships) might interfere or have the perception to
interfere with his or her professional obligations to
Clarkson.
 Such situations do NOT necessarily imply wrong-doing or
inappropriate activities.
 However, in a university setting, they can compromise, or
be perceived as compromising, important academic values,
research integrity, or the university mission.
 At Clarkson, it is essential for all employees (hereafter
“members”) to understand how these divergent interests
can become a issue.
Clarkson’s
Conflict of Interest Policy
 Applies to Members of the University community (Board
of Trustees, executive officers, deans, directors, faculty
and staff), their spouses, and dependent children.
 All Members:
 Have a primary commitment to the University.
 Have an obligation to make decisions in a way that
promote the best interests of the institution.
 Will conduct their relationships with each other and
the University with honesty and integrity.
 Need to be sensitive and aware of the possible
adverse effects of their external activities.
Clarkson’s
Conflict of Interest Policy
 All Members (cont.):
 Are required to identify, evaluate, and disclose potential
Conflicts of Interest that may appear to compromise their
obligation to the University.
 Must disclose Conflicts of Interest at the time of first
appearance or identification.
 Responsibility lies with the Institution to determine:
 If disclosed potential conflicts are evaluated in order to
determine if an actual conflict of interest exists.
 What conditions or restrictions should be in place to
eliminate, reduce, or manage any potential or actual
Conflict of Interest.
Types of Conflict
1. Conflict of Commitment
2. Conflict of Interest
Conflict of Commitment:
A Conflict of Commitment arises when a
member undertakes external commitments
which interfere with member’s obligations
and commitments to Clarkson.
– Compete with the University’s mission.
– Interfere with the ability perform the responsibilities associated with his or
her position.
What can cause a Conflict of
Commitment?
 External consulting by staff, if greater than the
allowable limit.
 Officer or Director in outside organizations,
including churches and nonprofit organizations.
 Start-up or other entrepreneurial businesses
Note: A conflict of commitment can often exists
alongside of a conflict of interest and both may need
to be addressed at the same time.
Types of Conflict
Conflict of Interest:
A Conflict of Interest may arise when a
member has the opportunity to influence the
University’s business, administrative,
academic or other decisions in ways that
could lead to personal gain or advantage of
any kind.
Types of Conflict
Conflict of Interest (Continued):
Additionally, for Members of the Faculty and
Staff of Instruction and Research (hereafter
“Investigator”), a Conflict of Interest exists
when a Significant Financial Interest, as
defined below, could directly and significantly
affect the design, conduct, or reporting of
sponsor funded research activities.
Significant Financial Interest
Significant Financial Interest is defined by the
regulation as 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);
 intellectual property rights (e.g., patents, copyrights, and
royalties from such rights).
Significant Financial Interest
Significant Financial Interest does not include:
 salary, royalties, or other remuneration from the Institution;
 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
 an equity interest that when aggregated for the Investigator and the Investigator's spouse
and dependent children, meets both the following tests: 1) does not exceed $10,000 in
value as determined through reference to public prices or other reasonable measures of fair
market value and 2) does not represent more than a five percent ownership interest in any
single entity; or
 salary, royalties or other payments that when aggregated for the Investigator and the
Investigator's spouse and dependent children over the next twelve months are not expected
to exceed $10,000.
 Participation in mutual funds that are not directed or controlled by the Investigator or
Investigator's spouse and dependent children.
Institutional Responsibilities
 Create and maintain a written policy.
 Inform each Investigator of the regulation, of the Conflict of Interest
Policy, and of the their disclosure responsibilities.
 Designate an institutional official(s) to solicit and review financial
disclosure statements from each Investigator.
 Review each disclosure and determine whether a conflict of interest
exists.
 Implement appropriate actions to manage, reduce, or eliminate
Conflicts of Interest.
 Maintain records of all financial disclosures and all actions taken by the
Institution.
 Establish adequate enforcement mechanisms
 Certify that the Institution complies with the Conflict of Interest
regulations with respect to all research proposals and projects.
Institutional Responsibilities
 Prior to proposal submission, require that each Investigator has
submitted a current Conflict of Interest Disclosure Form, including a
listing of his/her known Significant Financial Interests that relate to the
sponsored research activity.
 Report the existence of any Conflict of Interest to the funding agency:

Prior to expenditure of any funds under the award, the Institution may be
required to report the existence of an Conflict of Interest to the funding
agency and ensure that the conflicting interest has been managed,
reduced, or eliminated.
 Conflicts of Interest identified subsequent to the expenditure of any funds,
as described above and within 60 days of that identification.
 Respond to all requests by the funding agency regarding any identified
Conflicts of Interest.
Investigator Disclosure
Responsibilities
 Complete and submit a Conflict of Interest Disclosure Form
annually:
 Disclose all potential Conflicts of Interest and Conflicts of Commitment
(including spouse and dependent children) that may appear to
compromise their obligation to the University.
 Disclose all Significant Financial Interests (including spouse and
dependent children) that relate to your participation in any sponsor
funded research activity.
 Submit an updated Conflict of Interest Disclosure Form:
 When any new potential conflicts are first identified, including
Significant Financial Interests.
 During the research proposal process, Principal Investigators must
certify that there are no changes since most current disclosure was
submitted.
Activities That May Warrant
Updated Disclosures
 Updated Conflict of Interest Disclosure Forms may
be necessary before engaging in certain sponsor
funded activities.
 Investigators should evaluate the following
activities before engagement:




When submitting proposals or accepting awards
When submitting IRB applications
Before involvement in technology transfer
Prior to business start-up
Evaluation Process
Director of Research reviews each Conflict of Interest Disclosure Form
considering the following:
1. Establish Context


What are the external and organizational factors that impact on this situation?
Identify research activities that have an impact on this situation
2. Identify and Analyze Risks



What potential risks to the University’s objectives, policies, are present in the conflict situation?
Does the conflict appear to be affected by any research activities
Are the individual’s financial interests appear to be affected by any research activities
3. Evaluate Likelihood and Consequence of Risk, and any mitigating practices that
are in place


Likelihood
Consequences
rare………..almost certain
low……… ..very high
4. Treat Risk

Ensure that the conflict has been managed, reduced, or eliminated.
Evaluation Process
Once reviewed, the Director of Research may do the
following:
 Request additional information
 Review the disclosure with the Investigator to determine if
potential or actual conflicts exist.
 Eliminate, reduce, or manage potential or actual conflicts.
 Refer the disclosure to a Conflict of Interest Committee
who will review the disclosure.
Managing Conflict of Interest
Examples of conditions or restrictions that may occur in the
management of any potential or actual Conflict of Interest may
include, but are not limited to the following:




Disclosure to the funding agency.
Monitoring research by an independent reviewer.
Modification of the research plan.
Disqualification from participation in the portion of research affected by
the financial interests.
 Divestiture of financial interests.
 Severance of relationships that create the conflict.
 The institution may notify the external agency that the University is
unable to manage an actual or potential conflict of interest.
Potential Conflicts of Interest
That Should Be Disclosed
1. Purchasing equipment, instruments, or supplies from
sponsored funds for research from a firm in which the
principal investigator has a financial interest.
2. Giving well-paid lectures or consulting for companies or
organizations whose economic interests are affected by the
investigator’s work that are supported by sponsored funds.
3. Commitments that involve frequent or prolonged absences
from the University on non University business.
4. A member may not possess a substantial interest in or
participate in the profits of any organization that deals or
seeks to deal with the University without full disclosure of
relevant facts.
Potential Conflicts of Interest
That Should Be Disclosed
5. Researcher has a Significant Financial Interest in a
company that is sponsoring his/her University research.
6. Researcher conducts federally sponsored research on a
product (e.g., cancer detection method). Researcher also
consults for the company that intends to manufacture and
market the cancer detection method.
7. Researcher conducts privately sponsored research and
also consults for the sponsoring company.
Potential Conflicts of Interest
That Should Be Disclosed
8. Faculty member is on an advisory committee
for a for-profit company. The company
sponsors the faculty’s research to test a product
on human participants.
9. A faculty member has a startup company that
requests to use University facilities to continue
work for the startup company.
Conflict of Interest Tools
Clarkson Policies and Forms
 Conflict of Interest Policy
http://www.clarkson.edu/dor/compliance/COI.html
 Conflict of Interest Disclosure Forms
http://www.clarkson.edu/dor/compliance/COI.html
 Start-up Business Ventures Guidance
http://www.clarkson.edu/dor/tech_transfers.html
 Intellectual Property Policy
http://www.clarkson.edu/dor/tech_transfers.html
Conclusion
This concludes the self-guided conflict
of interest review. Please proceed to
Step 2 and complete the quiz.
Thank You!
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