Transcript Slide 1
THE UNIVERSITY of
NEW MEXICO
Research Compliance at UNM
What is a Conflict of Interest?
“A situation associated with an investigator’s participation in UNM research where it reasonably appears, on an actual or potential basis: 1. that the investigator’s significant financial interest could directly and significantly
affect the design, conduct or reporting
of UNM research activities; or 2. the investigator’s situation could directly and significantly
compromise his or her professional commitments or allegiance to UNM.”
Goals of the COI Policy
While it is not possible in modern research universities to
eliminate
all conflict, the goal is to
manage
actual or potential conflicts of interest and the key is:
DISCLOSURE
Keep in mind that…
• Conflicts of Interest are inevitable in modern research universities and do not imply any impropriety on the part of the investigator. • A conflict of interest may exist despite the highest standards of conduct and candor. • Conflicts of interest frequently involve
perceptions
, and are judged by others not by those directly involved. • UNM favors more rather than less disclosure. Disclosure does not automatically mean a conflict- this is what the Committee will decide.
Disclosure requirements apply to the following types of research:
Sponsored Research Human Subject Research Animal Subject Research Research funded by a formal award from UNM sources based on submission of a proposal (such as RAC awards)
Who must disclose?
• Any person who is responsible for the
design, conduct or reporting of UNM research.
• Principal investigator • Co-principal investigator • Faculty, staff and students • Non-UNM Consultants
What must be disclosed?
Generally, the following financial interest must be disclosed: •More than
$10,000
in consulting income, salaries, royalties, payments such as honoraria or equity. Interests and ownership. •More than
5% equity
in a company •
Intellectual Property rights
and royalties
other than
through than
UNM/STC
•
Outside employment
that could appear as a potential conflict •
Position as
a director, officer, partner, trustee, manager, or employee of an outside entity that conducts business in an
area related to the research
•
Other : A married couple or domestic partners working on the same research grant. Significant financial interests include those of the investigator, his or her spouse or domestic partner and dependent children.
What must be disclosed? NIH Thresholds Will be implemented in August 2012
• Aggregated salary, royalties or other payments, such as consulting fees and honoraria, other than through UNM or STC, that are expected to total more than
$5,000
over the next 12 months?
• Equity interests in a single entity, such as stocks, stock options and other ownership interests that are more than
$5,000
?
• Sponsored travel related to your institutional responsibilities from an entity that is NOT a federal, state, or local government agency associated with an institution of higher education?
• Required NIH FCOI Training
Disclosable Interest Related to the Research
Interests are "related to the research" if an investigator has a
relationship with an entity outside
of UNM that has either an
interest in the subject matter
of an investigator's research or whose
activities overlap
with an investigator's area of expertise.
Examples of Potential Conflicts of Interest
» » » » An investigator’s consulting relationship with the Sponsor of his/her research; A management role or equity holdings in an entity that is sponsoring his/her research, or selling goods or services to the university; Ownership in patents or technology that is the subject of his/her research; Supervising the same student(s) both in a University activity and as employees of his/her company.
Examples of what is NOT a Conflict of Interest
» » » An investigator’s consulting relationship with an organization that conducts business in an area not related to the research.
Stock or equity in a company that does not constitute a significant portion of the companies holdings. Volunteer work that is not directly related to the research
Annual Disclosure Process
In August of 2012 UNM Main and Branch Campuses be implemented an annual FCOI disclosure process. The annual FCOI disclosure focuses more broadly on how an investigator’s outside financial interest relate to their
institutional responsibilities
rather than focusing on how the disclosed interest relates to a specific project.
Annual Disclosure Process
We are defining institutional responsibilities using the NIH definition: “
An investigator’s professional responsibilities on behalf of the Institution, and as defined by the Institution, including, but not limited to, activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and serves on panels such as IRBs or Data Safety Monitoring Boards”
Annual Disclosure Process
Using this definition we hope to capture a broader picture of the investigator’s role at UNM and how it relates to their disclosable outside interests. The COI Committee will then create a management plan that will cover the investigator for the year of disclosure rather than for a specific project.
How do I disclose?
Disclosures are submitted via the electronic FCOI disclosure system. You can access the site by going to: http://researchcompliance.unm.edu/coi
Examples of managing potential conflict(s) of interest
Modification
of the research protocol to mitigate or eliminate the conflict Involve an
independent investigator
to collect, analyze and interpret the data Appoint a
monitor
to oversee the research
Disclosure
of the financial interest in
publications and presentations Severance
the conflict of the investigator's
relationships
that create
Exclusion
of the investigator from participation in some part of the research
Main Campus COI Website
http://researchcompliance.u
nm.edu/coi
Contact Information
Adelicia Gunn
Office Phone: 277-2968 [email protected]
MSC02 1665 1805 Sigma Chi NE Albuquerque, NM