Completion of the COI certification administered by the
General Counsel's Office at Miami does not meet the federal requirements for research activities. The
issues, reporting thresholds, and management differ. The
University wide certification addresses state law and addresses
contracting and purchasing issues whereas the FCOI research
certification is intended to support the ideal goal of scientific
objectivity.
Note: Information below provides more detail but the necessary information and training are conveyed in the certification form linked above.
Faculty and staff must comply with Miami Policies to minimize perceptions
that research findings may have been influenced by external
sources. When relationships with an external entity are
of a financial nature, such perceived or real Financial
Conflict of Interest
in Research (FCOIr) must be addressed.
When research is federally funded, Miami is contractually
obligated to comply with the policies for FCOIr (2 CFR 200.112:
which directs funding agencies to have established policies).
The policy at Miami unifies the policies of NIH and NSF
to meet the requirements of both. Conflicts are common and
not all warrant management, therefore the policies define
types of interests, relationships, and monetary thresholds
that need to be disclosed and potentially managed.
There
are four basic steps to addressing potential concerns regarding
FCOIr:
1.
Understanding the nature of Significant Financial Interests
(SFI's) and confidentially disclosing those that exist
to Miami administration. Absent reportable SFI's for researchers
and immediate family members, the researchers assure through
an annual online ceritification that they have no known
external SFI's. The online questionnaire (google form
linked above and below) requires logging in using Miami
UniqueID to establish a means of certifying identity.
Since there is a regulatory requirement for researchers
to understand the various aspects of FCOIr, the questionnaire
is used not only to respond to simple questions, but to
provide the information and certify that researchers have
completed the educational requirement.
2.
Research team members must also understand that if an
SFI develops after the most recent certification, it must
be disclosed within 90 days. If no SFI's are indicated
in the annual certification or develop, no further action
is required.
3.
If SFI's are disclosed, the Director of Research Compliance
or the Associate Provost for Research determines and confidentially
documents whether the SFI consititues a Financial Conflict
of Interest that may be perceived to influence the research
(FCOIr).
4.
If an FCOIr is identified, a conflict management plan is developed
to avoid the potential issues raised by FCOIr in the specific
project. The table below describes SFI's that must be
disclosed and managed if not explicitly excluded (column
2). SFI's from external entities and potential FCOIr's
are not prohibited, but disclosure, documentation, and
management may be required.
|
Nature
of SFI |
Excluded
Interests
(Does not require disclosure or management) |
Compensation
and/or other payments for service over $5000 |
Compensation
received less than $5,000, as well as any
compensation received for lectures, seminars, teaching
engagements, or service on advisory committees or review
panels relating to federal, state, or local government
agencies, an institution of higher education or research
institute that is affiliated with an institution of
higher education, and compensation received from MU
funds. |
Sponsored
or reimbursed travel valued at over $3000 |
Travel
administered through MU funds, and travel reimbursed
or sponsored by a federal, state, or local government
agency, an institution of higher education, an academic
teaching hospital, a medical center, or a research institute
that is affiliated with an institution of higher education. |
Equity
interests in a publicly-traded entity (stock) with
a value of over $5000 |
Interests in publically-traded entities valued at less
than
$5,000 as well as interests in any entity through personal
retirement accounts and mutual funds |
Any
equity interest in a non-publicly-traded entity of
any value (threshold = $0) |
Interests in any entity through personal retirement
accounts
and mutual funds |
Compensation
for intellectual property with a value of over $1000 |
Royalties
received from MU funds, and unlicensed intellectual
property that does not generate income |
|
A
PDF of the survey form is posted here.
Please do not submit this example, use the link to the secured
online survey above.
|