A specific format for an Institution's
management plan is not specified in the regulations. The regulations
define, however, key elements of the FCOI report and a description
of the management plan is one of the key elements of the FCOI
report. The regulation requires that the FCOI report contain
a description of the key elements of the Institution's management
plan including the following:
(A) The role and principal duties of
the conflicted Investigator in the research project;
(B) Conditions of the management plan;
(C) How the management plan is designed
to safeguard objectivity in the research project;
(D) Confirmation of the Investigator's
agreement to the management plan;
(E) How the management plan will be
monitored to ensure Investigator compliance; and
(F) A plan to disclose identified SFI's
as an addendum to publications and presentations.
Updated or annual FCOI reports must
include the status of the management plan (i.e., whether the
financial conflict is still being managed or explain why the
financial conflict no longer exists) and a description of
any changes to the management plan since the last FCOI report
was submitted to the NIH.
The management
plan will be made available to the public upon request. As
materials subject to Ohio Sunshine laws, access will be mediated
by the Miami General Counsel's office.
In any case in which the HHS determines
that an NIH-funded project of clinical research whose purpose
is to evaluate the safety or effectiveness of a drug, medical
device, or treatment has been designed, conducted, or reported
by an Investigator with a conflicting interest that was
not managed or reported by the Institution as required by
the regulation, the Institution must require the Investigator(s)
involved to disclose the Financial Conflict of Interest
in each public presentation of the results of the research
and to request an addendum to previously published presentations.
Institution’s Financial Conflict of Interest policy may have
additional requirements.
Non-Miami collaborators are
subject to the same requirements as Miami faculty, staff,
and students. Since non-Miami persons do
not have a Miami username and password, the certification
instrument is not accessible. These persons must contact the
Research
Ethics Office to obtain an email version of the
instrument. In addition, if there is a sub-award to anther
institution, the collaborator must meet the compliance requirements
of their home institution.
