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Financial Conflict of Interest in Research (FCOIr):
Documenting Objectivity in Science
 


Management Plan Requirements:

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.

Clinical Research:

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:

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.




Please contact the Research and Innovation Office if you have questions about this web site: 513-529-3600
    or email Neal Sullivan at sullivnh@miamioh.edu or Jennifer Sutton at suttonja@miamioh.edu

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