Reporting to External Sponsors

PHS/NIH

Where the DIO identifies a FCOI, the DIO will report the details concerning the FCOI (including Management Plan) to NIH via the eRA Commons FCOI Module. Prior to expenditure of any funds under the award. These reports are completed:

• Within 60 days of identifying a new FCOI for an existing investigator, during the period of the award (FCOI must be determined, and Management Plan implemented within those 60 days), or

• Within 60 days of identifying an FCOI for an investigator who is newly participating in the project, or

• Annually report on the status of FCOI and any changes in Management Plan (Due same time as annual progress report is submitted, including multi-year progress report, or at time of extension - with or without funds.

The FCOI Reports includes:

• Grant number; • PD/PI or contact PD/PI; • Name of Investigator with the FCOI; • Name of the entity with which the Investigator has an FCOI; • Nature of FCOI (e.g., equity, consulting fees, travel reimbursement, honoraria); • Value of the financial interest $0-4,999; $5K-9,999; $10K-19,999; amounts between $20K-100K by increments of $20K; amounts above $100K by increments of $50K or a statement that a value cannot be readily determined; • A description how the financial interest relates to NIH-funded research and the basis for the Institution's determination that the financial interest conflicts with such research; and • Key elements of the Institution's Management Plan, including: • Role and principal duties of the conflicted Investigator in the research project; • Conditions of the Management Plan; • How the Management Plan is designed to safeguard objectivity in the research project; • Confirmation of the Investigator's agreement to the Management Plan; • How the Management Plan will be monitored to ensure Investigator compliance; and • Other information as needed.

The FCOI Reports are accessible under FOIL.

If upon receipt of the FCOI report, NIH decides that the FCOI will bias the objectivity of research, NIH may impose special award conditions, suspend funding or impose other enforcement mechanisms until the matter is resolved.

In any case in which NIH determines that an PHS-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 an FCOI that was not managed or reported by the University as required by regulation, the University will require the Investigator involved to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.

Other External Funding Agencies

The DIO will report to the external funding agency/agencies as applicable:

• Any instances in which the University finds it is unable to satisfactorily manage an actual or potential conflict of interest, and

• Any instances where an Investigator participating in externally or selected internally supported research has not complied with this policy, and the specific corrective measures taken by the University.

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