42 CFR 50.604(a) or 45 CFR 94.4 for investigators (Disclosure)

OMB Control No. 0925-0417 Exp. XX/XX/XXXX

Reporting of the existence of a conflicting interest prior to spending any funds under an award:

Prior to spending any funds under an award, the Institution must report to the PHS awarding component (i.e., Chief Grants Management Officer or appropriate Director, Office of Acquisitions) the existence of any conflicting interests and assure that the interest has been managed, reduced, or eliminated in accordance with the regulation. The regulation does not require the Institution to report to NIH officials the nature or other details of a reported conflicting interest; however, the Institution is required to make information available, upon request, to the NIH regarding all conflicting interests identified by the Institution and how those interests have been managed, reduced, or eliminated to protect the research from bias. An Institution’s conflict of interest policy may have additional requirements.

The Institution’s report should include the following information:

• Grant or Contract number, as appropriate

• Principal Investigator (PI) or contact PI if the grant/contract is awarded under the multiple PI model;

• Name of the Investigator (if different from the PI) with the conflicting interest; and

• Method was used to protect the involved NIH-funded research from bias (e.g., managed, reduced, or eliminated).

In addition, when requested, the institution should be prepared to provide additional information to the PHS awarding component.

Reporting of the existence of a conflicting interest identified after the initial report under an award

When the Institution determines that a conflicting interest exists after the initial report, the Institution must notify the PHS awarding component (i.e., Chief Grants Management Officer or appropriate Director, Office of Acquisitions) of its existence and provide the following information:

• Grant number and Principal Investigator;

• Principal Investigator (PI) or contact PI if the grant/contract is awarded under the multiple PI model;

• Name of the Investigator (if different from the PI) with the conflicting interest; and

• Method that will be used to protect the involved PHS funded research from bias (e.g., managed, reduced, or eliminated), at least on an interim basis, within sixty days of that identification.

In addition, when requested, the Institution should be prepared to provide additional information to the PHS awarding component.

Failure of an Investigator to comply with policy of the Institution - Identification of bias affecting the design, conduct, or reporting of PHS funded research

When the Institution determines that the failure of an Investigator to comply with the Institution’s conflict of interest policy has biased the design, conduct, or reporting of PHS funded research, the Institution must promptly notify the PHS awarding component (i.e., Chief Grants Management Officer or appropriate Director, Office of Acquisitions) of its existence and provide the following information:

• Grant/contract number and Principal Investigator;

• Principal Investigator (PI) or contact PI if the grant/contract is awarded under the multiple PI model;

• Name of the Investigator (if different from the PI) with the conflicting interest; and

• Description of the corrective actions taken, and method used to protect the involved PHS funded research (e.g., managed, reduced, or eliminated) from the bias affecting the involved PHS funded research.

In addition, when requested, the institution should be prepared to provide additional information to the PHS awarding component.