Financial Conflicts of Interest for Awardees SOP

This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.

Some links will work for NIAID staff only.

Purpose

To make sure financial interests at awardee institutions do not affect the design, conduct, or reporting of research funded under NIAID grants, contracts, or cooperative agreements (Small Business Innovative Research and Small Business Technology Transfer phase I awards are exempt).

Procedure

Institutions must manage, reduce, or eliminate financial conflicts of interest on NIH-funded research. They must also have a written agreement with subawardees to ensure all parties comply with conflict of interest regulations.

If necessary, NIH may suspend funding if an institution does not adhere to financial conflict of interest rules. For more information, see the NIH Financial Conflict of Interest website.

Institutions

Establish a written policy that assigns an institutional official to identify financial conflicts of interest, enforce institutional policy, and report conflicts to NIAID. Use the NIH Checklist for Financial Conflict of Interest Policy Development as a guide.
You are required to submit your publicly accessible FCOI policy to NIH via the eRA Commons Institution Profile (IPF) Module. Failure to comply with this requirement may cause NIH to delay the issuance of awards, impose specific award conditions, or take other enforcement actions to address compliance.
Require investigators, offerors, subawardees, contractors, and collaborators to document conflicts before submitting a grant application or contract proposal to NIH.
Report financial conflicts of interest before spending funds on a new award or within 60 days of learning about a conflict on a funded grant or contract.
- For grants, report conflicts through the eRA Commons. Go to the eRA Financial Conflict of Interest (FCOI) page for more information.
- For contracts, report conflicts in writing to George Kennedy, Director of the NIAID Office of Acquisitions.
- Include the following information in the report:
  - Grant or contract number.
  - Principal investigator (PI), or contact PI if the grant or contract is a multiple PI award.
  - Name of the person with the conflict.
  - Which method—management, reduction, or elimination—was used to protect NIH-funded research from bias.
  - Name of the entity with which the investigator has a conflict.
  - Nature of the conflict (e.g., equity, consulting fees).
  - Value of the financial interest or a statement that it cannot be readily determined.
  - Description of how the financial interest relates to NIH-funded research and the basis for the institution's determination of a conflict.
  - Key elements of the institution's management plan.
- Send an annual report at the same time as your progress report, unless NIH requests you do so earlier. Include with the following information:
  - Status of the conflict. If the conflict no longer exists, explain what happened.
  - Changes to the management plan.
- If you need to revise any information, do so using the eRA Commons.

Principal Investigators

Disclose all significant financial interests to your institution. Include your financial interests in any entity that might be affected by your institutional responsibilities.
Comply with all additional requirements established by your institution or clinical trial network.

NIAID Staff

See the Financial Conflicts of Interest for Awardees—NIAID Staff Response SOP.

Contacts

Grantees and contractors with questions should contact the grants management specialist or contracting officer's representative listed in the eRA Commons. For more information, see Contacting Program Officers and Grants Management Specialists.

Use the contacts listed above for questions about your specific situation. If you have a general question or a suggestion to improve this page, email the Office of Knowledge and Educational Resources at deaweb@niaid.nih.gov.