Financial Conflicts of Interest for Awardees

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 (SBIR phase I awards are exempt).

Procedure

By law, institutions must manage, reduce, or eliminate financial conflicts of interests (FCOI) for any person -- including subawardees and collaborators -- responsible for the design, conduct, or reporting of funded research

NIH financial conflict of interest rules cover all significant financial interests that reasonably appear to be affected by the research and are in entities whose financial interests appear to be so affected.

If necessary, NIH may suspend funding if an institution does not comply. 

Institutions must have a written policy that assigns an institutional official to identify financial conflicts of interest, enforce institutional policy, and report conflicts to NIAID.

Investigators must give their institutional official a list of significant financial interests for themselves, their spouses, and their dependents. The list should include any financial opportunities that investigators would expect to be affected by their proposed research. Go to What Financial Interests Are Covered by the Regulation? for specific examples.

For a full list of institutional responsibilities for managing conflicting interests, read the federal rules under Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought, 42 CFR 50, subpart F. For additional information, go to OER's Conflict of Interest Web site.

Applicants, Offerors, and Awardees

• Institutional officials must keep a written policy on financial conflicts of interest. NIH may ask to see this policy at any time.
• Institutional officials must require investigators, offerors, subgrantees, contractors, and collaborators to document conflicts before they submit a grant or contract application to NIH. However, institutional officials need to report conflicts to NIH for a funded grant only.
• Institutions must report financial conflicts of interest at the time of the award or within 60 days of learning about a conflict on a funded grant or contract.
  • For grants, institutions must report the conflict in writing to Mary Kirker, program director of NIAID's Grants Management Program, at mk35h@nih.gov.
  • For contracts, institutions must report the conflict in writing to Chuck Grewe, director of NIAID's Office of Acquisitions, at grewec@niaid.nih.gov.
• Institutions must include the following information in their report:
  • Grant or contract number.
  • Principal investigator, or contact PI if the grant or contract is a multiple PI award.
  • Name of the person (if different from the PI) with the conflict.
  • Which method -- management, reduction, or elimination -- was used to protect NIH-funded research from bias.
• For more information, read NIH Regulatory Burden III. Financial Conflicts of Interest for Awardees and go to OER's Frequently Asked Questions.

Principal Investigators

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

Grants Management Specialists

When you receive notification of a financial conflict of interest, take the following actions:

• Verify that the notification letter includes at least the following information:
  • Grant number.
  • PI of NIH-supported project.
  • Name of investigator with the conflict of interest.
  • Indication of whether the conflict has been managed, reduced, or eliminated.
• If any of the data elements noted above are not provided, follow up with the grantee to obtain the missing information.
• Enter the information in the FCOI database.  Do not include financial details.
• Within 30 days of receiving a grantee's notification, send the grantee an acknowledgement letter using the sample acknowledgement letter in the FCOI database. 
• Send the program officer a copy of the grantee’s notification letter as a PDF file, using the sample memo in the FCOI database. Wait for the program officer to review and respond.
• Send a follow-up letter to the grantee if this conflict could affect the project. Discuss with the appropriate division coordinator and program director of the Grants Management Program whether further corrective action or follow-up is necessary.
• If there are no concerns about the effect of this conflict on the project, document correspondence and close out the file. Follow the procedures in GMP'sConflict of Interest SOP.

More information:

• Grantee FCOI Notifications Database
• Policy Topic: Objectivity in Research/Conflict of Interest

Program Officers

• Review incoming notification letters from grants management specialists.
• Give grants management specialists your feedback and sign off on the letter. If necessary, ask for more information or request further action, but work directly with the grantee and do not contact a grantee's clinical trials network.

Contracting Officers

• Review financial conflicts of interest in offeror proposals.
• Ask for documentation whenever you suspect an offeror did not manage, reduce, or eliminate a financial conflict of interest, even if you have not made a conclusion on the matter.
• If you are concerned with any conflicts, contact the HHS Office of the General Counsel for legal advice before taking any action.
• Monitor contractors for conflicts after they receive an award.
• For more information, go to Contract and RFP Workforms -- Representations, Certifications, and Other Statements of Offerors (part 4).

NIAID Conflict of Interest Liaison Officer

• Serve as NIAID's liaison to NIH on institutional conflicts of interest and policy.
• Advise program staff on resolution of cases of institutional conflicts of interest.
• Coordinate conflict of interest activities for NIAID.

Contacts

Grantees and contractors with questions should contact the appropriate program officer or grants management specialist, listed on their Notice of Grant Award. For more information, see Contact Staff for Help.

If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with this link and your message. Thanks for helping us clarify and expand our knowledge base.

Links

Bioethics Resources on the Web

Conflict of Interest in Peer Review SOP

ORI Conflicts of Interest tutorial

OER Conflict of Interest tutorial

Promoting Objectivity in Research – Key Points

Responsible Conduct of Research Resources -- Conflicts of Interest and Commitment