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Standard Operating Procedure Table of Contents
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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 interest (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.
- 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.
NIAID Staff
Contacts
Grantees and contractors with questions should contact the grants management or contracting 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
Financial Conflicts of Interest for Awardees -- NIAID Staff Response 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 |
