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ARCHIVED - Financial Conflict of Interest

1995 Regulations:

The 1995 Web-based tutorial has been moved to the Financial Conflict of Interest Archive site.

  • Public Health Service (PHS) Regulations:

  • Link to FAQs
  •   
    Frequently Asked Questions (FAQs) (07/29/2009) - These FAQs are related to the 1995 regulations (42 CFR Part 50 Subpart F and 45 CFR Part 94). FAQs related to the 2011 revised regulation for grants and cooperative agreements  (42 CFR Part 50 Subpart F) are posted in a separate document.
  • Link to FAQs
  •   
    Frequently Asked Questions (FAQs) (09/30/2011) - Applicable to the 2011 revised regulation on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 CFR Part 50 Subpart F) (commonly known as the Financial Conflict of Interest (FCOI) regulation).

    • 1995 Web-based Tutorial (07/29/2009) - (Adobe Flash Player Link to Non-U.S. Government Site - Click for Disclaimer is required) Also available in PDF format (PDF - 89 KB). This tutorial is related to the 1995 Regulations. The web-based tutorial related to the 2011 revised regulation is provided under the “Resources” section.

    • Notice of Proposed Rulemaking - Extended Comment Period (07/21/2010) - (PDF - 52 KB) Extended Comment Period on Proposed Rule on Financial Conflict of Interest Regulations, Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought and Responsible Prospective Contractors:

      • The comment period has been extended to allow the Department to seek public comment on whether the proposed changes to the regulations' references to available enforcement authorities should be further revised and clarified in the regulation. The Department also seeks public comment on whether it should clarify how the regulations apply in certain circumstances.
      • The extended comment period closes August 19, 2010

    • NIH Guide Notice (07/21/2010) - Notice of Extension of Comment Period on the Proposed Rule to August 19, 2010.

    • Notice of Proposed Rule Making (05/21/2010) - (PDF - 209 KB) Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought and Responsible Prospective Contractors

    • Summary of Major Proposed Changes (06/18/2010) - (PDF - 30 KB) - Table indicating major changes between current and proposed regulation.

    • NIH Guide Notice (05/21/2010) - NIH Requests Comments on Proposed Rule. Comments are due by July 20, 2010.

    • General inquires about the Notice of Proposed Rulemaking may be directed to: FCOI-NPRM@mail.nih.gov

    • Federal Register Notice (05/08/2009) (FR Doc. E9-10666) - (PDF - 61 KB) - Advance Notice of Proposed Rulemaking on Financial Conflict of Interest Regulations, Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought and Responsible Prospective Contractors; Request for Comments:

      • The Department of Health and Human Services (HHS) and the Public Health Service (PHS), a component of the HHS, and the National Institutes of Health (NIH) seeks comments from the public on whether the HHS should amend its regulation on the responsibility of applicants for promoting objectivity in research for which PHS funding is sought and on responsible prospective contractors on all aspects of the regulation and in particular the following issues:

        • Expanding the Scope of the Regulation and Disclosure of Interests;
        • The Definition of "Significant Financial Interest;"
        • Identification and Management of Conflicts by Institutions;
        • Assuring Institutional Compliance;
        • Requiring Institutions to Provide Additional Information to the PHS; and
        • Institutional Conflict of Interest.
      • The comment period closes on July 7, 2009.

    • NIH Guide Notice (05/08/2009) - NIH Requests Comments on Proposed Amendment of Regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors.

    • NIH Guide Notice (10/01/2008) - NIH Announces a New Business Process for Reporting an Identified Financial Conflict of Interest for Grants and/or Cooperative Agreements beginning October 10, 2008.

    • Reminder from NIH on Financial Conflict of Interest Requirements (08/25/2008) - Email from Dr. Norka Ruiz Bravo, NIH Deputy Director for Extramural Research to Institutional Officials.

    • NIH Oversight of Extramural Financial Conflicts of Interest (08/01/2008) - (MS Word - 34 KB)

    • NIH Guide Notice (04/10/2008) - NIH Announces the Posting of Updated Frequently Asked Questions (FAQs) on Financial Conflict of Interest Requirements for All NIH-Supported Institutions.

    • NIH Guide Notice (10/25/2007) - Pilot Compliance Program—Financial Conflict of Interest Requirements for All NIH-Supported Institutions.

    • Observations from NIH's FY2006 Targeted Site Reviews (02/15/2007) - (MS Word - 53 KB)

    • NIH Guide Notice (12/06/2004) - Reminder of Financial Conflict of Interest Requirements for All NIH-Supported Institutions.

    • NIH Guide Notice (02/10/2003) - Publication of "Financial Conflict Of Interest - Objectivity in Research: Institutional Policy Review".

    • Conflict of Interest Workshop Summary (09/30/2002) - (MS Word - 131 KB) or (PDF - 193 KB) - A workshop on conflict of interest was held on the NIH campus on September 30, 2002.

    • NIH Review of Financial Conflict of Interest Policies of Grantee Institutions (07/18/2002)




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