The NIH is committed to preserving the public’s trust that the research supported by us is conducted without bias and with the highest scientific and ethical standards. We believe that strengthening the existing regulations on managing financial conflicts of interest is key to assuring the public that NIH and the institutions we support are taking a rigorous approach to managing the essential relationships between the government, federally-funded research institutions, and the private sector. 

"The public trust in what we do is just essential, and we cannot afford to take any chances with the integrity of the research process." — Dr. Francis Collins, Director, NIH

FAQs to 2011 Revised Regulation

The U.S. Department of Health and Human Services (HHS) has issued a final rule in the Federal Register that amends the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94). An Institution applying for or receiving NIH funding from a grant or cooperative agreement must be in compliance with all of the revised regulatory requirements no later than 365 days after publication of the regulation in the Federal Register, i.e., August 24, 2012, and immediately upon making the Institution’s Financial Conflict of Interest policy publicly accessible as described in 42 CFR part 50.604(a).  Institutions must comply with the 1995 financial conflict of interest regulation until the Institution fully implements all of the regulatory requirements of the 2011 revised regulation. 

• 2011 Public Health Service (PHS) Regulations:
• Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F)
  
• Responsible Prospective Contractors (45 C.F.R. Part 94) (PDF - 22 KB)
  
  
• Federal Register Notice (08/25/2011) - (PDF - 369 KB) - Issuance of the Final 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.
  
  
• NIH Guide Notice (08/23/2011) - NIH Guide Notice to announce the publication of the Final 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.
  

• General inquires about the FCOI regulation for grants and cooperative agreements may be directed to: FCOICompliance@mail.nih.gov.
  
  
• General inquires about the FCOI regulation and the submission of FCOI reports for NIH research contracts should be sent to fcoicontracts@mail.nih.gov.

• Public Health Service (PHS) Regulations:
  
  
  • Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F)
  • Responsible Prospective Contractors (45 C.F.R. Part 94) (PDF - 22 KB)

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.

• 1995 Web-based Tutorial (07/29/2009) - (Adobe Flash Player 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.
  
  
• Observations from NIH's FY2006 Targeted Site Reviews (MS Word - 52 KB)
  

• eRA Commons FCOI report submission information
  
  
• NIH Guide Notice (03/27/2009) - Mandatory use of eRA Commons FCOI module begins July 1, 2009

• 2011 Web-based Tutorial (05/22/2012) - This tutorial is related to the 2011 revised Financial Conflict of Interest (FCOI) regulation provided at 42 CFR Part 50 Subpart F on Promoting Objectivity in Research. The tutorial is also available in PDF format (PDF - 277 KB).
  
  
• New and Updated Frequently Asked Questions (5/18/2012) – Applicable to the 2011 revised regulation on Promoting Objectivity in Research (42 CFR Part 50 Subpart F) (commonly known as the Financial Conflict of Interest [FCOI] regulation).  New and updated FAQs will be marked accordingly in the FAQ document for the next 30 days.
  
  
• Financial Conflict of Interest (FCOI) presentation – (04/26/2012) – (PowerPoint – 12 MB) - These slides provide an overview of the Federal FCOI regulation provided at 42 CFR Part 50, Subpart F on Promoting Objectivity in Research that was presented at the NIH Regional Seminar in Indianapolis, Indiana on April 17, 2012.
  
  
• NIH Guide Notice NOT-OD-12-103 (4/18/2012) - NIH Announces the Posting of a Checklist for Policy Development which serves as a resource when developing, revising, or reviewing an Institution’s Financial Conflict of Interest (FCOI) policy to determine compliance with the regulatory requirements provided in 42 CFR Part 50 Subpart F.  The checklist is intended to assist Institutions as they implement the requirements of the 2011 revised FCOI regulation for grants and cooperative agreements.
  
  
• Checklist for Policy Development (PDF) (4/12/2012) - A Checklist for policy development related to the 2011 Revised Financial Conflict of Interest (FCOI) Regulation Promoting Objectivity in Research (42 CFR Part 50 Subpart F). The checklist provides an overview of the requirements of the 2011 revised FCOI regulation to serve as a checklist resource when developing, revising or reviewing an Institution’s FCOI policy to determine compliance with all regulatory requirements. [MS Word version - 100 KB]
  
  
• NIH Guide Notice NOT-OD-12-079 (3/21/2012) – NIH Announces the Posting of New and Updated Frequently Asked Questions (FAQs) applicable to the 2011 revised regulation on Promoting Objectivity in Research (42 CFR Part 50 Subpart F) for all NIH-supported Institutions.

• NIH Guide Notice NOT-OD-12-080 (03/09/2012) - NIH Announces the posting of a Web-based tutorial applicable to the 2011 revised regulation on Promoting Objectivity in Research for all NIH-supported Institutions.  The tutorial focuses on the main requirements of the Financial Conflict of Interest (FCOI) regulation applicable to grants and cooperative agreements provided at 42 CFR Part 50 Subpart F. 
  
  
• What NIH Grantees Need to Know About the 2011 Revised Financial Conflict of Interest Regulation:
  Webinar, November 30, 2011, 2-3:30pm EST.
  
  
  • Archive
  • FCOI Webinar PowerPoint Slides (PowerPoint - 7.3 MB)
    
  • FCOI Webinar PowerPoint Slides (PDF - 2.5 MB)
    
    
• NIH Guide Notice (11/14/2011) - NIH Announces FCOI Webinar: What NIH Grantees Need to Know about the 2011 Revised Financial Conflict of Interest Regulation.

• NIH Guide Notice (09/30/2011) - NIH Announces  the Posting of Frequently Asked Questions (FAQs) applicable to the 2011 revised regulation on the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought for All NIH-Supported Institutions (42 CFR Part 50 Subpart F).
  
  
• Summary Slide Set for the revised 2011 FCOI Regulation (10/05/2011) - (PowerPoint - 3.84 MB) - Summary slides that describe the major changes to the 1995 regulations on Financial Conflict of Interest (FCOI) - Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought.
  
  
• Summary of Major Changes (09/22/2011) - (MS Word - 45 KB) - Table summarizing major changes between the 1995 regulation and the 2011 regulation.
  


• Additional Financial Conflict of Interest Information (07/14/2010)

•  Archive of Financial Conflict of Interest Documents