Financial Conflict of Interest

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

2011 Revised Regulations:​

FAQs to 2011 Revised Regulation

The U.S. Department of Health and Human Services (HHS) has issued a final rule in the Federal Register Link to External Site 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:
  • 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 NOT-OD-11-109 (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.
  • NIH Guide Notice NOT-OD-12-159 (09/21/2012) - Proactive Compliance Oversight Program – Financial Conflict of Interest for all NIH-Supported Institutions.  The purpose of the proactive compliance program is to assess institutional implementation and compliance with the 2011 revised Federal financial conflict of interest requirements pertaining to NIH grants and cooperative agreements.
  • General inquiries about the FCOI regulation for research contracts should be directed to NIH Contracting Officer identified on the Request for Proposal or the awarded contract.
Reporting:
 
  • NIH Guide Notice NOT-OD-14-081 (04/18/2014) - NIH is making improvements to the FCOI module for submission of financial conflict of interest (FCOI) reports to NIH beginning on April 25, 2014.  NIH requires grantees to use the FCOI module via eRA Commons, to submit FCOI reports for NIH grants and cooperative agreements subject to the Federal regulation at 42 CFR Part 50 Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought. 
  • Summary Chart of the One-time FCOI Reporting Guidance for FY 12 Awards - (08/24/2012) - (PDF) - This chart summarizes the one-time guidance for submitting Financial Conflict of Interest (FCOI) reports for FY 12 Noncompeting and multi-year funded awards due to the timing of the implementation of the 2011 revised FCOI regulation (42 CFR Part 50 Subpart F) applicable to NIH grants and cooperative agreements.
  • NIH Guide Notice NOT-OD-12-143 - (08/24/2012) - NIH Guide Notice Announces One-time Financial Conflict of Interest (FCOI) Reporting Guidance for Certain Fiscal Year 2012 Awards Issued On Or After August 24, 2012.
  • Summary Chart on FCOI Noncompliance Reporting Requirements – (8/21/2012) - (MS Word) - This chart summarizes the Financial Conflict of Interest (FCOI) reporting requirements when there is an instance of noncompliance with the 2011 revised FCOI regulation (42 CFR Part 50 Subpart F) for NIH grants and cooperative agreements.
  • Summary Chart of the Different Types of FCOI Reports – (8/21/2012) – (MS Word) - This chart summarizes the different types of Financial Conflict of Interest (FCOI) reports that can be submitted in the eRA Commons FCOI Module under the 2011 revised FCOI regulation (42 CFR Part 50 Subpart F) applicable to NIH grants and cooperative agreements.
  • NIH FCOI Reporting Requirements and eRA Commons FCOI Module Demonstration: Webinar, August 14, 2012 1:30pm-3:00pm EDT
  • NIH Guide Notice NOT-OD-12-118 (06/25/2012) - NIH Announces Changes to the eRA Commons Financial Conflict of Interest (FCOI) Module to Accommodate Additional Reporting Requirements Required by the 2011 Revised FCOI Regulation on Promoting Objectivity in Research (42 CFR Part 50 Subpart F Link to External Site) for all NIH-supported Institutions.

Resources:
 
  • NIH Guide Notice NOT-OD-18-160 (3/30/2018) – NIH Guide Notice to remind extramural research community about the requirements of 42 CFR Part 50, Subpart F, Objectivity of Research:  Financial Conflict of Interest: Investigator Disclosures of Foreign Financial Interests. 
  • Frequently Asked Questions (06/12/2014) - Applicable to the 2011 revised financial conflict of interest (FCOI) regulation at  42 CFR 50 Subpart F Link to External Site, “Responsibility for Promoting Objectivity in Research for Which PHS Funding is Sought” Promoting Objectivity in Research (commonly known as the FCOI regulation).  New and updated FAQs will be marked accordingly in the FAQ document for the next 30 days. 
     
  • NIH Guide Notice NOT-OD-13-004 (10/18/2012) - NIH provides policy clarification concerning disclosure requirements for reimbursed and sponsored travel under the Final Rule at 42 CFR 50 Subpart F Link to External Site, “Responsibility for Promoting Objectivity in Research for Which PHS Funding is Sought” applicable to NIH grants and cooperative agreements. 
     
  • Financial Conflict of Interest Presentation with Case Studies (06/26/2012) - (PowerPoint - 13.4 MB) - These slides provide an overview of the Federal FCOI regulation provided at 42 CFR Part 50, Subpart F Link to External Site on Promoting Objectivity in Research that was presented at the NIH Regional Seminar in Washington, DC on June 22, 2012.
     
  • FCOI Regulation Web-based Tutorial (Updated 11/30/2018, Adobe Flash Player Link to Non-U.S. Government Site - Click for Disclaimer is required) - This tutorial is related to the Financial Conflict of Interest (FCOI) regulation provided at 42 CFR Part 50 Subpart F Link to External Site on Promoting Objectivity in Research.  The November 30, 2018 posting provides the capability to easily save and print the FCOI Certificate.
     
  • 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 Link to External Site 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 Link to External Site) 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 Link to External Site.  
     
  • What NIH Grantees Need to Know About the 2011 Revised Financial Conflict of Interest Regulation:
    Webinar, November 30, 2011, 2-3:30pm EST.
     
  • 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)
 
Looking for information on Peer Review Conflict of Interest? Visit the Peer Review Policies Page 
 

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