Proactive Compliance Oversight Program-Financial Conflict of Interest Requirements for NIH-Supported Institutions

Notice Number: NOT-OD-12-159

Key Dates
Release Date: September 21, 2012

Issued by
National Institutes of Health (NIH)

Purpose

The purpose of this Notice is to announce that the NIH Division of Grants Compliance and Oversight, Office of Policy for Extramural Research Administration within the Office of Extramural Research, is launching a new Proactive Financial Conflict of Interest (FCOI) Compliance Program to assess institutional implementation and compliance with the 2011 Revised Federal FCOI regulatory requirements pertaining to NIH grants and cooperative agreements. These requirements are described in Title 42, Code of Federal Regulations, Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought that was published on August 25, 2011 in the Federal Register.  Institutions were required to be in compliance with the regulatory requirements no later than August 24, 2012.

Background

The FCOI regulations were revised to increase accountability, add transparency, enhance regulatory compliance and effective Institutional management of Investigators’ FCOIs, and strengthen NIH’s compliance oversight. The 2011 revised regulation includes comprehensive changes, focusing on these areas in particular:
Definition of Significant Financial Interest
Extent of Investigators’ disclosure of information to Institutions regarding their Significant Financial Interests;
Institutions’ management of identified FCOIs
Information reported to the PHS funding component (e.g., NIH);
Information made accessible to the public (i.e., Institutional FCOI policy and identified FCOIs of senior/key personnel); and
Investigator training.
Currently, all institutions applying for or receiving NIH funding, as described in the revised regulation, must have compliant policies to include the comprehensive changes noted above. 

NIH Compliance Oversight

The Proactive FCOI Compliance Oversight Program (FCOI Compliance Program) is a component of NIH’s oversight responsibilities to assure grantee compliance with FCOI requirements.  In addition to providing oversight, the FCOI Compliance Program will assist grantees in fully developing and implementing their FCOI policies by providing assistance in the form of constructive feedback.  The objective of this initial phase of the FCOI Compliance Program is to obtain and evaluate publicly accessible FCOI policies for a sample of NIH grantee institutions; however, the identity of participating institutions and correspondence with NIH will remain confidential.  As with other compliance programs, if deficient areas are noted, institutions will be expected to formally address and resolve all identified issues.  The DGCO staff will assist grantees compliance actions by offering technical assistance as well as addressing lingering questions to help clarify the FCOI requirements, as needed.  NIH plans to continue and expand the FCOI Compliance Program during FY 2013.

The results of the FCOI Compliance Program review will be shared as results are available with the research community as part of NIH’s continuing educational efforts to improve and enhance compliance with FCOI regulatory requirements. 

Inquiries

Please direct all inquiries to:

Division of Grants Compliance and Oversight
Office of Policy for Extramural Research Administration (OPERA)
Office of Extramural Research (OER)
National Institutes of Health
Telephone: 301-435-0949
Email: FCOICompliance@mail.nih.gov

 


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