Notice Number: NOT-OD-12-080

Key Dates
Release Date: March 9, 2012

Issued by
National Institutes of Health (NIH)

Purpose

This Notice announces the availability of a web-based tutorial which addresses the main requirements of the 2011 revised regulation, Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought at Title 42, Code of Federal Regulations, Part 50, Subpart F for grants and cooperative agreements (commonly known together with the revised regulation for contracts, as the Financial Conflict of Interest [FCOI] regulations).   The tutorial highlights the key Federal requirements for which the Investigator (through the Institution’s implementation of the regulation), the Institution, and the NIH, are accountable under the FCOI regulation; however, it is not intended in any way to substitute for the comprehensive review and implementation of all regulatory requirements. 

Background

To address the increasing complexities of the financial interests held by biomedical and behavioral researchers and the resulting interactions among Government, research Institutions, and the private sector, the Public Health Service (PHS) and the Office of the Secretary of the U.S. Department of Health and Human Services (HHS) published revised regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought for grants and cooperative agreementsand Responsible Prospective Contractors for contracts.  The regulations establish new standards and clarify previously established standards to be followed by Institutions that apply for or receive research funding from PHS Awarding Components, including the NIH, for grants, cooperative agreements, and research contracts.  The primary goal of the regulations is to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants, cooperative agreements and contracts will be free from bias resulting from Investigator financial conflicts of interest.  

As part of NIH’s continuing efforts to provide useful resources for extramural recipients, NIH developed this tutorial to support institutional training programs regarding the implementation of the revised FCOI regulation for NIH grants and cooperative agreements.   Questions regarding the applicability and/or compliance with the revised contract regulation (45 CFR Part 94) should be directed to [email protected]. 

The tutorial may be accessed on the Office of Extramural Research, Financial Conflict of Interest Web Page under “Resources” at:  https://grants.nih.gov/grants/policy/coi/index.htm. 

Inquiries

For general inquiries on this Notice or other FCOI-related matters, contact:

Division of Grants Compliance and Oversight
Office of Policy for Extramural Research Administration
Office of Extramural Research
National Institutes of Health
6705 Rockledge Drive, Suite 350
Bethesda, MD  20892
Telephone: (301) 435-0949
FAX:  (301) 435-3059
Email: [email protected]