Notice Number: NOT-OD-11-121

Key Dates
Release Date: September 30, 2011

Issued by
National Institutes of Health (NIH), Office of Extramural Research (https://grants.nih.gov/grants/oer.htm)

Purpose

This Notice announces the availability of new Frequently Asked Questions (FAQs) related to 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.

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 and Responsible Prospective Contractors (commonly known as the Financial Conflict of Interest (FCOI) regulations).  These 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 National Institutes of Health (NIH), for grants, cooperative agreements, and research contracts.  The 2011 revised regulations were written to increase accountability, add transparency, enhance regulatory compliance and effective Institutional management of Investigators’ financial conflicts of interest, and strengthen NIH’s compliance oversight.  The primary goal is to promote objectivity 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, we compiled answers to the most frequently asked questions regarding the implementation of the revised regulation for grants and cooperative agreements.  The purpose of the FAQs is to clarify issues that may arise and will assist Institutions as they develop and/or revise their FCOI policy that meets or exceeds the requirements of the regulation; the FAQs pertain only to grants and cooperative agreements.  Questions regarding the applicability and/or compliance with the revised contract regulation provided at 45 CFR Part 94 should be directed to [email protected]. 

We plan to add additional FAQs and provide an updated Web-based tutorial that will address the requirements of the revised regulation in the near future. The FAQs may be accessed on the Office of Extramural Research, Conflict of Interest Page at:  https://grants.nih.gov/grants/policy/coi/index.htm. 

Inquiries

Grants:

Division of Grants Compliance and Oversight
Office of Policy for Extramural Research Administration, OER
National Institutes of Health
Telephone: 301-435-0949
Email: [email protected]