NIH Announces the Posting of a Checklist for Policy Development related to the 2011 revised regulation on Promoting Objectivity in Research (Financial Conflict of Interest)

Notice Number: NOT-OD-12-103

Key Dates
Release Date: April 18, 2012

Issued by
National Institutes of Health (NIH)

Purpose

This Notice announces the availability of a checklist for policy development which provides an overview of the requirements of the 2011 revised Financial Conflict of Interest (FCOI) regulation, Promoting Objectivity in Research (Title 42, Code of Federal Regulations, Part 50, Subpart F) for grants and cooperative agreements. The document serves as a checklist resource when developing, revising or reviewing an Institution’s FCOI policy to determine compliance with all regulatory requirements. Institutions are required to develop an FCOI policy or revise an existing policy that will be maintained and enforced, and that meets or exceeds the regulatory requirements.  The Institution 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 policy publicly accessible as described in 42 CFR part 50.604(a).     
   
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 checklist for policy development to assist Institutions as they implement the requirements of the 2011 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 fcoicontracts@mail.nih.gov

The checklist for policy development may be accessed on the Office of Extramural Research, Financial Conflict of Interest Page under “Resources” at:  http://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: FCOICompliance@mail.nih.gov


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