Notice Number: NOT-OD-09-072

Key Dates
Release Date: March 27, 2009

Issued by
National Institutes of Health (NIH)

Purpose

Effective July 1, 2009: The purpose of the Federal regulation at 42 CFR Part 50 Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought, is to promote objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct or reporting of research funded under Public Health Service (PHS) grants or cooperative agreements will be biased by any conflicting financial interest of an investigator. Specifically, 42 CFR Part 50.604(g)(2) requires that prior to spending any funds under an award, the Institution must report to the NIH the existence of any conflicting financial interests, but not the nature of the interest or other details found by the institution, and assure that the interest has been managed, reduced, or eliminated. In addition, for any interest that the Institution identifies as conflicting subsequent to the Institution’s initial report under the award, a report must be made and the conflicting interest managed, reduced, or eliminated, at least on an interim basis, within sixty days of that identification.

Beginning July 1, 2009, the NIH will require all Financial Conflict of Interest (FCOI) reports for grants and cooperative agreements to be submitted using the new electronic Research Administration (eRA) Commons FCOI Module. The FCOI Module is part of the eRA Commons, an online interface where grantees and Federal staff share information. The FCOI Module provides institutional users the ability to electronically prepare and submit FCOI reports through the eRA Commons. NIH encourages Institutions to begin using the FCOI Module now; however, Institutions may continue to submit FCOI reports directly to the Chief Grants Management Officer of the NIH awarding component through June 30, 2009.

The FCOI Module allows institutional users to 1) initiate and prepare FCOI reports, 2) electronically submit reports, 3) search and view FCOI reports previously submitted through the Commons, 4) edit or rescind submitted reports, and 5) create and access a history of institutional actions.

The institution’s Signing Official (SO) must log into eRA Commons and assign FCOI roles to Institutional Users before a FCOI report can be initiated.

This change in business process for the submission of FCOI reports does not affect other funding components within the Department of Health and Human Services (HHS) (e.g., AHRQ, CDC, FDA, etc.) or other Federal agencies. This feature may become available to other HHS funding components sometime in the future.

Additional information, resources, and a User Guide for the FCOI Module can be found on the eRA Commons page at: http://era.nih.gov/services_for_applicants/other/fcoi.cfm.

Inquiries

General questions concerning using the eRA Commons and the FCOI Module should be directed to the eRA Commons Helpdesk at:

eRA Service Desk
Web : http://ithelpdesk.nih.gov/eRA/ (Preferred method of contact)
Toll-free: 1-866-504-9552
Phone : 301-402-7469
TTY : 301-451-5939
Hours : Mon-Fri, 7a.m. to 8 p.m. Eastern Standard Time

General inquires about this Notice may be directed to:

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