Notice Number: NOT-OD-08-010

Key Dates
Release Date: October 25, 2007

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

The purpose of this Notice is to announce that the NIH is beginning a pilot compliance program to assess institutional implementation and compliance with the regulatory requirements of the Federal financial conflict of interest (FCOI) in research 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.

This pilot program is an outgrowth of the NIH Targeted Site Reviews on FCOI that focused on institutional compliance with the FCOI regulation. As a result of the site reviews, an observational document was developed for use by the wider grantee community as a resource for evaluating implementation of the regulation. It contains a discussion of compliance issues and suggestions for implementation.

We will select a number of institutions for review by requesting a copy of their FCOI policy and related information. As with the Targeted Site Reviews, if areas of noncompliance are noted institutions will be expected to formally address and resolve the issues with the NIH Division of Grants Compliance and Oversight. The results of the pilot program will be shared with the NIH research community as part of our continuing educational efforts to improve and enhance compliance with FCOI requirements. The continuation of this program will be based on an assessment of this pilot.

Inquiries

Division of Grants Compliance and Oversight
Office of Policy for Extramural Research Administration, OER
National Institutes of Health
Telephone: 301-435-0949
Email: grantscompliance@od.nih.gov