Grants Compliance & Oversight
Compliance Requirements At A Glance
Recipients of NIH grant funds must comply with all applicable Federal statutes (such as those included in appropriations acts) regulations, and policies. Additionally, they must also comply with their institutional requirements. The table below summarizes the Federal administrative requirements, cost principles and audit requirements applicable to NIH grants.
- Notice of Award (NoA). Grantees must comply with all terms and conditions in the NoA. The Notice of Award may include both standard and special conditions that are considered necessary to attain the grant's objectives, facilitate post award administration of the grant, conserve grant funds, or otherwise protect the Federal Government's interests.
- NIH Grants Policy Statement - The NIHGPS (revised 12/03) is a term and condition for all NIH grant awards. By drawing funds from the payment system, the grantee indicates acceptance of an NIH award and its associated terms and conditions.
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NIH Compliance Activities
The Division of Grants Compliance and Oversight (DGCO) in the Office of Policy for Extramural Research Administration (OPERA), Office of Extramural Research (OER), NIH, is the focal point to advance external compliance with policy and legislative mandates and enhance compliance oversight by recipient institutions.
NIH and its recipient institutions share responsibility for compliance and oversight to ensure good stewardship of Federal funds. The relationship between NIH and its grantees is predicated on trust. Grantees are expected to properly administer sponsored activities and comply with applicable regulations and policies.
NIH Site Visits and Targeted Site Reviews
- Proactive Compliance Site Visits (PCSV)s:
DGCO initiated a series of site visits in FY 2000 to:
- assess institutional understanding of Federal policies and regulations
- minimize or eliminate areas of non-compliance
- nurture partnerships between NIH and its grantee institutions
The site visits are not designed to address specific problems. They are not viewed as investigations or audits. Rather, they are conducted in a proactive mode, intended to facilitate dialogue regarding NIH policies in a non-crises, non-adversarial manner.
Proactive Compliance Site Visits FY 2000-FY 2004: A Compendium of Findings and Observations (11/02/2002), Updated: May 30, 2007. (MS Word - 74.0 KB) - The purpose of this document is to summarize observations and comments from the NIH PCSVs and to serve as an education al tool to promote awareness of and compliance with NIH policies.
- Targeted Site Reviews:
The Targeted Site Review (TSR) program is an NIH initiative that focuses specifically on compliance with Financial Conflict of Interest (FCOI) regulations (42 CFR Part 50 Subpart F) as they pertain to NIH grants. The TSRs are part of NIH's oversight responsibilities and were developed to determine if (1) grantee institutions are fully and correctly implementing the FCOI regulation, and (2) reporting requirements are being met.
Observations from NIH's FY2006 Targeted Site Reviews on Financial Conflict of Interest (02/15/2007) - (MS Word - 53 KB) - The purpose of this document is to provide the wider grantee community with observations made during the TSRs and to serve as a resource in evaluating the implementation of the Federal FCOI regulations.
NIH’s Pilot Compliance Program
NIH Guide Notice (10/25/2007) - Pilot Compliance Program—Financial Conflict of Interest Requirements for All NIH-Supported Institutions. The purpose of the pilot compliance program is 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. This pilot program is an outgrowth of the NIH Targeted Site Reviews on FCOI that focused on institutional compliance with the FCOI regulation.
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Conflict of Interest Information
NIH Presentations on Compliance
Note: Some terminology used in these presentations may have changed but the compliance principles have not. Please refer to the Glossary on the NIH Grants Policy for current terms and definitions.
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Reporting Compliance Concerns
If you have questions or concerns about an NIH grant you may consider contacting:
- Your institutions' Office of Sponsored Research or other responsible office
- The NIH Chief Grants Management Officer (GMO) listed on the Notice of Award (NoA) for the Institute or Center that funded the grant
- The Division of Grants Compliance and Oversight, (DGCO) Office of Policy for Extramural Research Administration (OPERA), Office of Extramural Research (OER) at GrantsCompliance@nih.gov
To make a formal allegation about an NIH funded grant or cooperative agreement contact either:
HHS OIG Hotline
Matters involving fraud, waste and mismanagement in any Department of Health and Human Services program(s), including NIH funded grants or cooperative agreements, should be reported to the Office of Inspector General (OIG). The OIG maintains a hotline which offers a confidential means for reporting vital information.
Contacting the HHS OIG Hotline: http://oig.hhs.gov/hotline.html
For more information visit the HHS OIG Web Page
NIH Office of Management Assessment, Division of Program Integrity
You may also report allegations of fraud, waste, and abuse involving NIH funded grants or cooperative agreements to the NIH Office of Management Assessment/Division of Program Integrity:
National Institutes of Health
Office of Management Assessment
Division of Program Integrity
6011 Executive Blvd. , MSC 7669
Rockville , MD 20852
Phone: (301) 496-5586
Fax: (301) 402-0548
For more information visit http://oma.od.nih.gov/pi/dpi.html