Grants Compliance & Oversight

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Report Fraud at oig.hhs.gov

 
About Grants Compliance and Oversight

This site provides Federal requirements, guidelines and resources for the extramural community involving grants compliance. The information provided on this website is designed to assist the extramural community in understanding the recipient's responsibility for establishing and maintaining the necessary processes to monitor its compliance with Federal requirements, ensuring NIH-funded projects are conducted in accordance with the approved application and budget and the terms and conditions of award and informing NIH of any problems or concerns regarding compliance.

Division of Grants Compliance and Oversight (DGCO) at NIH 
The Division of Grants Compliance and Oversight (DGCO) is the focal point to advance external compliance with policy and legislative mandates and enhance compliance oversight by recipient institutions. The DGCO also ensures and evaluates the efficient and effective management of extramural resources.

Director:  Diane W. Dean 

Staff:

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 and cooperative agreements.

Summary of Federal Requirement References
Recipient Type
Administrative Requirements
Cost Principles
Audit Requirements
State & Local Governments

45 CFR Part 75, Subpart C Link to Non-U.S. Government Site - Click for Disclaimer  – Pre-Federal Award Requirements and Contents of Federal Awards §75.200-§75.217

 

AND

 

45 CFR Part 75, Subpart D Link to Non-U.S. Government Site - Click for Disclaimer  – Post Federal Award Requirements §75.300-§75.391
 

45 CFR Part 75, Subpart E Link to Non-U.S. Government Site - Click for Disclaimer

See also §75.416 and §75.417

45 CFR Part 75, Subpart F Link to Non-U.S. Government Site - Click for Disclaimer  at §75.501

Also applicable to non-profit Hospitals

 

Institutions of Higher Education

45 CFR Part 75, Subpart E Link to Non-U.S. Government Site - Click for Disclaimer

See also §75.418 and §75.419
Non-Profits  45 CFR Part 75, Subpart E Link to Non-U.S. Government Site - Click for Disclaimer
Hospitals 45 CFR Part 75, Appendix IX Link to Non-U.S. Government Site - Click for Disclaimer

45 CFR Part 75, Subpart F Link to Non-U.S. Government Site - Click for Disclaimer  at §75.501 (h)-(k) and §75.216

Also applicable to for-profit Hospitals

For-Profits FAR 31.2 (48 CFR Subpart 31.2Link to Non-U.S. Government Site - Click for Disclaimer
Foreign As stated above for recipient type Per NIH GPS, use 45 CFR Part 75, Subpart F Link to Non-U.S. Government Site - Click for Disclaimer  at §75.501 (h)-(k) and §75.216

 

Recipients also need to comply with:
 
NIH Compliance Activities

NIH and its recipient institutions share responsibility for compliance and oversight to ensure good stewardship of Federal funds. The relationship between NIH and its recipients is predicated on trust. Recipients are expected to properly administer sponsored activities and comply with applicable regulations and policies.

NIH Site Visits and Targeted Site Reviews

DGCO is involved in various site visit activities to advance compliance oversight at recipient institutions. Types of site visits and reviews include:

  • Proactive Compliance Site Visits (PCSVs): PCSVs assess institutional understanding of Federal policies and regulations, minimize or eliminate areas of non-compliance, and nurture partnerships between NIH and its recipient institutions. These 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.
  • 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 Link to Non-U.S. Government Site - Click for Disclaimer ) as they pertain to NIH grants. The TSRs are part of NIH's oversight responsibilities and were developed to determine if (1) recipient institutions are fully and correctly implementing the FCOI regulation, and (2) reporting requirements are being met.

Proactive Compliance Oversight Program

DGCO has conducted various compliance oversight activities for FCOI over the years. In particular, the Proactive FCOI Compliance Oversight Program is a component of NIH’s oversight responsibilities to assess institutional implementation assure recipient compliance with the 2011 revised Federal financial conflict of interest regulation. Under this program, DGCO assists recipients with developing and implementing their FCOI policies through reviewing publicly accessible FCOI policies and providing technical assistance. This program was instituted in 2012 (see: NOT-OD-12-159) and continues as an active program to date.

 
Compliance Resources  
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 website for current terms and definitions.

 

 
Compliance Questions?

If you have questions or concerns about an NIH award you should first contact:

  • Your institution’s Office of Sponsored Research or other responsible office. Recipient organizations are responsible for ensuring compliance within the organization, including compliance with Federal requirements and compliance with the recipient’s internal policies.
  • The Grants Management Specialist listed on the Notice of Award (NoA) from the NIH Institute or Center that funded the award.
  • 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. DGCO staff monitor this inbox and provide guidance on compliance topics.

Reporting Compliance Concerns

To make a formal allegation about an NIH-funded grant or cooperative agreement, contact:

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/fraud/report-fraud/index.asp Link to Non-U.S. Government Site - Click for Disclaimer

For more information visit: http://oig.hhs.gov/ Link to Non-U.S. Government Site - Click for Disclaimer

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) 480-1204

Report an allegation: https://oma.od.nih.gov/DPI/Pages/Submit-an-Allegation.aspx

For more information visit: https://oma.od.nih.gov/DPI/Pages/Home.aspx

HHS Office of Research Integrity

Matters regarding research integrity (i.e., plagiarism, falsification, or fabrication) should be reported to the Office of Research Integrity (ORI):

U.S. Department of Health and Human Services
Office of Research Integrity
The Tower Building
1101 Wootton Parkway, Suite 750
Rockville, Maryland 20852

AskORI@hhs.gov

For more information visit http://ori.hhs.gov/ Link to Non-U.S. Government Site - Click for Disclaimer