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
- Laura Gray, Assistant Grants Compliance Officer
- Brandon McCullough, Assistant Grants Compliance Officer
- Mary Catherine Robinson, Assistant Grants Compliance Officer
Joel Snyderman, Assistant Grants Compliance Officer
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.
|State & Local Governments||
45 CFR Part 75, Subpart C – Pre-Federal Award Requirements and Contents of Federal Awards §75.200-§75.217
45 CFR Part 75, Subpart D – Post Federal Award Requirements §75.300-§75.391
45 CFR Part 75, Subpart F at §75.501Also applicable to non-profit Hospitals
|Institutions of Higher Education|
|Non-Profits||45 CFR Part 75, Subpart E|
|Hospitals||45 CFR Part 75, Appendix IX||
45 CFR Part 75, Subpart F at §75.501 (h)-(k) and §75.216
Also applicable to for-profit Hospitals
|For-Profits||FAR 31.2 (48 CFR Subpart 31.2)|
|Foreign||As stated above for recipient type||Per NIH GPS, use 45 CFR Part 75, Subpart F at §75.501 (h)-(k) and §75.216|
- Notice of Award (NoA). Recipients must comply with all terms and conditions in the NoA. The Notice of Award may include both standard and special conditions (including specific requirements in the Funding Opportunity Announcement [FOA]) 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 is a term and condition for all NIH grant awards. By drawing funds from the payment system, the recipient indicates acceptance of an NIH award and its associated terms and conditions.
- NIH Guide for Grants and Contracts (for new requirements and policy changes)
- Additional Regulations:
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) regulation 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) 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.
- Guidance for Repayment of Grant Funds to the NIH in Chart Format (3/1/2018) – (MS Word - 28 KB) – Information for use by NIH award recipients when making repayments involving the financial recovery of NIH grant funds.
- NIH Guide to Grants and Contracts (for new requirements and policy changes)
- Compliance Inbox (GrantsCompliance@nih.gov) – DGCO staff monitor this inbox and provide guidance on compliance topics.
- Financial Conflict of Interest Page - Information on Objectivity in Research and Financial Conflict of Interest.
- FCOI Compliance Inbox (FCOICompliance@mail.nih.gov) - DGCO staff monitor this inbox and provide guidance on FCOI-related inquiries.
- All About Costs: A Post-Award Primer (05/2017) - (PowerPoint - 2.49 MB) - 2019 NIH Regional Seminar in Baltimore, MD
- Common Compliance Pitfalls and Strategies for Success (05/2017) - (PowerPoint - 2.33 MB) - 2019 NIH Regional Seminar in Baltimore, MD
- Presentations on Financial Conflicts of Interest are found on the OER Financial Conflicts of Interest page.
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.
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
For more information visit: http://oig.hhs.gov/
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/Allegations.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