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 and cooperative agreements.

Recipients Also Need to Comply With

• 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:
  • 42 CFR Part 52 - Grants for Research Projects
  • 45 CFR Part 46 - Public Welfare, Protection of Human Subjects
  • 2 CFR Part 376 (2 CFR Part 180) - Debarment and Suspension
  • 42 CFR Part 50, Subpart F - Financial Conflict of Interest (FCOI)

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) 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.

Conflict of Interest Information

• Financial Conflict of Interest Page - Information on Objectivity in Research and Financial Conflict of Interest.
• FCOI Compliance Inbox ([email protected]) - DGCO staff monitor this inbox and provide guidance on FCOI-related inquiries.