Federal research grant awardees are subject to strict statutory and regulatory requirements and compliance obligations. The penalties for noncompliance with these requirements and obligations can be severe—such as repayment responsibilities, civil liability, criminal prosecution, and/or exclusion from future federal funding opportunities.
At Epstein Becker Green, we are experienced at handling complex matters stemming from federal grants to the health care and life sciences sectors. We help clients—academic medical centers, universities, colleges, research institutions, and other entities that receive federal funding for research work—maintain compliance with the terms and obligations of their awards, conduct research-related internal investigations, and respond to government audits, investigations, and enforcement actions. Our clients value our in-depth knowledge of the legal and regulatory underpinnings and practical realities attaching to federal funding for their research projects and our experience in handling sensitive internal investigations and reports to the appropriate agencies.
Our strengths are highlighted in the following related areas, as further detailed below:
- Compliance Counseling
- Internal Investigations Related to Research
- Government Audits, Investigations, and Enforcement Actions
- Integrated Legal and Consulting Services
Federal awards are an important source of financial support for research institutions’ missions. However, accepting federal funding comes with unique responsibilities. Our group advises on complying with the terms and conditions of federal awards, the applicable Notice of Award, applicable grants policy statements, and all federal statutes, regulations, and policies relevant to recipients of federal funds, including, but not limited to, the uniform administrative requirements, cost principles, audit requirements, the Common Rule, the Public Health Service Policies on Research Misconduct, and federal financial conflict of interest regulations. We have experience preparing and implementing policies and procedures relating to time and effort reporting, the proper allocation of charges to award projects, the reporting of “Other Support” and foreign components, research misconduct, and conflict of interest management, among other things. Clients seek our counsel on structuring federally funded collaborative research agreements, consortia, and networks. We rely on our experience working with academic medical centers, universities, and other research stakeholders, among others, in thinking strategically about these collaborative arrangements.
Internal Investigations Related to Research
Our team is regularly asked to conduct or guide internal reviews and investigations relating to allegations of research misconduct (both within the strict meaning of the federal policy on research misconduct, with associated reporting to the Office of Research Integrity and similar enforcement bodies, and the penumbral definitions of particular institutional policies). In connection with such internal reviews and investigations, we counsel and assist clients with the sequestration and preservation of evidence and the conduct of inquiries and investigations in accordance with the Public Health Service Policies on Research Misconduct. We also assist clients with internal reviews and investigations concerning research-related conflicts of interest, the misuse of federal funds, and other federal grant compliance matters, including in connection with professional integrity matters (including, but not limited to, bullying, harassment, hostile work environment, violations of Title VI of the Civil Rights Act of 1964, etc.) and practices to prevent undue foreign influence. Our extensive experience with internal compliance investigations has accustomed us to the special challenges posed by internal investigations that implicate differing regulatory frameworks and internal offices and that require skillful coordination among parallel fact-finding systems and procedures. We leverage our experience managing government enforcement matters to the extent that voluntary self-disclosures through the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) protocol or otherwise are indicated.
Government Audits, Investigations, and Enforcement Actions
Government enforcement officials are focusing heavily on research grant fraud and research misconduct as an administrative, civil, and criminal enforcement priority. Therefore, federal grant recipients have increasingly become the target of government audits, investigations, and enforcement actions.
Our team prepares clients for government audits and investigations, provides advice during such audits and investigations, and assists clients in addressing and resolving potential findings to minimize exposure. We help clients respond to subpoenas and investigative demands by the OIG, the U.S. Department of Justice, U.S. Attorneys, and the FBI. Clients also count on us to defend them in False Claims Act litigation and to manage and defend cases subject to parallel government investigations under civil, criminal, and administrative laws.
Integrated Legal and Consulting Services
We have the ability to access complementary non-legal services that are critical to successful outcomes in grant-related investigations and enforcement actions. Using the technical, financial, and forensic services of consultants from our affiliate EBG Advisors, Inc., we bring together under our umbrella federal grants accounting services and systems review, as well as scientific forensic analyses relevant to misconduct and other noncompliance matters, including scientifically dependent materiality analyses in connection with False Claims Act reviews in the research grants space. We are also positioned to provide external research integrity services, such as serving as the designated research integrity officer for clients needing infrastructure support for various research noncompliance proceedings.