Litigation Research Compliance & Integrity

Our team is built to discretely and effectively conduct investigations into allegations bearing directly on an institution’s ability to conduct reputable and reliable research and recruit talent. We have extensive experience conducting internal investigations of all shapes and sizes, including relating to concerns of research misconduct, harassment/bullying, hostile workplace environment, IRB non-compliance, retaliation, “whistleblower” complaints, and/or false claims submitted to the government (i.e. False Claims Act) relating to federally-funded research.

With a strong background in civil litigation, in addition to white-collar criminal defense, we not only investigate an issue but also, advise our clients on how to proactively avoid risk for future litigation and government scrutiny. When needed, we also represent our clients in matters arising out of suspension of research access and/or credentialing decisions and institutional separations from Principal Investigators. We have also assisted clients in exploring and pursuing related defamation claims and obtain documents from government agencies through the Freedom of Information Act.

Representative Experience:

• Conducted a highly-sensitive internal investigation for premiere research institution into reports of sexual harassment and hostile work environment by senior Principal Investigator.
• Counseled Massachusetts university in addressing alleged violations of whistleblower protections under the False Claims Act based on internal investigation of research misconduct claims and related matters. Represented university in subsequent litigation of legal claims filed against the university in federal court.
• Conducted an internal investigation for a health/lifestyle app addressing allegations of federal grant mismanagement, submission of false claims to NIH, and retaliation.

We counsel institutions and individual researchers on unreported violations related to conflicts of interest/financial conflicts of interest, data privacy and cybersecurity, and foreign support and collaborations. Our team, many of whom have brought cases to trial before the United States Attorney’s Office and the Department of Justice, bring deep knowledge of law enforcement to help academic institutions and faculty members avoid finding themselves in the crosshairs of a government-led probe into potential noncompliance.

Our team can guide you through all phases, e.g. from receipt of subpoenas/Civil Investigative Demands through to self-disclosing concerns to the federal agencies. Our experienced attorneys routinely interface with regulators to ensure their clients, and most importantly their research, are not adversely impacted.

Representative Experience:

• Represented prominent scientist accused of failing to disclose financial conflicts of interest arising out of alleged participation in China’s Thousand Talent Program.
• Secured a favorable supervision agreement after defending research technician in research misconduct investigation at a large university and engaging in extensive negotiations with the DHHS Office of Research Integrity (ORI).
• Defended a university against a federal lawsuit alleging retaliation under the federal False Claims Act, based on the internal handling of an institutional research misconduct investigation.
• Successfully resolved workplace harassment/bullying investigation against tenured professor arising out of misconduct allegations by postdoctoral researchers and fellow faculty members.
• Represented principal investigator accused of inappropriately utilizing sub-award and violating compliance with Institutional Review Board protocol.  Following a full investigation, the client was found not responsible for any misconduct.
• Defended university diversity, equity, and inclusion (DEI) officer in institutional misconduct proceeding following accusations of plagiarism.
• Defended numerous Ph.D researchers suspected of engaging in research misconduct in institutional misconduct proceedings.

We can support your compliance and legal teams in helping protect your institution and your research. As external eyes, we bring a fresh perspective and work with internal legal and compliance professionals help to identify potential gaps in regulatory compliance and internal processes. Our team is experienced in reviewing and advising on the legality of sponsored research agreement, MTAs/DUAs, Indemnification Agreements, Service Agreements, Statements of Work, Amendments to Sponsored Research Agreements, Collaboration Agreements, and Sub-award Contracts.

Representative Experience:

• Co-drafted and assisted academic medical center’s research operations with revision and implementation with key compliance policies addressing topics including informed consent, conflict of interest, imports and exports, and human subject research protections.
• Supported Research Operations at large academic medical center and advise on the review and regulatory compliance pertaining to FDA-regulated clinical trials.