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 do not stop at investigating an issue, but 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.

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.
• Advised academic medical center addressing and responding to various matters involving allegations of potential data fabrication/falsification in connection with federally-regulated and federally-funded research.
• 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.
• Counseled Research Integrity Office of a Massachusetts university in responding to internal complaints of research misconduct and misuse of federal funding from the National Science Foundation.
• 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 favorable dispositions with the DHHS Office of Research Integrity (ORI), on behalf of various individual researchers facing significant debarment from federal funding after an institutional finding of research misconduct.
• Negotiated and secured supervisory plan for Research & Development (R&D) company pursing commercialization of therapies to manage participation of principal who had entered into a Voluntary Supervision Agreement with ORI based on allegations of research misconduct.
• Advised community health center on cyberattack/phishing incidents and interfaced with Office of Civil Rights and Massachusetts Attorney General’s Office, avoiding sanction or monetary penalties.
• Advised and responded to Form FDA 483 letter on behalf of academic medical center hosting FDA- regulated trial.

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.

Our team offers our unique perspective in serving as non-affiliated members of institutional compliance committees, such as Institutional Animal Care and Use Committee (“IACUC”), Conflict of Interest (“COI”) committees, and Embryonic Stem Cell Research Oversight (“ESCRO”) and can partner with a variety of internal committees and boards to enhance oversight.

Representative Experience:

• Serve as a continuous member of hospital/academic medical center’s internal Conflict of Interest Committee and provide legal advice on matters coming before the Committee.
• Drafted new conflict of interest policies for a non-profit research foundation and addressed related matters involving patient solicitation.
• Serve as a regular, non-affiliated member of University’s IACUC committee and advise on routine matters coming before the Committee.
• 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.
• Support Research Operations at large academic medical center and advise on the review and regulatory compliance pertaining to FDA-regulated clinical trials.