Health care and higher education counsel Leslie Thornton advises colleges and universities, academic medical centers, pharma and device manufacturers, and other health- and research-focused entities, with particular focus on scientific research and development matters across human, animal, bench, and applied research; data privacy and security; and digital health.
Leslie provides regulatory, compliance, and transactional advice on federal funding issues, including recent federal award terminations and associated administrative appeals and litigation, executive orders with ties to federal funding, and proposed revisions to the Uniform Guidance; research misconduct; government inquiries and investigations into research activities; human and animal research protections; design/strategy and negotiation of bespoke research collaborations; inter-institutional research disputes; tech-based health and research initiatives (including remote/app-based research, clinical monitoring, online tracking, and artificial intelligence/machine learning); conflicts of interest; and health privacy in research. Leslie provides these supports for both U.S. and ex-U.S. research activities.
Before rejoining Ropes & Gray in 2021, Leslie was senior health privacy counsel at Apple Inc., supporting the company’s health research initiatives and working directly with business and engineering teams to design privacy solutions for related products and services.
Prior to law school, Leslie completed doctoral studies at the Johns Hopkins Bloomberg School of Public Health. She has experience as an academic researcher in both public health and psychiatric settings, including extensive training in advanced statistical and epidemiologic methods. With this background, Leslie understands the day-to-day experience of researchers, research staff, and research administrators, and uses that knowledge base to help clients find practical solutions to challenging legal and compliance issues.
Experience
- Assisting clients in challenging the unprecedented mass terminations of federal grants and cooperative agreements, including through administrative appeals and litigation, and in interpreting ever-evolving federal guidance and proposed changes to regulation governing such federal funding assistance (e.g., recent Office of Management and Budget proposed revisions to the Uniform Guidance at 2 CFR Part 200).
- Conducting internal reviews of clients’ clinical research, health equity, and compliance activities to assess compliance with federal civil rights law, including Title VI, and to determine potential risks associated with acceptance of federal financial assistance.
- Advising a wide range of clients in their responses to various requests for information from, and more involved inquiries and investigations led by, federal agencies that support or oversee research activities, including the National Institutes of Health, National Science Foundation, Centers for Disease Control and Prevention, U.S. Food and Drug Administration, U.S. Department of Agriculture, and others.
- Leading internal review of the entire portfolio of studies overseen by a principal investigator, in coordination with other client consultants, including review of clinical research documentation, and coordinating reporting of review results to cognizant oversight and regulatory bodies (institutional review boards, Office for Human Research Protections).
- Advising on data sharing requirements for federally funded research, including responding to individual requests for data, dissemination of study results/study data, and requirements for posting data to public repositories.
- Leading assessments, inquires, and investigations for universities and academic medical centers into allegations of research misconduct (falsification or fabrication of data, or plagiarism).
- Advising clients in interpreting and implementing federal funding requirements as set forth in the Uniform Guidance and agency-specific guidance (e.g., NIH Grants Policy Statement), both pre- and post-award.
- Drafting and negotiating research agreements that create novel research structures to align parties’ research capabilities, capacities, and operations under an integrated framework, requiring alignment of ethical review bodies and reliance interests, human and animal research protection programs, data privacy and security, sponsored programs administration, intellectual property, and employment.
- Assessing clients’ conflict of interest and conflict of commitment review structures and proposing remediation steps for identified gaps or compliance issues, including revisions to policies and procedures.
- Leading international review of human subjects research requirements for various digital health studies across more than 50 countries.
- Advising on application of generative artificial intelligence (GenAI) tools to support client-developed workforce tools, including benchmarking the application of GenAI to specific company functions (e.g., medical affairs) and helping to set appropriate controls when standing up such novel tools in a highly regulated health care environment (data privacy, consumer protection, corporate practice of medicine, anti-kickback).
- Conducting regulatory diligence for numerous private equity and life sciences clients regarding their planned investments in companies that participate in the research enterprise, including pharmaceutical and device companies, contract research organizations, institutional review boards, and clinical trial support software.
- Advising pro bono clients, including evaluating case files for the Innocence Project’s Intake Department and representing persons seeking federal disability benefits.