Mark Barnes—named the 2019 Financial Times “Legal Innovator of the Year”—is a preeminent thinker and adviser to health care and life sciences companies, academic institutions and investors. He has extensive experience guiding clients on legal issues related to research with humans and animals, stem cell and genetic research, research grants and contracts, research misconduct, international research collaborations and “foreign influence” regulations, and data privacy. Using his background as a former senior official in the New York City and New York State Departments of Health in the 1980s and early 1990s, Mark has been assisting academic and industry clients to navigate critical legal issues related to the COVID-19 pandemic, including developing workplace policies in line with public health guidance and clinical trial guidelines in the context of the pandemic.
Throughout his career, Mark has played a leadership role in the areas of clinical trials and data privacy. Since the late 1990s and to the present, Mark has served, first as a member and later as a subcommittee chair, of the HHS Secretary’s Advisory Committee on Human Subjects Protections (SACHRP), formerly known as the HHS National Human Research Protections Advisory Committee (NHRPAC). In 2012, with Dr. Barbara Bierer, Mark started, and continues to serve as faculty co-chair of, the Multi-Regional Clinical Trials Center of Harvard University and Brigham and Women’s Hospital (MRCT Center), a project designed to improve the planning, conduct and regulation of multi-national clinical trials, with a special emphasis on trials in the emerging economies. Much recent effort of MRCT Center, which Mark has led, has been devoted to clarifying the secondary research uses of personal data under the jurisdiction of the EU General Data Privacy Regulation (GDPR), about which Mark has published extensively. Mark is a co-founder and board member of Vivli, a nonprofit that collects and shares participant-level anonymized data from clinical trials conducted by life sciences companies, hospitals and academic research institutions. Vivli is currently creating a special COVID-19 platform to allow for use in COVID-related data research.
Mark served as the executive vice-president of St. Jude Children’s Research Hospital, where, in 2005-6, he established a vaccine study center in the Eastern Highlands of Zimbabwe, in collaboration with Africa University. At Harvard University, Mark was the university-wide senior research officer and associate provost for research, and from 2008 to 2015 taught health care law and public health law at the Harvard Law School. During a period of regulatory crisis in 2012, Mark was the acting director of the Harvard Primate Center.
Mark has particular experience in establishing legal structures and operational plans for international service and research projects, especially in emerging economies, and he served as the first executive director of Harvard’s extensive PEPFAR-funded AIDS treatment programs in Nigeria, Tanzania and Botswana, later chairing the Harvard oversight committee for that project. At Harvard, he worked with faculty from across the University to establish service, demonstration and research projects throughout the world, including China, Viet Nam, Colombia, Peru, and the Gulf States, among other countries. From 2018 until the present, Mark has represented a number of universities and academic medical centers in allegations of “foreign influence” and academic espionage by faculty and post-doctoral fellows.
Since 1986, Mark has taught at a number of law schools, including Columbia, NYU, Harvard, and Yale. The subjects he has covered include health care law and finance, public health law, the law of human subjects research, occupational safety and health law, and managed care law. Since 2014, at Yale Law School, he has taught health care law and finance, public health law, and the law of biomedical research and is an affiliated faculty of the YLS Solomon Center for Health Law and Policy.
Mark’s diverse professional background includes senior policy and administrative positions at the New York State Department of Health and the New York City Department of Health, where, among other duties, he directed the Ryan White CARE Act program providing medical, substance abuse and mental health treatment to New Yorkers living with HIV/AIDS. and in 1993, was a senior legal advisor to the health reform efforts at the Clinton White House. Mark was president of the New York State Bar Association Health Law Section (2007-2008).