Mark Barnes—named the 2019 Financial Times “Legal Innovator of the Year”—is a preeminent thinker and adviser to universities, medical centers, health care and life sciences companies, and investors. He has extensive experience guiding clients on legal issues related to research with humans and animals, research misconduct/research fraud, stem cell and genetic research, federal research grants and contracts, international research collaborations and “foreign influence” regulations, and data privacy.
Throughout his career, Mark has played a leadership role in the areas of clinical trials and data privacy. From 1999 to 2024, Mark 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 Brigham and Women’s Hospital and Harvard (MRCT Center), a project in which government, industry and academic medicine have partnered to improve the planning, conduct and regulation of multi-site, multi-national clinical trials. Much recent effort of MRCT Center 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, and to issues of national and international diversity in clinical trial planning and recruitment. The MRCT Center is now pioneering approaches to ensuring data integrity in the conduct of clinical trials and in bench science research, in reaction to increased public concerns about data integrity in science. Mark was a co-founder and founding 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.
Mark served as the executive vice-president of St. Jude Children’s Research Hospital, where, in 2005-6, he established a vaccine research 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 Harvard’s national primate center, the New England Primate Research 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. Mark now serves as honorary consul in the U.S. for the Republic of Botswana.
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, and in his current law practice, he is often called upon by clients to assist with solving problems in their international research projects. From 2018 until the present, Mark has represented a number of universities and academic medical centers in allegations of “foreign influence” and scientific espionage by faculty and post-doctoral fellows.
Since 1986, Mark has taught at a number of law schools, including Columbia, NYU, Harvard, Cardozo and Yale. The subjects he has taught 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. In 2019, Yale Law students selected Mark as the best teacher at YLS, for which he won the annual “Inspiring Yale” award.
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).