Mark Barnes, LLM, JD, BA
Ropes & Gray, LLP
Yale Law School
Co-Chair, Multi-Regional Clinical Trials (MRCT) Center
Brigham & Women's Hospital and Harvard University
Mark focuses his practice in the areas of research, advising clients throughout higher education and the health care industry, including pharmaceutical companies, medical device manufacturers, hospitals, and universities. He has extensive experience in legal issues related to research with humans and animals, stem cell and genetic research, research grants and contracts, research misconduct, and international research. Mark also frequently advises clients on clinical trials compliance, Medicare reimbursement, False Claims Act issues, and medical privacy.
Mark was a partner at Ropes & Gray from 2001-2008, before leaving to serve as Executive Vice President and Chief Administrative Officer at St. Jude Children's Research Hospital. Before returning to the firm, Mark also served as Senior Associate Provost for Research and Chief University Research Compliance Officer at Harvard University. In these positions at Harvard, he supervised the University’s sponsored research operations and was responsible for the full range of research policy and compliance issues, including human subjects research, research misconduct, export controls, conflicts of interest, and grants and contracts compliance.
Mark has particular expertise in establishing legal structures and operational plans for international service and research projects, especially in emerging economies. For St. Jude, he established a vaccine study center in the Eastern Highlands of Zimbabwe, in collaboration with Africa University. While at Ropes & Gray, he started and served as the first executive director of Harvard’s extensive PEFPAR-funded AIDS treatment programs in Nigeria, Tanzania and Botswana, and later served as the chair of the 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.
Since 1986, Mark has taught at a number of law schools, including Columbia, NYU, Cardozo, Brooklyn, and Harvard. The subjects he has covered include health care law and finance, public health law, the law of human subjects research, occupational health law, and managed care law. He currently holds a faculty position at Harvard Law School, where he teaches health care law and finance and the law of federal grants and contracts, and at the Yale School of Medicine, where he teaches the history of the regulation of the medical profession, medical malpractice, and medical privacy.
Mark’s diverse legal background also 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. In 1993, he served as legal advisor to the health reform efforts at the Clinton White House, and has been president of the New York State Bar Association Health Law Section (2007-2008).