Mark Barnes advises clients throughout higher education and the health care industry, including pharmaceutical companies, medical device manufacturers, biotechnology firms, IT companies, 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, international research and data privacy.
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, 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.
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 at Harvard University.
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.
In 2012, during a period of intense regulatory scrutiny, Mark served as the managing director of Harvard’s Primate Research Center. Mark has particular experience 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, Harvard, and Yale. 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 Yale Law School, where he teaches health care law and finance and public health law, 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).
- LLM, Columbia University School of Law, 1991
- JD, Yale Law School, 1984
- BA, Bennington College, 1981
- Massachusetts, 2013
- New York, 1986
- Connecticut, 1985
PROFESSIONAL & CIVIC ACTIVITIES :
- Member, National Institute of Health’s National Heart, Lung and Blood Institute’s Clinical Data Science Institutional Review Board
- Co-Chair, Subcommittee on Harmonization of Research Regulations, HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP)
- Member, Ethics Working Group of NIH HIV Prevention Trials Network
- Co-Chair, Multi-Regional Clinical Trials Center at Harvard and Brigham & Women’s Hospital (MRCT Center)
- Visiting Lecturer, Yale Law School
- Lecturer, Department of Internal Medicine, Yale School of Medicine
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