About me
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. 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 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. The MRCT Center is now pioneering approaches to ensuring data integrity in the conduct of clinical trials and bench science research, in reaction to increased public concerns about data integrity in science. Mark was 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.