PRIM&R Service Award for 2023

Mark Barnes, JD, LLM

PRIM&R Service Award

The PRIM&R Service Award was created by the PRIM&R Board of Directors in 2021 to recognize individuals who have provided significant timely or timeless service to the human subjects protections or animal care and use communities that are at the core of PRIM&R. That service could be in teaching, mentorship, innovation, leadership, engagement, program improvement, or research. The intention of the award is to recognize the many and varied ways that people can have a significant impact on the field—awardees may be recognized for their long-time commitment or for one-time innovations and projects, whether early in their careers or after a lifetime of service.

Mark Barnes



PRIM&R is pleased to present Mark Barnes, JD, LLM, with the 2023 PRIM&R Service Award for being, in the words of his nominator, “an inspiring and influential leader in the research field.”  

During his 40-year career, Mark has been an unparalleled leader within the research community, in particular in the areas of research misconduct, human and animal research oversight, health care law, conflict of interest, international research, and data privacy.  

Mark is a partner in the Ropes & Gray LLP health care and life sciences practice based in Boston, Massachusetts. Since the late 1990s, Mark has been actively involved with Department of Health and Human Services (HSS) Secretary’s Advisory Committee on Human Subjects Protections (SACHRP), and before that, the National Human Research Protections Advisory Committee (NHRPAC), serving first as committee member, and for 20 years, as a subcommittee co-chair. Mark leads the intensive work of crafting the committee’s substantive recommendations to the Office for Human Research Protections and the Assistant Secretary of Health, HHS, on topics including broad consent, payment to research subjects, data sharing, and many more.   

Since its inception in 2009, Mark has served as faculty co-director, along with along with Barbara E. Bierer, MD, of the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center), a collaborative research and policy center dedicated to improving the integrity, safety, and rigor of global clinical trials, by engaging diverse stakeholders to define emerging issues and to create and implement ethical, actionable, and practical solutions. Mark also co-founded the MRCT Center’s regulatory science project in 2009.      

The MRCT Center has, over its 14-year existence, produced and made freely available a variety of trainings and resources on topics from good clinical practice and return of research results, to diversifying clinical trials and improving health literacy. More recently, Mark has devoted much of his time and energy to clarifying the secondary research uses of personal data under the jurisdiction of the EU General Data Privacy Regulation (GDPR).  

Mark’s nominee praised his “dedication to teaching and fostering talent” among both his students and his colleagues. Since 1986, Mark has taught health care law and finance, public health law, the law of human subjects research, occupational safety and health law, and managed care law at a number of the nation’s most prestigious law schools, including Columbia, NYU, Harvard, and Yale. Since 2014, Mark has been an affiliated faculty member at Yale Law School’s Solomon Center for Health Law and Policy. At Ropes & Gray, Mark is known to be a generous and supportive mentor to more junior associates. Mark regularly shares his deep knowledge and experience with many in the PRIM&R and wider research and ethics oversight community, through his writings and presentations. 

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. In 2004, Mark served as the first executive director for Harvard University’s AIDS/HIV treatment programs in Nigeria, Tanzania, and Botswana, funded through the US Department of State under the President’s Emergency Plan for AIDS Relief (PEPFAR) and later chaired the Harvard oversight committee for that project. As executive vice-president of St. Jude Children’s Research Hospital, in 2005-06, Mark established a vaccine study center in the Eastern Highlands of Zimbabwe, in collaboration with Africa University. While Senior Associate Provost for Research at Harvard University, Mark also served as acting director of the Harvard Primate Center during a period of regulatory crisis in 2012. 

Mark’s background also includes holding senior policy and administrative positions at the New York State and New York City Departments of Health, at the latter of which 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, Mark served as a senior legal advisor to the health reform efforts at the Clinton White House.  

The person who nominated Mark noted, “It is impossible to overstate Mark Barnes's contributions to the research community. He is a tireless advocate—not only for his clients, but also for ethical research and diversity among research participants and beneficiaries.” PRIM&R could not agree more. And so, it is with great pleasure and immense gratitude for his devoted service to the research ethics and oversight community, that PRIM&R presents Mark Barnes with the PRIM&R Service Award for 2023.

The PRIM&R Service Award will be presented to Mark in person on December 5, 2023 at the PRIM&R Annual Conference(PRIMR23) in Washington D.C.