Valerie H. Bonham
Valerie Bonham is a counsel in the firm’s health care and life sciences practice. She is a skilled health care attorney and nationally recognized expert in research compliance, government and internal investigations, integrity and bioethics.
Valerie has nearly 20 years of experience in the U.S. Department of Health and Human Services as a leader in health care, life sciences, enforcement and public policy. She served as a senior advisor in the Office of the Director of the National Institutes of Health and as a senior attorney in the Office of the General Counsel of the HHS. While at HHS and at NIH, she counseled on many of the most pressing legal issues facing universities, academic medical centers, foundations, small businesses and companies conducting research and delivering health care. Valerie led compliance program development and managed investigations, enforcement inquiries and Congressional oversight requests. Her expertise includes grants policies, clinical trial reporting, conflicts of interest, the False Claims Act, privacy, data sharing, material transfer, scientific misconduct and public-private partnerships. She also served for several years as the lead counsel for the NIH’s 300-bed hospital, advising on a range of issues from HIPAA privacy, end-of-life care and human subjects protection, to credentialing, accreditation, Food and Drug Administration inspections and Good Clinical Practice and Good Manufacturing Practice compliance.
While at NIH, Valerie was appointed and served for two years as the executive director of the Presidential Commission for the Study of Bioethical Issues. This key position placed her at the center of national and international debate. She worked with senior leaders from academia, industry, and government to formulate practical solutions for complex challenges at the forefront of science, innovation, and health care. Valerie’s deep experience and network, both in and outside government, enables her to efficiently and comprehensively address client needs.
- Lead counsel to the National Institutes of Health Clinical Center, a 300-bed clinical research hospital, including engagement with the U.S. Food and Drug Administration, the Office of Human Research Protections, the Office for Civil Rights, the Office of the Inspector General, and the U.S. Congress.*
- Lead NIH counsel for implementation of the Food and Drug Administration Amendments Act (FDAAA) and development of the ClinicalTrials.gov regulation.*
- Lead counsel and senior advisor across a multi-year NIH effort to promulgate guidance for Health Insurance Portability and Accountability Act (HIPAA) privacy compliance and to establish comprehensive HIPAA programs for the NIH Clinical Center.*
- Executive director for the President’s Commission for the Study of Bioethical Issues, an independent White House advisory committee of leading academic and government officials that produced policy proposals for science and technology sectors, federal agencies, universities and research institutions. Recruited and managed a 20-member team of specialists from both the public and private sectors to investigate emerging technologies, protection of human research subjects and privacy issues in genetics.*
- Oversaw development of three widely praised public reports for President Obama, including in-depth investigations into U.S.-funded clinical research around the globe and U.S.-led syphilis experiments in Guatemala that included the use of human subjects who were unknowingly infected with the disease.*
*Experience prior to joining Ropes & Gray
- Co-author, “Legal Issues in Clinical Research,” Principles and Practice of Clinical Research 4th Edition (2017)
- Co-author, “Research with Captive Populations: Prisoners, Students, and Soldiers,” The Oxford Textbook of Bioethics (2008)
- Presenter, “Lawyering at NIH,” National Human Genome Research Institute and University of Maryland Carey School of Law, Annual Seminar, Bethesda, MD (2016–2018)
- Presenter, “Changing the Model – Participant Permissions for Broad Data Sharing – Pros, Cons, and Practice in Real Life,” The American Society for Bioethics and Humanities Annual Meeting, Washington, D.C. (2016)
- Panelist, “Ethical and Regulatory Issues of Pragmatic Clinical Trials Workshop,” National Institutes of Health, Bethesda, MD (2016)
- Presenter, “Bringing Together Ethics and Law,” The American Society for Bioethics and Humanities Annual Meeting, Houston TX ( 2015)
- Presenter, “Legal Issues in Clinical Research,” 15th Annual Summer Institute on Randomized Behavioral Clinical Trials, National Institutes of Health, Bethesda, MD (2013–2015)
- Keynote Speaker, “Protecting Human Subjects, Promoting Clinical Research: What’s Behind Proposed Changes to the Common Rule,” The American Health Lawyers Association Conference on Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions (2012)
- Presenter, “Ethically Impossible STD Research in Guatemala from 1946 to 1948 and Contemporary Human Subjects Protection,” The American Public Health Association, Washington, D.C. (2011)
- Presenter, “Remarks on Global Health: Responsibility, Ethics and Policy,” The Nuffield Council on Bioethics, Global Health Symposium, London, UK (2011)
- Executive Leadership Certificate, American University, 2015
- JD, University of Virginia School of Law, 1998
- Epidemiology and Biostatics Training, Johns Hopkins Bloomberg School of Public Health, 1993
- BA, Rice University, 1991