Tracy Harmon Blumenfeld: A creative, experienced entrepreneur and health care executive with extensive experience helping life science companies, patient advocacy organizations, and health care institutions build and deploy networks of health care and clinical research professionals and organizations to accelerate clinical trials. Prior to starting her own companies, Ms. Blumenfeld worked for Baxter Healthcare, Booz Allen Hamilton, Parexel International, and as a consolidator of physical, occupational, and speech therapy services. Ms. Blumenfeld earned her M.B.A. from Harvard Business School and her B.A. in economics from Northwestern University.

Dr. Chisolm is retired from Cleveland Clinic. There, he was Professor in the Department of Cellular and Molecular Medicine and Vice Chair of the Lerner Research Institute. He served on Cleveland Clinic’s Board of Governors and Board of Trustees. He published over 100 articles on vascular biology and atherosclerosis. His research was funded by NIH (predominantly), American Heart Association (AHA) and industry. He received the Research Merit Award from the AHA’s Ohio Valley Affiliate and a Special Recognition Award for Vascular Biology Research from the AHA’s Council on Arteriosclerosis, Thrombosis and Vascular Biology. He served on multiple journal editorial boards and as member or chair of multiple grant review committees for NIH and AHA. Dr. Chisolm helped create the Cleveland Clinic Lerner College of Medicine (CCLCM). He was Director of the Basic Science Curriculum and on the Admissions, Faculty Appointments, Student Promotion and GI Curriculum committees. He received the Award for Excellence in Education and the Distinguished Faculty Award. Dr. Chisolm created, and was Director of, Cleveland Clinic’s Innovation Management and Conflict of Interest Program, Chairman of the IM&CoI Committee, a member of the Clinic’s Board of Trustees CoI Committee and helped draft the Clinic’s CoI policies. He helped organize multiple national conferences on conflicts of interest. He was on the Steering Committee for the AAMC’s Forum on CoI and Chaired the organization. He is on the Board of Directors of the AAHRPP and a member of its Executive Committee. He recently chaired the Scientific Advisory Board of Diffusion Pharmaceuticals (Charlottesville) and was a consultant for Kyruus, Inc (Boston), He is an advisor to Biospectal, (Silicon Valley and Switzerland). He received a BS from the University of Pennsylvania, MS and PhD from the University of Virginia and postdoctoral research training from Karolinska Institute (Stockholm) and MIT (Cambridge, MA).

Linda Coleman is the Director, Human Research Protection Program at Yale University. Before joining Yale in 2016, Ms. Coleman held several positions at Quorum Review an independent IRB and consulting company acquired by Advarra in 2019. (She was Vice President of Legal & Regulatory Affairs in 2016, Director of Regulatory Affairs & General Counsel from 2011-2016, and Director of Regulatory Affairs from 2007-2011). Prior to Quorum, Ms. Coleman was an attorney at Bennett, Bigelow & Leedom where her practice focused on health and employment law including Medicare and Medicaid reimbursement, litigation, transactional, and behavioral health.

Ms. Coleman is actively involved with several organizations. Some of her areas of involvement include the following: IRB harmonization; return of research results; diversity, equity, and inclusion in research; decentralized clinical trials; common rule and sIRB implementation strategies; research data protection; clinical trial process improvement; research quality and compliance; and the use of technology in research. She is also a frequent presenter on a variety of topics such as operations management, research integrity, good clinical practice, research oversight, the operationalization of regulatory and institutional requirements pertaining to research, and global bioethics. In 2019, Ms. Coleman was appointed as a member to the Secretary’s Advisory Committee on Human Research Protection (SACHRP) and SACHRP’s Subpart A Subcommittee (SAS) where she evaluates and provides recommendations on current issues related to human subjects research.

In addition to her work in human research protection, Ms. Coleman has been actively involved in the area of education access through her work as the Executive Director and Founder of Education Access Network, a nonprofit organization dedicated to providing students with limited financial resources with free and low cost access to courses and programs aimed at helping students prepare for and succeed in higher education and other career endeavors.

Barbara Entwisle is Kenan Distinguished Professor of Sociology and Fellow of the Carolina Population Center (CPC). She also holds adjunct and affiliate faculty positions in Geography and the Environment, Energy, and Ecology Program. Her research contributions have been recognized by her election as President of the Sociological Research Association (2015), President of the Population Association of America (2007), and Fellow of the AAAS (2003). Between August 2010 and June 2016, she served as Vice Chancellor for Research at UNC-Chapel Hill, leading a campus-wide research program with nearly $1billion in annual research expenditures; overseeing 10 research development, support, and compliance offices, and responsible for 15 pan-university research centers and institutes, including the CPC. Dr. Entwisle has led advisory and review panels for the National Academy of Sciences, Engineering, and Medicine, NSF, and NIH, and she recently chaired the Association for the Accreditation of Human Research Protection Programs (AAHRPP) Board of Directors.

Dr. Entwisle’s research focuses on demographic and health behavior in relation to larger social, cultural, and environmental contexts. Over her career, she has led the development and early application of new methodological tools, including statistical methods for estimating multilevel models, the integration of social and spatial data, and the development of spatially explicit agent-based modeling approaches. She has contributed to the design of innovative surveys around the world, including the National Longitudinal Study of Adolescent to Adult Health (Add Health), the China Health and Nutrition Survey, the Russia Longitudinal Monitoring Survey, and the Nang Rong (Thailand) Surveys of Social and Demographic Change. Between 2005 and 2013, she was PI for the North Carolina components of the National Children's Study (NCS). Currently, she is engaged in studies based on linkages between electronic health records and American Community Survey data.

Jonathan M. Green, MD MBA, is Director, Office of Human Subjects Research Protections for the National Institutes of Health where he oversees the human research protection program for the NIH Intramural Research Program. Prior to joining the NIH, Dr Green was professor of medicine, pathology, and immunology, as well as Associate Dean for Human Studies, and Executive Chair of the institutional review board at Washington University School of Medicine in St. Louis, MO. He received his medical degree from Wayne State University in Detroit followed by residency training in internal medicine at Boston City Hospital. He then completed a fellowship in pulmonary and critical care medicine at the University of Michigan Medical Center, and additional post-doctoral training at the University of Chicago. He received an MBA from Washington University Olin School of Business in 2017. He is board certified in internal medicine, pulmonary diseases, and critical care medicine.

Dr. Green continues to serve as an attending physician in the Medical Intensive Care Unit and Pulmonary Consult Service at the NIH Clinical Center and has conducted both basic science and clinical research on the regulation of the immune response. Dr Green has had a long standing interest in biomedical ethics. He had been a member of the Barnes Jewish Hospital Ethics Committee since 2000, leading the clinical ethics consultation service from 2001-2005 and serving as Chair of the Ethics Committee from 2005-2009. After joining the Washington University Institutional Review Board in 2008, he assumed the role of committee co-chair in 2009. In 2010, he was appointed Associate Dean of Human Studies and Executive Chair of the IRB at Washington University in St Louis. Dr Green served on the Secretaries Advisory Committee on Human Research Protections (SACHRP) from 2015-2018, also serving on the Subpart A subcommittee.

Harold (Hal) is a director in Ellin & Tucker’s Audit and Accounting Department. He is an engagement leader for many of the firm’s largest clients, and as such, is well-versed in the technical audit and financial reporting standards of privately owned companies, both nationally and internationally. Hal is a trusted advisor for a significant number of the firm’s employee benefit plan engagements. Hal has been a driving force behind the growth and development of the firm’s Wholesale Distribution Services Group. His experience with the wholesale distribution industry started with his father, who owned a food wholesale distribution company for many years. This connection gives Hal a unique perspective into the financial operations and accounting and financial reporting standards for these types of companies. Representing more than 50 distribution companies with operations globally, Hal has a strong grasp on audit and accounting best practices and procedures, as well as the consulting expertise to maximize profitability and operational capacity, regardless of the demographic or complexity of the engagement.

Nancy M. P. King, JD, is Professor in the Department of Social Sciences and Health Policy and Wake Forest Institute for Regenerative Medicine at Wake Forest University School of Medicine, and Co-Director of the Center for Bioethics, Health, and Society and the Bioethics Graduate Program at Wake Forest University. Her scholarship addresses a range of bioethics issues, including: informed consent, benefit, and uncertainty in health care and research; the development and use of novel experimental biotechnologies; international and cross-cultural questions in human subjects research; and equity and justice in health care and research.

Professor King has published over 100 scholarly articles and book chapters, and is co-editor of The Social Medicine Reader (3rd ed., Duke University Press, 2019), Beyond Regulations: Ethics in Human Subjects Research (UNC Press 1999), and Bioethics, Public Moral Argument, and Social Responsibility (Routledge 2012). Her new book, Bioethics: A Path Forward, coauthored with Larry R. Churchill and Gail E. Henderson, will be published by UNC Press in 2022. Professor King teaches a variety of courses in bioethics, medical humanities, and research ethics to medical students and faculty and to graduate students in bioethics and the health sciences, and has taught bioethics in national and international settings. She is a fellow of the Hastings Center, and has served on hospital ethics committees, IRBs, DSMBs, the NIH Recombinant DNA Advisory Committee, and the DHHS Secretary’s Advisory Committee for Human Research Protections.

Heather Pierce is Senior Director for Science Policy and Regulatory Counsel at the Association of American Medical Colleges (AAMC) and the Director of Policy for the AAMC’s Center for Health Justice. She serves as AAMC's leader for scientific regulatory issues including human subject protections, clinical research, conflicts of interest, research data sharing, evidence-based regulation, diagnostic test development, and collaborations between industry, government, and academia in biomedical research. She is the subject matter expert for the AAMC's Forum on Conflict of Interest in Academe and for Convey, the AAMC's global financial interest disclosure system. During the COVID-19 pandemic, she has led the organization on issues related to COVID-19 testing and regulatory aspects of vaccine and treatment development.

Ms. Pierce currently serves on the Board of Directors for the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and was previously the Chair of the Board of Directors of Public Responsibility in Medicine and Research (PRIM&R). She regularly speaks at national forums on issues related to the protection of human subjects, regulatory burden, research security, research ethics, biospecimens, scientific misconduct, and legislation and policymaking related to research, and has published articles and commentaries on these topics in Nature, Science, The New England Journal of Medicine, JAMA, the Journal of Public Health Management and Practice, and The American Journal of Bioethics. She has served on committees, working groups and task forces of organizations including the National Academies of Sciences, Engineering, and Medicine, The Pew Charitable Trusts, and the National Dialogue on Healthcare Innovation. Prior to joining AAMC, Ms. Pierce was an attorney in the Health Care Group of the law firm of Ropes & Gray LLP in New York. Her regulatory practice focused on medical research and clinical care. She received her law degree from NYU School of Law and her MPH in Health Law from Boston University.

Dr. Rosenfeld is a hematologist who earned his medical degree from Cornell. He trained in internal medicine at Dartmouth and completed his hematology fellowship at the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH). He spent 19 years at NIH, holding positions at NHLBI and the NIH Clinical Center, doing both basic and clinical research, and finally working in medical informatics and administration. He ended his time at the NIH as the Chief Information Officer of the Clinical Center.

Dr. Rosenfeld moved from Bethesda, Maryland to Portland, Maine, where he was the CIO of MaineHealth, a large independent delivery network, before moving to Olympia, Washington as the CEO of the Western Institutional Review Board (WIRB) and then the Executive Board Chair of Quorum Review, a position he held until 2019. In addition to his medical degree, he holds a Master's in Business Administration from Georgetown. Dr. Rosenfeld received the honor of Distinguished Professor of Medicine from Daegu Catholic University Medical Center in Korea in 2013. In July 2013, he was appointed to the Secretary's Advisory Committee on Human Research Protections (SACHRP) and in 2016 he was appointed Chair of SACHRP, and served in that role until 2021. In 2019 he joined the board of the Association for Accreditation of Human Research Protection Programs (AAHRPP).

Christopher Todd States graduated from Humboldt State Univerisity in 1986 with a BS in Forest Ecology. He has held many positions in commercial, municiple and utility forestry, including the past 21 years as a biologist working with State & Federal regulatory agencies conducting endangered species analysis. Chris has been involved in patient advocacy work after his first primary cancer diagnosis in 1984. While being treated for this 1st primary cancer diagnosis he was involved in the clinical trial process as a human research participant. In 2002 Christ underwent treatment for a second, primary cancer diagnosis. He has been an active AAHRPP Board member since 2013.

Julie Anne Zawisza is Senior Director, Global Regulatory Policy at Merck, a leading pharmaceutical company that works to bring forward medicines and vaccines for many of the world’s most challenging diseases. Prior to serving in her current role, Ms. Zawisza was Global Head of Regulatory Policy and Intelligence with Baxalta, a biotechnology company focused on rare diseases. Ms. Zawisza previously served in a variety of roles at FDA including Associate Director for External Relations at the Center for Device Evaluation and Research, Senior Advisor, Global Regulatory Policy, Director of the Center for Drug Evaluation and Research’s Office of Communications, and Assistant Commissioner for Public Affairs.

Ms. Zawisza holds an undergraduate degree in medical technology from the University of Michigan, a master’s degree in Science, Technology and Public Policy from The George Washington University, and a certificate in public health from Georgetown University.