Clinical Data Science Institutional Review Board (CDS-IRB)
The CDS-IRB will no longer be accepting applications and will be closed as of December 31, 2024.
The NHLBI established the Clinical Data Science IRB (CDS-IRB) to provide a useful resource for the research community by offering—at no cost—central review of secondary research proposals utilizing NHLBI datasets for which IRB approval is required.
As a central IRB for research protocols that propose secondary analyses of existing clinical data, the CDS-IRB will address the growing complexity of research and non-traditional uses of biomedical data. Broad utilization of the CDS-IRB will also provide an opportunity for the NHLBI to systematically understand the evolution and range of requests to conduct secondary analyses, recognize emerging trends, and explore ways to enhance data stewardship with the research community.
Barbara E. Bierer, M.D. (IRB Chair)
Professor of Medicine
Harvard Medical School
Brigham and Women’s Hospital
75 Francis St
Boston, MA 02115
Cell: (617) 827-7413
bbierer@bwh.harvard.edu
Barbara E. Bierer, M.D., a hematologist-oncologist, is Professor of Medicine at Harvard Medical School and the Brigham and Women’s Hospital (BWH). Dr. Bierer co-founded and now leads the Multi-Regional Clinical Trials Center of BWH and Harvard (MRCT Center, www.mrctcenter.org), a collaborative effort to improve standards for the planning and conduct of international clinical trials to harmonize policies for and approaches to clinical trial regulation. Dr. Bierer leads an effort to address the long-standing underrepresentation of diverse populations in research. In 2017, the MRCT Center launched the non-profit organization, Vivli (www.vivli.org), a global clinical research data sharing platform. In addition, she is the Director of the Regulatory Foundations, Ethics, and the Law program at the Harvard Catalyst, the Harvard Clinical and Translational Science Award, working across the academic spectrum to enable the clinical trial enterprise from study planning through recruitment to data acquisition and dissemination. She is the Director of Regulatory Policy for SMART IRB (www.SMARTIRB.org), a national effort to align single site IRB review of multi-site trials. She serves as Faculty in the Center for Bioethics, Harvard Medical School, and as Affiliate Faculty in the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. From 2003 – 2014, Dr. Bierer served as Senior Vice-President, Research at the Brigham and Women’s Hospital (BWH). During her tenure, Dr. Bierer founded and served as Executive Sponsor of the Brigham Research Institute and the Brigham Innovation Hub (iHub), a focus for entrepreneurship and innovation in healthcare. She has authored over 280 publications.
In addition to her academic responsibilities, Dr. Bierer served or serves as Chair of the Secretary’s Advisory Committee for Human Research Protections, Department of Health and Human Services (2008-2012); as a member of the National Academies of Sciences Committee on Science, Technology and the Law (2007-2016); on the Board of Directors of Public Responsibility in Medicine and Research (PRIM&R) (2011-2020), Management Sciences for Health (MSH) (2013-2022), Vivli (2017-), North Star Review Board (2020-), and Generation Patient (2023-). She chairs the Board of Trustees of the Edward P. Evans Foundation, a foundation supporting biomedical research, and is on the board of directors of Clinithink, a company that transforms unstructured clinical text into computable data for clinical trials and population health management.
Dr. Bierer received a B.S. from Yale University and an M.D. from Harvard Medical School.
Mark Barnes, J.D., L.L.M.
Partner, Ropes & Gray LLP
Co-chair, Subcommittee on Harmonization of Research Regulations, Secretary's Advisory Committee on Human Research Protections (SACHRP), US Department of Health and Human Services (HHS)
Faculty Co-director and Executive Committee Co-chair, Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center)
Faculty, Yale University
Mr. Mark Barnes is a partner at Ropes & Gray LLP, specializing in human and animal research, digital health, data privacy, stem cell and genetic research, research grants and contracts, research misconduct, and international research. He currently serves as co-chair of the Subcommittee on Harmonization of Research Regulations under the Secretary's Advisory Committee on Human Research Protections (SACHRP) for the US Department of Health and Human Services (HHS), faculty co-director of the MRCT Center and serves as co-chair on their Executive Committee, and holds faculty positions at Yale University where he lectures at the Law School and School of Medicine. Additionally, he serves on the NIH HIV Prevention Trials Network (HPTN) Ethics Working Group, serves as the Ethics Advisor for the HPTN Trial 071 in South Africa and Zambia, and is on the Board of Directors for Vivli, a non-profit organization founded by the MRCT Center dedicated to global clinical trial data sharing.
Previously, he served as Executive Vice President and Chief Administrative Officer at St. Jude Children's Research Hospital and helped establish a vaccine study center in Zimbabwe in collaboration with Africa University. At Harvard University, he served as Senior Associate Provost for Research, Senior Research Officer, as well as the managing director of Harvard's Primate Research Center. During his tenure at Harvard, he started and directed the university’s PEPFAR-funded HIV/AIDS treatment programs in Nigeria, Tanzania and Botswana. Early in his career and as an associate professor at Columbia Law School, Mr. Barnes co- founded the AIDS Law Clinic, the first legal clinic that allowed law students to represent persons living with AIDS in anti-discrimination cases. The program was funded in part by the US Department of Education and received referrals from the New York City Commission on Human Rights and the State Division of Human Rights.
Mr. Barnes has held senior appointed positions in the New York City and State departments of health, worked on the National Health Care Reform Task Force, and has authored or co-authored over 50 publications. He received his BA from Bennington College, his JD from Yale Law School, and his Master of Laws (LLM) degree from Columbia University School of Law.
R. Graham Barr, M.D., Dr.P.H
Hamilton Southworth Professor of Medicine
Professor of Epidemiology
Chief, Division of General Medicine
Columbia University Medical Center
Attending Physician, New York Presbyterian Hospital
Dr. Barr is the Hamilton Southworth Professor of Medicine, Professor of Epidemiology, and Chief of the Division of General Medicine at Columbia University Medical Center. He is a general internist and respiratory epidemiologist whose research focuses on chronic lung disease, pulmonary vasculature, and cardiopulmonary interactions using advanced imaging and molecular approaches on a population level. He is PI of the Multi-Ethnic Study of Atherosclerosis (MESA) Lung Study, a 16-year investigation of emphysema on CT in the general population, and the SPIROMICS Heart Failure Study, a 12-year investigation of heart-lung interactions.
Dr. Barr has authored over 375 peer-reviewed papers and has received numerous awards for his research. He received his BA from Duke University, his MD from McGill University, and his Doctorate in Public Health at the Harvard School of Public Health. He completed his residency at Columbia-Presbyterian Medical Center and a fellowship at Massachusetts General Hospital.
Marcela Nava, Ph.D., M.S.S.W., M.P.P.
Assistant Professor, School of Social Work, The University of Texas at Arlington
Health Policy Research Scholar, Robert Wood Johnson Foundation
Dr. Nava is a health equity researcher who studies the political economy of health and public policy to look for “what works” in reducing health inequities and protecting community health. She is a Robert Wood Johnson Foundation Health Policy Research Scholar and Assistant Professor in the School of Social Work at The University of Texas at Arlington. She has a PhD in Public Policy and Political Economy and a Master of Public Policy from The University of Texas at Dallas, Master of Science in Social Work from The University of Texas at Arlington, and a Bachelor of Science in Social Work from Texas Christian University.
Her current research focuses on the intersection of political, economic, and social contexts of immigrants and other marginalized groups in the U.S. She studies the ways that institutions influence health to develop multi-level, innovative, and common sense approaches for community health improvement. In the past, she practiced social work with homeless and runaway youth, families at risk of child abuse, and immigrant and refugee communities and oversaw various federally-funded community-based participatory research (CBPR) projects focused on women’s health. As an educator, she teaches graduate and undergraduate courses in social research methods, immigration and health policy, and community-based practice.
Efthimios Parasidis, J.D., M.BE.
Professor of Law, Moritz College of Law
Professor of Public Health, College of Public Health
Faculty Affiliate, College of Medicine, Center for Bioethics
The Ohio State University
Mr. Efthimios Parasidis holds a joint academic appointment with The Ohio State University at the Moritz College of Law and the College of Public Health and is a faculty affiliate with the College of Medicine’s Center for Bioethics. Additionally, he serves as Faculty Advisor for several boards and committees at Ohio State and as a consultant on law and bioethics for the US Air Force. His areas of expertise include health law, public health law and policy, bioethics, human subjects research, regulation of medical products, intellectual property, biotechnology law, military research ethics, and informed consent. In addition to teaching, he also counsels start-up companies on corporate and intellectual property matters and is a co-inventor on a patent application related to health information technology.
Early in his career, Mr. Parasidis was selected as a Fulbright Scholar where he researched legal and ethical issues related to medical informed consent policies and practices in Greece. More recently, he was awarded a Faculty Scholar in Bioethics fellowship from the Greenwall Foundation where he examined the law and ethics of military research involving service members and biomedical enhancements. This work led to a book project with Oxford University Press (currently under contract). Prior to joining the Ohio State faculty, he was a professor at the Center for Health Law Studies at Saint Louis University and was an appointed member of the Law & Policy Workgroup of Missouri Health Connection, the entity responsible for creating Missouri’s health information exchange. Mr. Parasidis served as Assistant Attorney General for the State of New York, under Eliot Spitzer and Andrew Cuomo, as an associate with the Litigation group of Jones Day, and as a senior associate in the Intellectual Property group of Dickstein Shapiro. He also co-founded a health informatics start-up company.
Mr. Parasidis has authored over 30 publications, several book chapters, and three books that include a casebook on the ethics and regulation of research with human subjects that he co-authored; he has given over 75 professional presentations to scientific and academic communities. He received his BA in philosophy from The College of New Jersey, and his master’s in bioethics (MBE) and JD from the University of Pennsylvania.
Peipei Ping, FAHA, FISHR, Ph.D.
Professor, Physiology, Medicine/Cardiology, and BioinformaticsProfessor, Physiology, Medicine/Cardiology, and Bioinformatics
Director, Data Science in Cardiovascular Medicine
Director, NIH BD2K CoE and Coordination Center
Associate Director of Scalable Analytics Institute
Principal Investigator, Center for Excellence (CoE) for Big Data Computing
Faculty, Cardiovascular Research Laboratory, University of California, Los Angeles (UCLA), David Geffen School of Medicine and School of Engineering
President, North American Section , International Society of Heart Research
Founder and Executive Operation Officer, International Forum of Proteomics
Dr. Peipei Ping is a Professor of Physiology, Medicine/Cardiology, and Bioinformatics at the David Geffen School of Medicine, UCLA where she directs the Data Science in Cardiovascular Medicine research program, and the NIH BD2K Center of Excellence in Biomedical Computing program. She also serves as associate director of the Scalable Analytics Institute (ScAi) in the School of Engineering. Her research programs focus on cardiovascular proteomics and metabolomics, bioinformatics and data science, cardiac mitochondrial biology, and proteasome biology. Dr. Ping has made significant contributions to cardiovascular research, proteomics phenotyping, and Big Data science. She has led her investigative teams in characterizing the cardioprotective role of PKCε as well as other underlying mechanisms in cardiac injury and protection; pioneered the conceptualization and development of functional proteomics approaches to characterize signaling pathways in the heart; advanced proteomics/metabolomics technologies, including model systems, quantitative analyses, post-translational modification (PTM) studies, protein spatial/temporal dynamics, and omics data-driven biomarker discovery. Her programs have developed data science technologies including software tools and computational platforms that aim to integrate multi-omics data, text-mine electronic health records, promote data annotations, and thereby translate data to knowledge. In addition to her research, Dr. Ping is strongly committed to supporting and mentoring her students and has developed several cross-disciplinary educational programs that integrate computational biology, bioinformatics, computer science, statistics, and medical informatics in order to equip future investigators with skills required for the digital era of biomedicine.
Dr. Ping sits on numerous advisory boards, editorial boards, and committees at both the national and international level, including President of the North American Section (NAS) of the International Society for Heart Research (ISHR). She is a Fellow of the American Heart Association, the American Physiological Society, and ISHR. She has authored over 200 peer reviewed papers and original articles and has received numerous awards for her scientific and medical contributions. She received her BS in biomedical engineering from Zhejiang University and her PhD from the University of Arizona in cardiovascular physiology. She completed postgraduate training in vascular biology, molecular cardiology and translational research.
Mario Sims, Ph.D., M.S., FAHA
Professor, Department of Medicine
Chief Science Officer, Jackson Heart Study (JHS)
Associate Director, Research Training, JHS Field Center
Graduate Faculty, School of Graduate Studies in the Health Sciences
Co-Investigator, JHS, Coordinating and Field Centers
University of Mississippi Medical Center
Graduate Learning Community Advisor, JHS Graduate Training and Education Center (GTEC)
Jackson State University
Dr. Mario Sims is a Full Professor of Social Medicine, Population and Public Health in the School of Medicine at University of California at Riverside. He is the Co-Director of the U54 NIH/NIMHD Health Disparities Research Center in the School of Medicine at the University of California at Riverside. He was recently a Professor of Medicine in the Department of Medicine at the University of Mississippi Medical Center and Chief Science Officer of the NIH/NHLBI-funded Jackson Heart Study (JHS). He was also Interim Director and Principal Investigator (PI) of the JHS and is a Social Epidemiologist with a background in Medical Sociology and Demography.
His current research focuses on understanding the social and psychosocial determinants of cardiovascular disease (CVD) disparities, with a specific interest in examining the extent to which racism, stress, residential segregation, and psychosocial factors (e.g., resilience) influence CVD disparities. He has been the PI of NIH funding related to the social determinants of health and resilience and CVD among African American adults. Dr. Sims has published over 230 papers in scientific peer-reviewed journals and has given over 230 professional presentations at scientific conferences, symposia, and grand rounds.
Dr. Sims He is the immediate Past Chair of the Social Determinants Committee of the American Heart Association’s Council on Epidemiology and Prevention and Council on Quality of Care and Outcomes Research. He is a member of the NIH National Advisory Council on Minority Health and Health Disparities (NACMHD). He is also a member of the NIH Clinical Data Science Institutional Review Board, and a member of the Observational Study Monitoring Board for the Nation Institutes of Heart Lung and Blood (NHLBI) American Lung Association Lung Health Cohort Study (Lung Health). He was recently elected a member of the National Academy of Medicine (NAM).