REKS Director : Jane Otado, PhD
Dr. Jane Otado holds a Doctorate in Medical Sociology/Social Demography and a Master’s in International Development and Health. She completed a post-doctoral fellowship at the Centers for Disease Control and Prevention (CDC). Dr. Otado is currently with GHUCCTS and serves as Regulatory Ethics, Knowledge and Support, REKS Director. Her responsibilities include coordination of REKS activities and providing regulatory assistance to research investigators. This entails assisting investigators to meet regulatory and ethical obligations regarding human research protection via consultations with investigators, research ethicists, and regulatory personnel at GHUCCTS institutions, thereby reducing the regulatory burden on investigators and facilitating the conduct of research in an ethical, efficient and compliant manner.
Prior to joining the faculty of Howard University's Department of Community Health and Family Medicine, Dr. Otado served as the Manager of Comprehensive Cancer Prevention Program for the District of Columbia Department of Health. Prior to joining the DC Dept. of Health, served as a Senior Research Associate in Geriatrics section, Howard University Department of Medicine and as a Senior Associate with Institute of College Research Development & Support, Silver Spring, MD. Dr. Otado has extensive experience working with clinical trials and as a research participant advocate for more than 10 years. She has presented workshops on health services research relative to issues on minority aging; informed consent process, recruitment strategies; and research ethics.
Her research interests include minority population relative to issues of availability of and accessibility to health care services to include maternal and child health issues; prenatal care utilization; and adolescent health. Her current research activities focus on recruitment strategies and retention of minorities into clinical trials; satisfaction and perceptions of research participants in clinical trials; and understanding of informed consent among African Americans; and Knowledge, attitude and behavioral aspects of genetic research among African Americans.
Director, REKS Ethics Subcomponent : James Giordano, PhD
Dr. James Giordano is a Professor in the Departments of Neurology and Biochemistry, and Chief of the Neuroethics Studies Program of the Pellegrino Center for Clinical Bioethics at the Georgetown University Medical Center, Washington DC. He has served as a Research Fellow of the European Union Human Brain Project; a consultant to the Organization for Economic Cooperation and Development (OECD), an appointed member of the US Department of Health and Human Services Secretary’s Advisory Council for Human Research Protection; as an appointed member of the Neuroethics, Legal and Social Issues Advisory Panel of the Defense Advanced Research Projects Agency (DARPA), and as Senior Science Advisory Fellow of the Strategic Multilayer Assessment Group of the Joint Staff, Pentagon.
The author of over 275 publications, 7 books, and 15 governmental whitepapers, he is an Overseas Fellow of the Royal Society of Medicine (UK); was elected to the European Academy of Science and Arts (EC) and the Dana Alliance of Brain Initiatives (DABI), and named as a Distinguished Lecturer of both the Institute for Electrical and Electronics Engineers (IEEE), and Sigma Xi – The National Scientific Honor Society in recognition of his achievements.
REKS Ethics Subcomponent Member : Assya Pascalev, PhD
Dr. Assya Pascalev is an Associate Professor of Philosophy and Director of the Interdisciplinary Bioethics Program at Howard University, Washington, DC. She is a member of the Steering Committee of the Georgetown-Howard Universities Center for Clinical and Translations Science and serves as Ethics Co-director for its Regulatory and Ethics Knowledge Support.
Dr. Pascalev is a Board Member of the national Association for Clinical and Translational Science and a member of the Medical Academy of Washington, DC. She is a book series editor for Perspectives in Bioethics, Trivent Publishing, Hungary and is co-editor (with Dr. Gergely Tari) of an edited collection “Ethical Issues of the SARS-CoV-2 Outbreak in East-Central Europe and Beyond”.
Dr. Pascalev has expertise in biomedical ethics, moral philosophy, applied and professional ethics (including research ethics and the ethics of biotechnology), ethical theory and the philosophy of death and dying. She has over 50 publications in her areas of expertise. In 2004, she became Founding Director of the Bulgarian Center for Bioethics in Sofia, Bulgaria.
REKS Leadership : Marc R. Blackman, MD
Marc R. Blackman, M.D is a Professor of Medicine and Rehabilitation Medicine at Georgetown University; VA representative to the GHUCCTS Executive Committee, member of the Steering Committee, co-chair of the Scientific Evaluation and Prioritization Committee and faculty member of the Strategic Management (Element B) and Resources and Services (R&S) modules of the Clinical and Translational Science Resource and Pilots Element (D) of the GHUCCTS CTSA; Clinical Professor of Medicine, Biochemistry and Molecular Medicine at George Washington University, Professor of Medicine (Part-time) at The Johns Hopkins University
Dr. Blackman serves as a Sr. Physician Scientist, and previously served as Associate Chief of Staff for R&D, at the Washington DC VA Medical Center. He is a physician scientist, teacher, and administrator; and is ABIM Certified in Internal Medicine and Endocrinology, Diabetes and Metabolism. As an endocrinologist and gerontologist/geriatrician, he has extensive grant, publication, and practical experience in T1-T4 research, research mentoring and research administration. His clinical and translational research relates to (1) endocrine and metabolic changes that occur in healthy and unhealthy aging individuals, and in patients with age-related sarcopenia, traumatic brain injury, and chronic kidney disease; and (2) AI studies in geriatrics, heart failure and opioid use. He is a primary mentor and co-I on several previous and ongoing clinical trials investigating neuromuscular health and exercise in patients with stages 3 and 4 chronic kidney disease at the DC VAMC and will serve as lead site investigator on a new, VA funded, multicenter study examining the effects of recombinant human GH administration on health related QOL, as well as body composition and cardiometabolic outcomes, in Veterans with mild TBI. To date, he has mentored 48 pre-doctoral students, post-doctoral fellows and faculty, many of whom have gone on to highly successful, grant funded research careers.
Dr. Blackman serves as Chief Editor, Endotext (Section on Endocrinology of Aging); Specialty Chief Editor, Frontiers In Endocrinology (Aging Section) and Associate Editor of the textbook “Endocrinology of Aging, Clinical Aspects in Diagrams and Images”, published by Elsevier S&T Books, in both English language (September, 2020) and Spanish language (July, 2023) editions. He has published > 500 scientific journal articles, editorials, chapters, books, and abstracts.
REKS Ethics and Research Participant Advocate : Sarah B. Vittone DBe, MSN, RN
Dr. Vittone is an Assistant Professor, Georgetown University and Clinical Ethics Consultant with the Pellegrino Center for Clinical Bioethics at the Georgetown University Medical Center, Washington DC. She holds a Doctor of Bioethics and has twenty years’ experience in clinical and research ethics. She is a member of the GHUCCTS Scientific and Prioritization Committee for Safety and Human Protection Reviews with cross over responsibilities on the GHUCCTS IRB-E. She serves on the Adverse Event/ DSMB Committee of the GHUCCTS IRB-E. Dr. Vittone provides consultation to Investigators and Research Teams on specific issues in human protection and safety. She provides research ethics training in collaboration with GHUCCTS REKS members. Dr. Vittone has research interests in decision making for others and research ethics. She is a frequent regional and national speaker on these topics. Dr. Vittone serves as the Georgetown Research Participant Advocate supporting CTSA research participants.
REKS Leadership: James (Jim) H. Boscoe, MA, CIP
Jim Boscoe is the Director of the MedStar Health Research Institute Office of Research Integrity (ORI). ORI is primarily responsible for the regulatory oversight of clinical and pre-clinical research for MedStar Health and coordinates the research process with other components of the MedStar Health Human Research Protections Program as well as Research Operations. Jim is also the MedStar Health representative to the Regulatory, Ethics, Knowledge & Support (REKS) component of GHUCCTS. Jim previously worked as an IRB Manager with the Johns Hopkins University School of Medicine IRB. Prior to his work in research ethics and regulations, Jim was a Board Certified Behavior Analyst and has worked with children with feeding disorders, children and adults with developmental disabilities, and adults with substance use disorders.
Shaunagh Browning, DNP, RN, FNP-BC serves as the director for the Office of Research Quality Assurance (ORQA) and Interim Director of the Institutional Review Board. Her work in clinical research at Georgetown began as a study coordinator in 1990. Since then, she has coordinated numerous clinical trials. In addition, Shaunagh has been a certified family nurse practitioner since 1999 and provided clinical care to research patients in addition to coordinating the projects. In the past, her work included managing a clinical research unit and assisting many investigators in the implementation of their clinical research projects. Shaunagh received her BSN from George Mason University in 1988, her MS in Nursing from Georgetown University in 1998, and her Doctorate in Nursing Practice in 2019. Shaunagh’s work has centered on the role of the clinical research coordinator, with emphasis on the clinical research nurse and education of staff and scientists with the goal of research quality and efficiency.
REKS Consultant : Priscilla Adler
Currently a consultant for the Institute for Clinical Research, the non-profit corporation (NPC) for the DC VAMC. In this role she provides guidance on regulatory issues related to human subjects research. She also provides guidance to the ICR staff on grants and contracts related to medical research. In addition, Ms. Adler is also a consultant for the GHUCCTS REKS and provides guidance on regulatory and ethical matters as well as training and educational topics for Washington DC area Clinical Research Coordinator workshops hosted by GHUCCTS REKS. Ms. Adler is Vice-Chair for the Northwell Health System Institutional Review Board in New York. Previously she held several positions at MedStar Health Research Institute (MHRI) where she provided oversight and regulatory guidance to the mandated research oversight committees of MHRI. Other previous positions include St. Jude Children’s Research Hospital in Memphis, TN, where she was the Director of Clinical Research Regulatory Affairs. In her role at St. Jude, she developed the research compliance program, established guidelines for conducting research at international sites and provided oversight for FDA IND/IDE submissions, and export controls compliance. Throughout her career, Priscilla has served in a variety of research positions from bench researcher to administrative director of a large NIH-funded outpatient clinical research center at the University of Connecticut Health Center. She has also served as a Research Subject Advocate and was the Administrative Director for the Clinical and Translational Science Institute initiative at the University of Tennessee.
Priscilla holds a bachelor of arts in biology from Beloit College and a master of business administration in healthcare administration from the University of Hartford. She is a past member of the Society of Clinical Research Associates and is also a member of PRIM&R (retired).
Clinical Research Coordinator & Consultant: Claudia Gunawan
Claudia Gunawan is a clinical research coordinator and a consultant for the Institute for Clinical Research, a non-profit corporation for the Washington DC Veterans Affairs Medical Center. She is also a member of the GHUCCTS REKS committee. In this role, she assists in the development and execution of training and educational topics and events hosted by GHUCCTS REKS. Prior to these roles, she worked as a clinical research coordinator at a private practice in Los Angeles, CA.
Claudia received her bachelor’s degree in 2018 from UCLA, where she studied Psychobiology with a minor in Society & Genetics. She received her master’s degree in 2021 from Georgetown University, where she studied Physiology & Biophysics.
REKS Consultant : Sheila Zimmet, BSN, JD
Sheila Cohen Zimmet was the Georgetown University Medical Center Senior Associate Vice President for Regulatory Affairs and Conflict of Interest Officer, the Georgetown University Research Integrity Officer. and until recently, the REKS Director. Ms. Zimmet previously served as Associate Dean for Research Integrity for Weill Cornell Medical College, until returning to Georgetown in these roles, in which she had oversight responsibility for an array of research ethics and compliance matters. She currently maintains her faculty position as an Adjunct Associate Professor at the Georgetown University Medical Center.
Ms. Zimmet is a former neonatal intensive care nurse, Senior Associate Counsel to the Georgetown University Medical Center, and the University’s first Director of Research Assurance and Compliance. Ms. Zimmet completed a four-year term on the Advisory Council of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). She also served on the Steering Committee for the AAMC Forum on Conflict of Interest in Academe. She is a former two-term member of the National Center for Research Resources (NCRR) Advisory Council (1996-2000 and 2004-2008). Ms. Zimmet frequently speaks on issues related to research ethics and compliance matters at local, national and international professional meetings.
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For Research Participants
Research (RPA) Program
The Research Participant Advocacy (RPA) Program is a program that assists current and potential research subjects/participants with their participation in research/clinical trials. If you need help with reaching and/or communicating with a member of the research team, the RPAs can help you by facilitating communication with the study investigators and/or other members of the research team. The RPAs are also available for general inquiries about participation in research or to discuss questions/concerns about participation in research.
Research Participant Advocates