Ethics, Regulations and Study Implementation for Research Involving Human Subjects
March 23, 2018
MedStar Health Research Institute
Co-Sponsored by GHUCCTS
Overview: Georgetown-Howard Universities Center
for Clinical and Translational Sciences
Presenter: Jason Umans, MD, PhD (MHRI)
Investigational Drug, Device & Biologic Development
Presenter: Mary Anne Hinkson, MBA
Investigational Test Articles: Accountability,
Handling and Storage
Presenter: Tamaro Hudson, PhD (HU)
Internal and External Aduits
Presenter: Maureen McNulty, RN, MS (MHRI)
Coverage Analysis and Billing Compliance
Presenter: Mary Anne Hinkson, MBA (MHRI)
Research Integrity: COI, HIPAA, GINA, Scientific Misconduct
Presenter: Kate Cohen, JD, CHRC, CIP (MHRI)
Ethics: Informed Consent and Participant Capacity
Presenter: Sarah Vittone, DBe, MSN, MA, RN (GU)
Good Clinical Practice (GCP) Documentation
and Regulatory Binder
Presenter: Maureen McNulty, RN, MS (MHRI)
Study Initiation, Implementation and Termination
Presenter: Shaunagh Browning MSN, RN, FNP-BC (GU)
Recent Updates: Common Rule & GCP
Presenter: Kate Cohen, JD, CHRC, CIP (MHRI)
Christina (Tina) Stanger, MA, CRA, serves as the Director of the Office of Contracts and Grants Management for MedStar Health Research Institute. In this capacity, she is responsible for overseeing the proper administration of the Institute's sponsored programs including—proposal review and submission; awards negotiation; electronic research administration; compliance; cost analysis and amendments; sub awards administration; and external relations. She provide expertise and advice in the development of policies and procedures governing the sponsored research enterprise, and acts as primary contact with the federal government, professional associations and other MedStar entities on issues pertaining to sponsored research agreements, policy and administration. She is also responsible for the management of the OCGM office staff and their development.
Prior to joining MedStar Health Research Institute, Tina served as the Director of Sponsored Programs at the University of Maryland Baltimore County, where she was responsible for managing an $80 million dollar portfolio in extramural funding. She also has 14 years in research administration experience from John Hopkins University. Tina received her Bachelor of Arts from Johns Hopkins University, her Master of Science in Applied Sociology from the University of Maryland Baltimore County, and a Master’s Certificate in Government Contracting from George Washington University. Tina is also a Certified Research Administrator.
Mary Anne Hinkson, MBA, Vice President, Research Operations, is responsible for managing all operational aspects of the scientific centers and ensuring that operating goals and performance standards are met. In this role, Mary Anne drives research excellence and operational efficiency and champions efforts to enhance customer service and promote ongoing process improvement. Additionally, she ensures ongoing training and education of research staff and foster relationships with sponsors and physicians conducting clinical trials.
Mary Anne brings more than 15 years of domestic and global regulatory and clinical experience in both the pharmaceutical and medical device industries, including ten years of leadership experience in clinical research. Prior to this position, she was the Scientific Center Administrative Director for the MedStar Clinical Research Center in Baltimore.
Prior to joining MedStar Health Research Institute, she served as the Senior Manager of Clinical and Regulatory Affairs for both pharmaceutical and medical device companies, where she was responsible for the implementation and operations of their clinical research programs. Her experience makes her uniquely adept at program development, start-up, and process re-engineering of research operations.
Mary Anne received her MBA degree from George Washington University. She also received her BS in Health Care Management and began her career as a cardiovascular technologist.
Jason G. Umans, MD, PhD, is Scientific Director of the Biomarker, Biochemistry, and Biorepository Core and of the Field Studies Division and Phoenix Field Office at MedStar Health Research Institute (MHRI). He directs the Translational Workforce and Mentored Career Development (KL2) programs in the Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS) and is co-director of the pre- and post-doctoral (TL1) training programs. In addition, he is Associate Professor of Medicine and of Obstetrics and Gynecology at Georgetown University.
As an experienced clinical and translational investigator, Dr. Umans is committed to multidisciplinary team science. At MHRI, his core laboratory has primary responsibility for sample acquisition, processing, transport, storage, and assay procedures for several large NIH-supported observational studies and clinical trials. These responsibilities include overseeing the design of complex multisite sample collection, processing and transport protocols; training and supervising field and laboratory staff; coordinating activities with multidisciplinary, geographically dispersed study teams; and providing rigorous quality control. Dr. Umans has expertise in developing, validating, and adapting new assays using multiple laboratory techniques and instrument platforms.
His research has been continuously-supported by NIH and non-profit sponsors for approximately 30 years. His commitment to training and nurturing the next generation of researchers include his creation of the MedStar Research Scholars Program, his GHUCCTS training activities, his service as Director of Graduate Studies for the MS program in Clinical and Translational Research at Georgetown, his leadership of GHUCCTS programs for mentor training, along with leadership roles in the national CTSA training program and his own mentorship of postdoctoral and junior faculty colleagues from multiple disciplines. His NIH-supported research is currently focused on genetic, lifestyle, and environmental mechanisms contributing to cardiovascular disease and health disparities in Native populations.
Dr. Umans, has been board-certified in internal medicine, nephrology, clinical pharmacology, and as a clinical hypertension specialist. He is internationally recognized as an expert in medical disorders during pregnancy, particularly hypertension, diabetes, and kidney disease.
He has published more than 200 peer-reviewed articles, on topics including vascular biology, pharmacokinetic modeling, drug assay development, obstetric and fetal pharmacology, neuropharmacology, vascular and renal physiology, hemodynamic regulation, inflammatory mechanisms, diabetes, kidney, and cardiovascular disease and health disparities. He also has written book chapters and review articles, and has spoken widely on clinical pharmacology, hypertension, diabetes, and renal disease in pregnancy, and on cardiovascular disease, pharmacotherapy, and health disparities .
Dr. Umans received his PhD in Pharmacology and Biomathematics as well as his MD from Cornell University. He completed a residency in medicine and a fellowship in nephrology at the University of Chicago.
Maureen McNulty, RN, MS, CCRP
A MedStar Health Associate for almost 20 years in various clinical and research roles, Maureen has been involved with MHRI’s quality assurance program since 2009. She conducts internal reviews of clinical trials and assists research teams with implementing best research practices.
Shaunagh Browning, MSN, RN, FNP-BC is the Nurse Manager for the Clinical Research Unit at Georgetown University. In addition, she works with the GHUCCTS recruitment core to assist in recruitment of participants into clinical trials. In this role she assisted in the formation of the GHUCCTS Participant Advisory Board and continues to collaborate with that group. She is a founding member of the International Association of Clinical Research Nurses and Friends of the International Association of Clinical Research Nurses. Both of these nonprofit organizations are dedicated to supporting nurses who engage with clinical research participants.
She is passionate about the difference the nurse makes in clinical research, with the safety of the participant always a priority. Shaunagh teaches international about the role of the Clinical Research Nurse. She received her baccalaureate degree in nursing from George Mason University on 1988 and completed her master’s education at Georgetown University in 1998 as a Family Nurse Practitioner Program. In the past Shaunagh has worked as a Diabetes Nurse Educator, Practitioner, Study Coordinator, and Diabetes Program Manager for Georgetown University Endocrinology Department. Shaunagh has dedicated her career to clinical research and the care of participants engaged in clinical research.
Sarah B. Vittone, DBe, MSN, MA, RN is an assistant professor at Georgetown University. She joined the the School of Nursing and Health Studies in 2007. She completed her Doctor of Bioethics (DBe) from Loyola University Chicago. Her final work addressing decision making for others, refusal by surrogates and surrogate's experience with decisional paralysis. She earned a BSN and MSN (Pediatric Clinical Nurse Specialist) and a MA in Clinical Ethics and Religious Studies, all from the University of Virginia. Dr. Vittone's teaching interests are in pediatrics and clinical ethics. She teaches undergraduate and graduate students in the School of Nursing as well as in Health Studies.
Dr. Vittone has 20+ years experience in clinical ethics consultation and since 2007 has been a primary consultant with the Ethics Consultation Service of the Pellegrino Center for Clinical Bioethics here at GUMC and MGUH. Her clinical ethics interests are in decision making and surrogacy, and issues at the interface of vulnerable populations and health systems. She provides ethics education to the MGUH staff and for their residency program. She teaches HEST 254/PHIL 105 Introduction to Health Care Ethics as well as NURS 518 Health Care Ethics. Since 2011, Mrs. Vittone has received salary support for her work in human protection and research ethics for the Clinical and Translational Sciences Award with Georgetown-Howard Universities-Veterans Administration- Oak Ridge National Lab and Medstar Health Research Institute as a Research Subject Advocate. She also currently serves on IRB-E at Georgetown University.
Dr. Vittone has been a speaker at a number of national meetings on nursing, and ethics, including the American Society for Bioethics and Humanities; and the National Teaching Institute-American Association Critical Care Nurses Annual Conference, National League for Nursing, International Association of Clinical Research Nurses and the National Press Foundation.
Tamaro Hudson, Ph.D., M.P.H is currently an Assistant Professor at Howard University in Department of Pharmacology and holds an appointment as a Health Research Specialist at the Washington VA Medical Center. Dr. Hudson received his Bachelor of Science from Iowa State University in Biology in 1994 and went on to receive a Master of Science in Preventive Medicine from Ohio State University in 2007. Afterwards, he received a PhD from Ohio State University in 2002 where he focused on evaluating the functional differences among isothiocyanates in the rat esophageal tumor model.
Following his PhD, Dr. Hudson was selected to complete a prestigious Cancer Prevention Fellowship Program at the National Institute of Health, National Cancer Institute, where he focused on utilizing in vitro and in vivo cancer models to assess the biological activity of bioactive compounds on prostate cancer molecular pathways. At the same time he completed a Master of Public Health from George Washington University in 2003 where he focused on assessing the degree of agreement between a food frequency questionnaire and 4-day food record as it related dietary fiber intake. After completing his MPH and fellowship he was recruited by Howard University Cancer Center in 2007 as an Assistant Professor. Since joining Howard faculty,
Since joining Howard faculty, Dr. Hudson has integrated his research focus by identifying novel signature biomarkers that could have a significant impact on both the diagnosis and targeted treatment of prostate cancer with the evaluation of new chemopreventive strategies which have been evaluated in Phase I and Phase II clinical trials. As important, Dr. Hudson received the first five year VA-HBCU Research, Scientist, and Training grant that focuses on developing a biomarker based risk prediction model for prostate cancer. Dr. Hudson serves on several University committees and has many peer-reviewed publications. Certainly, Dr. Hudson research interest continues to expand as he tries to build collaborations that will broaden across disciplines that could help him make an impact in translational research.
Kate Cohen, JD, CHRC, CIP is the Research Compliance Director for MedStar Health. She leads the Research Compliance Program, administered by the MedStar Health Office of Corporate Business Integrity, which supports and promotes ethical research practices throughout the MedStar Health system.
Kate is an attorney licensed to practice law in both Florida and Missouri. She obtained her law degree, cum laude, from Florida International University College of Law in Miami, Florida and her Bachelor of Arts in Latin American Studies from Colgate University. Kate is a native of Kansas City but has lived in a number of different places, including Santiago, Chile.
Kate most recently served as the Research Compliance Officer for Saint Luke’s Health System in Kansas City, Missouri. In that role, Kate oversaw the research compliance program and directed the Institutional Review Board, managing the day to day operations of the IRB office, the staff and review of research. Prior to entering the research compliance role, Kate served as the Ethics, Compliance and Privacy Officer for multiple entities within the Saint Luke’s Health System.
As the Ethics, Compliance and Privacy Officer, Kate provided general compliance guidance and education and investigated compliance and privacy complaints from staff and patients. Before becoming compliance professional, Kate was the Director of the Medical Legal Partnership within Saint Luke’s Health System, representing indigent patients with the goal of removing legal obstacles to healthcare access. In that role, she represented patients in varied legal areas including access to public benefits, Medicaid denials, Social Security disability benefit denials, domestic violence, divorce and custody, housing issues, and guardianships.
