Talks focused on regulatory issues and emerging topics in research. Regulatory Education and Events Series

Planning committees for previous symposia

The Investigator IND/IDE Education Symposium

Stanley Estime, MSCI, CIP, is responsible for providing Quality Improvement Program (QIP) services to the Harvard T.H. Chan School of Public Health, Harvard Medical School (HMS), and Harvard School of Dental Medicine (HSDM) research community through the Office of Regulatory Affairs and Research Compliance (ORARC). He manages incoming research support requests, works with investigators and study staff providing consultation and guidance on regulatory requirements and institutional policies, and presents educational lectures upon request and as part of the QIP's monthly education series. He has served on the Harvard Catalyst IND/IDE Subcommittee for the past two years and also serves as a member of the Data Protections Subcommittee. Prior to joining ORARC's QIP, he worked as a QA/QI Specialist with the Partners Human Research Quality Improvement Program. Stanley earned his Certification of IRB Professionals (CIP) designation in 2012. He received his BS in biomedical laboratory and clinical science from Boston University and holds a master's degree in clinical investigations from the MGH Institute of Health Professions.

Emily Ouellette, JD, is a specialist in the Human Research Quality Improvement Program at Partners HealthCare. In this role, she provides training and guidance to the research community regarding human subject protection, regulations, and policies. She provides guidance to investigators holding investigational product applications from the FDA (IND/IDE) as well as support regarding clinical trials registration. As a member of the QI program, she conducts for cause and educational audits. Prior to joining the QI Program, she worked at The Center for Information and Study on Clinical Research Participation (CISCRP) as senior project manager responsible for project management and oversight of regulatory matters affecting clinical trials. She is a graduate of Colby College and the University of Pittsburgh School of Law where she was a member of the Journal of Environmental and Public Health Law. She is admitted to the Bar in MA and ME.

Leigh Read, CIP, is the manager of research compliance/assurance and programs at the Joslin Diabetes Center. Read started her career in research as a research medical assistant in the section of clinical research at the Joslin. Her interest in the clinical research process led to a position on the Joslin's IRB team which has grown to her current position in research compliance at Joslin. Read is a certified IRB professional with experience as a pharmacy technician and medical assistant. She studied communications/media at Fitchburg State College with a concentration in graphic design.

Sarah White, MPH, CIP, RAC, is the director of the Human Research Quality Improvement Program (QI Program) at Partners Healthcare. The QI Program is an education and support group whose mission is to ensure investigator and study compliance with federal, state, and institutional policies. The program's scope includes auditing, education, and assistance to local FDA sponsor-investigators at Massachusetts General Hospital (MGH) and Brigham and Women's Hospital (BWH), as well as the oversight of clinical trials registration at the Partners' institutions. She is the chair of the CTSA Clinical Trials Registration Workgroup and co-chair of the Harvard Catalyst Quality Assurance/Quality Improvement Subcommittee. She received her undergraduate degree from Dartmouth College, and her MPH from Boston University School of Public Health, where she was the first recipient of the Leonard H Glantz Award for academic excellence and creative and critical thinking in the field of public health.

Delia Wolf, MD, JD, is assistant dean for regulatory affairs & research compliance and director for human research administration at Harvard T.H. Chan School of Public Health. In her role as assistant dean, Wolf is responsible for the development and implementation of policies and procedures, and ensuring faculty and institutional regulatory compliance in the areas of clinical research. As the director of human research administration for the Harvard Longwood medical area, Wolf is responsible for establishing and implementing a comprehensive human research protection program (HRPP) at Harvard T.H. Chan School of Public Health, HMS, and Harvard School of Dental Medicine. Wolf earned her medical degree from her native country, China, and a master of science in clinical investigation and a juris doctor from Suffolk University Law School. She is a licensed attorney in Massachusetts and a Certified IRB Professional (CIP). Wolf has extensive experience conducting, organizing, developing, and overseeing the full spectrum of clinical research.

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Adaptive Clinical Trials: Ethical, Regulatory & Statistical Considerations Symposium

Rebecca Betensky, PhD, is professor of biostatistics at Harvard T.H. Chan School of Public Health. She is a fellow of the American Statistical Association, an elected member of the International Statistical Institute, and the 2005 recipient of APHA's Mortimer Spiegelman Award for outstanding contributions to health statistics. Her current methodological interests are survival analysis under complex sampling and with auxiliary information, high dimensional imaging and genomic analysis under outcome-based sampling, and analysis of biomarker studies. She has collaborated on studies of Alzheimer's disease, Parkinson's disease, multiple sclerosis, brain tumors, and kidney injury. She is currently serving on the Institute of Medicine Committee on Review of the Health Effects in Vietnam Veterans of Exposure to Herbicides, and recently completed service on the IOM Committee on Cognitive Rehabilitation Therapy for Traumatic Brain Injury. At Harvard, she directs the Biostatistics Program at Harvard Catalyst and the Harvard NeuroDiscovery Center, and co-leads the Biostatistics Program at the Dana-Farber/Harvard Cancer Center (DF/HCC).

Barbara E. Bierer, MD, is senior vice president for research at Brigham and Women's Hospital (BWH) and professor of medicine at Harvard Medical School (HMS). Bierer, a graduate of HMS, completed her internal medicine residency at Massachusetts General Hospital (MGH) and her hematology and medical oncology training at BWH and the Dana-Farber Cancer Institute (DFCI). She is the co-chair of the Partners HealthCare Committee on Conflict of Interest and the program director of the Regulatory Foundations, Ethics, and Law Program at Harvard Catalyst. She has authored or co-authored over 150 publications and is on the editorial boards of a number of journals including Current Protocols of Immunology.

Michele Russell-Einhorn, JD, is an expert in the field of the protection of human subjects in research. She is currently the senior director of the Office for Human Research Studies at DCFI and is responsible for the management and support of scientific review and institutional review board review, as well as other regulatory matters, involving all cancer relevant research involving human subjects conducted at the five Harvard clinical institutions under the umbrella of the Dana-Farber/Harvard Cancer Center (DF/HCC). She is a member of the Subcommittee on Subpart A of the USDHHS Secretary's Advisory Committee on Human Research Protections and co-chair of the annual Ethics in Research Conference sponsored by Public Responsibility in Medicine and Research; and, a member of the Vanderbilt University Steering Committee for an NIH Grant on Alternative IRB Models. She has been the co-chair of the annual ethics in research conference sponsored by PRIM&R and is one of the leaders of the IRB Directors Group of the National Comprehensive Cancer Center.

Steven Joffe, MD, MPH, is associate professor of Pediatrics and of Global Health and Social Medicine at HMS. He is also a pediatric hematologist/oncologist at DFCI and Boston Children's Hospital (BCH). Joffe attended Harvard College, received his medical degree from the University of California at San Francisco (UCSF), and received his public health degree from UC Berkeley. He trained in pediatrics at UCSF and undertook fellowship training in pediatric hematology/oncology at DFCI and Boston Children's Hospital. His clinical work is in the area of stem cell transplantation in children. His research addresses the many ethical challenges that arise in the conduct of clinical and translational investigation, both in pediatric oncology and in other areas of medicine and science. He currently serves as chair of the Children's Oncology Group Bioethics Committee, and as a member of both the FDA's Pediatrics Ethics Subcommittee and the Secretary's Advisory Committee on Human Research Protections.

Susan Kornetsky, MPH, is the director of clinical research compliance at BCH and vice chair of PRIM&R. For the past 29 years, her responsibilities have included directing an IRB administrative office, educating principal investigators regarding IRB regulations, assisting investigators with protocol development, assuring institutional compliance with all federal and state regulations pertaining to human research, establishing appropriate policies and procedures, and overseeing a quality improvement program for human research protections. Her education includes a BA in biology from Brandeis University, and an MPH from Boston University. In May 2010 she completed a Medical Ethics Fellowship at HMS. Kornetsky is a past appointed member of the Secretary's Advisory Committee on Human Research Protections (SACHRP) and was co-chair of the SACHRP Sub-committee on Children. In 2003, Kornetsky received PRIM&R's Distinguished Service Award. She lectures at many national meetings, in addition to PRIM&R's conferences and educational programs, and is co-chair of PRIM&R's 2012 AER Conference.

Lisa Lehmann, MD, PhD, is the director of the Center for Bioethics at BWH and associate professor of Medicine, Global Health and Social Medicine at HMS. She is chair of the Framingham Heart Study Ethics Advisory Board, chair of the Society of General Internal Medicine Ethics Committee, and a founding fellow of The Academy for Professionalism in Health Care. Her research is focused on empirical and philosophical analysis of contemporary ethical issues in medicine. She aims to improve our understanding of the physician-patient relationship in clinical practice and the investigator-participant relationship in research. She is currently studying biobank participants' preferences for disclosure of genetic research results, institutional review board perspectives on disclosure of incidental findings, the integration of whole genome sequencing into clinical medicine, and is developing a normative analysis of researchers' obligations to research participants.

P. Pearl O'Rourke, MD, is the director of human research affairs at Partners HealthCare Systems in Boston and an associate professor of pediatrics at HMS. As the director of human research affairs, she is responsible for the systems that support the regulatory and ethical oversight of human research and the responsible conduct of research. O'Rourke is the past chair of PRIM&R's Board of Directors, and has been a speaker at a number of PRIM&R meetings, addressing topics such as privacy, human embryonic stem cells, and the reporting of serious adverse events. She is also chair of Partners Healthcare System's newly formed ESCRO Committee. O'Rourke has worked as a pediatric critical care physician at BCH and at the Children's Hospital, University of Washington in Seattle, where she was the director of the pediatric intensive care unit.

Sabune Joane Winkler, JD, is the director of Regulatory Foundations, Ethics, and Law Program for Harvard Catalyst. As director, she is responsible for lowering the barriers to inter-institutional research collaboration. She is responsible for designing, overseeing, and evaluating a coordinated approach to multi- and inter-institutional regulatory collaborations and implementation among the 34 institutions that comprise the Harvard CTSA: 22 of the institutions are distinct corporate and legal entities with exceptionally robust, comprehensive human research protection programs. Prior to HMS, Sabune was associate general counsel and director of research contracting for Beth Israel Deaconess Medical Center (BIDMC). Before joining BIDMC, she served as a clinical trial agreement associate for Partners Healthcare System Inc., where she negotiated corporate sponsored contracts on behalf of BWH, MGH, and Dana Farber/Partners Cancer Care. Winkler received a BA in East Asian Studies from Bates College in Lewiston, Maine, and her JD in 2001 from Northeastern University School of Law in Boston.

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