|Talks focused on regulatory issues and emerging topics in research.||Regulatory Education and Events Series|
This half-day symposium explored Cluster Randomized Trial Design and the ethical and regulatory concerns involved in the design process.
November 3, 2016
1:00pm - 4:30pm, Bray Room, Joseph B. Martin Conference Center
Speakers and Slides:
Barbara Bierer, MD [PDF]
Holly Fernandez Lynch, JD, MBioethics [PDF]
Michael Hughes, PhD [PDF]
Rui Wang, PhD [PDF]
Michele Russell-Einhorn, JD [PDF]
Moderated by Barbara Bierer, MD and Rebecca Betensky, PhD
Bringing medicines to patients to address unmet medical needs is the goal of most physicians in pharmaceutical research. However, few situations are more difficult for physicians in research than deciding how to help patients with life threatening conditions who seek "compassionate access" to investigational medicines outside of clinical trials. Many factors need to be taken into consideration, including regulatory requirements, drug supply, evolving efficacy and safety risks, and numerous ethical questions.
Joanne Waldstreicher, MD, Chief Medical Officer of Johnson & Johnson, will discuss these challenges along with one novel approach being piloted by Johnson & Johnson.
December 7, 2015, 12:30pm - 2:00pm
Harvard Medical School Center for Bioethics
Presented in partnership with the Harvard Medical School Center for Bioethics, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and The Multi-Regional Clinical Trials (MRCT) Center of Harvard and Brigham and Women's Hospital.
Explore the complexities of issues around cultural competence in research & participant advocacy through interactive performances and facilitated discussions from the Bok Players.
November 3, 2015, 9:00am-11:00am
Jimmy Fund Auditorium, Dana-Farber Cancer Institute
October 16, 2015, 12:30pm - 2:00pm
HMS Countway Library, Ballard Room
10 Shattuck Street, Boston, MA 02115
The Research Ethics Consortium allows real-life cases to be discussed in a confidential format. As such some presentations may be closed sessions.
Little is known about the nature of and triggers for suicidal thoughts, since much research on suicidality has been done with retrospective self-report. Mobile technologies may provide an opportunity to learn more about this important problem. A research study conducted in an adult inpatient psychiatry unit is designed to:
This and other aspects of the study will be described by Co-Principal Investigators Matthew K. Nock, PhD, Professor of Psychology at Harvard University and Research Scientist at Massachusetts General Hospital (MGH); and Jeffrey Huffman, MD, Medical Director, Inpatient Psychiatry, MGH, and Associate Professor of Psychiatry at Harvard Medical School. Melissa Abraham, PhD, Chair of Partners Human Research Committee, Associate Psychologist, MGH, and Assistant Professor at HMS, will describe ethical concerns addressed in the review process. Our commentator will be Paul Barreira, MD, Associate Professor of Psychiatry and Director of Harvard Health Services.
Society of Clinical Research Associates (SOCRA)
Boston Chapter Monthly Meeting
Monday, January 26, 2015
Boston Children's Hospital - Enders Building
320 Longwood Avenue, Seminar Room #1
This 3½-day results-oriented conference explored innovation in recruitment to clinical trials and examined the ethical and legal challenges to innovative recruitment strategies. The workshop took up such issues as compensation to participants, appropriate uses of financial incentives for referrals, demographic targeting in recruitment (e.g. recruitment from specific age or ethnic populations), use of social media, and retention strategies.
Learn more [PDF]
Speaker: Effy Vayena, PhD, Institute of Biomedical Ethics, University of Zurich
Thursday, January 15, 2015
Center for Bioethics, 1st floor conference room
641 Huntington Avenue, Boston, MA 02115
The recent flourishing of citizen science is an exciting phenomenon with the potential to catalyze scientific progress. Millions of people have already signed up for projects that range from bird watching to self-experimentation with medical compounds. Health research, in particular, stands to benefit from large-scale citizen participation. However, this form of public participation raises ethical questions that push the boundaries of our research governance mechanisms. Effy Vayena, PhD, will explore ethical challenges and propose a framework for harnessing the potential of citizen science in health research that meets ethical standards.
Speaker Bio: Effy Vayena, PhD, is a senior fellow at the Institute of Biomedical Ethics (IBME), University of Zurich, and the academic coordinator of the PhD program in Biomedical Ethics and Law/medical track. Before joining the IBME she worked for the World Health Organization in Geneva where she was involved with the organization's activities on infertility, assisted reproduction, and research ethics. She has served as a member of the WHO's Research Ethics Review committee and continues consulting for the organization. Vayena has published on the ethics of health research, on issues surrounding assisted reproductive technologies, biobanks, pediatric research, and genomics. Her research focus is currently on ethical and policy issues that arise in the areas of genomics, personalized medicine, and the novel uses of online health data for research.
September 30, 2014
Co-sponsored by the Petrie-Flom Center and Harvard Catalyst
For decades, OIG has served as the foremost government watchdog of federal healthcare programs, overseeing Medicare, Medicaid, the Food and Drug Administration, the National Institutes of Health, and the Centers for Disease Control and Services. Among other topics, the Boston office's recent work has focused on the labeling of dietary supplements and human subjects protections, including the informational risks associated with biospecimen research and other topics.
Joyce Greenleaf, MBA, regional inspector general, and Jessica Fargnoli, MPH, program analyst. Moderated by Matthew Lawrence.
Joyce Greenleaf is the regional inspector general for the Department of Health and Human Services Office of the Inspector General (OIG), Office of Evaluation and Inspections, in Boston. In this position, she has overseen evaluations on a wide range of issues. Her expertise includes the oversight of hospital quality, human subjects protections in clinical trials, and dietary supplements. Greenleaf began her career with the OIG in 1986. She has served in various leadership positions including team leader and assistant regional inspector general. She is co-author of the chapter entitled "The Ebb and Flow of Federal Initiatives to Regulate Healthcare Professionals," published in "Regulation of the Healthcare Professions" in 1997. Prior to coming to the OIG, Greenleaf held research positions on a grant funded by the Robert Wood Johnson Foundation. She is a graduate of Clark University where she earned a BA in Sociology and an MBA.
Jessica Fargnoli is a program analyst at the Department of Health and Human Services Office of Inspector General (OIG), Office of Evaluations and Inspections, in Boston. Fargnoli began her career with the OIG in 2010 and has conducted work related to dietary supplements, sterile compounded drugs, and FDA oversight of prescription drugs and medical devices. Prior to coming to the OIG, Fargnoli worked as an epidemiologist for the Massachusetts Department of Public Health. She also attended Boston University where she earned a BA in biology and an MPH in epidemiology.
June 9-12, 2014
677 Huntington Avenue, Harvard T.H. Chan School of Public Health
Check back soon for available materials.
August 22-23, 2013
651 Huntington Avenue, Harvard T.H. Chan School of Public Health's FXB Building, Room G-12
Susie Corl, MSW, MPH, CIP, CCRP
Quality Improvement Specialist, Office of Clinical Investigation, Education, and Quality Improvement Program (EQuIP), Children's Hospital Boston
Susan (Susie) Corl is a specialist with Boston Children's Hospital's Education and Quality Improvement Program ("EQuIP"). She has served in either a research QA/QI or IRB administration capacity for over a decade, and before coming to BCH worked at both University of California, San Francisco, and University of California, Los Angeles. She is originally from the Boston area, and received her BA from the University of Richmond, Virginia, and her MSW and MPH degrees from Boston University.
Leslie Howes, MPH, CIP Director, Quality Improvement Program (QIP), Office of Regulatory Affairs & Research Compliance, Harvard T.H. Chan School of Public Health
Leslie Howes is responsible for all education, compliance, and human research support activities and initiatives provided by the Office of Regulatory Affairs & Research Compliance (ORARC). Specifically, Leslie conducts routine on-site reviews of Harvard Longwood IRB-approved studies; she works directly with investigators and their study staff to facilitate research through a variety of support services, such as IRB submission assistance, study consultation, and external audit preparation. As QIP Director, Leslie is also charged with evaluating Harvard Longwood's Human Research Protection Program. In addition, Leslie serves as the Director of ORARC Operations for which she is responsible for personnel management, office budget, and OHRP filings. Prior to the formation of ORARC's Quality Improvement Program, Leslie worked as Assistant Director to ensure compliance with all applicable federal regulations, state laws, institutional and departmental rules, policies, and procedures. Leslie earned her Certification of IRB Professionals (CIP) designation in 2004. She received her BS in Neuroscience from Bates College and her Masters in Public Health from Tufts University School of Medicine.
Stanley Estime, MSCI, CIP
QA/QI Specialist, Office of Regulatory Affairs & Research Compliance, Harvard T.H. Chan School of Public Health
Stanley Estime 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.
Edward Greg Koski, MD, PhD
Senior Scientist, James Mongan Institute for Health Policy; Associate Professor, Department of Anesthesiology and Critical Care, Massachusetts General Hospital and Harvard Medical School
Edward Greg Koski is currently a senior scientist at the James Mongan Institute for Health Policy and associate editor of the Journal for Empirical Research in Human Research Ethics (JERHRE). He served as the first director of the Office for Human Research Protections (OHRP) within the Office of the Secretary of the Department of Health and Human Services. He was past-president and former chairman of the Board of Trustees of the Academy of Pharmaceutical Physicians and Investigators, Association of Clinical Research Professionals. He received his undergraduate education, PhD, and MD from Harvard and did post-doctoral work in pharmacology at the National Institutes of Health before returning to the MGH Department of Anesthesia in 1981 to complete residency training and a fellowship in cardiothoracic anesthesia. He joined the faculty in 1984. During his four decades at Harvard, Dr. Koski has actively participated in every aspect of academic medicine including basic research, clinical investigation, teaching, administration, and patient care.
Cynthia Monahan, MBA
Director, Institutional Review Board (IRB), Boston University
Cynthia (Cindy) Monahan holds a Master's degree in Business Administration and has attained the Certified IRB Professional (CIP) designation. Prior to joining Boston University, Cindy worked as an IRB coordinator at Tufts Medical Center, a clinical research coordinator at Massachusetts General Hospital, and a QI Specialist at Partners Healthcare. In addition to working at Boston University, Cindy is a site visitor for the Association for the Accreditation of Human Subject Protection Programs (AAHRPP).
Alyssa Speier, MS, CIP
QA/QI Education Specialist, Office of Regulatory Affairs & Research Compliance, Harvard T.H. Chan School of Public Health
Alyssa Speier is responsible for providing Quality Improvement Program (QIP) services to the Longwood Medical Area, serving Harvard T.H. Chan School of Public Health, HMS, and HSDM. Alyssa works with investigators and their study staff providing consultation and guidance on regulatory requirements and institutional policies. Alyssa also develops and presents focused educational material to investigators and study staff upon request. Alyssa joined the Harvard T.H. Chan School of Public Health Office of Human Research Administration in 2005 and worked as an IRB analyst conducting protocol reviews. Prior to that, she worked at the Harvard Business School coordinating the computer lab for experimental research. Alyssa earned the Certification of IRB Professionals (CIP) designation in 2007. She received her BA in Psychology from the University of Virginia and her Masters of Science in Health Communication from Tufts School of Medicine.
Terry M. VandenBosch, PhD, RN, CIP, CCRP
Senior Research Compliance Associate, Office of Human Research Compliance Review (OHRCR), University of Michigan
Terry VandenBosch joined OHRCR in 2004. She obtained her academic qualifications, including her PhD, from the University of Michigan, and has been a registered nurse since 1972. She has worked in the UM Health System in intensive care settings, and in the development and evaluation of healthcare programs. As a consultant in the area of pain management, she helped start the Acute Pain Service, was an investigator and co-investigator for sponsored studies and was on the faculty in the School of Nursing. For over a decade, she was associated with the Saint Joseph Mercy Health System (SJMHS). She has also served on the national educational programming steering committee for Public Responsibility in Medicine and Research (PRIM&R). Her research interests include various clinical areas, evidence-based practice, and pain control. Dr. VandenBosch is interested in the application of human subjects regulations in real world settings while reducing regulatory burden, and providing guidance for investigators.
Sarah White, MPH, CIP, RAC
Assistant Director, Quality Improvement Program, Partners HealthCare
Sarah White 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 Y. Wolf, MD, JD, MSCI
Assistant Dean, Regulatory Affairs and Research Compliance, Director, Office of Regulatory Affairs & Research Compliance; Assistant Professor, Health Policy and Management, Harvard T.H. Chan School of Public Health
Delia Wolf 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 HSDM. 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.
Presented in partnership by the Harvard Catalyst Regulatory Foundations, Ethics, and Law Program and Harvard T.H. Chan School of Public Health Office of Regulatory Affairs & Research Compliance.
June 12, 2013, 9:00am-11:00am
Harvard Medical School, Armenise Building (D), Amphitheater
Video from the symposium:
Elizabeth Hohmann, MD, IRB Representative and IND Holder
Chair and Physician Director, Partners Human Research Committee, Partners Healthcare
Nazem Atassi, MD, MMSc, IND Holder
Associate Director, Neurological Clinical Research Institute (NCRI), Massachusetts General Hospital
Alexa Kimball, MD, MPH, IND Holder
Associate Professor, Harvard Medical School
Senior V.P. for Practice Improvement, Massachusetts General Physician Organization
Leigh R. Hochberg, MD, PhD, FAAN, IDE Holder
Senior Lecturer, Neurology, Massachusetts General Hospital
Panel Discussion moderated by: Sarah White, MPH, CIP, RAC, Director, Human Research Quality Improvement Program (QI Program), Partners Healthcare
Topics include: IRB assistance & the IRB's role, FDA submission/working with the FDA, dealing with intellectual property, sponsor-investigator monitoring responsibilities, non-traditional INDs, and additional resources required to conduct a sponsor-investigator initiated research study
Audience Question/Answer Session:
Watch the full symposium:
Planning Committee: Stanley Estime, Emily Ouellette, Leigh Read, Sarah White, Delia Wolf
Read more about the planning committee.
Friday, May 31, 2013, 1:00 - 5:00pm
Folkman Auditorium, Ender's Building, Boston Children's Hospital
Download materials from the symposium.
Adaptive Clinical Trials: Statistical, Ethical & Regulatory Considerations [PDF]
Adaptive Clinical Trials: Design and Implementation [PDF]
Regulatory Perspectives [PDF]
Ethical Issues in Adaptive Clinical Trials [PDF]
Check back soon for video from the symposium.
Planning Committee: Rebecca Betensky, Barbara E. Bierer, Michele Russell-Einhorn, Steve Joffe, Susan Kornetsky, Lisa Lehmann, Pearl O'Rourke, Sabune Winkler
Read more about the planning committee.