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

Past Events


Cluster Randomized Trials: Ethics, Regulations, Statistics & Design

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This half-day symposium explored Cluster Randomized Trial Design and the ethical and regulatory concerns involved in the design process.

This symposium was co-sponsored by Harvard Catalyst's Biostatistics Program and Regulatory Foundations, Ethics, and Law Program.

November 3, 2016
1:00pm - 4:30pm, Bray Room, Joseph B. Martin Conference Center

CRT Symposium News Coverage

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


Ethical Challenges in Compassionate Access to Investigational Medicines

with Joanne Waldstreicher, MD, Chief Medical Officer of Johnson & Johnson

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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.


Cultural Competency in Research Symposium, Featuring the Bok Players

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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


Research Ethics Consortium

Real-time Assessment of Suicidal Thoughts in Psychiatric Inpatients: What are the ethical considerations?

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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:

  1. Examine the natural occurrence of suicidal thoughts using smart-phone based self-report assessments, and
  2. Examine novel behavioral and physiological predictors of suicidal thoughts using mobile smartphone technology and wearable devices

Challenges include:

  • What are the issues that arise when collecting information on suicidal thoughts in research studies?
  • What are the privacy risks of participating in this research, and how can participants be protected? What is done with the information collected? How is a thorough consent process ensured?
  • What are some of the other issues ethical review boards should address in reviewing human subjects research using new technologies?

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.


Case Studies in Social, Behavioral, and Educational Research (SBER)

Society of Clinical Research Associates (SOCRA)
Boston Chapter Monthly Meeting

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Monday, January 26, 2015
5:00-6:00pm
Boston Children's Hospital - Enders Building
320 Longwood Avenue, Seminar Room #1

Speakers:

  • Jennifer Graf, Manager, Human Research Protection Program and Research Integrity, Cambridge Health Alliance
  • Alyssa Speier, Assistant Director for Regulatory Affairs and Research Compliance, Harvard T.H. Chan School of Public Health
  • Matt Stafford, Assistant Director, Office of Clinical Investigation, Boston Children's Hospital

Objectives:

  • Participants will begin to analyze the ethical and practical issues surrounding risk to subjects that investigators should make when designing and implementing SBER research protocols.
  • Participants will examine how research that does not necessarily pose risk of physical harm to subjects can nevertheless challenge researchers in protecting their subjects from other kinds of risks: psycho-social, legal, psychological, etc.
  • Participants will discuss IRB assessment of SBER research risks and explore strategies for addressing the risks.
  • Participants will have a chance to share from their collective experience and develop a greater understanding of the potential risks of SBER research.



Clinical Trial Recruitment: Problems, Misconceptions, and Possible Solutions

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Organizers:

  • Robin Pierce, Petrie-Flom Center, Harvard Law School, Senior Law and Ethics Associate
  • Holly Lynch, Petrie-Flom Center, Harvard Law School, Executive Director

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]



Health Research By The People, For The People: Citizen Science in Search of an Ethic

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Speaker: Effy Vayena, PhD, Institute of Biomedical Ethics, University of Zurich

Thursday, January 15, 2015
4:30-6:00pm
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.



A Conversation with the Health and Human Services Office of the Inspector General

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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.

Speaker Bios:

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.



Ethical Issues in Global Health Research: Blending Cultures, Building Capacity, and Bolstering Collaboration

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June 9-12, 2014
677 Huntington Avenue, Harvard T.H. Chan School of Public Health



3rd Annual QA/QI Boot Camp: Shape Up or Ship Out

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June 2-3, 2014

651-677 Huntington Avenue, Harvard T.H. Chan School of Public Health

Hosted by The Harvard T.H. Chan School of Public Health in partnership with Harvard Catalyst's Regulatory Foundations, Ethics, and Law Program and PRIM&R.



2nd Annual QA/QI Boot Camp: Resistance is Futile!

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August 22-23, 2013
651 Huntington Avenue, Harvard T.H. Chan School of Public Health's FXB Building, Room G-12

Available Materials:

Faculty

Susie Corl, MSW, MPH, CIP, CCRP
Quality Improvement Specialist, Office of Clinical Investigation, Education, and Quality Improvement Program (EQuIP), Children's Hospital Boston

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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

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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

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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

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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

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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

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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

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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

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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

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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.



Investigator IND/IDE Education Symposium

Featuring investigators with IND/IDE expertise and experience
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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.



Adaptive Clinical Trials: Ethical, Regulatory & Statistical Considerations Symposium

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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]

Session 1
Adaptive Clinical Trials: Design and Implementation [PDF]
Regulatory Perspectives [PDF]
Ethical Issues in Adaptive Clinical Trials [PDF]

Session 2:
Adaptive Clinical Trials: Case Study [PDF]
Statistical Considerations [PDF]
Ethical Issues in Adaptive Clinical Trials [PDF]

Keynote Speaker:

Donald Berry, PhD
Donald Berry, PhD, is a professor in the department of biostatistics at the University of Texas MD Anderson Cancer Center. He is well known as a developer of Bayesian adaptive designs that efficiently use information that accrues over the course of the trial. These trials minimize sample size while increasing the likelihood of detecting drug activity. Under his direction, the department of biostatistics designed over 300 clinical trials that take a Bayesian approach. He is co-developer (with Giovanni Parmigiani) of BRCAPRO, a widely used program that provides individuals' probabilities of carrying mutations of breast/ovarian cancer susceptibility genes BRCA1 and BRCA2. Berry is the author of several books on biostatistics and over 300 published articles, including first-authored articles in the New England Journal of Medicine, the Journal of the American Medical Association, and Nature. Berry has been the principal investigator for numerous research grants from the National Institutes of Health and the National Science Foundation. He is a fellow at the American Statistical Association and the Institute of Mathematical Statistics.

Presenters:

Robert D. Truog, MD
Robert Truog is professor of medical ethics, anesthesia, and pediatrics at Harvard Medical School (HMS). He has practiced pediatric intensive care medicine at Boston Children's Hospital for more than 25 years, including serving as chief of the division for more than a decade. He is director of clinical ethics at HMS and executive director of the Institute for Professionalism and Ethical Practice, where he creates and teaches highly interactive seminars to enhance the relational and communication skills of clinicians across a variety of topics, including breaking bad news, discussing organ donation with families, and disclosure of adverse events and medical error. He has published more than 200 articles and books in bioethics and related disciplines.
Rebecca Betensky, PhD
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).
Amanda Hammond, JD
Amanda J. Hammond, JD, is the director, strategy & operations, in the Office for the Human Research Studies (OHRS) for the Dana-Farber Cancer Institute (DFCI) and the DF/HCC. OHRS is responsible for scientific and institutional review board review for all oncology protocols conducted by the five Harvard hospitals that conduct clinical research. Hammond has also been a member of the DFCI's IRB since 2005. She regularly speaks at conferences on human subject protections. Before coming to DFCI, she served as the director for the Office of Research Administration at the Naval Medical Research Center in Silver Spring, MD. During this time, she conducted site visits to all the command's subordinate research centers (in Egypt, Indonesia, Peru, and Great Lakes, IL) where she designed and implemented ongoing quality improvement in scientific and ethical reviews of human subject research, management of conflicts of interest, pre- and post-award administration, and clearance of manuscripts and presentations involving animals and human subjects.
Zoran Antonijevic
Zoran Antonijevic is the senior director, strategic consulting and adaptive implementation, at Cytel. He is responsible for strategic quantitative input at the trial, program, or portfolio level. He also contributes to developing processes and tools for implementation of adaptive clinical trials. Research areas include: adaptive design, interim data monitoring, pharmaceutical portfolio optimization, and decision making within clinical drug development process. Externally, Zoran Antonijevic is active within DIA adaptive design scientific working groups where he is the chair-elect, and has been leading collaborative initiatives on data monitoring committees, adaptive dose-ranging studies, adaptive programs, and portfolio optimization. Zoran Antonijevic's prior experience includes Quintiles Innovation, GlaxoSmithKline, and Harvard T.H. Chan School of Public Health.

Presented in partnership by the Harvard Catalyst Regulatory Foundations, Ethics, and Law and Biostatistics Programs.

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.