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

Research Community Forum
Informed Consent: Content, Communications and Emerging Technologies

May 1-2, 2018
Joseph B. Martin Conference Center
Harvard Medical School

Hosted by the Office for Human Research Protections and the 2018 Boston OHRP RCF Planning Committee.

Forum Workshop: May 1, 2018
8:00am-5:00pm

The Forum Workshop is presented by the Office for Human Research Protections. It will combine didactic instruction and engaging interactions to help participants interpret and apply the federal regulations and policies on human research protections. This event will focus on the Revised Common Rule and will address the upcoming changes to informed consent. OHRP will engage institutional experts to share their unique viewpoints and insights. The workshop will be limited to a smaller audience to ensure an engaging and interactive exchange — reserve your spot soon!

Forum Symposium: May 2, 2018
8:00am-5:00pm

"Informed Consent: Content, Communications & Emerging Technologies" is presented by the co-sponsoring institutions. This full day symposium will present a program of speakers in lecture, panel, and workshop format. Speakers will address issues of Informed Consent and how we can move forward as a community to address issues of content, communications, and emerging technologies.

Conference Fees
Forum Workshop: $75
Forum Symposium: $100
Both Days: $175
Breakfast and lunch provided by Harvard Catalyst
Register for this event.

Speakers

Keynote Speakers:

David Fajgenbaum, MD, MBA, MSc
Assistant Professor of Medicine, Translational Medicine & Human Genetics Associate Director, Patient Impact, Orphan Disease Center, University of Pennsylvania
Executive Director, Castleman Disease Collaborative Network

David Fajgenbaum, MD, MBA, MSc, is assistant professor of medicine and associate director of the Orphan Disease Center at the University of Pennsylvania, co-founder/executive director of the Castleman Disease Collaborative Network (CDCN), and a patient battling the same rare and deadly disease — idiopathic multicentric Castleman disease (iMCD) — that he studies. Fajgenbaum was diagnosed with iMCD during medical school.

Between five life-threatening flares and hospitalizations, Fajgenbaum created the CDCN, which has become a model for international collaboration and an innovative approach for accelerating research. He has published research that has changed the way iMCD is researched and treated. Currently, he is in his longest remission ever thanks to a precision treatment that he identified, which had never been used for iMCD. Fajgenbaum's work has been profiled by the New York Times, Science, Today Show, Reader's Digest, Everylife Foundation's 2016 RareVoice Award, Global Genes' 2015 RARE Champion of Hope: Science award, and Forbes Magazine's 2015 30 Under 30 Healthcare List. Fajgenbaum received his BS from Georgetown University, MSc from Oxford University, his MD from the University of Pennsylvania, and MBA from the Wharton School of Business.


Steven Joffe, MD, MPH
Emanuel and Robert Hart Professor Medical Ethics and Health Policy Chief, Division of Medical Ethics
University of Pennsylvania Perelman School of Medicine

Steven Joffe, MD, MPH, is the Emanuel and Robert Hart Professor of Medical Ethics and Health Policy and professor of pediatrics at the University of Pennsylvania Perelman School of Medicine. He is chief of the Division of Medical Ethics and directs the department's postdoctoral training programs in bioethics and in the ethical, legal, and social implications of genomics. Joffe attended Harvard College, received his MD from the University of California at San Francisco (UCSF), and received his MPH from UC Berkeley.

Joffe trained in pediatrics at UCSF and in pediatric hematology/oncology at the Dana-Farber Cancer Institute and Boston Children's Hospital, and his clinical work focuses on stem cell transplantation in children. His research addresses the ethical challenges that arise in clinical and translational investigation. He has led or participated in NIH-, PCORI-, and foundation-funded studies that examine the roles and responsibilities of principal investigators in multicenter randomized trials, accountability in the research enterprise, governance within learning healthcare systems, return of genetic results to research participants, and the integration of genomic sequencing technologies into cancer care.

Joffe is a member of the U.S. Food and Drug Administration's (FDA) Pediatrics Ethics Subcommittee and the National Human Genome Research Institute's Genomics and Society Working Group.


Additional speakers:

Melissa Abraham, PhD, MSc
Chair of the Partners Human Research Committee (PHRC)
Assistant professor in psychiatry at Harvard Medical School (HMS)

Melissa Abraham, PhD, MSc, is a chair of the Partners Human Research Committee (PHRC), the IRB for the Massachusetts General and Brigham and Women's Hospitals. She is an assistant professor in psychiatry at Harvard Medical School, an associate psychologist at Massachusetts General Hospital, and is a faculty associate at the Center for Bioethics at HMS. Abraham obtained her doctorate in clinical psychology from Northwestern University Medical School, and a master's degree in epidemiology from the Harvard T.H. Chan School of Public Health. Abraham completed the Fellowship in Medical Ethics at HMS and went on to become a chair at the PHRC in 2004. She reviews minimal risk biomedical and social and behavioral research conducted at Massachusetts General and Brigham and Women's Hospitals. Abraham is interested in issues related to quality of review of social and behavioral research in the biomedical setting, and has developed guidance on topics related to the use of deception, quality improvement, social media and the internet, and emerging digital technologies in research for the IRB and investigator community at Partners HealthCare System, Inc. Abraham has a psychotherapy practice in Boston, MA.

Laura Beskow, MPH, PhD
Professor of Health Policy, Vanderbilt Center for Biomedical Ethics & Society

Laura Beskow, MPH, PhD, received her BS in nutrition from Iowa State University and her MPH with a concentration in health law from Boston University. She completed her PhD in health policy, with a minor in epidemiology at the University of North Carolina at Chapel Hill. She is currently professor of health policy in the Vanderbilt Center for Biomedical Ethics & Society at the Vanderbilt University School of Medicine.

Beskow's work focuses on ethics and policy issues in biomedical research, particularly human subjects issues in large-scale genomic and translational research. She has been a principal investigator on empirical studies of research recruitment, informed consent, confidentiality protections, the return of research results to participants and families, and the research use of electronic health records. Nationally, she chaired the eMERGE Network's Informed Consent Task Force, co-chaired a committee for NCI's initiative to develop a concise informed consent template for cancer clinical trials, and served on the Subpart A Subcommittee of the Secretary's Advisory Committee for Human Research Protections, and the Federal Advisory Committee for the National Children's Study. She is an active member of several committees for the NIH Precision Medicine Initiative's All of Us Research Program.

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Jonathan Davis, MD
Associate Director, Tufts CTSI
Director, Tufts CTSA Trial Innovation Network Center
Chair, Neonatal Advisory Committee, Office of the Commissioner, FDA
Director, International Neonatal Consortium (INC), FDA/European Medicines Agency/Critical Path Institute

Jonathan Davis, MD, is vice chair of Pediatrics, chief of Newborn Medicine, and the associate director of the Clinical and Translational Science Institute at the Floating Hospital for Children at Tufts Medical Center, and professor of pediatrics at Tufts University School of Medicine. His research has focused on neonatal drug development for the prevention and treatment of a variety of neonatal conditions. He has authored approximately 200 manuscripts and book chapters and received numerous grant awards from the NIH, the FDA, the March of Dimes, and many others. He is currently funded by NIH and FDA to develop better outcome measures for clinical trials and new and existing therapeutics to improve neonatal outcome.

Davis is chair of the Neonatal Advisory Committee in the Office of the Commissioner at FDA, director of the International Neonatal Consortium, and a member of the Leadership Council of the American Pediatric Society. These positions permit him to work closely with governments, academic leaders, industry, and families to promote the development of important therapeutics for infants and children.

Celia Fisher, PhD
Marie Ward Doty University Chair in Ethics, Fordham University
Professor of Psychology
Director, Center for Ethics Education
Director, HIV and Drug Abuse Prevention Research Ethics Training Institute, Fordham University

Celia Fisher, PhD, the Marie Ward Doty Endowed University Chair in Ethics and professor of Psychology, is founding director of the Fordham University Center for Ethics Education and the NIDA funded HIV and Drug Abuse Prevention Research Ethics Training Institute. She chaired the Environmental Protection Agency's Human Studies Review Board and the American Psychological Association's Ethics Code Task Force, and was a member of the Secretary's Advisory Committee on Human Research Protections (SACHRP), the National Academies' Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences, the National Institute of Mental Health Data Safety and Monitoring Board, and the Institute of Medicine's Committee on Clinical Research Involving Children.

Fisher was awarded the Lifetime Achievement Award for Excellence in Human Research Protection in 2010 and the America Psychological Association 2017 Award for Outstanding Contributions to Ethics Education, and named a 2012 Fellow of the American Association for the Advancement of Science. She is the author of "Decoding the Ethics Code: A Practical Guide for Psychologists" (4th edition, 2017), co-editor of eight books, and author of over 200 articles and chapters on ethics, and research and practice with vulnerable populations.

John Goldberg
Deputy Dean and Eli Goldston Professor of Law
Harvard Law School

John Goldberg, Deputy Dean and Eli Goldston Professor of Law at Harvard Law School, is an expert in tort law and theory. He joined the Harvard faculty in 2008. From 1995 until then, he was a faculty member of Vanderbilt Law School. He is co-author of a leading Torts casebook "Tort Law: Responsibilities and Redress" (4th ed. 2016), as well as "The Oxford Introductions to U.S. Law: Torts" (2010). He has published dozens of articles and essays in scholarly journals, has taught an array of first-year and upper-level courses, and has received multiple teaching prizes.

An associate reporter for the American Law Institute's Fourth Restatement of Property, Goldberg also serves as an advisor to the Third Restatement of Torts. He is a member of the editorial boards of the Journal of Tort Law and Legal Theory, and in 2009 was chair of the Torts and Compensation Systems Section of the Association of American Law Schools. After receiving his JD in 1991 from New York University School of Law, Goldberg clerked for Judge Jack Weinstein of the Eastern District of New York and for Supreme Court Justice Byron White. Before joining the Vanderbilt faculty, he briefly practiced law in Boston.

Stephen Latham, JD, PhD
Director, Yale Interdisciplinary Center for Bioethics

Stephen Latham, JD, PhD, is director of the Interdisciplinary Center for Bioethics at Yale University. He is faculty chair of Yale's Human Subjects Committee (its social/behavioral IRB), and co-chair of its Embryonic Stem Cell Research Oversight Committee. Latham has been a graduate fellow of Harvard's Safra Center on Ethics, a research fellow of the University of Edinburgh's Institute for Advanced Studies in the Humanities, and a board member of the American Society for Bioethics and Humanities, from which he received a Distinguished Service Award.

Latham formerly did clinical ethics consultation with the Pediatric Ethics Committee of Yale-New Haven's Children's Hospital, and currently serves on the medical review board of Connecticut's Department of Children and Families. Latham is author of over 100 publications in bioethics and health law; his most recent book is "Genetics, Ethics and Education" (Cambridge, 2017), co-edited with Susan Bouregy, Elena Grigorenko, and Mei Tan. Latham is a graduate of Harvard College, Harvard Law School, and the UC Berkeley doctoral program in jurisprudence and social policy.

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Sally Okun
Vice President, Policy and Ethics, PatientsLikeMe

Sally Okun is vice president for policy and ethics at PatientsLikeMe. She joined the company in 2008 as manager of health data integrity. She is responsible for bringing patient voice and insight to diverse health policy discussions at the national and global level, and is the company's liaison with external organizations, government and regulatory agencies, and also functions as the company's human protections administrator.

Okun is frequently sought to represent the patient perspective at numerous external activities, advisory boards, and expert panels. In 2017 she joined the Board of Directors for Public Responsibility in Medicine and Research (PRIM&R). She was a 2010 fellow in biomedical informatics for the National Library of Medicine and a 2014 Salzburg Global Fellow in New Paradigms for Behavioral and Mental Health. Okun is a registered nurse who completed her graduate studies at the Heller School for Social Policy & Management at Brandeis University.

Jordan Smoller, MD, ScD
Professor of Psychiatry, Harvard Medical School
Co-Director, Partners Biobank at Massachusetts General Hospital (MGH)
Principal Investigator, New England Precision Medicine Consortium of the All of Us Research Program

Jordan Smoller, MD, ScD, is the MGH Trustees Endowed Chair in Psychiatric Neuroscience, professor of psychiatry at Harvard Medical School, and professor in the Department of Epidemiology at the Harvard T.H. Chan School of Public Health. He is associate chief for research in the MGH Department of Psychiatry and director of the Psychiatric and Neurodevelopmental Genetics Unit in the MGH Center for Genomic Medicine.

Smoller is a Tepper Family MGH Research Scholar and also serves as director of the Omics Unit of the MGH Division of Clinical Research and co-director of the Partners HealthCare Biobank at MGH. He is also an associate member of the Broad Institute and vice president of the International Society of Psychiatric Genetics. He is currently the lead PI of the New England Precision Medicine Consortium as part of the NIH Precision Medicine Initiative's All of Us Research Program. The focus of Smoller's research interests has been understanding the genetic and environmental determinants of psychiatric disorders across the lifespan, integrating genomics and neuroscience to unravel how genes affect brain structure and function, and using "big data," including electronic health records and genomics, to advance precision medicine.

John Wilbanks
Chief Commons Officer, Sage Bionetworks

John Wilbanks is the chief commons officer at Sage Bionetworks. Previously, Wilbanks worked as a legislative aide to Congressman Fortney "Pete" Stark, served as the first assistant director at Harvard's Berkman Center for Internet & Society. He founded and led to acquisition the bioinformatics company Incellico, Inc., and was executive director of the Science Commons project at Creative Commons.

In February 2013, in response to a "We the People" petition that was spearheaded by Wilbanks and signed by 65,000 people, the US government announced a plan to open up taxpayer-funded research data and make it available for free. Wilbanks holds a BA in philosophy from Tulane University and also studied modern letters at the Sorbonne.

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Agenda coming soon

A detailed agenda will be posted soon.

Hotel

Hotel rooms at a discounted rate are available at The Inn at Longwood Medical Center, conveniently located within walking distance to the Joseph B. Martin Conference Center. To make a reservation call or visit the registration website:

  • Call 800-468-2378 or 617-731-4700 and request group code OHRP0501,
  • Or visit the OHRP RCF Event Page
FAQs

What are my transportation/parking options for getting to and from the event?

The Joseph B. Martin Conference Center is located off the D or E line of the MBTA. Driving Directions can be found at the Conference Center Directions Page.

Parking is not provided; a full list of local public parking garages can be found at the Conference Center Parking Page.

What's the refund policy?

Full refunds are available up to seven days prior to the start of the event. If you need to cancel closer to the event, no refund will be provided.

Registration

Please register for this event by April 24, 2018.

Contact

For more information, please email us.

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Hosted by the 2018 New England OHRP Research Community Forum Planning Committee: The Office for Human Research Protections, Harvard Catalyst | The Harvard Clinical and Translational Science Center, Boston Children's Hospital, Boston University, Partners HealthCare, Tufts Clinical and Translational Institute, and Yale Center for Clinical Investigation.