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.

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.

To request reasonable accommodations for a disability, please email Kathleen McGroarty at least two weeks prior to the conference.

Agenda

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 Perelman School of Medicine
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
Director, Research Ethics Consultation Unit, Division of Clinical Research, Massachusetts General Hospital
Associate Psychologist, Department of Psychiatry, Massachusetts General Hospital
Assistant Professor, Harvard Medical School
Faculty Associate, Center for Bioethics, Harvard Medical School

Melissa Abraham, PhD, MSc, is director of the Research Ethics Consultation Unit in the Division of Clinical Research at Massachusetts General Hospital. She is a former chair at the Partners Human Research Committee. Abraham is a clinical psychologist, with a background in epidemiology and public health. She is an assistant professor in Psychology, and a faculty associate at the Center for Bioethics, Harvard Medical School. She is interested in the oversight 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.

Mark Alexander, MD
Assistant Professor of Pediatrics, Harvard Medical School
Associate in Cardiology, Co-Director Exercise Physiology, Boston Children's Hospital

Mark Alexander, MD, is a pediatric cardiologist at Boston Children's Hospital and a vice chair of the Boston Children's Hospital IRB. He has a busy practice focusing on arrhythmia management in children and adults with congenital heart disease. After college and medical school in Massachusetts, Alexander served in the military as a resident in Hawaii and a pediatrician in rural Louisiana before returning for cardiology and electrophysiology fellowships, joining the staff in 1998. He has been on the IRB since 2013 and became one of three vice chairs in 2016. In anticipation of the new common rule, Alexander is spearheading efforts to streamline the multiple approaches taken to assent. He is married to an obstetrician and has three grown children, two of whom actively participated in clinical research as teens and young adults.

Misti Ault Anderson, MS, MA
Senior Advisor for Public Health Education, Division of Education and Development
HHS Office for Human Research Protections

Misti Ault Anderson, MS, MA, serves as a senior advisor for public health education in the Division of Education and Development of the HHS Office for Human Research Protections (OHRP). Prior to joining OHRP, Anderson was a senior policy and research analyst at the Presidential Commission for the Study of Bioethical Issues, where she served as staff lead for the Bioethics Commission's educational materials and for both volumes of the Bioethics Commission's Gray Matters report on neuroscience and ethics. She holds an MS in biomedical science policy and advocacy from Georgetown University, an MA in science education from UNC-Chapel Hill, and a BS in microbiology from Clemson University.

Madelon Baranoski, PhD
Professor of Psychiatry; Directory of Psychological Services, Law and Psychiatry Division, Yale School of Medicine

Madelon Visintainer Baranoski obtained a PhD in psychology at the University of Pennsylvania. Since 1999 she has been at the Yale School of Medicine, Law and Psychiatry Division. She is professor of Psychiatry and is director of Psychological Services in the division. She established and now directs the New Haven Jail Diversion Program and developed Community Forensic Services at a community mental health center. As faculty, she teaches medical students, residents, and fellows in both psychiatry specialties and psychology. She also teaches in the Yale Law School and participates in Yale Law School clinics, including the veterans and the immigration clinics, consulting to law students and conducting evaluations. She has served on the Yale University IRB for 20 years and has been a vice chair for 10 years and a chair for two years. As chair, she educates new members and serves on the Pediatric Protocol Committee and the Research Ethic Review Committee for Psychiatry. Her current research, publications, and presentations are on vicarious trauma, risk assessment, and management strategies for persons with psychiatric disorders, and assessment and augmentation of decision-making in persons with cognitive limitations.

Mark Barnes, JD, LLM
Partner, Ropes & Gray LLP
Faculty Co-Chair, Multi-Regional Clinical Trials Center of Harvard and BWH
Lecturer, Yale Law School and Yale School of Medicine

Mark Barnes, JD, LLM, focuses on human and animal research, stem cell and genetic research, research grants and contracts, research fraud, and international research in his law practice at Ropes & Gray. Formerly, he was the senior associate provost for research at Harvard University, and in 2004 started and directed Harvard's HIV/AIDS treatment programs in Nigeria, Tanzania, and Botswana for several years. Barnes has served as chief administrative officer at St. Jude Children's Research Hospital, and has held senior appointed positions in the New York City and State departments of health. He is co-chair of the Subcommittee on Harmonization of Research Regulations, HHS Secretary's Advisory Committee on Human Subjects Protections, and is a member of the Ethics Working Group of the NIH HIV Prevention Clinical Trials Network. Barnes serves as the faculty co-chair of the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women's Hospital, which works with researchers, industry, and regulators to improve standards and regulations for clinical trials, with a focus on the emerging economies. He teaches health care law and finance and public health law at Yale Law School.

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.

Return to top


Barbara E. Bierer, MD
Senior Vice President for Research, Brigham and Women's Hospital
Professor of Medicine, Harvard Medical School
Program Director, Harvard Catalyst Regulatory Foundations, Ethics, and Law Program
Faulty Director, Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

Barbara E. Bierer is the faculty director of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center), a professor of medicine, Harvard Medical School and Brigham and Women's Hospital, and a hematologist/oncologist. She is the director of the Regulatory Foundations, Ethics and the Law Program of the Harvard Clinical and Translational Science Center. Previously she served as senior vice president, research at Brigham and Women's Hospital for 11 years, and was the institutional official for human subjects and animal research, for biosafety, and for research integrity. She initiated the Brigham Research Institute and the Innovation Hub (iHub), a focus for entrepreneurship and innovation. In addition, she was the founding director of the Center for Faculty Development and Diversity at BWH.

In addition to her academic responsibilities, she serves on the Board of Directors of Public Responsibility in Medicine and Research (PRIM&R), dedicated to promoting the ethical conduct of biomedical and behavioral research; Management Sciences for Health (MSH), an international organization working in partnership globally to strengthen health care, local capability, and access; and the Edward P. Evans Foundation, a foundation supporting biomedical research. Previously she has served as the chair of the Board of Directors of the Association for Accreditation of Human Research Protection Programs (AAHRPP) and as chair of the Secretary's Advisory Committee on Human Research Protections, HHS. She has authored or co-authored over 180 publications and is on the editorial boards of a number of journals including Current Protocols of Immunology. Bierer received a BS from Yale University and an MD from Harvard Medical School.

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, JD, MA, Mphil
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.

Susan Kornetsky, MPH
Senior Director of Clinical Research Compliance, Boston Children's Hospital

Susan Kornetsky, MPH, is senior director of clinical research compliance at Boston Children's Hospital. She has a Masters of Public Health and completed a Medical Ethics Fellowship at Harvard Medical School. Currently, Kornetsky is the chair of board for the organization Public Responsibility in Medicine and Research. She is a past member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), a former co-chair of the Sub-committee on Children, and currently serves on the Subpart A subcommittee. She is a past board member of the Association for the Accreditation of Human Research Programs (AAHRP), and past site visitor. Kornetsky was a member of the Institute of Medicine's Committee on Clinical Research Involving Children, the Council for Certification of IRB Professionals (CCIP), and served as a Council co-chair. She is faculty for Harvard Medical School's Office of Global Education, and lectures at national and international meetings — most recently teaching clinical research ethics in London, Turkey, and Portugal. Kornetsky is a consultant for the Office for Protection from Research Risks' site visit teams. She lectures on research ethics and IRB regulations for Harvard Medical School courses on research ethics. Topics of interest include pediatric research, boundaries between research and innovation, biobanking, and the obligation to return research results to subjects.

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.

Return to top


Yvonne Lau, MBBS, MBHL, PhD
Director, Division of Education and Development
HHS Office for Human Research Protections

Yvonne Lau, MBBS, MBHL, PhD, is the director of the Division of Education and Development (DED) at the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP). She joined OHRP in June 2014 from the Office of Extramural Research of the National Institutes of Health (NIH) where she served as the Extramural Research Integrity Officer. Lau had also worked with the NIH Office of Extramural Program as a Human Subjects Specialist, and had served on the Institution Review Board of the MedStar Health Research Institute in Maryland. Prior to coming to the U.S., Lau was a consultant surgeon with the Hospital Authority of Hong Kong and founded Hong Kong's first multidisciplinary breast center and breast cancer patient support group. She received her medical degree from the University of Hong Kong, and is a Fellow of the Royal College of Surgeons of Edinburgh (FRCSEd) in the United Kingdom, and Foundation Fellow of the Hong Kong Academy of Medicine (HKAM). She obtained her Master in Bioethics and Health Law (MBHL) and her PhD in Bioethics from the University of Otago in New Zealand.

Jerry A. Menikoff, MD, JD
Director, Office for Human Research Protections (OHRP)

Jerry A. Menikoff, MD, JD, is the director of the office for Human Research Protections (OHRP), a component of the U.S. Department of Health and Human Services (HHS). This office is responsible for protecting the rights, welfare, and wellbeing of subjects involved in research conducted or supported by HHS. In addition, OHRP provides leadership in the protection of subjects by providing clarification and guidance, developing educational programs and materials, and maintaining regulatory oversight.

Prior to joining OHRP, Menikoff served as the director of the National Institutes of Health (NIH) Office of Human Subjects Research, responsible for day-to-day oversight of the NIH intramural research program's human research protection program, including policy development and educational activities.

He held several academic positions prior to his government service. Menikoff served for nine years as the chair of the human subjects committee and the hospital ethics committee at the University of Kansas Medical Center. He was also on the faculty of schools of law at the University of Chicago and other universities. Immediately prior to coming to the federal government, he was associate professor of law, ethics and medicine at the University of Kansas.

Menikoff's research interests have concentrated on bioethics in general and more particularly, on the ethics of research with human subjects. He is the author of Law and Bioethics: An Introduction (Georgetown University Press) and What the Doctor Didn't Say: The Hidden Truth about Medical Research (Oxford University Press).

He received his undergraduate degree from Harvard University (magna cum laude in Mathematics, 1973), and also received in 1977 a JD (magna cum laude; Editor and Officer of the Harvard Law Review) and MPP (Public Policy) from Harvard. Menikoff earned an MD in 1986 from Washington University, St. Louis.

Megan Morash, RN
Chair, Partners Human Research Committee

Megan Morash is a chair of the Partners Human Research Committee (PHRC). She obtained her nursing degree from the University of Pennsylvania and a master degree in education from Suffolk University, Boston. Morash became a chair at the PHRC in 2012 where she focuses on minimal risk research conducted in a biomedical setting. She is interested in issues related to tissue, genetics, and health information sharing and has developed guidance on topics related to genetic, consent, and patient-centered outcomes research for the IRB and investigator community at Partners HealthCare.


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.

P. Pearl O'Rourke, MD
Director, Human Research Affairs
Partners HealthCare

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 Harvard Medical School. She is responsible for the systems that support the regulatory and ethical oversight of human research and the responsible conduct of research. She is also chair of the Partners Healthcare System Embryonic Stem Cell Research Oversight (ESCRO) Committee.

O'Rourke has worked as a pediatric critical care physician at Boston Children's Hospital, and at the Children's Hospital, University of Washington, Seattle, where she was the director of the pediatric intensive care unit. She was active in clinical research in extracorporeal membrane oxygenation (ECMO), liquid ventilation, high frequency ventilation, and pediatric resuscitation. In Seattle, she served many years as a member of the IRB.

In 1995-1996, O'Rourke was a Robert Wood Johnson Health Policy fellow, working for Senator Edward Kennedy. Following this fellowship, she became the deputy director of the Office of Science Policy in the Office of the Director at the NIH where she worked on issues such as privacy, gene therapy (transfer) embryonic stem cells, and genetic discrimination.

She has also been involved in international medical care, serving in China and Indonesia with Project HOPE, and has been very active with PRIMR, serving many years on the board as well as a term as board chair.

Patricia Seymour, CCRC, CIP, MA
Director of IRB Operations, New England IRB
Human Subject Protection Administrator at Hummingbird IRB

Patricia Seymour, CCRC, CIP, MA, is the director of IRB Operations for New England IRB and human subject protection administrator at Hummingbird IRB. She has over 25 years of experience in research and IRB administration. She has served as the manager of the MetroWest Medical Center IRB in Framingham, MA; director of research administration at MetroWest Medical Center; director of site development/operations at Clinical Studies, Ltd. in RI; and the director of the human subjects protection office at Beth Israel Deaconess Medical Center in Boston.

Seymour worked as a regional representative and consultant for Western IRB (WIRB) before becoming their director of business development/institutions from 2008–2011. During her tenure at WIRB, she served as interim director for several major academic medical centers. She has also served as a regulatory analyst and board administrator for Quorum Review. Seymour has extensive experience in drafting standard operating procedures, reorganization of IRB offices, development and training of managers, staff and board members, and all aspects of IRB review. She has facilitated transitions to outsourcing of all or some IRB review to central IRBs at Columbia, Yale, and Boston University, and she developed a new IRB for a joint effort of University Hospitals of Cleveland, Case Western Reserve University, and the Cleveland Clinic, an Oncology IRB for Quorum Review, and Hummingbird IRB.

Seymour has been a speaker at DIA, NCURA, Public Responsibility in Medicine and Research (PRIM&R) and other conferences. Her international experience includes training investigators and board members for private research companies and sponsors. She received her BA degree at Simmons College, attended Boston College for two years to pursue an MA degree in American Studies, and earned an MA in Health Administration at Framingham State College.

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.

David H. Strauss, MD
Director of Research Operations and Compliance
Columbia University Department of Psychiatry

David Strauss, MD, is director of research operations and compliance at the Columbia University Department of Psychiatry and the NYS Psychiatric Institute (NYSPI) where he oversees human and animal research ethics, regulatory affairs, and core research facilities. Strauss co-chairs Columbia University's Standing Committee on the Conduct of Research. He is a senior consultant to the Multi-Regional Clinical Trials Center at Harvard and Brigham and Women's Hospital.

From 2010-2016, Strauss served as vice chair for research administration, ethics and policy for the Columbia University Department of Psychiatry, and director of research at NYSPI. From 2000 until 2010, he chaired the NYSPI IRB and directed its Office of Humans Subjects Research. He co-directed the Ethics, Public Policy, and Human Rights Core of the HIV Center for Clinical and Behavioral Studies.

Strauss is a past recipient of two NIH grants on research ethics training and the enhancement of human subjects oversight for psychiatric research. He is a former member of the HHS Secretary's Advisory Committee on Human Research Protections and co-chaired its Subcommittee on the Inclusion of Individuals with Impaired Decision-making in Research. He currently serves on a SACHRP subcommittee charged with developing recommendations to enhance Subpart A or the "Common Rule."

Strauss is a member of the executive committee of the Board of Directors of PRIM&R, and chairs its Public Policy Committee. He is a member of the Bioethics Advisory Group at Takeda Pharmaceuticals.

He is a principal in the firm HSN & Associates Consulting. Strauss practices psychotherapy and psychopharmacology, and teaches, lectures, and consults on matters of human subjects protections and applied research and professional ethics.

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.

Return to top

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 at:
77 Avenue Louis Pasteur
Boston, MA 02115

Click the following links to download helpful transportation PDFs.

Directions

Parking

Campus Map

Additional information can be found at the Joseph B Martin Conference Center website.

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.

Will CME and CIP credits be available?

Yes. We hope to accredit as many session hours as possible. An accurate count of the credit hours available will be communicated after the event has concluded. Information on how to apply for credits will be provided at registration.

Registration

Please register for this event by April 24, 2018.

Contact

For more information, please email us.

The 2018 Boston OHRP RCF Planning Committee:

Barbara Bierer, MD, Aaron Kirby, MSc, and Kathleen McGroarty, BS, Harvard Catalyst
Susan Kornetsky, MPH, Boston Children's Hospital
P. Pearl O'Rourke, MD, Partners Healthcare Systems
Cynthia Monahan, Boston University
Andreas Klein, MD, Tufts Medical School CTSI
Linda Coleman, JD, and Tesheia Johnson, MBA, MHS, Yale Center for Clinical Investigation
Misti Ault Anderson, MS, MA, and Yvonne Laue, MBBS, MBHL, PhD, Office of Human Protections


Return to top

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.

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Boston University School of Medicine (BUSM) and Harvard Catalyst.

Boston University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

This program meets the criteria of the Massachusetts Board of Registration in Medicine for risk management study.

BUSM CME Course Director: Susan S. Fish, PharmD, MPH, Professor of Biostatistics and Epidemiology. Boston University School of Public Health

Learning objectives:

  • Identify the core federal regulations governing human subjects research and know how to put them into practice and apply them to your everyday work
  • Develop strategies for managing successful HRPPs/IRBs
  • Assess how your HRPP/IRB policies and procedures compare with the best practices in the field
  • Communicate effectively with those involved in various aspects of the research enterprise to ensure adherence to federal regulations and that human subjects are properly protected before, during, and after a research study
  • Implement best practices for obtaining informed consent including the Common Rule and new industry technologies and innovations

Target audience: HRPP/IRB chairs, members, and administrators; researchers and research staff; institutional officials; regulatory officials; compliance officers - those charged with overseeing "responsible conduct of research" programs; hospital/university patient advocate attorneys; representatives of voluntary health organizations; industry and biotechnology representatives; and those involved with science policy

This program is jointly provided by Boston University School of Medicine and Harvard Catalyst | The Harvard Clinical and Translational Science Center, in collaboration with Boston Children's Hospital, Partners HealthCare, Tufts Clinical and Translational Institute, and Yale Center for Clinical Investigation.



PRIM&R Workshop

Immediately preceding this Research Community Forum, PRIM&R is hosting a workshop in the same location on April 30. Make the most of your trip and the cost of travel by registering for and attending both programs. This workshop, "A Systematic Exploration of IRB Review and Oversight of Research On, About, and Including Vulnerable Populations," will provide a basic overview of the regulations that cover and explore vulnerable populations using an expanded definition of vulnerability.

Learn more about the PRIM&R Workshop and register.

Please note: registration for the PRIM&R workshop is separate from registration for the Research Community Forum. If you would like to attend both programs, be sure you register for each via the respective websites for each program. The PRIM&R workshop is not sponsored by the 2018 New England OHRP Research Community Forum Planning Committee.