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ETHICAL, LEGAL AND SOCIAL IMPLICATIONS of LEARNING HEALTH SYSTEMS SYMPOSIUM November 18, 2016

ETHICAL, LEGAL AND SOCIAL IMPLICATIONS · 2016-11-29 · ethical, legal and social implications of creating this system. ... sensus Committee on Ethical and Social Policy Aspects

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Page 1: ETHICAL, LEGAL AND SOCIAL IMPLICATIONS · 2016-11-29 · ethical, legal and social implications of creating this system. ... sensus Committee on Ethical and Social Policy Aspects

ETHICAL, LEGAL ANDSOCIAL IMPLICATIONSof LEARNING HEALTH SYSTEMS

SYMPOSIUM

November 18, 2016

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DATA 1.0

DATA 2.0

DATA 3.0...

IRB INFORMEDCONSENT

HIPAA

BIOBANKS

DATA ACCESS

DATAMONITORING

IDENTIFIABILITY

EQUITY

PUBLICENGAGEMENTPEER

REVIEW EXPERT PANELS

INTERPROFESSIONALPRACTICE

EQUITY

REGULATIONS

IRB

PRAGMATICCLINICAL

TRIALS

PUBLIC ENGAGEMENT

COMPARATIVEEFFECTIVENESS

PUBLICENGAGEMENT

ACTIONS ANALYSIS

INFEREN

CES

Organizing a Learning Health SystemLearning health systems are networks that self-study and adapt using data and analytics to generate knowledge and transform practice. Continous innova-tion and improvement of health and health care can occur at all levels of scale, from individuals to local, national and global systems.

Yet harnassing the power of health data strains para-digms for how data information should be collected, stored, accessed, used and destroyed. Questions about the ethical, legal and social implications of this work arise at every procedural stage. By engaging these questions we will help achieve the vision of learning health systems to improve health for all in a way that is equitable and just.

[vision]The vision of the Learning Health System is “one in which progress in science, informatics, and care culture align to generate new knowledge as an ongoing, natural by‐product of the care experience, and seamlessly refine and deliver best practices for continuous improvement in health and health care” (Institutes of Medicine). Realizing the vision of the Learning Health System requires a new era of responsible research and innovation in which multiple stakeholders (researchers, health care providers, citizens, policy makers, industry, etc.) work together throughout the learning cycle, thus better aligning both the process and its outcomes with social values, needs and expectations.Today’s aim is to discuss and establish a research agenda that engages the ethical, legal and social implications of creating this system.

The LHS is an information infrastructure, or a “smart grid” for health (above) that can routinely aggregate data from disparate sources and convert that data into actionable knowledge that is then put into practice. Along a continous cycle of improvement (below), ethical, legal and social questions attend every procedural stage.

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[agenda]

#elsilhs

Moderator/discussantJodyn Platt + Raymond De Vries • The Learning Health System Visionand the ELSI Research Agenda

Welcome

8:30-8:45

Session 1: Ethics

8:45-10

Scott Kim • Ethical Issues in Pragmatic Trials in Learning Health Systems

John Lantos • Conflicting Ethical Imperatives in Research and QI

Jeff Botkin • Transparency & Choice in Healthcare Research

Andrew Shuman

Peter Jacobson

Joy Downs-Young

Gretchen Piatt

Dorene Markel

Scott Roberts

Kayte Spector-Bagdady

Raymond Hutchinson

10-10:15

10:15-11:30

BREAK

Session 2: Engagement

Session 3: Equity

Session 4: Law and Policy in Practice

Conclusion

Charles Bosk • Horse and Carriage: Mobilizing Engagement + System Ownership

Richard Sharp • Patient Engagement in the Era of Big Data:Challenges of Representation and Scale

Kent Key + E. Yvonne Lewis • Sustainable Community Engagement in aConstantly Changing Health System

LUNCH WITH SPEAKERS

12:30-1:45

1:45 - 3

3-3:30

Patricia Kingori • Understanding how Ideas of Race, Gender and SESbecome embedded in LHS: Challenges + Opportunities for Change

Vence Bonham • Health Equity and the Learning Health System

David Magnus • A ROMP in the PARC: Research on Medical Practices--Patient (& IRB) Attitudes about Research Consent

Jerry Menikoff • Chasing Unicorns

Tania Simoncelli • Data to Practice at The Broad Institute: Lessons forLearning Health Systems

Todd Rice • The ICU as a Learning Healthcare Environment: Bumps in theRoad from Quality Improvement to Comparative Effectiveness Resarch

Jodyn Platt, Sharon Kardia + Charles Friedman

11:30-12:30 *Speakers will have assigned seats

BREAKFAST8 - 8:30

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[contributors]Jeffrey R. Botkin, MD, MPH • University of Utah School of MedicineDr. Botkin is a Professor of Pediatrics and an Adjunct Professor of Human Genetics. He is Chief of the Division of Medical Ethics and Humanities and serves as the Associate Vice President for Research Integrity with oversight responsibilities for the human subjects protection program at the University of Utah. He has received consistent NIH funding for research on the ethical, legal, and social implications of genetic technology with a particular emphasis on research ethics, genetic testing for cancer susceptibility, biobanking, newborn screening, and prenatal diagnosis. Dr. Botkin has been the Chair of the DHHS Secretary’s Advisory Committee on Human Re-search Protections and a member of the Secretary’s Advisory Committee on Heritable Diseases in Newborns. He chairs the NIH’s Embryonic Stem Cell Eligibility Working Group and serves on the FDA Pediatric Ethics Subcommittee. Dr. Botkin is a member of the Institute of Medicine’s Con-sensus Committee on Ethical and Social Policy Aspects of Mitochondrial Replacement Therapy.

Vence L. Bonham, Jr., JD • National Human Genome Research InstituteSince 2003, Mr. Bonham has served as an associate investigator in the NHGRI Division of Intra-mural Research’s Social and Behavioral Research Branch. He leads the Health Disparities Genomics Unit, which conducts research that evaluates approaches to integrating new genomic knowledge and precision medicine into clinical settings without exacerbating inequities in healthcare delivery. His research focuses primarily on the social influences of new genomic knowledge, particularly in communities of color. He studies how genomics influences the use of the constructs of race and ethnicity in biomedical research and clinical care and the role of genomics in health inequities.Mr. Bonham serves as senior advisor to the NHGRI director on genomics and health disparities. From 2011-2015, Mr. Bonham was project leader and co-curator for the NHGRI/Smithsonian exhibition “Genome: Unlocking Life’s Code.” A Michigan State University graduate with a JD from Ohio State University, he was a fellow in the American Association of Medical Colleges Health Services Research Fellowship Program and was a faculty member at Michigan State University in the Colleges of Medicine and Law.

Charles L. Bosk, PhD • University of PennsylvaniaDr. Bosk is Professor of Sociology and of Anesthesiology and Critical Care (Perelman School of Medicine), and a Senior Fellow of the Leonard Davis Institute of Health Economics. His research focuses on the culture of medicine, sociology of bioethics, research ethics, the regulation of research, and the rise and fall of health care problems in the public arena. Dr. Bosk investigates how health care professionals make sense of experiences in which time-pressured decisions are required in situations filled with un-resolvable uncertainty, and at which decisions, when they lead to adverse outcomes, are deemed blameless or blameworthy. Ongoing funded research projects include an RWJ Health Investigator Award looking at how ideas about safety are formulated and converted into policies that are then embraced or evaded in care provision; (2) an ethnographic exploration of mandated duty hour limits on graduate medical education; and (3) a federally funded, state-coordinated initiative to reduce complications in surgery and improve the culture of safety in surgical departments. His books inlcude What would you do? Juggling Bioethics and Ethnography (2008) and What is a Medical Mistake? Forty Years Wondering (in progress). Dr. Bosk was elected to the National Academy of Medicine in 2013.

Raymond De Vries, PhD • University of MichiganDr. De Vries co-directs the Center for Bioethics and Social Sciences in Medicine at the University of Michigan and is a Professor in the Department of Learning Health Sciences and the Department of Obstetrics and Gynecology. He is also visiting professor at CAPHRI School for Public Health and Primary Care, University of Maastricht, the Netherlands. He is particularly interested in the regulation of science and the production of scientific knowledge; clinical trials of genetic therapies; the export of western moral traditions to non-western societies; and the social, ethical, and policy issues associated with the medicalization of pregnancy and birth. In 2005, he published A Pleasing Birth: Midwifery and Maternity Care in the Netherlands (Temple University Press), and he is co-editor of The View from Here: Bioethics and the Social Sciences (Blackwell, 2007) and Bioethics in the Field, a special issue of Social Science in Medicine (2013).

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Charles P. Friedman, PhD • University of Michigan Dr. Friedman is the Josiah Macy Jr. Professor of Medical Education and Chair of the Department of Learning Health Sciences at the University of Michigan Medical School. He joined U-M in 2011 as Professor of Information and Public Health, and Director of the Michigan health informatics program. Dr. Friedman’s academic interests have intertwined biomedical and health informatics with the processes of education and learning. His department is a “first in the nation” medical school academic department dedicated to the sciences of learning at all levels of scale: from learning by individuals, to learning by teams and organizations, and learning by ultra-large scale systems such as entire nations. Prior to coming to Michigan, Dr. Friedman held executive positions at the Office of the National Coordinator for Health IT (ONC), from 2007-2009 as Deputy National Coordinator and from 2009-2011 as ONC’s Chief Scientific Officer. While at ONC, Friedman oversaw a diverse portfolio that included the initial funding for the SMART platform. Prior to his work in the government, Dr. Friedman was Associate Vice Chancellor for Biomedical Informatics, and Founding Director of the Center for Biomedical Informatics at the University of Pittsburgh.

Raymond J. Hutchinson, MD, MS • University of Michigan Dr. Hutchinson is Associate Dean for Regulatory Affairs and Professor of Pediatrics and Commu-nicable Diseases at the U-M Medical School, where he oversees the research of the Children’s On-cology Group and has been a faculty member since 1978. His research examines clinical treatments for cancer patients and the informed consent process for patients entering stem cell transplant and phase I oncology trials. His responsibilities include providing leadership, expertise and advice on regulatory issues that impact research in the Medical School and the U-M Health System, includ-ing human subject and animal research. He chairs the Medical School’s Compliance Committee and the Conflict-of-Interest Committee and co-chairs the IRBMED Leadership Committee. As Associate Dean, Dr. Hutchinson serves as a contact for investigators in solving problems related to research regulatory issues, and also interacts with federal and state agencies to enable the Medical School to anticipate, influence and plan for new research regulations.

Peter D. Jacobson, JD, MPH • University of Michigan Mr. Jacobson is Professor of Health Law and Policy at the School of Public Health and Director of the Center for Law, Ethics, and Health. Before coming to U-M, he was Senior Behavioral Scientist at RAND from 1988 to 1996. His current research interests focus on the relationshipbetween law and health care delivery and policy, law and public health systems, and health care safety net services. In 1995, he received an Investigator Award from the Robert Wood Johnson Foundation to examine the role of the courts in shaping health care policy. The project culminated in the publication of the book Strangers in the Night: Law and Medicine in the Managed Care Era (2002). Mr. Jacobson is co-author of the law school casebook Law and the Health System (2014), and is also a co-author of False Hope vs. Evidence-Based Medicine: The Story of a Failed Treatment for Breast Cancer (2007). He is currently the Associate Editor for Health Law and Public Health at the Journal of Health Politics, Policy and Law.

Joy Downs-Young, RN, CDE • University of MichiganMs. Downs-Young is a Certified Diabetes Educator and Clinical Research Coordinator in the Department of Learning Health Sciences at the University of Michigan Medical School. Her areas of responsibility include diabetes self-management education and support in church-based settings, recruitment of participants, development and implementation of study procedures, developing relationships with church leadership and parish professionals, and Peer Leader training. Ms. Downs-Young’s scholarly and research interests are in patient empowerment and engagement, faith-based and community diabetes self-management education and support, and psychosocial and spiritual aspects of health management in underserved, faith-based commnities. She is an expert in diabetes education for community-based research, diabetes care and self-management, patient engagement and education.

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Kent D. Key, PhD, MPH • Michigan State UniversityDr. Key is Director of the Office of Community Scholars and Partnerships at MSU’s College of Human Medicine in the Division of Public Health. His interests include health disparity research, translational research, and community engaged research, and his work spans 15 years in his native Flint, Michigan. He serves as a bridge to build equitable relationships between community and academic partners and to elevate community research priorities to the health research enterprise. Dr. Key is the Executive Deputy Director of Community Based Organization Parnters (CBOP), an umbrella organization of more than 40 Flint CBOs. Immediately following the Flint Water Disaster in 2016, Dr. Key and his colleagues brokered a collaborative effort among MSU, U-M and CBOP to form the Healthy Flint Research Coordinating Center (HFRCC), where he is a core director. Dr. Key is also a member of the National Patient Stakeholders Council for PCORI.

Scott Kim, MD, PhD • National Institutes of Health Dr. Kim is a Senior Investigator in the NIH Department of Bioethics, an adjunct professor of psychiatry, University of Michigan and adjunct professor of neurology, University of Rochester. Previously, he was professor of psychiatry and co-director of the U-M Center for Bioethics and Behavioral Sciences in Medicine. Dr. Kim received his MD from Harvard and PhD in moral phi-losophy (on Kantian ethics) from the University of Chicago, and trained in adult psychiatry at the Massachusetts General Hospital. Dr. Kim combines philosophical, clinical, and empirical research approaches to his scholarly work to address several bioethical topics, including: ethical issues in pragmatic clinical trials, assessment of decision-making capacity, surrogate consent for incapacitat-ed patients, theory of informed consent, end of life issues, and a variety of topics in research ethics. Dr. Kim’s work has been supported by the NIMH, NINDS, NIA, NHGRI, Michael J. Fox Foundation, American Association for Geriatric Psychiatry, and the Greenwall Foundation. His work has appeared in New England Journal of Medicine, Nature, JAMA, and others.

John Lantos, MD • University of MissouriDr. Lantos is Professor of Pediatrics at University of Missouri in Kansas City and the founding director of the Children’s Mercy Hospital Bioethics Center. Prior to moving to Kansas City, he was a Professor of Pediatrics at The University of Chicago. There, he served in various leadership roles, including Chief of General Pediatrics and Associate Director of the MacLean Center for Clinical Medical Ethics. He is a leader in the field of bioethics. He has served as President of the American Society of Bioethics and Humanities (ASBH) as well as of the American Society of Law, Medicine, and Ethics (ASLME). He has published hundreds of peer-reviewed articles and many books. His monthly case reports in the journal Pediatrics analyze a wide range of topics in pediatric bioethics, health policy, and research ethics. From Kansas City, he directs an innovative, on-line program that is training a new generation of scholars from around the world in pediatric bioethics.

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Sharon L. R. Kardia, PhD • University of Michigan Dr. Kardia received her master’s degree in statistics and her doctoral degree in human genetics from the University of Michigan. She has over 30 years of experience in the genetic epidemiology of common chronic diseases. A major emphasis of her epidemiological work is on the cerebral, cardiac, renal, and peripheral arterial target organ damage associated with hypertension. She has also been interested in the impact of hypertension medications on the control of blood pressure in populations, including the investigation of pharmacogenetic mechanisms. Over the last decade, Dr. Kardia’s group has led investigations of genomic, epigenomic, and transcriptomic factors affecting a broad range of traits, including cardiovascular outcomes, hypertension, chronic kidney disease, lipid metabolism, cognition, obesity, diabetes, metabolic syndrome, inflammation, health behaviors, and mental health outcomes. She is also director of the Life Sciences and Society program at the School of Public Health that has focused on community engagement and trust in health data sharing.

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Patricia Kingori, PhD • University of OxfordDr. Kingori is a Wellcome Trust Biomedical Society and Ethics Fellow at the Ethox Centre, University of Oxford. Her disciplinary background is in Medical Sociology and her current research interests lie at the intersection of sociology of science and medicine and a critical examination of ethics with a particular interest in the frontline practitioners of medical research, the politics of health and what research and guidelines come to mean in practice. Her work has focused on the views, values and experiences of fieldworkers and similar frontline workers involved in collecting data and interacting with research participants. This has taken place in East Africa but has recently extended its focus to South East Asian and West African countries.

David Magnus, PhD • Stanford UniversityDr. Magnus is the Thomas A. Raffin Professor of Medicine and Biomedical Ethics and Professor of Pediatrics and Medicine at Stanford University, where he is Director of the Stanford Center for Biomedical Ethics and co-Chair of the Ethics Committee for the Stanford Hospital. He is the for-mer President of the Association of Bioethics Program Directors, and is the Editor in Chief of the American Journal of Bioethics. Dr. Magnus received his PhD in philosophy from Stanford and has published articles on a wide range of topics in bioethics, including research ethics, genetics, stem cell research, organ transplantation, end of life and patient communication. He has served on the National Research Council Ad Hoc Committee on the Bioconfinement of Genetically Engineered Organisms, as an “expert consultant” for the World Bank on food security and biotechnology and a consultant for the National Conference of State Legislators on cloning. He was a member of the Secretary of Agriculture’s Advisory Committee on Biotechnology in the 21st Century and currently serves on the California Human Stem Cell Research Advisory Committee. He is the principal editor of a collection of essays entitled Who Owns Life? (2002).

Dorene S. Markel, MS, MHSA • University of MichiganMs. Markel is the Director of the University of Michigan Brehm Center and an Assistant Research Scientist in the Department of Learning Health Sciences (DLHS) at the University of Michigan Medical School. The Brehm Center focuses on transforming the way research and collaborations are undertaken using a systems analysis approach and utilizing diabetes as a primary platform. She is the coordinator of the Brehm Coalition, a national “dream team” of 10 senior scientists in type 1 diabetes research. In her faculty appointment in DLHS she is working on a Learning Health System (LHS) approach to diabetes care and also has a focus on the ethical, social and policy issues of implementing a LHS. She also serves as a coordinator and mentor to the Brehm Scholarship programs for undergraduates and medical students at UM. Ms. Markel has been on staff at the University of Michigan Medical School since 1984 and has held leadership roles in growing the clinical and translational research enterprise and has previously worked in the genetic counsel-ing and genetic research fields, including the ethical and social issues involved in those areas. Ms. Markel received a Master’s Degree in Human Genetics, specializing in genetic counseling, from the University of Michigan Medical School and a Master’s Degree is Health Services Administration from the University of Michigan School of Public Health.

E. Yvonne Lewis, BS • National Center for African American Health ConsciousnessMs. Lewis is a leader in developing and implementing community/academic partnerships, both as founder and CEO of the National Center for African American Health Consciousness and as co-director of the Healthy Flint Research Coordinating Center uniting MSU and U-M with the community in addressing the Flint Water Crisis. Last year and this term, she moderated U-M Flint courses on the Water Crisis. Ms. Lewis is also outreach director for the non-profit Genesee Health Plan designed to provide coverage to the county’s uninsured residents, including efforts to inform, engage and serve the most difficult-to-reach population groups. She is currently Chair of the Board of Directors of the Genesee Community Health Center, Federally Qualified Health Center, as well as a member of other community based organization advisory councils. She was previously Execu-tive Director of both the Universal Kidney Foundation (2011–2014) and Faith Access to Commu-nity Economic Development (1999-2009). Ms. Lewis holds BS degrees in business administration and clinical/community psychology and will complete an MS in health education at U-M Flint in 2017.

BREHMDLHS CBSSM

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Jodyn Platt, PhD, MPH • University of Michigan Dr. Platt is an Assistant Professor in the Department of Learning Health Sciences, Division of Learning and Knowledge Systems at the University of Michigan. She is trained in medical sociology, health policy, and public health. Her research currently focuses on informed consent in cancer and genomic studies, and the Ethical, Legal, and Social Implications (ELSI) of public health genetics, newborn screening, and learning health systems. She is interested in understanding what makes learning health systems trusted and the pathways for earning and sustaining trust, using qualitative and survey methods.

Todd W. Rice, MD, MS • Vanderbilt UniversityDr. Rice is an Associate Professor of Medicine in the Division of Allergy, Pulmonary and Critical Care Medicine at Vanderbilt University. He serves as the director of the Medical ICU. As a physi-cian scientist, he conducts clinical research in the ICU, specifically in patients with sepsis, ARDS, and acute respiratory failure. Dr. Rice’s research has expanded in the last few years to using the ICU as a learning healthcare environment and conducting comparative effectiveness trials. In addition to having his own National Institutes of Health (NIH) funding, Dr. Rice serves as the Vanderbilt PI for the Prevention and Early Treatment of Acute Lung injury (PETAL) network. He is also the Medical Director of the Vanderbilt Human Research Protections Program, where he has extensive experience in regulatory oversight of clinical research. He is the PI of an R01 investigating different single IRB mechanisms for multicenter trials. His regulatory and research experience involve nu-merous studies conducted with waiver of consent and alterations to the traditional consent process.

J. Scott Roberts, PhD • University of Michigan Dr. Roberts is an Associate Professor in the Department of Health Behavior & Health Education (HBHE) and Director of the SPH Public Health Genetics Certificate program. Prior to joining the HBHE faculty in Fall 2006, he was Assistant Professor in the Department of Neurology at Boston University (BU) School of Medicine, where he was Co-Director of the Education Core in the NIH-funded BU Alzheimer’s Disease Center. At U-M, he serves as a Co-Director of the U-M dual-degree program in Public Health and Genetic Counseling and leads the Genomics, Health & Society program within the U-M Center for Bioethics & Social Sciences in Medicine. He also directs the Outreach, Recruitment and Education Core of the Michigan Alzheimer’s Disease Center.8

Gretchen Piatt, PhD, MPH • University of Michigan Dr. Piatt is an Assistant Professor in the Departments of Learning Health Sciences and Health Behavior and Health Education. Dr. Piatt completed her masters and doctoral training in chronic disease epidemiology with specific training and expertise in designing and evaluating efforts aimed at improving health systems and health care delivery for people with diabetes; understanding the behavioral and psychological aspects of diabetes self-management and support, and developing and implementing diabetes prevention and self-management treatment interventions in the commu-nity and primary care settings. Her work consists of designing and evaluating interventions for the primary and secondary prevention of diabetes and its complications, including translation of the Diabetes Prevention Program, implementation of the Chronic Care Model, and implementation and evaluation of peer leader self-management support interventions in underserved communities, federally qualified health centers, and primary care.

Jerry A. Menikoff, MD, JD • Office of Human Research Protections Dr. Menikoff is the Director of the Office for Human Research Protections (OHRP), which is part of the U.S. Department of Health and Human Services. Prior to joining OHRP, he served as the director of the NIH Office of Human Subjects Research, responsible for day-to-day oversight of the NIH intramural human research protection program. Immediately prior to coming to the federal government, he was Associate Professor of Law, Ethics and Medicine at the University of Kansas. Dr. Menikoff ’s research interests have concentrated on the intersection of bioethics and law. Among other works, 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).

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Richard Sharp, PhD • Mayo ClinicDr. Sharp is Director of the Biomedical Ethics Program at Mayo Clinic. Prior to joining Mayo Clinic in July 2013, he was Director of Bioethics Research at Cleveland Clinic and Co-Director of the Center for Genetic Research Ethics and Law at Case Western Reserve University, one of six NIH Centers of Excellence in Ethics Research. Dr. Sharp has published widely on topics in biomedical ethics, including clinical ethics consultation, informed consent, financial conflicts ofinterest, and ethical tensions in patient advocacy. His current research is examining how patients and healthcare providers view new forms of personalized medicine and clinical interventions enabled by molecular diagnosis. Dr. Sharp frequently advises healthcare organizations on ethical issues and has served on advisory committees for the National Institutes of Health, Institute of Medicine, American College of Medical Genetics, and US Environmental Protection Agency.

Tania Simoncelli, MS • Broad Institute of MIT and HarvardMs. Simoncelli is Director of Science Policy and Advocacy at the Broad Institute of MIT and Har-vard. Prior to her appointment at the Broad, Simoncelli served for two years as Assistant Director for Forensic Science and Biomedical Innovation within the White House Office of Science and Technology Policy, where she played lead roles in developing the President’s Precision Medicine Initiative and creating a national strategy for strengthening the forensic sciences. From 2010-2013, Ms. Simoncelli served as Special Assistant to Commissioner Margaret Hamburg and Senior Advi-sor in the Office of Medical Products and Tobacco at FDA. From 2003-2010, she served as Science Advisor to the American Civil Liberties Union, where she guided the organization’s responses to cutting-edge developments in science and technology and spearheaded the ACLU’s successful ef-forts to invalidate patents on the BRCA genes and end the practice of gene patenting in the United States. In 2013, she was named by the journal Nature as one of “ten people who mattered this year” for her work in overturning gene patents. Ms. Simoncelli has a B.A. in Biology and Society from Cornell University and her M.S. in Energy and Resources from UC Berkeley.

Kayte Spector-Bagdady, JD, MBioethics • University of MichiganMs. Spector-Bagdady is a Research Investigator in the Department of Obstetrics and Gynecology at the University of Michigan Medical School and also leads the Program in Research Ethics in the Center for Bioethics and Social Sciences in Medicine (CBSSM). Her current research explores informed consent to emerging technologies with a focus on reproduction and genetics. Ms. Spector-Bagdady received her J.D. and M.Bioethics from the University of Pennsylvania Law School and School of Medicine respectively after graduating from Middlebury College. She completed a research fellowship in bioethics at CBSSM. She is a former drug and device attorney and Associate Director of the Presidential Commission for the study of Bioethical Issues where she acted as a lead staff investigator for the report “Ethically Impossible”: STD Research in Guatemala from 1946 to 1948. She is a member of the UM Pediatric and Adult Ethics Committees and the UM IRB Council.

Andrew Gregg Shuman, MD • University of Michigan Dr. Shuman, MD is an Assistant Professor in the Department of Otolaryngology - Head and Neck Surgery at the University of Michigan Medical School. He is also Chief of the ENT Section of the Surgery Service at the VA Ann Arbor Health System. He serves as Co-Director of the Program in Clinical Ethics in the Center for Bioethics and Social Sciences in Medicine (CBSSM). His current research interests explore ethical issues involved in caring for patients with head and neck cancer, and in managing clinical ethics consultations among patients with cancer. Dr. Shuman completed fellowships in head and neck surgical oncology in the Department of Surgery at Memorial Sloan-Kettering Cancer Center, and in medical ethics at Weill Medical College of Cornell University. He completed his residency in the Department of Otolaryngology - Head and Neck Surgery at the University of Michigan. He is a graduate of the University of Michigan Medical School, and also graduated from the University of Michigan’s College of Literature, Science and the Arts.

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UMHSU-M SPONSORS

Department of Learning Health SciencesCenter for Bioethics and Social Sciences in MedicineMichigan Institute for Clinical and Health Research

The Brehm CenterSchool of Public HealthUniversity of Michigan Health System

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[sponsors]

[planning committee]Mimi Dalaly Raymond De VriesRaymond Hutchinson Sharon L. R. Kardia Phillip Kurdunowicz Frank Manion Dorene Markel Mina RajTricia Piechowski Jodyn Platt Tevah Platt Joshua Rubin Kanchan Sehgal Lota Kayte Spector-BagdadyMary Wines Georgiann Ziegler

[email protected] [email protected]

[email protected]@umich.edu

[email protected] [email protected]

[email protected]@umich.edu

[email protected]@[email protected]

[email protected]@[email protected]@umich.edu [email protected]

University of Michigan • University of Michigan • University of Michigan • University of Michigan • Michigan Department of Health and Human ServicesUniversity of Michigan • The Cancer CenterUniversity of Michigan • University of Michigan • University of Michigan • University of Michigan • University of Michigan • University of Michigan • University of Michigan • University of Michigan • University of Michigan • University of Michigan •

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[stay connected]

JOURNAL: Submissions to a special journal issue of Learning Health Systems are welcome. See the call for papers below.

SURVEY: Please provide symposium feedback by returning the enclosed paper survey.

MOBILE and ONLINE: www.elsilhs.org

SOCIAL MEDIA: Join & continue the conversation: #elsilhs /ELSILHS @elsilhsumich

MAILING LIST: Stop at the registration table and sign up tohear about topics and events that interest you.

Symposium visitors may access MGuest or MGuest-UMHS limited, unsecure WiFi networks. Enter any Web address on your device to be directed to the sign-in page. Eduroam is also available for those enrolled through their home institutions.

A special journal issue of Learning Health Systems will be devoted to ELSI-LHS.Submissions are due Feb. 21, 2017.

Find the journal and its submission guidelines at:http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)2379-6146

To learn more, contact Jodyn Platt at [email protected].

[call for papers]

QUESTIONS? Visit the registration table or email [email protected]

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[notes]