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Returning Individual Research Results to Participants: Guidance for a New Research Paradigm (2018)

Chapter: Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff

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Suggested Citation:"Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
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E

Biographical Sketches of Committee Members, Consultants, and Staff

COMMITTEE

Jeffrey R. Botkin, M.D., M.P.H. (Chair) is a professor of pediatrics at The University of Utah and an adjunct professor of human genetics. He is the chief of the Division of Medical Ethics and Humanities in the Department of Internal Medicine. He obtained his B.A. from Princeton University, M.D. from the University of Pittsburgh, and M.P.H. from the Johns Hopkins Bloomberg School of Public Health. Dr. Botkin is the associate vice president for research integrity at The University of Utah with oversight responsibilities for the institutional review board, conflict of interest, responsible conduct of research, biosafety, and research ethics education. His research and publications are focused on the ethical, legal, and social implications of genetic technology, with a particular emphasis on research ethics, newborn screening, and prenatal diagnosis. Dr. Botkin was formerly the chair of the Secretary’s Advisory Committee on Human Research Protections at the Department of Health and Human Services and also of the Committee on Bioethics for the American Academy of Pediatrics. He served on the National Academies’ Committee on Ethical and Social Policy Aspects of Mitochondrial Replacement Therapy and is a member of the National Advisory Council for the National Human Genome Research Institute. Dr. Botkin chairs the National Institutes of Health’s Embryonic Stem Cell Working Group and is a member of the Food and Drug Administration’s Pediatric Ethics Advisory Committee. Dr. Botkin is an elected fellow of the Hastings Center.

Paul S. Appelbaum, M.D., is the Elizabeth K. Dollard Professor of Psychiatry, Medicine, and Law and the director of the Center for Law, Ethics, and Psychiatry

Suggested Citation:"Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
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in the Department of Psychiatry, College of Physicians and Surgeons of Columbia University; he is also a research psychiatrist at the New York State Psychiatric Institute; and an affiliated faculty member at Columbia Law School. He directs Columbia’s Center for Research on Ethical, Legal, and Social Implications of Psychiatric, Neurologic, and Behavioral Genetics, and heads the Clinical Research Ethics Core for Columbia’s Clinical and Translational Science Award program. Dr. Appelbaum is the author of many articles and books on law and ethics in clinical practice. His current research focuses on the implications of new genetic technologies. Dr. Appelbaum is past president of the American Psychiatric Association (APA) and of the American Academy of Psychiatry and the Law and has twice served as the chair of the Council on Psychiatry and Law and of the Committee on Judicial Action for APA. Dr. Appelbaum is currently the chair of the Diagnostic and Statistical Manual of Mental Disorders Steering Committee for APA, and immediate past chair of the Standing Committee on Ethics of the World Psychiatric Association. He has received the Isaac Ray Award of the American Psychiatric Association for “outstanding contributions to forensic psychiatry and the psychiatric aspects of jurisprudence,” was the Fritz Redlich Fellow at the Center for Advanced Study in the Behavioral Sciences, and has been elected to the National Academy of Medicine.

Suzanne Bakken, R.N., Ph.D., FAAN, FACMI, is the Alumni Professor of Nursing and a professor of biomedical informatics at Columbia University, and she is the co-chair of the health analytics center of the Data Science Institute. Following doctoral study in nursing at the University of California, San Francisco, she completed a National Library of Medicine postdoctoral fellowship in medical informatics at Stanford University. The goal of Dr. Bakken’s program of research is to promote health and reduce health disparities in underserved populations through the application of innovative informatics and data science methods. A major focus of her current grant portfolio is the visualization of health care data for community members, patients, clinicians, and community-based organizations. Dr. Bakken currently directs the Precision in Symptom Self-Management Center and the Reducing Health Disparities Through Informatics pre-doctoral and postdoctoral training program, both funded by the National Institute of Nursing Research. She also served as the principal investigator of the Agency for Healthcare Research and Quality–funded Washington Heights Inwood Informatics Infrastructure for Comparative Effectiveness Research (WICER) and its follow-up study, WICER 4 U, which is focused on promoting the use of WICER infrastructure through stakeholder engagement, including the return of individual research results. She has also received funding from the National Cancer Institute, National Library of Medicine, National Institute of Mental Health, and the Health Resources and Services Administration. Dr. Bakken has published more than 250 peer-reviewed papers and in January 2019 she will assume the role of the editor-in-chief of the Journal of the American Medical Informatics Association. In 2010

Suggested Citation:"Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
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she received the Pathfinder Award from the Friends of the National Institute of Nursing Research and she was inducted into the International Nurse Researcher Hall of Fame in 2018. In 2015–2016 Dr. Bakken served as the American Academy of Nursing, the American Nurses Association, and the American Nurses Foundation Distinguished Nurse Scholar-in-Residence at the National Academy of Medicine and is a member of the National Academies’ Roundtable on Health Literacy. She is a fellow of the New York Academy of Medicine, American Academy of Nursing, American College of Medical Informatics, International Academy of Health Sciences Informatics, and a member of the National Academy of Medicine.

Chester Brown, M.D., Ph.D., is the St. Jude Chair of Excellence in Genetics and a professor in and the division chief of genetics at the University of Tennessee Health Science Center, Le Bonheur Children’s Hospital and St. Jude Children’s Research Hospital. He was recruited to his current position to help develop precision medicine initiatives in Memphis, Tennessee, including the development of DNA and tissue repositories and large-scale omics technologies to aid in population-based genomic research, considering also the ethical, legal, and social implications of such efforts in underserved communities. His clinical interests include a variety of rare genetic syndromes in children and adults with a research emphasis on rare genetic disorders that have severe, early-onset obesity as a feature. He completed his undergraduate degree at Howard University, followed by M.D./Ph.D. training at the University of Cincinnati College of Medicine. His postdoctoral and subsequent faculty roles were in pediatrics and medical genetics at Baylor College of Medicine. He has more than 20 years of clinical experience with medical genetics patients representing a broad spectrum of conditions. He is an active member of the Society for Pediatric Research and a member of a National Institutes of Health (NIH) study section, and he recently completed service as a committee member for the National Academies of Sciences, Engineering, and Medicine to develop a framework to inform decision making related to genetic testing. He also directs a basic science research laboratory supported by grants from the National Institute of Child Health and Human Development, the National Institute of Diabetes and Digestive and Kidney Diseases, industry, and a variety of foundations. He works collaboratively to better understand the host genomic factors that contribute to HIV and tuberculosis progression in African children, funded by the NIH/National Institute of Allergy and Infectious Diseases H3Africa initiative. He has continued clinical practice throughout his career and has never lost sight of the fundamental importance of careful observation and listening carefully to patients.

Wylie Burke, M.D., Ph.D., is a professor emeritus and former chair of the Department of Bioethics and Humanities at the University of Washington. Her work focuses on the ethical and policy implications of genetic information in research, public health, and clinical care. She founded the University of Washington Center for Genomics and Healthcare Equality, a National Human Genome Research

Suggested Citation:"Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
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Institute–funded center of excellence in ethical, legal, and social implications research addressing the implications of genomic research for underserved communities, and she co-directs the Northwest Alaska Pharmacogenomics Research Network, a research partnership involving universities and tribal communities in Alaska, Montana, and Washington State. Dr. Burke received a Ph.D. in genetics and an M.D. from the University of Washington and she completed internal medicine residency training at the University of Washington, where she was also a medical genetics fellow. She is a member of the National Academy of Medicine and past president of the American Society of Human Genetics.

Richard Fabsitz, Ph.D., joined the Department of Global and Community Health as adjunct faculty after a long-term career with NIH. His NIH career began with the National Institute of Mental Health but was primarily spent at the National Heart, Lung, and Blood Institute where he last served in the position of deputy chief of the Epidemiology Branch. His professional experience is primarily in research team management, program administration, and the conduct of cardiovascular epidemiology research in large population-based studies focused on longitudinal cohort studies, Native Americans, families, twins, and genetics. Additional research interests include the use of metrics in the management of scientific research, methods to promote collaboration and innovation in research projects, research translation, and the ethical and practical issues surrounding the return of genetic research results to study participants. He has authored or co-authored a wide range of journal articles related to cardiovascular epidemiology and the above research interests.

Vanessa Northington Gamble, M.D., Ph.D., a physician and medical historian, is the University Professor of Medical Humanities and a professor of health policy and American studies at The George Washington University (GWU). Before coming to GWU, she was the director of Tuskegee University’s National Center for Bioethics and Health Care. She is an internationally recognized expert on the history of race and American medicine, racial and ethnic inequities in health and health care, and bioethics. Dr. Gamble chaired the committee that took the lead role in the successful campaign to obtain an apology in 1997 from President Clinton for the infamous United States Public Health Syphilis Study at Tuskegee. She has been appointed to numerous boards and committees including the National Advisory Council of the Agency for Healthcare Research and Quality, the ethics subcommittee of the Advisory Committee to the director of the Centers for Disease Control and Prevention, the National Advisory Council for Human Genome Research, Ibis Reproductive Health, National Caucus and Center on Black Aged, Inc., and Hampshire College. Dr. Gamble is a member of the National Academy of Medicine and a fellow of the Hastings Center.

Suggested Citation:"Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
×

Gregg Gonsalves, Ph.D., is an assistant professor of epidemiology of microbial diseases at the Yale School of Public Health. His research focuses on the use of quantitative models for improving the response to epidemic diseases. Dr. Gonsalves is also an associate professor (adjunct) and research scholar in law at Yale Law School, a co-director of the Yale Collaboration for Research Integrity and Transparency, and a leading HIV/AIDS activist. For more than 20 years, he worked on HIV/AIDS and other global health issues with several organizations, including the AIDS Coalition to Unleash Power, the Treatment Action Group, Gay Men’s Health Crisis, and the AIDS and Rights Alliance for Southern Africa. He was also a fellow at the Open Society Foundations and in the Department of Global Health and Social Medicine at Harvard Medical School from 2011 to 2012. He is a 2011 graduate of Yale College and received his Ph.D. from the Yale Graduate School of Arts and Sciences/School of Public Health in 2017.

Rhonda Kost, M.D., is the director of the Clinical Research Support Office, co-director of the Community Engaged Research Core, and an associate professor of clinical investigation in The Rockefeller University Center for Clinical Translational Science. She is interested in developing models and evidence-based measures of the research process that reflect the values of the stakeholders. Her research has included the areas of informed consent, participant experience, and the development of a academia–community research partnership. She led a multicenter team that developed a suite of validated participant-centered research participant perception surveys now adopted by academic centers to drive improvements in the participant experience. She recently co-authored a guide for investigators along with participant materials to help the parties align their informed consent discussion of research involving next-generation sequencing with a potential return of results. She also developed a collaborative Community-Engaged Research Navigation model to foster sustainable research partnerships between basic scientists and affected communities. She is the Rockefeller principal investigator on several federally funded collaborative projects to study innovations in participant recruitment. Dr. Kost has served on numerous NIH/Clinical and Translational Science Awards Program national committees, chairing the Regulatory Support Key Function Committee as well as its recruitment and research advocacy taskforces. At Rockefeller, she chairs the Action Committee for Community Engaged Research and is vice-chair of the institutional review board. Dr. Kost received her M.D. from Harvard, completed internal medicine residency training at Yale and an infectious diseases subspecialty training at Case Western Reserve, and served as a medical staff fellow at NIH’s National Institute of Allergy and Infectious Diseases. Prior to joining Rockefeller, she designed and conducted clinical trials at the Aaron Diamond AIDS Research Center.

Debra G. B. Leonard, M.D., Ph.D., received her M.D. and Ph.D. from the New York University School of Medicine and is currently a professor in and the chair

Suggested Citation:"Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
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of the Department of Pathology and Laboratory Medicine at the Robert Larner, M.D. College of Medicine at the University of Vermont and at the University of Vermont Health Network. She was previously the vice chair for laboratory medicine in the Department of Pathology and Laboratory Medicine at Weill Cornell Medical College and the director of the clinical laboratories for New York-Presbyterian Hospital-Weill Cornell, where she also served as the director of the Pathology Residency Training Program. Dr. Leonard is a nationally recognized expert in molecular pathology. She has served on several national committees that develop policy for the use of genetic and genomic technologies and information, including the Secretary’s Advisory Committee on Genetics, Health and Society that advised the Secretary of Health and Human Services, and the Roundtable on Genomics and Precision Health of the National Academies of Sciences, Engineering, and Medicine. Dr. Leonard is the editor of two molecular pathology textbooks and has spoken widely on various molecular pathology test services, the future of molecular pathology, the impact of gene patents on molecular pathology practice, and the transition to genomics as a tool for population health management.

Amy McGuire, J.D., Ph.D., is the Leon Jaworski Professor of Biomedical Ethics and the director of the Center for Medical Ethics and Health Policy at Baylor College of Medicine. Dr. McGuire’s research focuses on the clinical integration of emerging technologies, with a particular focus on ethical and policy issues in human genetics and genomic research. Her research is funded by the National Institutes of Health. Dr. McGuire served as a member of the National Advisory Council for Human Genome Research from 2011 to 2015. Currently she is on the program committee for the Greenwall Foundation Faculty Scholars Program in Bioethics and is the president of the Association of Bioethics Program Directors.

James H. Nichols, Ph.D., D.A.B.C.C., F.A.C.B., is a professor of pathology, microbiology, and immunology and the medical director of clinical chemistry and point-of-care testing at Vanderbilt University School of Medicine in Nashville, Tennessee. Dr. Nichols received his B.A. in general biology/premedicine from Revelle College, University of California, San Diego. He went on to complete an M.S. and a Ph.D. in biochemistry from the University of Illinois, Urbana-Champaign. Dr. Nichols was a fellow in the postdoctoral training program in clinical chemistry at the Mayo Clinic in Rochester, Minnesota. He is board certified in both clinical chemistry and toxicological chemistry by the American Board of Clinical Chemistry. Dr. Nichols spent several years as the associate director of clinical chemistry, the director of point-of-care testing, and an associate professor of pathology at Johns Hopkins Medical Institutions. He later served as the medical director of clinical chemistry for Baystate Health in Springfield, Massachusetts, and was a professor of pathology at Tufts University School of Medicine. Dr. Nichols’ research interests span evidence-based medicine, information management, laboratory automation, point-of-care testing, and toxicology. Dr. Nichols

Suggested Citation:"Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
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has served on the Clinical Laboratory Improvement Amendments Advisory Committee and has been involved with the Clinical and Laboratory Standards Institute (CLSI) in a number of roles including the CLSI board of directors. He was a member of the CLSI Subcommittee on Point-of-Care Testing as well as the vice-chairholder and chairholder of the CLSI Consensus Committee on Point-of-Care Testing, the CLSI Consensus Council and chairholder of the Evaluations Protocols Expert Panel. Dr. Nichols has also served in several leadership positions with the American Association for Clinical Chemistry (AACC), the AACC Academy, and Laboratory Medicine Best Practices committees with the Centers for Disease Control and Prevention.

Bray Patrick-Lake, M.F.S., as the director of stakeholder engagement for Duke Clinical Research Institute, supports efforts to actively engage patients, health advocacy organizations, and other stakeholders in local and national research programs. She has led extensive efforts through the Clinical Trials Transformation Initiative to incorporate patient voices into clinical trial design, conduct, oversight, and regulatory frameworks as well as in improvement of the clinical trial enterprise. She co-chaired the advisory committee for the NIH director’s working group responsible for authoring the vision and roadmap to launch the Precision Medicine Initiative Cohort Program. She served as the interim director of engagement for several months after the program launched and became the All of Research Program, for which she currently serves on the national advisory panel. She also leads engagement work at Duke’s Coordinating Center for the NIH Environmental Influences on Child Health Outcomes (ECHO) program and serves on the National Academies of Sciences, Engineering, and Medicine Health Sciences Policy Board. Ms. Patrick-Lake founded a nonprofit disease advocacy organization for cardiac patients and served as a patient representative at the Food and Drug Administation on a variety of advisory committees and panels; in workgroups for the European Medicines Agency, the Innovative Medicines Initiative, NIH, and the National Academy of Medicine; and as a patient stakeholder or co-investigator for Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute (PCORI). She has been a member of the PCORnet Coordinating Center’s executive leadership committee, where she developed patient engagement strategies. She is member of the American Cancer Society’s clinical trials steering committee and has served on the MDEpiNet’s National Medical Device Registry Task Force, the Medical Device Innovation Consortium’s Patient-Centered Benefit–Risk Steering Committee, the American College of Cardiology (ACC) Foundation’s patient-centered care shared decision making and patient-generated health data working groups, and the ACC Trans-catheter Valve Therapy Registry Stakeholder Advisory Committee. She currently also serves as a PCORI reviewer and ambassador.

Suggested Citation:"Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
×

Consuelo H. Wilkins, M.D., M.S.C.I., is the executive director of the Meharry-Vanderbilt Alliance and an associate professor of medicine at both Vanderbilt University Medical Center and Meharry Medical College. As the associate director of the Vanderbilt Institute for Clinical and Translational Science, she oversees programs in team science and community engagement. Dr. Wilkins is currently a principal investigator of the Vanderbilt-Miami-Meharry Center of Excellence in Precision Medicine and Population Health, which focuses on decreasing disparities among African Americans and Latinos using precision medicine, and the Vanderbilt Recruitment Innovation Center, a national center dedicated to enhancing recruitment and retention in clinical trials. She has pioneered methods of stakeholder engagement that involve community members and patients in research across the translational spectrum. One approach, the Community Engagement Studio, was recently scaled to engage more than 650 community members across 12 states in 77 face-to-face consultations for the Precision Medicine Initiative Pilot. This work included eliciting perspectives from diverse communities on returning individual research results. With colleagues at Vanderbilt, Dr. Wilkins has developed a framework that extends the concept of return of results to “return of value,” which integrates influencers of participants’ perspectives of value and considers clinical and personal utility. Prior to joining the faculty at Vanderbilt University Medical Center in 2012, Dr. Wilkins was an associate professor in the Department of Medicine, Division of Geriatrics, with secondary appointments in psychiatry and surgery (public health sciences) at Washington University School of Medicine in St. Louis. She served as the founding director of the Center for Community Health and Partnerships in the Institute for Public Health, the co-director of the Center for Community Engaged Research in the Clinical and Translational Science Awards Program, and the director of “Our Community, Our Health,” a collaborative program with Saint Louis University to disseminate culturally relevant health information and facilitate community–academic partnerships to address health disparities.

Brian J. Zikmund-Fisher, Ph.D., is an associate professor in the Department of Health Behavior and Health Education, University of Michigan (UM) School of Public Health, as well as a research associate professor in the Division of General Internal Medicine, University of Michigan Medical School, and an associate director of the UM Center for Bioethics and Social Sciences in Medicine. Dr. Zikmund-Fisher uses his interdisciplinary background in decision psychology and behavioral economics to study factors that affect individual decision making about a variety of health and medical issues. His research in health communications focuses on making risk statistics, test results, and other types of quantitative health information intuitively meaningful and useful for decision making by patients and the public. Dr. Zikmund-Fisher also studies the effects of poor numeracy on people’s ability to use numbers to inform their health decisions and the role of narratives in health communications. He serves as an associate editor

Suggested Citation:"Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
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for the journals Medical Decision Making and Medical Decision Making: Policy and Practice.

CONSULTANTS

Rebecca L. Davies, Ph.D., is the director of Quality Central at the University of Minnesota College of Veterinary Medicine. Dr. Davies received her Ph.D. in comparative animal physiology from the University of Minnesota and is an associate professor in the Department of Veterinary Population Medicine. From 2003 to 2016, Dr. Davies was the faculty advisor for the Veterinary Diagnostic Laboratory Comparative Endocrinology and Immunology Laboratory. From 2009 to 2012, Dr. Davies also served as the quality assurance manager for the Veterinary Diagnostic Laboratory. In 2012 Dr. Davies founded the Quality Central program to provide support for the integration of quality assurance (QA) best practices into service and research programs. In 2016 she began to focus on the integration of QA best practices into research and training programs in order to support the intent of research scientists to conduct rigorous and reproducible research. Quality Central provides the expertise needed to execute a sustainable and risk-based plan that will generate evidence that research data meet quality, integrity, and stewardship requirements throughout the research life cycle. Dr. Davies serves on the American Association of Veterinary Laboratory Diagnosticians laboratory accreditation committee and is an active member of the Society for Quality Assurance and the Research Quality Association. She is a member of the Committee for Core Rigor and Reproducibility within the Association of Biomolecular Resource Facilities, and a member of the education and training working group within the Asian and Pacific Rim Research Integrity Network. Dr. Davies’ current interests include the adoption of voluntary QA practices within non-regulated research programs, sustainable models for incorporating research QA into basic research environments, research on research, and the use of laboratory error data and QA metrics to drive continuous improvement in laboratory and research settings.

Christi Guerrini, J.D., M.P.H., is an assistant professor in the Center for Medical Ethics and Health Policy at Baylor College of Medicine (BCM), where she conducts research at the intersection of innovation, health, policy, and ethics. In 2016 Ms. Guerrini was awarded a 4-year K01 award from the National Human Genome Research Institute to study ownership interests in citizen science. She also currently serves as an affiliated researcher at the University of Houston Law Center’s Institute for Intellectual Property & Information Law. Ms. Guerrini received her J.D. from Harvard Law School and M.P.H. from The University of Texas School of Public Health. She graduated Phi Beta Kappa with highest honors from the University of Virginia, where she received her B.A. Prior to joining BCM, Ms. Guerrini served as the intellectual property fellow at Chicago-Kent College of Law and taught patent law and legal writing courses at Brooklyn Law School. Ms. Guerrini also litigated patent, trademark, contract, and class action disputes

Suggested Citation:"Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
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across a spectrum of industries in private practice. She is admitted to practice in Texas and Illinois and before the U.S. Patent and Trademark Office.

E. Haavi Morreim, J.D., Ph.D., is a professor in the College of Medicine at the University of Tennessee Health Science Center. She does clinical teaching, consulting, and writing, with special interests in health care’s changing economics, conflict resolution, and the litigation issues surrounding clinical medical research. She has been on the editorial board of several journals, including IRB: Ethics and Human Research, The Journal of Law, Medicine & Ethics, and Accountability in Research. She also chaired the Independent Patient Advocacy Council created to serve patients enrolled in the AbioCor artificial heart trial in the early 2000s. Dr. Morreim is an active Tennessee Supreme Court–listed mediator for disputes in both civil and family matters. She is also a licensed attorney, assisting clients pro bono in selected cases and representing clients successfully before the Tennessee Court of Appeals. Dr. Morreim has authored two books and more than 160 articles in journals of law, medicine, and bioethics, including California Law Review, Vanderbilt Law Review, Journal of the American Medical Association, Archives of Internal Medicine, and The Wall Street Journal. She has presented hundreds of invited lectures nationally and internationally to such groups as the American Medical Association and the American Bar Association.

STAFF

Michelle Mancher, M.P.H., is a program officer on the Board on Health Sciences Policy and study director for this study. She served as a staff co-director for the Integrating Clinical Research into Epidemic Response: The Ebola Experience report and as a liaison for the Sharing Clinical Trial Data Action Collaborative. Ms. Mancher joined the National Academies of Sciences, Engineering, and Medicine in 2009 and has since worked on many consensus studies and workshops related to health care services delivery, clinical trial data sharing, and medical product research and development, including Initial National Priorities for Comparative Effectiveness Research; Clinical Practice Guidelines We Can Trust; Variation in Health Care Spending: Target Decision Making Not Geography; Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk; and Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Prior to joining the National Academies, Ms. Mancher held positions at the Arthritis Foundation: Metro DC Chapter, Clinton Foundation’s Alliance for a Healthier Generation, and the New York City Health and Hospital Corporation’s office of managed care. Ms. Mancher holds a master’s degree in public health in health care management and policy from Columbia University and a bachelor of arts in international relations from The George Washington University.

Suggested Citation:"Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
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Autumn S. Downey, Ph.D., joined the Board on Health Sciences Policy at the National Academies of Sciences, Engineering, and Medicine as a program officer in 2012. She is currently co-directing a consensus study on evidence-based practices for public health emergency preparedness and response as well as a standing committee on the health risks of air pollution exposure for Department of State employees and their families stationed overseas. Other National Academies studies she has worked on include Preventing Cognitive Decline and Dementia; A National Trauma Care System; Healthy, Resilient, and Sustainable Communities After Disasters; BioWatch PCR Assays; and Advancing Workforce Health at the Department of Homeland Security. Dr. Downey received her Ph.D. in molecular microbiology and immunology from the Johns Hopkins Bloomberg School of Public Health, where she also completed a postdoctoral fellowship at the school’s National Center for the Study of Preparedness and Catastrophic Event Response. Prior to joining the National Academies, she was a National Research Council postdoctoral fellow at the National Institute of Standards and Technology, where she worked on environmental sampling for biothreat agents and the indoor microbiome.

Emily R. Busta, M.S., is an associate program officer on the Board on Health Sciences Policy at the National Academies of Sciences, Engineering, and Medicine. Ms. Busta joined the National Academies in October 2014 as a member of the staff of the Forum on Drug Discovery, Development, and Translation. She worked on the consensus report Integrating Clinical Research into Epidemic Response: The Ebola Experience. Prior to joining the National Academies, she held positions as a research assistant in a laboratory studying placentology at the University of Colorado Denver–Anschutz Medical Campus (CU Anschutz) and as a toxicology review fellow at the Center for Food Safety and Applied Nutrition of the Food and Drug Administration, where she developed and tested computational toxicology models and performed safety reviews of new food contacts. Ms. Busta holds an M.S. in biomedical basic sciences from CU Anschutz and a B.S. in molecular toxicology from the University of California, Berkeley.

Olivia C. Yost, M.S., is a research associate on the Board on Health Sciences Policy. She currently provides research support to several consensus and standing committees, including the Committee on the Use of Elastomeric Respirators in Health Care. Prior to joining the National Academies in 2015, Ms. Yost worked as a research officer for ARCHIVE Global, where she managed field studies focused on evaluating the impact of malaria, tuberculosis, and gastrointestinal infection control strategies in Bangladesh, Cameroon, and Haiti. Ms. Yost received her M.S. in the control of infectious diseases from the London School of Hygiene & Tropical Medicine in 2012. Her graduate research focused on developing rapid testing methodologies for assessing soil contamination from decaying, small-scale wastewater infrastructure in rural Alabama. She received her B.A. in history and communications from Franklin University Switzerland in 2011.

Suggested Citation:"Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
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Caroline M. Cilio, M.B.E., is a senior program assistant on the Board of Health Sciences Policy at the National Academies of Sciences, Engineering, and Medicine. Ms. Cilio joined the National Academies in 2016 and works on the Forum on Aging, Disability, and Independence and on Physician-Assisted Death: Scanning the Landscape and Potential Approaches—A Workshop. Ms. Cilio holds a master of bioethics and a B.A. in health and societies, an interdisciplinary study focused on medical sociology and health policy, from the University of Pennsylvania.

Andrew M. Pope, Ph.D., is the director of the Board on Health Sciences Policy. He has a Ph.D. in physiology and biochemistry from the University of Maryland and has been a member of the National Academies of Sciences, Engineering, and Medicine staff since 1982 and of the Health and Medicine Division staff since 1989. His primary interests are science policy, biomedical ethics, and environmental and occupational influences on human health. During his tenure at the National Academies, Dr. Pope has directed numerous studies on topics that range from injury control, disability prevention, and biologic markers to the protection of human subjects of research, National Institutes of Health priority-setting processes, organ procurement and transplantation policy, and the role of science and technology in countering terrorism. Since 1998, Dr. Pope has served as the director of the Board on Health Sciences Policy, which oversees and guides a program of activities that is intended to encourage and sustain the continuous vigor of the basic biomedical and clinical research enterprises needed to ensure and improve the health and resilience of the public. Ongoing activities include forums on neuroscience, genomics, drug discovery and development, and medical and public health preparedness for disasters and emergencies. Dr. Pope is the recipient of the Health and Medicine Division’s Cecil Award and the National Academy of Sciences President’s Special Achievement Award.

Suggested Citation:"Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
×
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Suggested Citation:"Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
×
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Suggested Citation:"Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
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Suggested Citation:"Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
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Suggested Citation:"Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
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Suggested Citation:"Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
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Suggested Citation:"Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
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Suggested Citation:"Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
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Suggested Citation:"Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
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Suggested Citation:"Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
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Suggested Citation:"Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
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Suggested Citation:"Appendix E: Biographical Sketches of Committee Members, Consultants, and Staff." National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press. doi: 10.17226/25094.
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Returning Individual Research Results to Participants: Guidance for a New Research Paradigm Get This Book
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When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research results—such as results with unknown validity—and the associated burdens on the research enterprise are competing considerations.

Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholders—investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participants—and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.

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