An Examination of
Emerging Bioethical Issues
in Biomedical Research
PROCEEDINGS OF A WORKSHOP
Siobhan Addie, Meredith Hackmann, Kelly Choi,
Theresa Wizemann, and Sarah H. Beachy, Rapporteurs
Board on Health Sciences Policy
Health and Medicine Division
THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu
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This activity was supported by a contract between the National Academy of Sciences and the National Institutes of Health (Contract No. HHSN263201800029I; Order No. 75N98019F00859). Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.
International Standard Book Number-13: 978-0-309-67663-2
International Standard Book Number-10: 0-309-67663-0
Digital Object Identifier: https://doi.org/10.17226/25778
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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2020. An examination of emerging bioethical issues in biomedical research: Proceedings of a workshop. Washington, DC: The National Academies Press. https://doi.org/10.17226/25778.
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PLANNING COMMITTEE FOR A WORKSHOP ON AN EXAMINATION OF EMERGING BIOETHICAL ISSUES IN BIOMEDICAL RESEARCH1
JEFFREY KAHN (Chair), Andreas C. Dracopoulos Director; Core Faculty; Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy, Berman Institute of Bioethics, Johns Hopkins University
ANITA LaFRANCE ALLEN, Vice Provost for Faculty, Henry R. Silverman Professor of Law and Professor of Philosophy, University of Pennsylvania
CECIL M. LEWIS, JR., Professor, University of Oklahoma
BERNARD LO, President, The Greenwall Foundation
MARIA MERRITT, Associate Professor, Berman Institute of Bioethics; Associate Chair, Student Matters, Department of International Health, Johns Hopkins University
CAMILLE NEBEKER, Associate Professor, University of California, San Diego, School of Medicine
BENJAMIN S. WILFOND, Director, Treuman Katz Center for Pediatric Bioethics, Seattle Children’s Hospital and Research Institute; Professor and Chief, Division of Bioethics and Palliative Care; Department of Pediatrics; University of Washington School of Medicine
National Academy of Medicine Greenwall Fellow in Bioethics
RACHEL FABI, Assistant Professor, Center for Bioethics and Humanities, State University of New York Upstate Medical University
Board on Health Sciences Policy Staff
SARAH H. BEACHY, Senior Program Officer
SIOBHAN ADDIE, Program Officer
MEREDITH HACKMANN, Associate Program Officer
MICHAEL BERRIOS, Research Associate
KELLY CHOI, Senior Program Assistant
BRIDGET BOREL, Program Coordinator
ANDREW M. POPE, Senior Board Director
___________________
1 The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.
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Reviewers
This Proceedings of a Workshop was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process.
We thank the following individuals for their review of this proceedings:
Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the proceedings nor did they see the final draft before its release. The review of this proceedings was overseen by DAN G. BLAZER II, Duke University School of Medicine. He was responsible for making certain that an independent examination of this proceedings was carried out in accordance with standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies.
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Contents
Current and Historical Support for Bioethics Research
Overview of Topics Highlighted During Presentations and Discussions
Organization of the Workshop and Proceedings
2 ETHICALLY LEVERAGING DIGITAL TECHNOLOGY FOR HEALTH
Developing, Testing, and Integrating Digital Technologies into Research and Clinical Care
Ethical Issues for Emerging Digital Technologies
Using Artificial Intelligence and Machine Learning in Research and Clinical Care
Ethical Issues in Machine Learning and Deep Learning Neural Networks
3 ETHICAL QUESTIONS CONCERNING NONTRADITIONAL APPROACHES FOR DATA COLLECTION AND USE
Governance of Unregulated Health Research Using Mobile Devices
4 UNDERSTANDING THE IMPACT OF INEQUALITY ON HEALTH, DISEASE, AND WHO PARTICIPATES IN RESEARCH
Thinking Ethically and Structurally About Race and Racism
Federal Indian Law and Bioethics
5 BIOETHICS RESEARCH WORKFORCE
Bioethics Training: A U.S. National Perspective
Bioethics Training in Latin America and the Caribbean
Learning from Workforce Development in Science, Technology, Engineering, and Mathematics
6 REFLECTING ON THE WORKSHOP AND LOOKING TO THE FUTURE
Evolving Technologies, Research Models, and Collaborations
Boxes and Figure
BOXES
1-1 Workshop Statement of Task
2-1 Existing and Emerging Bioethical Concerns Associated with Digital Health Technologies
FIGURE
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Acronyms and Abbreviations
| ABPD | Association of Bioethics Program Directors |
| AI | artificial intelligence |
| CDC | Centers for Disease Control and Prevention |
| CHARM | Cancer Health Assessments Reaching Many |
| CPSC | Consumer Product Safety Commission |
| EHR | electronic health record |
| ELSI | ethical, legal, and social implications |
| FDA | U.S. Food and Drug Administration |
| FTC | Federal Trade Commission |
| HHMI | Howard Hughes Medical Institute |
| HHS | U.S. Department of Health and Human Services |
| IRB | institutional review board |
| LMIC | low- and middle-income country |
| NHGRI | National Human Genome Research Institute |
| NIH | National Institutes of Health |
| PAHO | Pan American Health Organization |
| PI | principal investigator |
| RCD | research, condition, and disease |
| STEM | science, technology, engineering, and mathematics |
| UC | University of California |
| UMBC | University of Maryland, Baltimore County |
