Translating Bioethics into Policy: Bioethics Legislative Opportunities, Outcomes and Models (BLOOM)

Translating Bioethics into Policy: Bioethics Legislative Opportunities, Outcomes and Models (BLOOM)

Project Description

The controversy surrounding the recent Alabama Supreme Court decision finding that frozen embryos created through IVF are “minors” for the purpose of the state’s wrongful death statute, has spotlighted a bioethics policy issue that requires attention. While IVF is an accepted part of American reproductive medicine—with nearly 3% of all births conceived with IVF—the lack of state law governing the disposition of embryos makes the practice vulnerable to limitation, prohibition, and custodial disputes over surplus embryos. There is a 50-year record of bioethics scholarship on the moral and legal status of embryos, their permissible uses for reproduction and research, dispositional authority over embryos, and the role or rights of gamete donors and surrogate mothers. Yet, there is no comparable body of statutory drafts available for policymakers to review and adopt that reflects a consensus reflecting those findings and recommendations. BLOOM seeks to address the problem of state-level policy for the management and disposition of IVF embryos, drawing on the existing bioethics and legal literature to develop model legislation that can be adapted by each state.

Methodologically, the project will entail a Core Team (PI and Co-Is) who will lead the process of drafting model legislation, supplemented by an Advisory Group. The Core Team will be supported by the work of research assistants who will provide data on existing state law and formal drafting assistance. The Core Team and Advisory Group will meet 4-5 times over the year of the project, once in-person (at the Hopkins Bloomberg Center in Washington, DC ) and the rest by video conference.

BLOOM: Advisory Group

The drafting of the model legislation will be led by the Core Project Team, in consultation with the Advisory Group. The Advisory Group will meet 4-5 times over the course of the project, with one in-person meeting in Washington D.C. and the rest being virtual. The Group has the following roles:

1. Drafting: Together with the Core Team, the Advisory Group will help produce a full draft of the model legislation (goal of the in-person meeting in Washington D.C)
2. Feedback and Review: The Advisory Group will provide feedback and review of the draft model legislation, after which the Core Team will produce a near-final model law with section-by-section explanatory text.

Agenda

BLOOM Advisory Group Meeting #1

March 14, 2025, 2:00-4:00 p.m., EDT

Zoom Link: https://jh.zoom.us/j/95632224278?pwd=HIB42W05Q0YGKj55wwwjDfOZ22b9Bz.1

2:00-2:20 p.m.
Welcome & Zoom Introductions (All)

2:20-3:00 p.m.
BLOOM Project Overview & Discussion
(Core Project Team)

3:00-4:00 p.m.
Group Discussion (All).  Topics may include, but are not limited to:

• What are the legal and policy issues that model legislation should address?
• What are the key areas that should be harmonized across the United States?
• What practical needs and challenges might there be?
• Are all important stakeholders represented?
• What resources should we know about?

4:00 p.m.
Adjourn

R. Alta Charo is the Warren P. Knowles Professor Emerita of Law and Bioethics at the University of Wisconsin at Madison. In the past, she also has served on the faculty of the UW Masters in Biotechnology Studies program and the Dept. of Medical History and Bioethics at the School of Medicine & Public Health. For the 2019-2020 academic year, she was on leave while a Berggruen fellow at the Center for Advanced Study in Behavioral Sciences at Stanford University. She later completed service as the inaugural David A. Hamburg Fellow at the Nuclear Threat Initiative in Washington DC, where she joined the biosecurity team.

From 2021-2023, Charo was the lead co-chair of the 4S (safety, security, sustainability and social responsibility) unit of the new Dept of Defense biotechnology manufacturing innovation institute, “BioMADE” and now consults on gene therapy and genome editing in medical and enviromental applications for various pharmaceutical, gene therapy, xenotransplant, infertility therapy, and conservation genetics companies, and for the Dept of Defense Advanced Research Projects Agency (DARPA).

Alta Charo (B.A. biology, Harvard 1979; J.D. Columbia, 1982) is an elected member (2004) of the World Technology Network and (2005) the Wisconsin Academy of Sciences, Arts and Letters.  In 2006 she was elected to membership in the National Academies’ Institute of Medicine (IOM) (now known as the National Academy of Medicine).  In 2013 she was awarded the Adam Yarmolinsky Medal for her service to the IOM. In 2020, she was elected to the American Association for the Advancement of Science and the American Academy of Arts & Sciences.  She was elected to the German Academy of Sciences (Leopoldina) in December 2022.

Professor Charo served on President Obama’s transition team, where she was a member of the HHS review team, focusing her attention particularly on transition issues related to NIH, FDA, bioethics, stem cell policy, and women’s reproductive health.  She was on leave 2009-2011 to serve as a senior policy advisor on emerging technology issues in the Office of the Commissioner at the US Food & Drug Administration.

Jeffrey Kahn, PhD, MPH, is the Andreas C. Dracopoulos Director of the Johns Hopkins Berman Institute of Bioethics, a position he assumed in July 2016, and was re-appointed to for a second five-year term in 2023. From 2011, he has been the inaugural Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy.  He is also Professor in the Dept. of Health Policy and Management of the Johns Hopkins Bloomberg School of Public Health.  He works in a variety of areas of bioethics, exploring the intersection of ethics and health/science policy, including human and animal research ethics, public health, and ethical issues in emerging biomedical technologies.

Prof. Kahn has served on numerous state and federal advisory panels. He was most recently chair of National Academies of Sciences, Engineering, and Medicine’s Board on Health Sciences Policy, and previously chaired its committee on the Use of Chimpanzees in Biomedical and Behavioral Research (2011); the committee on Ethics Principles and Guidelines for Health Standards for Long Duration and Exploration Spaceflights (2014); and a committee on the Ethical, Social, and Policy Considerations of Mitochondrial Replacement Techniques (2016).  He also formerly served as a member of the National Institutes of Health (NIH) Recombinant DNA Advisory Committee.

Anna C. Mastroianni, JD, MPH, joined the Berman Institute in 2022 as Research Professor in Bioethics and Law and Core Faculty. Her scholarly work is widely published and examines complex issues at the intersection of law, bioethics, public health, and health policy, with special emphasis on the legal and ethical challenges arising in research in pregnancy, the use of genetic technologies in public health, reproductive rights, and family building through assisted reproductive technologies. She is executive producer (with Jeffrey Kahn) of the Berman Institute-Pushkin Industries bioethics podcast, playing god? and Co-Investigator of the Berman Institute’s oral history project, Moral Histories: Voices of the Founders of Bioethics.

Professor Mastroianni is Charles I. Stone Emerita Professor of Law at the University of Washington (UW) School of Law and until stepping down in 2022 served as associate director of the UW’s Institute for Public Health Genetics and held additional faculty appointments in the UW’s School of Public Health (Health Services) and School of Medicine (Bioethics and Humanities; Pediatrics).

Before joining the full-time faculty at the University of Washington in 1998, she was a practicing attorney and served in a number of legal and governmental policy positions in Washington, D.C. including as Staff Director of the White House Advisory Committee on Human Radiation Experiments and Study Director for the National Academy of Medicine. Professor Mastroianni is an elected Fellow of The Hastings Center and the American Association for the Advancement of Science, recognized for her contributions to health policy, law, and bioethics. She serves on consensus, advisory, and oversight committees, both nationally and internationally.

Debra JH Mathews, PhD, MA, is the Associate Director for Research and Programs for the Johns Hopkins Berman Institute of Bioethics, and a Professor in the Department of Genetic Medicine, Johns Hopkins University School of Medicine. Dr. Mathews also runs the Genomics and Society Mentorship Program and serves as the Chair of the Berman Institute’s Inclusion, Diversity, Anti-Racism, and Equity (IDARE) Committee. Within the Institute for Assured Autonomy (IAA), Dr. Mathews serves as the Ethics & Governance Lead. In this role, she leads work focused on the ethical, societal, and governance implications of autonomous systems, and identifies opportunities across IAA for the integration of ethics and governance work and priorities.

Dr. Mathews’s academic work focuses on ethics and policy issues raised by emerging technologies, with particular focus on genetics, stem cell science, neuroscience, synthetic biology, and artificial intelligence. Dr. Mathews is a member of the steering committee of The Hinxton Group, an international collective of scientists, ethicists, policymakers and others, interested in ethical and well-regulated science, and whose work focuses primarily on stem cell research. She has been an active member of the International Neuroethics Society since 2006, has been on the Society’s Board of Directors since 2015, and is currently serving as President of the Society. In addition to her academic work, Dr. Mathews has spent time at the Genetics and Public Policy Center, the US Department of Health and Human Services, the Presidential Commission for the Study of Bioethical Issues, and the National Academy of Medicine working in various capacities on science policy.

Leslie Meltzer Henry, JD, PhD, MSc, is a core faculty member at the Johns Hopkins Berman Institute of Bioethics.  She is also a law professor at the University of Maryland Carey School of Law. Her teaching and scholarship focuses on issues in constitutional law, bioethics, public health law and policy, reproductive justice, and research ethics. She is an associate editor of the Oxford Handbook for Public Health Ethics (OUP, 2016), and a contributor to the Oxford Textbook of Clinical Research Ethics (OUP, 2008).

Professor Henry provides expert commentary for federal and local agencies, organizations, and the media. She has served as a bioethics consultant to the Department of Defense and has presented before panels of the Department of Health and Human Services, the Food and Drug Administration (FDA), and the National Institutes of Health Bioethics Advisory Committee. Professor Henry has provided written commentary for the Mid-Atlantic Ethics Committee Network, and she has been quoted in media outlets including the Atlantic, the Wall Street Journal, CNN, ABC, NPR, the Chronicle of Higher Education, Forbes, and the Baltimore Sun.

Professor Henry is a co-investigator on a project focused on addressing the ethical and legal challenges of conducting research with pregnant women during public health emergencies, like the Zika crisis, where there is an urgent need to attend to the health needs of pregnant women and their offspring.  She is also a member of PHASES, a research team aiming to develop ethically and legally acceptable strategies for conducting research about HIV treatment and prevention during pregnancy

Katherine Cheung (she/her) is a doctoral student in Bioethics and Health Policy in the Department of Health Policy and Management. Her primary research interests include psychedelic ethics and policy, such as the value of the acute subjective experience, the place of meaningfulness in medicine and how psychedelics might impact conceptions of wellbeing.

Prior to coming to Hopkins, Katherine was a Health Science Policy Analyst stationed at the National Institutes of Health, within their Data Sharing Policies Implementation Team. She received her M.A in Bioethics from New York University, and her B.A in International Development from McGill University.

Ripple Sato is a JD Candidate at the University of Maryland Francis King Carey School of Law.

Ripple was awarded the Lewis A. Noonberg Scholarship for her interest in health law, is a Diversity & Inclusion Scholar, and is a Staff Editor for the Maryland Journal of Health Care Law & Policy. She is on track to receive the Health Law Certificate.

Previously, Ripple worked in the Alaska Court System as a Judicial Assistant for the Honorable David A. Nesbett and for the Honorable Catherine M. Easter, and as a Case Manager for the Child in Need of Aid Division. She was also selected to represent the ACLU of Alaska in Washington, D.C., speaking to Alaska’s Senators regarding upcoming congressional decisions.

Ripple attended Harvard University, where she received her Bachelor of Arts degree in Human Evolutionary Biology, with a minor in Psychology, and was a member of the Harvard-Radcliffe Crew Team.

Naomi Cahn is an expert in family law, trusts and estates, feminist jurisprudence, reproductive technology, and aging and the law. Prior to joining the University of Virginia faculty in 2020, she taught at George Washington Law School, where she twice served as associate dean. She is the co-director of UVA Law’s Family Law Center.

Cahn is a co-author of casebooks in both family law and trusts and estates, and she has written numerous articles exploring the intersections among family law, trusts and estates, and feminist theory, as well as essays concerning the connections between gender and international law. In addition, she is the author or editor of books written for both academic and trade publishers. Her books include Red Families v. Blue Families (Oxford University Press, 2010, with Professor June Carbone); Homeward Bound (Oxford University Press, 2017, with Amy Ziettlow); and Unequal Family Lives (Cambridge University Press, 2018, co-edited with UVA professor Brad Wilcox and others).

Katherine Cameron is a reproductive endocrinology and infertility specialist in the Baltimore area who specializes in diagnosing and treating women facing infertility. Dr. Cameron treats patients with a wide range of conditions, including recurrent pregnancy loss, polycystic ovarian syndrome, premature ovarian insufficiency and medical endocrinology syndromes, at the Johns Hopkins Fertility Center.

Dr. Cameron completed her undergraduate degree at Washington University in St. Louis and her medical school, residency and fellowship training at the University of Pennsylvania. Her research has focused on fertility and quality of life issues for cancer survivors. She has also investigated how exposure to certain environmental factors in the womb — such as if a mother smoked or took certain medications while pregnant — affects a woman’s future reproductive health.

In addition to her medical degree, Dr. Cameron holds a master’s degree in bioethics and serves on the American Society for Reproductive Medicine Ethics Committee.

Robert Cook-Deegan is a professor in the School for the Future of Innovation in Society, and with the Consortium for Science, Policy and Outcomes at Arizona State University. He founded and directed the Duke Center for Genome Ethics, Law and Policy (2002-2016). Prior to Duke, he was with the National Academies of Science, Engineering and Medicine (1991-2002); National Center for Human Genome Research (1989-1990); and the congressional Office of Technology Assessment (1982-1988). His research interests include science policy, health policy, biomedical research, cancer, and intellectual property. He is the author of The Gene Wars: Science, Politics, and the Human Genome and more than 350 other publications.

Dean and Professor of Law Judith Daar is the Ambassador Patricia L. Herbold Dean of Chase College of Law. She is the sixteenth dean in the 130-year history of the college. As a law school administrator, she has focused on helping students, faculty, and staff achieve their goals and aspirations; as a professor, she has taught core law school courses and specialty health law courses while concentrating her scholarship at the intersection of law, medicine and ethics. She is widely recognized as an expert in the area of law and assisted reproductive technologies.

Prior to her academic career, Dean Daar was a practicing attorney following graduation from Georgetown University Law Center. She has been an interim dean, associate dean and professor of law at Whittier Law School, in Costa Mesa, California, a clinical professor of medicine at the University of California, Irvine School of Medicine, and a visiting professor of law at the University of California, Los Angles School of Law, the University of California, Irvine School of Law, Loyola School of Law, and the University of Houston Law Center. She became dean of Chase College of Law in July 2019.

Her most recent first-edition academic book is The New Eugenics: Selective Breeding in an Era of Reproductive Technologies, published in 2017 by Yale University Press. In 2006, she published the first and to date only casebook in the field of assisted reproductive technologies, Reproductive Technologies and the Law, followed by a second edition in 2013 and a third edition, joined by co-authors, in 2022

She has published dozens of law review articles, primarily on topics related to bioethics and reproductive medicine. She has written for or been interviewed for specialty and general-interest publications on such topics as stem cell research, genetic testing of embryos, family formation through surrogacy and gamete donation, access to infertility care, and human cloning. Dean Daar is a frequent commentator for media outlets on emerging topics in reproductive medicine.

Ruth R. Faden, PhD, MPH, is the founder of the Johns Hopkins Berman Institute of Bioethics and its director from 1995 until 2016. She was the inaugural Andreas C. Dracopoulos Director (2014-2016) and has been since 1995 the inaugural Philip Franklin Wagley Professor of Biomedical Ethics. Dr. Faden’s current research focuses on structural justice theory and on national and global challenges in public health policies and pandemic preparedness, learning health systems, women’s health, the rights and interests of pregnant women, and advances in science and technology. She is currently working part time at the FDA in the Office of the Commissioner. Her latest book, with Madison Powers, Structural Injustice: Power, Advantage, and Human Rights, was released in paperback in 2024 (earlier edition, September, 2019; Oxford University Press).

Henry T. (Hank) Greely specializes in the ethical, legal, and social implications of new biomedical technologies, particularly those related to genetics, assisted reproduction, neuroscience, or stem cell research. He is a founder and immediate past president of the International Neuroethics Society; chair of the Ethical, Legal, and Social Issues Committee of the Earth BioGenome Project; and chair of California’s Human Stem Cell Research Advisory Committee. He served from 2016 through 2022 as a member of the Multi-Council Working Group of the NIH’s BRAIN Initiative, whose Neuroethics Working Group he co-chaired; a member of the Committee on Science, Technology, and Law of the National Academies from 2013-2019; Neuroscience Forum of the Institute of Medicine from 2012-2019; as a member of the Advisory Council of the NIH’s National Institute for General Medical Sciences from 2013-2016; and from 2007-2010 as co-director of the Law and Neuroscience Project, funded by the MacArthur Foundation. Professor Greely chairs the steering committee for the Stanford Center for Biomedical Ethics and directs the law school’s Center for Law and the Biosciences. Greely is also a professor (by courtesy) of genetics at Stanford School of Medicine. In 2007 Professor Greely was elected a fellow of the American Association for the Advancement of Science, received Stanford University’s Richard W. Lyman Award in 2013, and the Stanford Prize in Population Genetics and Society in 2017.  He published The End of Sex and the Future of Human Reproduction in 2016. His second book, CRISPR People: The Science and Ethics of Editing Humans, was published in 2021.

Patricia King’s expertise is in the study of law, medicine, ethics and public policy. She is also an adjunct professor in the Department of Health Policy and Management, School of Hygiene and Public Health at Johns Hopkins University. She is the co-author of Cases and Materials on Law, Science and Medicine. She teaches Family Law courses and offers a seminar in Bioethics and the Law. She is a member of the American Law Institute and the Institute of Medicine and a Fellow of the Hastings Center. Her work in the field of bioethics has included service on the HEW-Advisory Recombinant DNA Advisory Committee, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and the Ethics, Legal and Social Issues Working Group of the Human Genome Project. She is a fellow of the Harvard Corporation and a member of the Board of Trustees of Wheaton College. Her professional experience before joining the Law Center faculty in 1973 was primarily in the civil rights field; she was the Deputy Director of the Office of Civil Rights and Special Assistant to the Chairman of the EEOC. She also served as a Deputy Assistant Attorney General in the Civil Division of the Department of Justice.

At the California Institute for Regenerative Medicine, Geoff focuses on managing the Alpha Clinics Network, a world-class clinical research infrastructure that supports transformative cell and gene therapy trials at the state’s leading academic medical centers. With over 19 years experience in patient access and policy, his strategic initiatives have been instrumental in advancing CIRM’s mission and impact across California.

Jerrine R. Morris, MD, MPH, is board certified in Obstetrics and Gynecology (OB/GYN) and Reproductive Endocrinology and Infertility (REI). Dr. Morris earned her medical degree at Virginia Commonwealth University School of Medicine in Richmond, Virginia. She then continued her studies at Emory University for her residency in OB/GYN, where she was recognized for her excellence in research. From there, Dr. Morris trained in REI at the University of California, in San Francisco, California.

Dr. Morris has contributed to numerous publications and presentations, focusing on topics such as polycystic ovary syndrome (PCOS), third party reproduction, and disparities in reproductive health access and treatment outcomes. She is a member of several professional societies, including the American College of Obstetricians and Gynecologists (ACOG), the American Society for Reproductive Medicine (ASRM), and the Society for Reproductive Endocrinology and Infertility (SREI).

Kimberly Mutcherson is an award-winning professor whose scholarship focuses on reproductive justice, bioethics, and family and health law. She has presented her scholarship nationally and internationally and publishes extensively on assisted reproduction, families, and the law. She was a visiting scholar at the University of Pennsylvania Center for Bioethics and the Columbia Law School Center for Gender and Sexuality Law.

Professor Mutcherson is a reproductive justice scholar whose work focuses on assisted reproduction and abortion among other topics. Cambridge University Press released her edited volume, Feminist Judgments: Reproductive Justice Rewritten in 2020.

In 2023, Professor Mutcherson received the Trailblazer Award from the New Jersey Women Lawyer’s Association. She was a co-recipient of the 2021 M. Shanara Gilbert Human Rights Award from the Society of American Law Teachers and the 2020 Association of American Law Schools inaugural Impact Award as one of the creators of the Law Deans Antiracist Clearinghouse Project.

Joanne Rosen is a Senior Lecturer in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health and holds a joint appointment in the Department of Population, Family and Reproductive Health. She is the Co-Director of the Center for Law and the Public’s Health. Educated in Canada, Joanne obtained her JD and MA at the University of Toronto. Her interests include reproductive health, intimate behavior and relationships, sexual and gender minorities, and discrimination. She is particularly interested in laws that regulate in these areas and their impact on public health. Joanne has written on abortion, LGBTQ health disparities, and crisis pregnancy centers. She teaches courses in LGBTQ Health Policy and Legal and Public Health Issues in the Regulation of Intimacy. Before moving to the United States, Joanne served as counsel to the Ontario Human Rights Commission, and specialized in human rights and administrative law.

Sonia M. Suter’s scholarship focuses on issues at the intersection of law, medicine, and bioethics, with a particular focus on reproductive rights, emerging reproductive technologies, and ethical and legal issues in genetics. She has published widely in law reviews, peer-reviewed interdisciplinary journals, and science journals. One of her recent articles was selected for Editors’ Choice 2020 by the Journal of Law and the Biosciences, one of the leading peer-reviewed journals in medical ethics and legal medicine. Another was chosen by the same journal’s editorial team as one of its “favorite widely read and cited articles” that has “made a big impact.” An internationally recognized expert in genetics and the law and assisted reproductive technologies, Professor Suter is a co-author of the leading textbooks in those areas. She also participates in national working groups and advisory boards and as a consultant to policymakers on issues in her field of expertise. At GW Law, she teaches Torts, Law and Medicine, Genetics and the Law, and Assisted Reproductive Technologies.

Before coming to GW Law, Professor Suter held a Greenwall Fellowship in Bioethics and Health Policy at Georgetown and Johns Hopkins Universities. She was also a Visiting Assistant Professor at the University of Michigan Law School and an adjunct at Georgetown University Law Center.