Research Ethics Consortia

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Earlier this academic year, the Center for Bioethics convened two panel discussions to explore the educational, research, and/or clinical use of information and human biological specimens originally obtained via ethically concerning circumstances: one on October 21, 2022, Medical Research in Nazi Germany and another on February 9, 2023, Respecting the Remains of Those Who Were Enslaved. This session represents the Center's third offering to explore the ethical landscape within this space. This discussion welcomes a cadre of guests, each of whom has contributed to Harvard's ongoing work to identify the most pressing concerns relating to the identification and ethical disposition of human remains of questionable provenance within the university museums. The panelists' work falls across a broad spectrum of endeavors relating to this effort including ethnography, archival research, biomedical research and administration, museums and cultural heritage centers, Indigenous communities, archaeological studies and education, and bioethics.

Presenters:

Aja Lans, PhD
Postdoctoral Fellow, Inequality in America Initiative, Faculty of Arts and Sciences, Harvard University

Willy Lensch, PhD
Fellow, Harvard Medical School Center for Bioethics
Associate Provost for Research, Office of the Provost, Harvard University 

Kelli Mosteller, PhD
Executive Director, Harvard University Native American Program, Harvard University

Christina Warinner, PhD
Associate Professor of Anthropology, Faculty of Arts and Sciences, Harvard University
Group Leader of Microbiome Sciences, Max Planck Institute for Evolutionary Anthropology

Moderator:

Robert D. Truog, MD, MA
Director, HMS Center for Bioethics
Frances Glessner Lee Professor of Legal Medicine
Professor of Anaesthesia (Pediatrics)

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The USPHS Study of Untreated Syphilis in the Negro Male at Tuskegee and Macon County began in 1932, after US Public Health Service doctors recorded a 39.8% prevalence of syphilis among patients seen in Macon County, Alabama during a treatment study in one corner of the county. While these data might have raised many possible research questions, USPHS doctors chose to focus on the natural history of untreated syphilis.

They not only denied participants the treatments available in the 1930’s; they also chose to continue to study untreated syphilis long after highly-effective, inexpensive, and extraordinarily safe treatment with penicillin became widely available. While the research methods they used are now universally condemned, far less attention has been given to more fundamental questions about the ethics of research, including:

What should the goals of research even be? Who should decide those? What are the most crucial ethical characteristics of relationships between investigators and research subjects?

Introductory Remarks:

Carmen J. Thornton, MPH, MCHES
Director of Research, Development, and Workforce, American Academy of Child & Adolescent Psychiatry
Consultant, Voices for Our Fathers Legacy Foundation
Granddaughter of Fred Tyson, subject in USPHS Syphilis Study at Tuskegee

Presenters:

Susan M. Reverby, PhD
Marion Butler McLean Professor Emerita in the History of Ideas
Professor Emerita of Women's and Gender Studies, Wellesley College
Author of Examining Tuskegee: The Infamous Syphilis Study and Its Legacy

Jesse Milan, Jr., JD
President and CEO, AIDS United

Wangui Muigai
Assistant Professor, Brandeis University
Greenwall Faculty Scholar, class of 2025

Moderator:

Lachlan Forrow, MD
Director, Ethics & Palliative Care Program, Beth Israel Deaconess Medical Center
Lecturer on Global Health and Social Medicine, Part-time, Harvard Medical School
President, The Albert Schweitzer Fellowship

Commentator:

David Augustin Hodge, Sr., DMin, PhD
Associate Director of Education and Associate Professor, National Center for Bioethics in Research and Health Care, Tuskegee University

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Harvard Medical School supports a culture that advances research rigor, reproducibility and responsibility (R3). HMS is committed to identifying, exploring, and fostering R3 principles and practices relevant to our research community through cross-discipline conversations and collaborations. To ensure the continued advancement of research excellence at HMS, the HMS R3 effort identifies opportunities to enhance R3, with a focus on evidence-based research, institutional support, training and educational programs, and resources and tools for our students, trainees, faculty, and staff.

Ethical questions:

• Who is responsible for ensuring rigorous, reproducible, and responsible research practices in the academic setting? Is it the individual researcher, the laboratory leader, the department chair, the university, editors and publishers?
• What factors lead to breaches in R3 practices, e.g., questionable research practices?
• What distinguishes questionable research practices from outright research misconduct? What is the best approach for preventing such practices – incentives, modeling best practices, education and training, sanctions?

Discussants:

Alexa T. McCray, PhD
Professor of Medicine
Harvard Medical School

Mary C. Walsh, PhD
Special Advisor to the R3 Effort
Office for Academic and Research Integrity
Harvard Medical School

Jim Gould, PhD
Director, HMS/HSDM Office for Postdoctoral Fellows
Program Director for Responsible Conduct of Research
Harvard Medical School

Moderator:

Robert D. Truog, MD, MA
Director, HMS Center for Bioethics
Frances Glessner Lee Professor of Legal Medicine
Professor of Anaesthesia (Pediatrics)

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The history of anatomy is one of both beneficial knowledge gain, and ethical transgressions. The history of anatomy in Nazi Germany highlights the consequences to humanity when the destructive potentials inherent to all science and medicine are enabled by an anti-democratic, totalitarian regime. Anatomy presents an example of ethical transgressions by scientists and health care professionals that were amplified in the criminal political climate of the Nazi regime. This can happen anywhere, as science is never apolitical.

This presentation gives a short account of key events of medicine in Nazi Germany and the specifics of what happened in anatomy, which is followed by an outline of the tangible and intangible legacies from this history, to then discuss implications for anatomy education today. While Jewish and politically dissident anatomists were forced out of their positions and country by the Nazi regime, the majority of remaining anatomists joined the Nazi party and used bodies of Nazi victims for education and research. Physical anthropologists among German anatomists provided the scientific biological basis for Nazi policies. Some anatomists even performed deadly human experiments.

Patterns and legacies that emerge from this history can be traced into the present, and concern research ethics in general and anatomical body procurement specifically. They shed light on current practices and controversies in the anatomical sciences, including anthropology.

Speaker:

Sabine Hildebrandt, MD
Associate Professor of Pediatrics and Lecturer on Global Health and Social Medicine, Harvard Medical School
Division of General Pediatrics, Department of Pediatrics, Boston Children's Hospital

Discussants:

Danish Zaidi MD, MTS, MBE
Resident in Internal Medicine
Former Fellow, FASPE
AMA Council on Ethical and Judicial Affairs, Resident Member

Dominic Hall, MA, ALM
Curator, Warren Anatomical Museum, Center for the History of Medicine
Harvard Medical School
Countway Library

Moderator:

Rebecca Weintraub Brendel, MD, JD
Director, Master of Science in Bioethics Degree Program
Associate Director, Center for Bioethics
Associate Professor of Psychiatry

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Dr. J. Julie Kim and colleagues specialize in studying uterine diseases such as endometriosis, endometrial cancer, and uterine fibroids. To study the initiation and progression of these diseases, their team has developed microphysiological models of the female reproductive tract built from a range of cell types. The first of these systems, called EVATAR, was developed to demonstrate functional endocrine signaling on reproductive tissues, including ovary, fallopian tube, endometrium, ectocervix, and liver in vitro. With EVATAR, Kim and colleagues triggered the system to produce the cascade of hormones that occur during a woman's 28-day menstrual cycle. The cycle culminated in the ovarian tissue releasing an egg.

Recently, Dr. Kim and colleagues created a second-generation microfluidic model called LATTICE, which is a simple yet robust system to study multi-organ endocrine inputs and their pathological disturbances. Given that uterine diseases do not occur spontaneously in laboratory animals and since conventional cell culture studies are limiting, Dr. Kim’s approach may provide a better screening tool for drug discovery.

Join Dr. Kim and moderator Dr. Insoo Hyun in this interactive public webinar, as they lead the audience through the science and ethical implications of EVATAR, LATTICE, and other bioengineered models of the female reproductive system. 

Discussant:

Ji-Yong Julie Kim, PhD
Susy Y. Hung Research Professor of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine
Co-Director, Center of Reproductive Science, Northwestern University

Recent advances in bioengineering, genome editing, and human embryo research have heightened the need for public consultation and engagement across a broad spectrum of scientific and bioethical controversies. It is not so clear, however, how best to fulfil this social need.

Dr. James Fishkin and moderator Dr. Insoo Hyun will lead the audience in a discussion of one promising approach called Deliberative Polling. Deliberative Polling is a distinctive form of public consultation that engages stratified random samples of a population in deliberations probing the pros and cons of policy proposals with moderated small group discussions as well as plenary sessions with competing experts or policy makers. Deliberative Polling has not yet been applied to bioethical controversies, but it has been applied to many policy issues that engage scientific issues (especially climate change, energy policy, as well as health care). This interactive talk will focus on what Deliberative Polling could accomplish as distinct from other methods of public consultation, such as standard opinion polls, focus groups, town meetings, citizens juries and citizens assemblies.

Discussant:

James Fishkin, PhD
Janet M. Peck Professor of International Communication and Professor, by courtesy, of Political Science, Stanford University
Director, Center for Deliberative Democracy, Stanford University

‘Solar geoengineering’ refers to large-scale interventions that attempt to cool the Earth by reflecting a small portion of sunlight back into space. While these proposed interventions seem promising to some concerned about climate change, others see ‘technofixes’ such as solar geoengineering and carbon removal as morally fraught because they seem to absolve actors from taking more difficult steps toward systemic solutions.  

Join speaker Dr. Gernot Wagner and moderator Dr. Insoo Hyun to learn more about the science and ethics of solar geoengineering. In this interactive session, Dr. Wagner will urge participants to consider that "moral hazards" are ubiquitous and that especially those opposed to solar geoengineering technology should use it as an opportunity to expand the attention paid to the underlying climate problem in the first place, actively invoking its opposite: "inverse moral hazards."

Discussant:

Gernot Wagner, PhD
Associated Clinical Professor, NYU Robert F. Wagner Graduate School of Public Service
Clinical Associate Professor of Environmental Studies and Public Service, NYU Department of Environmental Studies

Coral reefs provide fundamental ecosystems services - from feeding us, to protecting our homes and cities, to providing substantial global economic benefits. Yet coral reefs are under siege around the world. Mary Hagedorn works to conserve the biodiversity and genetic diversity of coral by using a wide array of human fertility techniques to cryopreserve their sperm, larvae, symbionts, and small fragments. She and her colleagues have deployed these novel approaches to creating new coral to help restore coral reefs by producing thousands of new coral genotypes with potentially helpful resiliency for Florida reefs. Unfortunately, their newly engineered corals have sat in limbo in captivity for 3 years while managers discuss the merits and challenges of allowing these fragments to be placed back into the water. Dr. Insoo Hyun and Dr. Hagedorn take the audience through an interactive discussion of how Dr. Hagedorn's experiments highlight the ability of science to produce potential solutions to climate change issues, while at the same time underscoring how local stakeholders may resist embracing these potential solutions.

Discussant:

Mary Hagedorn, PhD
Research Scientist, Center for Species Survival, Smithsonian's National Zoo & Conservation Biology Institute
Principle Investigator, Reef Recovery Initiative, Smithsonian Institution

Breakthroughs in genetic technologies make possible a new method of changing our environments using gene drives, the introduction of certain traits into wild populations. From reducing the impact of invasive species to wiping out disease-carrying mosquitoes, gene drives offer the possibilities to improve human health. But, they also raise concerns—once this Pandora’s box is opened, can it ever be closed and what will be the lasting effects on other species? We will examine the science making gene drives possible, their potential to eradicate some diseases, and the ethical implications of research in the wild that reshapes our environment.

Discussants:

Jason Delborne, PhD
Professor of Science, Policy, and Society University Faculty Scholar Genetic Engineering and Society Center Executive Committee Member North Carolina State University

Omar Akbari, PhD
Professor Division of Biological Sciences Cell and Developmental Biology Section
University of California, San Diego

Moderator:

Insoo Hyun, PhD
Director of Research Ethics, Center for Bioethics, Harvard Medical School; Professor of Bioethics, Case Western Reserve University School of Medicine

Dr. Penninger studies the cellular and molecular mechanisms behind a range of illnesses, including cancer and infectious diseases. As a young investigator in the 1990s, Dr. Penninger discovered the angiotensin-converting enzyme 2 (or ACE2) cellular receptor, a protein on the surface of many cell types that acts as a “cellular doorway” to allow viruses to enter. During the 2002 SARS outbreak, Dr. Penninger and others discovered that ACE2 played a key role in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV) infections. 

When the viral genome sequence of COVID-19 was released in early 2020, Dr. Penninger saw that it was very similar to the coronavirus that caused the first SARS outbreak - they both entered using the ACE2 cellular receptor. As COVID-19 spread rapidly around the world, many realized how important Dr. Penninger’s research could be in this context. 

The study of ACE2 and its role in SARS-CoV infections is bringing science closer to developing medical interventions for the COVID-19 pandemic; however, there are many bumps along the road to clinical translation. Drs. Hyun and Penninger will take the audience through some of the major scientific and ethical lessons learned from the clinical translation of ACE2. During the interactive portion of the session, they will explain how ongoing explorations of this cellular mechanism might provide important insights into a host of other diseases, including cancer.  

Discussant:

Josef Penninger, MD
Director, Life Sciences Institute, University of British Columbia; Professor, Department of Medical Genetics, University of British Columbia; Professor of Genetics, University of Vienna

Chimeric antigen receptor (CAR) T-cell therapies offer an exciting approach to treating certain cancers that are unresponsive to treatment. In this form of cell-based gene therapy, a patient’s white blood cells (T cells) are genetically modified and reinfused back into the patient to hunt down and kill cancer cells that have previously been able to hide from the patient’s immune system. Different cancer cells can have different proteins (antigens) on their surface, and some of these unique antigens allow cancer cells to camouflage themselves from unmodified T cells. CAR T cells are genetically modified white blood cells that are given surface receptors specifically designed to detect and bind to cancer cells with antigens that the patient’s normal T cells were unable to recognize.

Dr. Caron Jacobson has spent years treating lymphoma patients and has gained expertise in CAR T-cell therapies as the Principal Investigator of several CAR T-cell studies at the Dana-Farber Cancer Institute.  In this interactive session, Dr. Jacobson and Dr. Hyun will discuss the opportunities and challenges facing the advancement of CAR T-cell therapies, as well as Dr. Jacobson’s experiences conducting clinical trials with lymphoma patients.

Speaker:

Caron Jacobson, MD, MMSc
Medical Director, Immune Effector Cell Therapy Program, Dana Farber Cancer Institute; Assistant Professor of Medicine, Harvard Medical School

CRISPR-Cas9 and other genome editing tools present researchers with a double-edged capacity to produce great medical advancements and grave harm. Given the promise and perils associated with this this powerful new technology, is the global governance of human genome editing desirable? Is it possible?

Recently, the World Health Organization (WHO) convened an expert advisory committee on developing global standards for governance and oversight of human genome editing, including somatic as well as germline and heritable approaches. Robin Lovell-Badge served on this WHO committee, bringing his scientific expertise as the head of the Laboratory of Stem Cell Biology and Developmental Genetics at the Francis Crick Institute. Dr. Lovell-Badge also recently chaired an international task force for the International Society for Stem Cell Research (ISSCR) which updated the ISSCR guidelines on genome editing research. Both these efforts suggest that a global governance framework is possible. But what challenges lie ahead? In this interactive session, Dr. Lovell-Badge and Insoo Hyun will lead the audience through a discussion of the scientific, ethical, and policy considerations raised by efforts to successfully implement oversight and governance.

Speaker:

Robin Lovell-Badge, PhD
Senior Group Leader, The Francis Crick Institute, UK

Professor Magdalena Zernicka-Goetz is a developmental biologist and a pioneer in creating stem cell-derived embryos and in culturing human embryos beyond implantation. Dr. Zernicka-Goetz has developed the world's first in vitro systems to culture mouse and human embryos through implantation stages in the absence of maternal tissues. Her embryo culture system allows researchers to observe key events in early human development in real time and under controlled conditions outside the womb. Her research could help increase our knowledge of early human development, improve the efficiency of IVF for reproduction, and uncover some of the mysteries of early pregnancy loss.

In addition to these many scientific possibilities, there are important policy implications for her work. In accordance with the 14-day limit for human embryo research - an international and national limitation on how long researchers can study embryo development in vitro - Dr. Zernicka-Goetz's team concludes their embryo cultivation research by the 13th consecutive day of embryo development. But should researchers be allowed to explore human embryo development any further than this?

Join Magdalena Zernicka-Goetz and Insoo Hyun for this interactive session as they discuss this exciting new area of human developmental biology. Dr. Zernicka-Goetz will explain what can be learned from her stem cell-derived embryo research and human embryo culture system, and Dr. Hyun will discuss the controversy surrounding the 14-day limit and its possible extension.

Speaker:

Magdalena Zernicka-Goetz, PhD
Bren Professor of Biology and Biological Engineering
Lab Head, Zernicka-Goetz Lab CalTech

Dr. Nenad Sestan and colleagues have developed an artificial perfusion system that can restore many key cellular functions and preserve anatomical structures in pig brains several hours after death. Their work challenges the long-held assumption that large mammalian brains are irreversibly damaged just minutes after circulation ceases. It also raises the possibility that researchers and doctors can get better at salvaging a person's brain even after the heart and lungs have stopped working for a long period of time.

In this session, Dr. Sestan will explain how this revolutionary brain perfusion system, called BrainEx, works and the possibilities he sees for this technology in the future. Dr. Robert Truog, Director of the HMS Center for Bioethics, will consider the ethical implications of Dr. Sestan's work for human brain resuscitation and the concept of brain death. Questions from the audience and an interactive discussion moderated by Dr. Insoo Hyun will follow.

Speakers:

Nenad Sestan, MD, PhD
Harvey and Kate Cushing Professor of Neuroscience, and
Professor of Comparative Medicine, of Genetics and of Psychiatry;
Executive Director, Genome Editing Center
Yale School of Medicine

Robert Truog, MD
Director Center for Bioethics,
Frances Glessner Lee Professor of Legal Medicine,
Professor of Anaesthesia Harvard Medical School

Currently there is a dire shortage of organs available for transplantation in the United States, leading to approximately twenty-two deaths per day among patients waiting for organs. While cell replacement therapies hold great promise for treating a variety of medical conditions, their utility for treating patients who require organ replacement is unclear. These patients need whole organs, not cells.
To address this challenge, Hiro Nakauchi and others have proposed the use of genetically engineered livestock animals to generate transplantable rejection-free human organs derived from patients' own pluripotent stem cells. This proposal builds upon Dr. Nakauchi's interspecies work involving the generation of rat pancreases in mice, which provided proof of principle that an organ derived from one species can be generated in the body of another species host from donor pluripotent stem cells.
Hiromitsu Nakauchi and Insoo Hyun will lead the audience through the scientific, ethical, and policy challenges facing this remarkable strategy to alleviate the shortage of  transplantable human organs.

Speaker:

Hiromitsu Nakauchi, MD, PhD
Professor of Genetics Stanford University

Infertility is a disease that affects millions of reproductive age men, women, and non-binary persons in the U.S. For persons who want a biologically related child, one of the most common treatments involves invitro fertilization (IVF). However, IVF is not an option for persons who no longer make gametes. Instead, a new experimental procedure known as in vitro gametogenesis (IVG) could be used in these cases.

IVG involves making gametes outside of the body either from stalled gamete precursor cells, or from skin cells that can be turned into egg or sperm cells in the laboratory. Animal models have successfully used IVG to restore fertility, and basic science research is currently translating this technology to human cells - with particular emphasis on reprogramming skin cells into stem cells, followed by IVG into gametes. Amander Clark and Insoo Hyun will consider the scientific, ethical, and policy issues related to IVG as a next generation approach for human reproduction.

Speaker:

Amander Clark, PhD
Professor and Chair Department of Molecular Cell and Developmental Biology
University of California Los Angeles