BERGIT
BERGIT
Integrating ethics, regulation, and policy with cutting-edge science
About
The Berkeley Ethics and Regulation Group for Innovative Technologies (BERGIT) is an ideas exchange and a meeting ground for discussions across disciplines to integrate ethics, regulation, and policy with science. Our goal is to provide space for discussion, facilitate insight, and instigate a proactive cultural shift in responsible innovation. BERGIT is led by an interdisciplinary team with expertise in Ethics, Law, Public Health, and Molecular Biology and has participants from the Bay Area and beyond.
BERGIT is a program co-hosted by the Kavli Center for Ethics, Science, and the Public and the Innovative Genomics Institute, where it began. The Kavli Center has brought in expertise in AI and Neuroscience and provides the catalyst to expand topics and create new series integrated with the Kavli Fellows.
2023 Series
Innovation Within Society: The role of markets and the political economy in the governance of innovative technology.
Science and technology are developed in a society and are therefore subject to social frameworks, including capitalism and the political economy. In this series we will examine three different innovative technologies in the context of the political economy; some with an existing regulatory environment, and some without. We’ll ask whether different ethical concerns are raised when different things are monetized. How does the political economy impact our willingness to regulate, what are potential solutions, and what are the individual versus collective responsibilities that flow from these realities?
Meetings 1–3: Lectures that bring in speakers introducing ethical questions raised by the political economy in three innovative technologies:
- AI & digital information: How digital technologies influence cognition and democracy (March 22)
- Genome editing therapies: Incentives in the commercialization of new drugs (2nd half of April)
- Neurotechnology: When digital tech and neuroscience meet commercialization (TBD)
Meetings 4-5: Panel and group discussions that will compare and contrast these cases and begin to ask whether different ethical concerns are raised when different things are monetized. How does the political economy impact our willingness to regulate, and what are the individual versus collective responsibilities that flow from these realities?
Past Meetings
Information on past meetings can be found by expanding the dates below. Presenters, descriptions, and available resources are provided for each meeting.
| Description | Who’s affected most by climate change, who bears the risks of the intervention, who benefits? Who is responsible; Who decides? How can we be inclusive in decision-making? In this meeting, we will expand the lens through which we look at innovative technologies to address climate change by focusing on lessons from the field of environmental justice. We will hear from the Biden Administration’s Rachel Morello-Frosch about her work on environmental justice. |
| Presenter | Rachel Morello-Frosch White House Environmental Justice Advisory Council Professor of Environmental Science, Policy and Management, School of Public Health, UC Berkeley has joined the Morello-Frosch is an expert in environmental health and environmental justice. Her research focuses on how race and class affect distributions of health risks in the United States, the causes and consequences of health inequalities and environmental disparities, and how research can create opportunities for intervention and prevention. In particular, her lab focuses on addressing challenges faced by communities of color and low-income communities with high exposures to environmental hazards and the toxic effects of pollution. |
| Description | In the face of another known, imminent global threat – climate change – how can the known and unknown safety, security, social and ethical risks be balanced with the potential benefits of new capabilities in environmental genome editing? At this meeting, we will host a discussion and hear an overview of potential applications, hear from a laboratory scientist developing new capabilities in microbes, and a policy and public health scholar and professor on the governance challenges and historical references for how we might begin to think about decision-making. | |
| Panelists | Ann Keller, PhD Associate Professor of Health Policy and Management, School of Public Health, UC Berkeley | Ann C. Keller is Associate Professor of Health Politics and Policy at the UC Berkeley School of Public Health. Keller studies the politics of science and expertise in public policy, focusing on environmental, health and technological innovation. Keller is an expert in US regulation and studies governance in a number of contested political domains including the storage of nuclear waste in the United States, acid rain, climate change, firearm ownership and comparative effectiveness of medical therapies. Keller’s current research, stemming from her role as the PI on a recent NSF grant, compares public sector regulation of connected and autonomous vehicle technologies and of CRISPR medical therapies. Keller’s book, Science in Environmental Policy: The Politics of Objective Advice won the 2011 Don K. Price Award from the American Political Science Association for the best book in Science and Technology Politics. |
| Spencer Diamond, PhD Associate Project Scientist, Banfield Lab, IGI, UC Berkeley | Lea Witkowsky, PhD Policy and Engagement Manager, IGI, UC Berkeley | |
| Description |  Following the screening, a discussion will address what we see as a global crisis requiring action rather than inaction. In this case, the cause of the crisis is the rapid deployment of a highly innovative technology without sufficient time for the public to catch up. Artificial Intelligence is shaping every aspect of our lives, and while there are many benefits, we have almost no public safeguards to protect us from the serious downsides, including problems of surveillance, algorithmic bias and manipulative microtargeting.What are the cross-disciplinary learnings we can draw and share from this film and the problems it brings to light? |
| Format | Following registration (here), participants will receive a link to watch the documentary “Coded Bias” during a window of time, and will meet on Zoom for a facilitated discussion using breakout rooms, led by BERGIT & C-GEM organizers. |
| Description | Professor Emeritus John Swartzberg, MD, a national leader in the COVID 19 crisis, will lead us in a discussion of the debate about whether to delay offering 2nd doses of COVID 19 mRNA vaccines in favor of vaccinating as many people as possible with a single dose. If the limited evidence of the effectiveness of the initial dose is correct, this approach can double the pace at which a country can vaccinate its population. If the assumptions about initial dose effectiveness are incorrect, however, substantial adverse effects can follow. Information is incomplete but the need is great. Opportunity knocks. How should we answer? |
| Presenter | John Swartzberg MD, FACP UC Berkeley School of Public Health, Infectious Diseases and Vaccinology UC Berkeley-UCSF Joint Medical Program |
| Join | Friday, March 4th 12–1 pm PT |
| Description | In the face of a global climate crisis, new genomic technologies are being explored for bio-based solutions. At the same time, the climate crisis has already had unequal impacts, and we’ve seen examples of facially neutral interventions meant to combat global threats reveal unintended inequities in their results. In this meeting, we will provide space to bring what we learned in our last meeting from the Biden Administration’s Rachel Morello-Frosch and attempt to apply it to a case study based on our first meeting in November on genome editing in microbial communities. Come for an interactive, case-based discussion that aims to brainstorm how justice-based forethought might be applied to urgent global interventions. |
| Presenter | Art Reingold, MD Professor, Epidemiology in the School of Public Health UC Berkeley |
| Description | In early spring, over 100 vaccines began their journey through development and testing. The severity and magnitude of the global COVID-19 pandemic catalyzed an unprecedented race of innovation to develop novel vaccines with the goal of suppressing a growing public health crisis. As summer turns into fall, top candidates have entered phase 3 clinical trial testing. This race is not purely scientific, but also political. Recent decisions by the FDA, CDC, and other government agencies have raised concerns about veiled interests and hasty decisions. As the public looks for objective decision-making and clear communication, trustworthiness continues to degrade leaving people skeptical of quickly advancing vaccine developments. How can we ensure that those in charge of regulating data and deliverables remain shielded from politicization and reestablish trustworthiness? |
| Presenters | Anneliese Taylor, MLIS Head of Scholarly Communication UCSF Spencer Hey, PhD Faculty Member Harvard Center for Bioethics |
| Description | Within weeks of the formal pandemic declaration, scientists began applying for newly established funding opportunities, pivoted their research focus towards COVID-19 questions, and began freely releasing their data. This fast pace was facilitated in part by the widespread adoption of preprint servers and motivated by a drive to understand and fix a growing public health crisis. Across diagnostic innovation, vaccine development, and contact tracing, advanced technologies were quickly moving out of labs and into testing. How do we balance speed and safety? Who controls the flow of information and where does responsibility reside during an unprecedented pandemic and beyond. |
With reports of sequencing at the US border and uses to identify groups of interest to governments, it is clear that drivers of translation can move beyond commercial or biomedical applications and include political motivations. In this meeting, we will examine case studies of government uses of genetic technologies, and discuss policy implications.
The wealth of information contained in our genetic code has led to leaps in the diagnosis and treatment of disease. But in addition to regulated medical uses, commercial applications have sparked the curiosity of the public for everything from learning about your genetic predispositions to identifying your ancestral roots, to dating and dieting advice. In this meeting, we will build on the last meeting’s themes of overinterpretation and overpromising, and examine case studies of commercially-driven phenotypic prediction where regulation is sparse and market incentives are high. What can these case studies tell us about what responsible entrepreneurship in genomic prediction looks like, and how can we apply it in our own work?
| Presenter | Paul Knoepfler Professor, Cell Biology and Human Anatomy School of Medicine UC Davis |
| Description | In this BERGIT meeting confronted the questions, what can we learn from the history of rogue stem cell clinics in the US? What contributed to the creation of commercial stem cell clinics peddling unsubstantiated claims? Are there attributes of genome editing technologies that may predict a similar future? Or protect against one? What are the regulatory and enforcement limits that contribute to these negative outcomes? And perhaps most critically, how can the genome-editing field guard against a similar future? |
| Resources | For more information about stem cell clinics, fraudulent scientific claims, and regulation of unverified technologies, visit Dr. Knoepfler’s blog The Niche. |
Read the blog post from last year’s meeting on paying for CRISPR cures!
| Presenters | Ross Wilson Principal Investigator, IGI Assistant Adjunct Professor, Molecular & Cell Biology UC Berkeley James Robinson Director of the Berkeley Center for Health Technology Professor of Health Economics, School of Public Health UC Berkeley Rena Conti Associate Research Director of Biopharma & Public Policy Associate Professor, Questrom School of Business Boston University |
| Description | With the announcement of a $1.8M price tag for Bluebird Bio‘s gene therapy treatment for beta-thalassemia, the latest in a string of shocking prices assigned to new gene therapies, concerns mount over prospects for the affordability of CRISPR therapies. This BERGIT meeting examined the question of price and accessibility from three experts in diverse fields. |
| Resources | Readings • The Economist | Consider the Lobster Roll | PDF • Casey Quinn et al. | June 2019 | Value in Health | Estimating the Clinical Pipeline of Cell and Gene Therapies and Their Potential Economic Impact on the US Healthcare System • James C. Robinson | July 2, 2019 | Health Affairs Blog | Innovation Prizes To Support Cell And Gene Therapy • Ross C. Wilson and Dana Carroll | Oct. 9, 2019 | The CRISPR Journal | The Daunting Economics of Therapeutic Genome Editing | PDF • Ted Alcorn | Sept. 13, 2019 | The Wall Street Journal | Louisiana’s Deal for Hepatitis C Drugs May Serve as Model | PDF • Emily Mullin | Oct 24, 2017 | Tracking the Cost of Gene Therapy • Antonio Regalado | May 23, 2019 | MIT Technology Review | Gene therapy may have its first blockbuster |
| Presenters | Osagie K. Obasogie Chair of the Haas Institute’s Diversity and Health Disparities research cluster Professor of Bioethics, Joint Medical Program and School of Public Health UC Berkeley Andrea Roth Professor of Law Faculty Director, Berkeley Center for Law and Technology UC Berkeley Rori Rohlfs Assistant Professor, Cell and Molecular Biology San Francisco State University |
| Description | Professors Roth, Rohlfs, and Obasogie led a discussion focused on the technical, legal, and ethical consideration of law enforcement access to commercial DNA databases such as 23andMe or MyHeritage. |
| Resources | Readings • Elizabeth Joh | June 11, 2019 | The New York Times | Want to See My Genes? Get a Warrant • Heather Murphy | May 18, 2018 | The New York Times | Technique Used to Find Golden State Killer Leads to a Suspect in 1987 Murders • Heather Murphy | Oct. 15, 2018 | The New York Times | Sooner or Later Your Cousin’s DNA Is Going to Solve a Murder • The New York Times “The Daily” podcast | A New Way to Solve a Murder | Part 1: The Genetic Detectives | Part 2: The Future of Genetic Privacy |
| Presenters | Lea Witkowsky, Sharon O’Hara, & Lex Owen – led a discussion |
| Description | This meeting continued the previous conversation. As scientific advances like CRISPR have accelerated the time from discovery to application, what role should education in ethical, legal, and social implications take in future life science training? What kind of ethical knowledge and capacities are essential in the future? Prior to this meeting, an electronic, updated questionnaire was sent to all members and IGI as a whole and some of the results of that questionnaire were discussed. |
| Resources | From the Meeting • Online questionnaire |
| Presenters | Jodi Halpern – What is Bioethics and where does it come from? Sharon O’Hara & Lex Owen – led a discussion |
| Description | This meeting built on a topic that came up in our meeting following the announcement of the first CRISPR babies born. Participants raised the point that the researcher who led this experiment was trained at some of the best scientific institutions, and here in the USA. What can we learn from this? How should we be training future generations of researchers, particularly in Bioethics? Will the future of biological research require a different training approach? Jodi Halpern and researchers Sharon O’Hara and Lex Owen put together a questionnaire to prompt discussion in the group about what kind of ethics training do current researchers in the life sciences receive. |
| Resources | From the Meeting • The Belmont Report | Ethical Principles and Guidelines for the Protection of Human Subjects of Research Additional Resources • Mark Yarborough | STAT | Who missed the chance to stop the CRISPR babies scientist? Look in the mirror • Kathryn M Hart, Karen Ingram, Rachel Bernstein, Natalie Kuldell PhD | BioBuilder | Chapter 4: Fundamentals of Bioethics | Publisher: O’Reilly Media, Inc. June 2015 | ISBN: 9781491907504 |
| Presenters | Megan Hochstrasser – The “Science” of the Experiment Santiago Molina – The atmosphere on the ground Mark Yarborough – The role of IRBs in Clinical Trials Jodi Halpern – Informed Consent, Culture of Ethics |
| Description | On the eve of the Second International Summit on Human Genome Editing, reports emerged that the first CRISPR-edited babies had been born, spurring widespread condemnation and controversy. This BERGIT meeting will provide a forum for discussion about this revelation and the conditions under which the experiment happened. The meeting will be structured starting with a few short presentations, followed by open discussion. We intend to use the majority of the time for discussion. |
| Resources | From the Meeting • Megan Hochstrasser’s presentation • The Belmont Report | Ethical Principles and Guidelines for the Protection of Human Subjects of Research Additional Resources • Second International Summit on Human Genome Editing | Session With He Jiankui (starts at 1:15:25) | Summit webpage | Concluding statement by the Organizing Committee • First reports of CRISPR edited babies | AP Report | MIT Technology Review • Screenshots of He Jiankui’s Slides |
| Presenters | Santiago Molina & Gordon Pherribo – “Democratizing” Technology: Expertise and Innovation in Genetic Engineering |
| Description | CRISPR-Cas gene editing has the potential to increase individual and community wellness through the development of agricultural products and treatments for genetic diseases. Debates held in the 1970’s about recombinant DNA technology (rDNA) are frequently used as a model of successful governance for emergent technologies. Using these debates as models reinforces information boundaries between scientists and the public by having scientists with technical expertise lead decision-making that influences local, national and global communities. This project aims to understand the democratic governance of novel technologies. How have scientists constructed the boundaries of public engagement in deliberations around new technologies in genetic engineering? How do these boundaries shape the potential of new technologies to improve individual and community wellness and healthcare? To address these concerns, we are comparing the process of public involvement and expert decision-making surrounding rDNA and CRISPR-Cas9 technologies. |
| Resources | From the Meeting • Santiago and Gordon’s Preliminary Findings Additional Resources • CSHL DNA Learning Center page about the Asilomar Meeting • Napa Meeting resulting publication: A prudent path forward for genomic engineering and germline gene modification | Science | 3 Apr 2015 | web | download |
| Presenters | Lea Witkowsky – Brief history of gene therapy, and Draft Guidances for Long Term Follow-up Ken Taymor – Draft Guidance for Chemistry, Manufacturing, and Control |
| Description | This meeting focused on the recently released Draft Guidances for Gene Therapies from the FDA. These guidance documents describe how the FDA will be regulating gene editing therapies (as a subset of gene therapy), and were open for public comment until Oct. 10. Their release presented an opportunity for us to discuss if and how regulation of gene editing therapies should differ from the regulation of classic gene therapies. Separately, Lea and Ken led an effort to collect comments for submission to the FDA. This meeting of BERGIT was not be an official part of this effort, but helped shape it. To facilitate discussion, Lea and Ken provided an overview of what is in the guidance that may warrant consideration, and then opened the floor to discussion from the group. |
| Resources | FDA’s Draft Guidances • Statement from FDA Commissioner Scott Gottlieb, M.D. on agency’s efforts to advance development of gene therapies • Gene Therapy Draft Guidances for Industry ◦ Chemistry, Manufacturing, and Control (CMC) ◦ Long Term Follow-up (LTFU) ◦ Testing for Replication Competent Retrovirus ◦ Human Gene Therapy for Hemophilia ◦ Human Gene Therapy for Retinal Disorders ◦ Human Gene Therapy for Rare Diseases Final Comments Submitted by IGI • CMC | LTFU |
| Presenters | Ben Hurlbut – the Global Observatory for Genome EditingKen Taymor – Draft Guidance for Chemistry, Manufacturing, and Control |
| Description | Recently, two groups published proposals for similar deliberative bodies to examine the ethics of genome editing – the Global Observatory for Genome Editing, and the European-based Association for Responsible Research and Innovation in Genome Editing (ARRIGE). Coauthor of the Global Observatory, Ben Hurlbut, will present his proposal, and Ken Taymor will go over highlights of ARRIGE. We will then open the floor for discussion. What are the merits of these approaches? What are their pitfalls? The publications presenting these two entities will be sent ahead of the meeting so that attendees can come prepared. |
| Resources | Readings • Sheila Jasanoff & J. Benjamin Hurlbut | A Global Observatory for Gene Editing | 21 March 2018 | Nature • Lluis Montoliu et al | ARRIGE Arrives: Toward the Responsible Use of Genome Editing | 1 Apr 2018 |The CRISPR Journal Additional Readings and Resources • Stephen Toulmin | The Tyranny of Principles | December 1981 | The Hastings Center Report • Simon Burall | Rethink public engagement for gene editing | 21 March 2018 | Nature • Hervé Chneiweiss et al | Fostering responsible research with genome editing technologies: a European perspective | 20 July 2017 | Transgenic Res. • J. Benjamin Hurlbut et al | Building Capacity for a Global Genome Editing Observatory: Conceptual Challenges | July 2018 | Trends in Biotechnology Websites • ARRIGE Website • Ben Hurlbut |
| Presenters | Bruce Conklin – Genome Editing as Genome Surgery |
| Description | The Conklin lab is developing medical applications of CRISPR technology to treat severe mono-allelic genetic diseases of the retina, motor neurons, and cardiomyocytes. As part of his efforts to bring gene-editing technologies to bear on intractable medical problems, he has coined the term “genome surgery”. In the first part of our meeting, Bruce Conklin will tell us about the choice of this term and the novel regulatory pathways it may suggest for clinical uses of CRISPR. Following the presentation, we will have a discussion on the regulatory and ethical merits/concerns of recasting the technology to use alternative regulatory pathways. |
| Resources | Conklin Lab page |
| Presenters | Peggy Lemaux – History of Modification of Plants and Gene Editing Regulatory Landscape David Zilberman – Economics of Genome Editing in Agriculture |
| Description | Drs. Lemaux and Zilberman will tell us about old and new methods of plant modification, and the economic and regulatory landscape associated with new gene-editing technology. A discussion will follow as usual. |
| Resources | Presenter Websites: • Peggy Lemaux • David Zilberman |
| Presenters | Marci Harris – Introduction to POPVOX and the idea behind BigQuestions Lea Witkowsky – Review of the draft survey questions |
| Description | At this meeting, we will continue our discussion about the collaboration between POPVOX and the IGI to create an informational video and survey to invite public participation in the debate on the ethics and societal implications of CRISPR. At our last meeting we learned about this project, and at this upcoming meeting, we will discuss a draft of the survey questions. A brief background to the project will be included at the start of the meet for those that could not join us previously. To make the most of our meeting time, the draft questions will be sent out ahead of time so we can spend the bulk of the time in discussion. |
| Resources | POPVOX website |
| Presenters | Marci Harris – Introduction to POPVOX and the idea behind BigQuestions Megan Hochstrasser – IGI’s outreach and engagement efforts Lea Witkowsky – Current surveys on public opinion of gene editing |
| Description | Marci Harris will introduce her civic startup and her goals with BigQuestions spinoff. Megan and Lea will discuss our intended collaboration and what’s already been done to assess the public’s opinions of gene editing. We will then discuss how our efforts should differ, and as for feedback from the group. |
| Resources | POPVOX website Past Surveys • George Gaskell et al | Public views on gene editing and its uses | 09 November 2017 | Nature Biotechnology • Dietram A. Scheufele et al | U.S. attitudes on human genome editing | 11 August 2017 | Science • Cary Funk et al | U.S. Public Way of Biomedical Technologies to ‘Enhance’ Human Abilities | July 2016 | Pew Research Center • Robert J Blendon et al | The Public and the Gene-Editing Revolution | 14 April 2016 | NEJM • STAT, and Harvard T.H. Chan School of Public Health | The Public and Genetic Editing, Testing, and Therapy | 2016 • Pew Research Center | Americans, Politics and Science Issues | 1 July 2015 |
Learn More
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Learn more at the Kavli Center for Ethics, Science & the Public.