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Want to discuss the societal, ethical, and regulatory challenges associated with CRISPR and other genetic technologies? Come to a BERGIT meeting!
The Berkeley Ethics and Regulation Group for Innovative Technologies (BERGIT) is an ideas exchange and a meeting ground for collaborations across disciplines to integrate ethics, regulation, and policy with science. Our goal is to provide space for discussion, facilitate opportunities, and instigate a proactive cultural shift in responsible innovation. BERGIT is hosted by the Innovative Genomics Institute and led by an interdisciplinary team with expertise in Ethics, Law, and Molecular Biology. Participants come from institutions around the SF Bay Area and beyond.
Please join our email list to hear about future meetings.
Professor of Bioethics and Medical Humanities
UC Berkeley & IGI
Executive Director, Center to Advance Science in Policy & Regulation
UC Berkeley & IGI
Policy Analyst
Innovative Genomics Institute
Date: Roughly two to three times a semester (see Upcoming Meetings below for dates)
Time: 12:00 – 1:00 pm PST
Remote Access: Contact bergit@berkeley.edu for access to remote participation information.
The pace and severity of the COVID-19 pandemic necessitated a rapid and concerted response from scientific and government institutions. Starting with the first sequenced viral genome, researchers embraced the open dissemination of scientific data in order to quickly address the growing public health crisis. In parallel, government entities reevaluated regulatory pipelines with the goal of streamlining the introduction of innovative technologies into the public. While this rapid response proved beneficial in many regards it was not without its concerns and shortcomings. This semester’s discussions will focus on the vetting and regulation of scientific data and innovative technologies, exploring how rapid responses can impact safety, trust, and our ability to overcome the pandemic.
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| Presenters |
Anneliese Taylor, MLIS Spencer Hey, PhD |
| 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. |
| Presenter |
Art Reingold, MD |
| 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? |
Information on past meetings can be found by expanding the dates below. Presenters, descriptions, and available resources are provided for each meeting.
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 |
| 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 James Robinson Rena Conti |
| 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
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| 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 Rori Rohlfs |
| 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
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| 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? |
| Resources |
From the Meeting |
| 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
Additional Resources
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| 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
Additional Resources
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| 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
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| 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
Final Comments Submitted by IGI |
| Presenters |
Ben Hurlbut - the Global Observatory for Genome Editing Ken 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
Additional Readings and Resources
Websites
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| 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: |
| 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 |
Past Surveys
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To suggest a topic for a future BERGIT meeting, please fill out this form.
We strive to make our events accessible and inclusive. The Innovative Genomics Institute Building is ADA accessible, and has a lactation room that visitors can use. For disability accommodation information and requests and/or access to the lactation room, please contact Kristy Nordahl at knordahl@berkeley.edu or 510-664-7110.