ArticlePDF Available

Remember Asilomar? Reexamining Science's Ethical and Social Responsibility

Authors:

Abstract

Perspectives in Biology and Medicine 44.2 (2001) 162-169 --Robert Sinsheimer Who remembers Asilomar? A generation ago, it was a familiar name for most molecular biologists and many other scientists, as well as science journalists, politicians, and members of the public concerned about the "biohazards" posed by the then-new field of recombinant DNA research. At the time, the term "Asilomar" was shorthand for a singular moment in the annals of science: a voluntary moratorium at the frontiers of science. In the most literal sense, "Asilomar" refers to the rustic retreat on the Monterey Peninsula where, in February 1975, 140 biologists and physicians and four lawyers gathered to examine recombinant DNA's possible technical and scientific risks and to consider how they could be controlled. Pending the resolution worked out at Asilomar, scientists around the world had curtailed their experiments. Given the normal drives of curiosity, competition, and celebrity, it took great leadership to inspire scientists to forgo their cutting-edge research, even for a few months. Thus, it is hardly surprising that several of the scientists who led the Asilomar process were later honored by the American Association for the Advancement of Science with its Scientific Freedom and Responsibility Award. Yet even at that time, some observers regarded Asilomar as not solely an instance of scientific responsibility but also of scientific autonomy, that is, as an attempt by scientific leaders to maintain control in the face of possible regulation. In this view, Asilomar was a peremptory strike aimed at shielding science from the public and its elected representatives. By exercising a measure of self-restraint, scientists could reassure the public that they could be trusted to take appropriate account of the public welfare in the way they carried out their research. Since the February 1975 meeting was both a response to earlier events and a prologue to future ones, the term "Asilomar" is often used for the whole process of scientific self-control around recombinant DNA, from the events precipitating the meeting to the actions that flowed from it. It encompasses initial concerns about the safety of early gene slicing experiments expressed at the June 1973 Gordon Conference on Nucleic Acids, and published in a letter to Science that September, signed by the conference co-chairs, Maxine Singer and Dieter Söll. Those concerns prompted the National Academy of Sciences to create an ad hoc study group, chaired by Paul Berg, which in July 1974 took the extraordinary action of calling for a worldwide moratorium on certain types of experiments and caution in undertaking others. The group also recommended that an international conference be convened and an advisory committee be established at the National Institutes of Health (NIH). Donald Fredrickson, the NIH director, soon appointed a group which became the Recombinant DNA Advisory Committee or, as it is now commonly called, the RAC. And with support from the NIH and others, Berg and his planning committee set about arranging the international conference for the Asilomar conference center at the end of the following February. Berg and his colleagues from Stanford had met there before; indeed, several years earlier, biomedical scientists met to consider the dangers of DNA in cancer viruses. Although that meeting resulted in neither new public policies nor public attention to the issues, it is still regarded in some circles as the first "Asilomar meeting" on the risks in DNA research, so the 1975 meeting is sometimes referred to as Asilomar 2. Although broader in focus than the earlier meeting, the 1975 Asilomar conference still focused on technical safety issues and set aside the broader social and ethical implications of this new research. Participants agreed on graduated safety guidelines, which were calibrated to the anticipated risk of the experiments. The new RAC, which met...
Remember Asilomar?
reexamining science’s ethical and
social responsibility
162
We were a bunch of academics—focused, idealistic, and often naïve—trying to do good, strug-
gling to reconcile our conflicts, our apprehensions, our scientific ambitions, our careers, our some-
times murky sense of obligation and emerge with a practical resolution: proceed, carefully.A mid-
dle ground was reached—too restrictive for some, insufficiently restrictive for others....But
Asilomar surely helped in many ways to launch the complex world of biotechnology we know
today.
—Robert Sinsheimer
WHO REMEMBERS ASILOMAR? A generation ago, it was a familiar name for
most molecular biologists and many other scientists, as well as science
journalists, politicians, and members of the public concerned about the “biohaz-
ards” posed by the then-new field of recombinant DNA research. At the time,
the term “Asilomar” was shorthand for a singular moment in the annals of sci-
ence: a voluntary moratorium at the frontiers of science.
In the most literal sense,“Asilomar” refers to the rustic retreat on the Monterey
Peninsula where, in February 1975, 140 biologists and physicians and four lawyers
gathered to examine recombinant DNA’s possible technical and scientific risks
and to consider how they could be controlled. Pending the resolution worked
*Pacific Center for Health Policy and Ethics, University of Southern California, Los Angeles, CA
90089-0071.
Email: acapron@law.usc.edu.
6413 Antietam Lane, Madison,WI 53705.
Email: rschapir@facstaff.wisc.edu.
Perspectives in Biology and Medicine, volume 44, number 2 (spring 2001):162–69
© 2001 by The Johns Hopkins University Press
Alexander M. Capron*and Renie Schapiro
Remember Asilomar?
spring 2001 • volume 44, number 2 163
out at Asilomar, scientists around the world had curtailed their experiments.
Given the normal drives of curiosity, competition, and celebrity, it took great
leadership to inspire scientists to forgo their cutting-edge research, even for a few
months. Thus, it is hardly surprising that several of the scientists who led the
Asilomar process were later honored by the American Association for the
Advancement of Science with its Scientific Freedom and Responsibility Award.
Yet even at that time, some observers regarded Asilomar as not solely an instance
of scientific responsibility but also of scientific autonomy, that is, as an attempt by
scientific leaders to maintain control in the face of possible regulation. In this
view,Asilomar was a peremptory strike aimed at shielding science from the pub-
lic and its elected representatives. By exercising a measure of self-restraint, scien-
tists could reassure the public that they could be trusted to take appropriate
account of the public welfare in the way they carried out their research.
Since the February 1975 meeting was both a response to earlier events and a
prologue to future ones,the term “Asilomar” is often used for the whole process
of scientific self-control around recombinant DNA, from the events precipitat-
ing the meeting to the actions that flowed from it. It encompasses initial con-
cerns about the safety of early gene slicing experiments expressed at the June
1973 Gordon Conference on Nucleic Acids, and published in a letter to Science
that September, signed by the conference co-chairs, Maxine Singer and Dieter
Söll. Those concerns prompted the National Academy of Sciences to create an
ad hoc study group, chaired by Paul Berg, which in July 1974 took the extraor-
dinary action of calling for a worldwide moratorium on certain types of exper-
iments and caution in undertaking others.The group also recommended that an
international conference be convened and an advisory committee be established
at the National Institutes of Health (NIH).
Donald Fredrickson, the NIH director, soon appointed a group which
became the Recombinant DNA Advisory Committee or, as it is now commonly
called, the RAC.And with support from the NIH and others, Berg and his plan-
ning committee set about arranging the international conference for the
Asilomar conference center at the end of the following February. Berg and his
colleagues from Stanford had met there before; indeed, several years earlier, bio-
medical scientists met to consider the dangers of DNA in cancer viruses.
Although that meeting resulted in neither new public policies nor public atten-
tion to the issues, it is still regarded in some circles as the first “Asilomar meet-
ing” on the risks in DNA research, so the 1975 meeting is sometimes referred
to as Asilomar 2.
Although broader in focus than the earlier meeting, the 1975 Asilomar con-
ference still focused on technical safety issues and set aside the broader social and
ethical implications of this new research. Participants agreed on graduated safety
guidelines, which were calibrated to the anticipated risk of the experiments.The
new RAC, which met nearby immediately after the conference ended, adopted
the Asilomar recommendations as interim rules for federally supported labora-
164
Alexander M. Capron and Renie Schapiro
Perspectives in Biology and Medicine
tories. Flexibility was key to the design: restrictions could be changed in response
to increased understandings of risks involved.
The concerns expressed about the biohazards of the new technology quickly
spread beyond the circle of molecular and microbiologists whose work was most
directly affected. Twelve journalists were invited to the Asilomar 2 meeting.
While they had to agree not to file their reports until the conclusion of the con-
ference, interest in the issues was great, and the conference received extensive
coverage.Articles appeared in publications ranging from Nature to the Wall Street
Journal, from the Frankfurter Allgemeine Zeitung to Rolling Stone.The public—fol-
lowed by policy makers—took notice. What grabbed everyone’s attention, of
course, were the amazing feats being produced (or predicted) by the scientists.
But the meeting itself was widely regarded as a landmark in science, signaling a
willingness of researchers to engage in open, honest dialogue about the implica-
tions of their work.
Today, who remembers Asilomar? Senior researchers who themselves attended
the meeting or who waited back home in their labs for word from the Monterey
Peninsula about what experiments they could undertake report that their stu-
dents and postdoctoral fellows today seem surprisingly unaware of the events of
1975.After a flurry of initial interest, the Asilomar process has received relatively
little attention from social scientists and lawyers. And the public and politicians—
with their notoriously short time-horizons—seem also to have forgotten
Asilomar, now that it is not a matter of media attention.
Why hasn’t the Asilomar process been revived to address controversial appli-
cations of the new genetic technology that have arisen over the past 25 years?
The framework that resulted from Asilomar (both the substantive standards and
the process of ongoing oversight) helped to ensure the success of recombinant
DNA research and, by avoiding problems, may have diverted continued atten-
tion to the meeting, which was prompted by concerns that the biohazards might
not be so easily controlled.Yet for all the success of the framework, the Asilomar
process was not invoked for other, newer areas of biotechnology, such as genet-
ically modified foods, gene therapy, and genomics.
What then is the legacy of Asilomar 2? Twenty-five years to the month after
that meeting was held,Alex Capron assembled another group at Asilomar to reex-
amine what transpired then and to consider the utility of the Asilomar process for
resolving the growing range of issues raised by the process and products of scien-
tific research (Asilomar Symposium on Science, Ethics, and Society, <http://
www.usc.edu/dept/law/Pacific_Center/Main_Links/Asilomar.html>). Capron,
University Professor of Law and Medicine at the University of Southern
California and Co-Director of the Pacific Center for Health Policy and Ethics,
was one of the handful of lawyers who had been at the 1975 meeting. The plan-
ning committee included others from the earlier meeting (David Baltimore,
Joshua Lederberg, and Maxine Singer, in addition to Berg); funding was provided
by the Greenwall Foundation, the Eugene Garfield Foundation, and the Alfred P.
Sloan Foundation. Among the 50 or so participants in Asilomar 3 were about a
dozen people who were at Asilomar 2, including several from that meeting’s
organizing committee. This time, along with scientists and lawyers, the organiz-
ers invited historians, social scientists, philosophers, government officials, and pub-
lic interest representatives. Scientists working in the field participated, as did
scholars and activists who have criticized it. Experts from England, Canada,
Germany, Sweden, and Switzerland, where issues of scientific responsibility have
emerged and been addressed in varied ways, were also present.The meeting was
open to the press.
In the three-day symposium, the conferees considered questions such as
“What became of the consensus reached at Asilomar and how has it affected the
development of genetic technologies?” “Among mechanisms to grapple with
these issues, is the Asilomar model still useful, has it been superseded, or has it
had a pervasive (and perhaps not fully appreciated) influence on public policy-
making?”The purpose of the symposium was not to revisit recombinant DNA
policies, much less to decide what should be done about current issues. Instead,
the focus was on the model itself: to what extent is a process that is scientist-ini-
tiated and scientist-led suitable for dealing with contemporary problems? What
amounts to responsible behavior on the part of scientists and of the society that
nurtures them and benefits from their work?
The Asilomar 3 conference was divided into four sessions: (1) The Path to
Asilomar and the Road Beyond; (2) The Public: Alerted, Educated, Unduly
Alarmed?; (3) Contending with Contemporary Issues in Light of the Accom-
plishments and Shortcomings of Asilomar; and (4) Asilomar Then and Now:What
Roles for Scientists, the Press, Policymakers and the Public-at-Large? There was
no formal attempt to reach consensus, but there was general agreement on sev-
eral major points and a mix of perspectives and viewpoints on other topics.This
introduction provides an overview of some of the major discussion points at the
meeting. It is followed by selected papers delivered at the conference.
From the outset, it was clear that much had changed in the 25 years since sci-
entists last gathered at Asilomar. The profound differences reflect not only the
state of the science but, importantly, its social context as well. The decision to
limit the agenda of Asilomar 2 to technical health and safety issues—topics
within the scientists’ purview—was hailed by organizers Berg and Singer 25
years later as perhaps the single most important decision in planning the meet-
ing. It enabled the scientists to focus on, and ultimately agree to, a concrete
course of action.The inclusion of social and ethical implications of the research,
Berg argued, would have bogged down the meeting in fruitless debate.
Yet it was clear that in the year 2000 scientists can no longer debate the impli-
cations of genetic technologies and choose to set those issues aside.The public
is today deeply engaged in debating the risks of genetic technologies in very per-
sonal terms—not simply as the scientists define them. The uproar, particularly in
Europe, over genetically modified foods is a clear case in point. In addition, the
Remember Asilomar?
spring 2001 • volume 44, number 2 165
emergence of a powerful commercial and entrepreneurial presence in the field
has engendered conflicts of interest for scientists and put their credibility on the
line. Conferees also noted that Asilomar 2 cannot be separated from its unique
time. It was a product not only of the scientific revolution of the period, but also
the pervasive spirit of social responsibility reflected in that era’s antiwar protests,
environmental activism, and civil rights revolution.
The ability of the scientists to engender public trust in 1975—regarding both
the social responsibility that scientists would exercise and their approach to the
particular topic—was seen by many conferees as a key accomplishment of
Asilomar 2. The meeting was credited with elevating the field and accelerating
the development of the science. The promise of responsible stewardship assured
young scientists that this was a field with a future and that it was safe to enter it.
One consequence of the public confidence that scientists enjoyed was Con-
gress’ willingness not to pronounce on these issues. Instead,scientists at Asilomar
developed, and the RAC implemented, flexible policies that could be adapted
over time to new understandings of the risks involved. In his keynote address,
Fredrickson articulated the reigning view that thwarting legislation was a very
positive effect of the Asilomar meeting. In entertaining “what ifscenarios, some
conferees conjectured that had there not been a Gordon conference and Asilo-
mar meeting, DNA research would have become a major public policy issue
with congressional intervention. Europeans in particular reminded the group,
however, that legislative involvement with its public input can be advantageous,
even if clumsy, at times.Local ordinances in Cambridge,Massachusetts,and other
American cities may even have fostered commercial investment in the field by
clarifying the rules of engagement.
The control that scientists would ultimately be able to exert over how the risks
were to be defined and controlled depended on the public’s perception of the
new technology as well as their trust of scientists.And over the past 25 years, the
media has become a major influence in shaping public attitudes about the bene-
fit and risks of genetic technologies. Although initial press coverage after Asilomar
2 focused on the technical and scientific risks that were the subject of the meet-
ing, coverage soon expanded to broader and more controversial social concerns,
and the media coverage itself became part of the controversy.
Some scientists at the time were highly critical of coverage that they felt gave
credence to alarming (and unrealistic) scenarios and therefore threatened public
support of genetic research. In his keynote address on press coverage of scientific
risks, New York Times science reporter Nicholas Wade (who had been at Asilomar
2) noted that reporters write what they hear from credible sources. He argued
that the media had a responsibility to include the range of positions on recombi-
nant DNA research, including dire warnings that in hindsight proved to be exag-
gerated. His comments, however, invited reflection on how the media might have
done a better job of helping readers put the varied viewpoints in 1975 into some
kind of context.
166
Alexander M. Capron and Renie Schapiro
Perspectives in Biology and Medicine
With the public now both more engaged and more skeptical, the social and
ethical issues no longer sequestered, and the commercial context of the research
more glaring, is the Asilomar model still appropriate? In light of the accom-
plishments and shortcomings of Asilomar 2, the Asilomar 3 meeting considered
three contemporary scientific controversies—genetically modified organisms,
genomics, and somatic and germline gene therapy—to test the utility of an
Asilomar-style process and to look at what other processes have been used.What
if an Asilomar conference had been convened to address these issues? Would such
an approach work today?
The consensus of the group was that an Asilomar meeting would not be an
effective means for addressing these controversies today, for several reasons. First,
conferees agreed that it is too late. Deeply held views are already entrenched.As
Berg noted, we are now dealing with chronic issues, in contrast to the just-
emerging or acute safety concerns of Asilomar 2.
The controversies are also entangled in diverse, complicated, and personalized
concepts of risk that go well beyond the taxonomy of hazards that scientists can
address. Furthermore, the public may be less tolerant of risk today. In the wake
of scares such as mad cow disease in Europe, additional uncertainties about the
food supply brought about by new technologies may represent “the last straw”
for consumer tolerance.
Considerable discussion at the conference focussed on public perceptions of
acceptable risks or balances between benefits and risks. A new technology typi-
cally generates public unease or suspicion, but as its benefits become apparent
acceptance usually follows. This has occurred with medical products, such as
genetically engineered insulin; patients become advocates for the science and
tolerant of the risks because they can see the benefits. With the introduction of
genetically modified foods like BT corn, however, many users see the benefits
accruing primarily to the corporations that create the crops and perhaps to the
farmers who grow them. These consumers are, therefore, less tolerant of risks
they might assume in eating the food.
One policy approach to the potential dangers of a new technology is to adopt
the “precautionary principle,” as has occurred in Europe. One interpretation of
this principle is that a new technology is assumed to have risks and must be
shown to be risk-free before it can be pursued. But a risk-free standard is both
elusive and inconsistent with the standards we apply to other new developments
in the world.An alternative interpretation of the precautionary principle would
be requiring that risks be identified along with a showing of safety. The safety
standard is commonly involved in screening new technologies or products—in
premarket approval of drugs, for example—and aims to achieve an acceptable
balance between benefits and risks. Some participants, however, underscored the
impossibility of quantifying the theoretical risks and unpredictable long-term
environmental impacts of genetically modified foods as some critics seem to
demand.
Remember Asilomar?
spring 2001 • volume 44, number 2 167
The term risk, however, may not even always reflect concern about specific
hazards that can be sorted out as the biohazards were at the 1975 meeting.
Instead, risk sometimes seems to be a proxy for a generalized unease about
change.Willy de Greef from Switzerland noted that many of the concerns about
the long-term effects of genetically modified organisms on the environment
stem from a deep desire not to alter the environment as it exists today. But with
the environment constantly changing, that is an arbitrary starting point, he
argued. The question then becomes, is the risk at issue a risk of actual damage,
or is it in reality a risk of change?
While there was agreement that it is now too late for an Asilomar-type
process to address genetically modified organisms, such a meeting early on might
have been of some benefit. However, some critics of developments in the field
doubted whether the companies involved would have been able to garner pub-
lic trust. This suspicion of corporate self-interest is the flip side of the success of
Asilomar, where scientists reinforced their existing image (as searchers for truth,
rather than as self-interested entrepreneurs) by acting responsibly in the public
interest.Yet today, with commercial interests so deeply embedded in the field,
generating actual or perceived conflicts of interests for scientists, the public is no
longer so willing to trust their motivations. It is difficult to imagine how an
unbiased group of scientists could be convened today to consider genetic tech-
nologies or be counted on to speak out in the public interest if they have alle-
giances to commercial interests as well. Even if they ended by urging strong
restraints on the use of a new development in biotechnology, their cautions
would be suspected—if not by the public, then by other scientists—of arising
from the scientists’ being devoted to other forms of technology, in competition
with those that they disfavored.
The near-term promise of gene therapy has been overhyped, in part bcause
companies have an interest in creating excitement and expectations that will bol-
ster their financial standing and have learned how to get their message to the pub-
lic.With their own commercial ties, scientists are not necessarily in a position to
counter those messages. For some, “Asilomar” came to mean the willingness of
scientists to openly confront potential scientific hazards, and several conferees
were critical of scientists today for failing to voice concerns about new tech-
nologies, particularly gene therapy. The issue was of particular significance in light
of the death of Jesse Gelsinger in a gene therapy experiment at the University of
Pennsylvania only months earlier. Many scientists knew that the adenovirus vec-
tors used in that experiment could cause fatal immune reactions, conferees noted,
and yet scientists failed to stand up at meetings and raise those concerns.
Similarly, over the past 25 years the line between the research-academic com-
munity and the private world working on genomics has, as geneticist Michael
Kaback noted, become “heavily blurred.” Many academic researchers hold
equity positions, patent rights, and stock options in biotech companies, and there
is now a great rush from genetic discovery to patent application, venture capital
168
Alexander M. Capron and Renie Schapiro
Perspectives in Biology and Medicine
development, company formation, and public stock offering.This not only has
implications for the education of the general public and informed consent of
patients and research subjects, but can also discourage the search for genetic tests
and therapies with less commercial value.
Despite the dramatic changes of the last 25 years that would probably make
replicating the historic Asilomar conference impossible, conferees found much
to admire about that meeting and its enduring legacy. An Asilomar process might
still benefit selected technologies—germline engineering and xenotransplanta-
tion were suggested as candidates.And there was also widespread agreement that
the Asilomar process offers a precedent for socially responsible behavior for
researchers.The core of that precedent was the willingness of researchers to eval-
uate and modify their own work because of its impact on others. In the words
of Princeton President Harold Shapiro, who chairs the National Bioethics
Advisory Committee, a group of scientists were willing “to reflect on how their
work affected other people’s lives. Asilomar was unique and should be cele-
brated, he said to the nods of others, because scientists “gave other people’s per-
spectives some standing.
Remember Asilomar?
spring 2001 • volume 44, number 2 169
... This new molecular tool is quickly taking over and transforming the field of genome editing (Pennisi 2013). Importantly, with the advent of this tool the editing of living human embryos is rapidly becoming a reality: in February 2016 the first research project in the UK to modify the genomes of human embryos using CRISPR-Cas9 has been approved by the Human Fertilisation and Embryology Authority (HFEA) (Callaway 2016). Before that, researchers in China already applied the method to (non-viable) human embryos (Liang et al. 2015). 1 The method, however, is not perfect and there is still considerable uncertainty surrounding its application, especially when it comes to (a) the precision and (b) the effects of the DNA modifications it allows researchers to make. ...
... As mentioned in the introduction, calls for a voluntary ban on emerging technologies have been made before by the scientific community. One example is the call for a temporary ban on the use of recombinant DNA technology in the mid-1970s (Berg et al. 1974) that culminated in the famous Asilomar conference in 1975 (Berg et al. 1975;Fredrickson 1991;Capron and Schapiro 2001). ...
Article
Full-text available
In 2015 scientists called for a partial ban on genome editing in human germline cells. This call was a response to the rapid development of the CRISPR– Cas9 system, a molecular tool that allows researchers to modify genomic DNA in living organisms with high precision and ease of use. Importantly, the ban was meant to be a trust-building exercise that promises a ‘prudent’ way forward. The goal of this paper is to analyse whether the ban can deliver on this promise. To do so the focus will be put on the precedent on which the current ban is modelled, namely the Asilomar ban on recombinant DNA technology. The analysis of this case will show (a) that the Asilomar ban was successful because of a specific two-step containment strategy it employed and (b) that this two-step approach is also key to making the current ban work. It will be argued, however, that the Asilomar strategy cannot be transferred to human genome editing and that the current ban therefore fails to deliver on its promise. The paper will close with a reflection on the reasons for this failure and on what can be learned from it about the regulation of novel molecular tools.
... Published under a CC BY-SA license 110 organizers of the original Asilomar conferences, Asilomar 3 convened a more diverse gathering including scientists but also philosophers, historians, ethicists, legal scholars, and government officials (Capron and Shapiro, 2001). The attendees agreed that the original Asilomar model was no longer appropriate for the following reasons. ...
Article
Full-text available
Recent developments in large language models and computer automated systems more generally (colloquially called ‘artificial intelligence’) have given rise to concerns about potential social risks of AI. Of the numerous industry-driven principles put forth over the past decade to address these concerns, the Future of Life Institute’s Asilomar AI principles are particularly noteworthy given the large number of wealthy and powerful signatories. This paper highlights the need for critical examination of the Asilomar AI Principles. The Asilomar model, first developed for biotechnology, is frequently cited as a successful policy approach for promoting expert consensus and containing public controversy. Situating Asilomar AI principles in the context of a broader history of Asilomar approaches illuminates the limitations of scientific and industry self-regulation. The Asilomar AI process shapes AI’s publicity in three interconnected ways: as an agenda-setting manoeuvre to promote longtermist beliefs; as an approach to policy making that restricts public engagement; and as a mechanism to enhance industry control of AI governance.
... General Introduction 5 biological barriers, and the use of additional safety factors such as physical containment. Measures derived from the Asilomar Conference are perceived as an early application of the PP (Capron & Schapiro, 2001;Peacock, 2010), which was further developed in the Montreal Protocol (1987), the United Nation's Rio Declaration on Environment and Development (1992), and the Cartagena Protocol (2003). ...
Thesis
Full-text available
The current regulatory regime regarding GMOs within the Netherlands and Europe does ensure safety but struggles in balancing this notion with innovation. In particular, the way the Precautionary Principle (PP) is operationalized in GMO legislation has resulted in a highly precautionary culture in which there is little room to conduct research with associated uncertain risks or uncertainties – it has resulted in a culture of compliance. Although the debate on how ‘new’ genetic engineering techniques such as CRISPR should be assessed in comparison to recently exempted techniques is ongoing within the European Union (EU), this might not have any consequences for GMO regulation at all. These issues do not only stifle innovation but also illustrate that the current regime is not resilient in dealing with emerging techniques. To break free from the impasse between safety and innovation, researchers should be able to learn what uncertain risks entail, for instance, through Safe-by-Design (SbD). The main question addressed in this thesis is: “How to create an environment that is suitable to learn safely and responsibly what uncertain risks associated with emerging biotechnologies entail?”. I conclude that to enable responsible learning by means of SbD, 3 conditions are needed; regulatory flexibility, co-responsibility and awareness. Thereby, SbD could be a suitable approach to arrive at responsible learning, given that the 3 conditions are met. If not, SbD provides guidelines to lower or mitigate known risks but fails to provide a step-by-step approach to gradually learn what uncertain risks entail. This will leave a knowledge gap between known and uncertain risks which stifles innovation and hinders risk management in ensuring future safety for people, animals and the environment.
... Although the organizers of Asilomar were honored with the Scientific Freedom and Responsibility Award from the American Association for the Advancement of Science, more cynical observers have criticized the event for being motivated as much by preempting public concerns and regulation (Berg & Singer, 1995) as by acting responsibly to ensure the safety of the technology (Capron & Schapiro, 2001). Until policy makers reformulate policies to accommodate new technologies, debates and deliberation about them occur in the frames provided by existing legal notions. ...
Chapter
Science, Technology, and Society - edited by Todd L. Pittinsky November 2019
... In a very short time, a real cultural revolution occurred in the world of biological research, in which a frightened and worried reaction emerged both from the general public and from many scientists [14]. It was as if with the discovery of genetic engineering, a real sense of loss had taken place within the biological sciences community. ...
Article
Full-text available
The aim of the presentation is to focus on the differences between two scientific contexts: the genetic engineering context of the 1970s, with specific attention paid to the use of the recombinant DNA technique to generate genetically modified molecules, and the current genome editing context, with specific attention paid to the use of CRISPR-Cas9 technology to modify human germ line cells genetically. In both events, scientists have been involved in discussions that have gone beyond mere professional deontology touching on specific policy issues such as freedom of research, responsibility for the consequences of research, the right of the public to participate in the evaluation of the goals of research methods, the relationship between cost and benefit and possible social consequences. The comparison between these two scientific contexts suggests the need of handling such issues by defining procedures that meet the criteria of democracy and responsibility towards society. The underlying objective should be to effectively launch actions and interventions based not on a hierarchical approach but rather a reticular conception of knowledge.
Book
Full-text available
The prospect of creating children through somatic cell nuclear transfer has elicited widespread concern, much of it in the form of fears about harms to the children who may be born as a result. There are concerns about possible physical harms from the manipulations of ova, nuclei, and embryos, which are parts of the technology, and about possible psychological harms, such as a diminished sense of individuality and personal autonomy. There are ethical concerns as well about a degradation of the quality of parenting and family life if parents are tempted to seek excessive control over their children's characteristics, to value children according to how well they meet overly detailed parental expectations, and to undermine the acceptance and openness that typify loving families. Virtually all people agree that the current risks of physical harm to children associated with somatic cell nuclear transplantation cloning might justify a prohibition at this time on such experimentation[i]. In addition to physical harms, many worry about psychological harms associated with such cloning. One of the forms of psychological harm most frequently mentioned is the possible loss of a sense of uniqueness. Although the myth of genetic determinism is dispelled, but some doubts about cloning and identity remain that I am going to argue that somatic cell nuclear transfer cloning creates serious issues of identity and individuality especially in the Psychological identity and forces us to reconsider how we define ourselves because Cloned children each will be genetically virtually identical to a human being who has already lived and also the expectations for their lives may be shadowed by constant comparisons to the life of the “original.”[ii] Moreover, comment on the importance of genetic uniqueness not only for individuals but also in the eyes of their parents
Book
Full-text available
Chapter
This chapter sketches the context of the rest of the book, of which the central question is: considering the fundamental differences of opinion about novel technologies, how should governments deal politically with the intractable disagreement following from this? The broad debate about the genetic modification of animals in plants in is analysed. It is shown that disagreements exist, for example, about whether or not genetic engineers commit the fallacy of genetic determinism, whether biotechnology is like playing God, about the question whether the welfare and integrity of animals is violated, about whether or not we should label genetically modified food, about the question whether GM-crops lead to a loss of biodiversity, etc. This analysis reveals that this debate is multi-dimensional and that different sources of disagreement underpin the pluralism in our society regarding novel technologies, such as biotechnology. Seven sources of disagreement are distinguished: factual, scientific, definitional, interest-based, value, moral, and metaphysical disagreements. Because of their fundamental nature many of these problems are intractable. It is argued that in a policy context the controversy about biotechnology can be characterised as an unstructured problem: a problem which is based on both normative and scientific uncertainties and which involves conflicts about the goals of policy, the procedures that should be followed, and the instruments that should be used, and which involves a large number of political actors. Intractability can occur on a policy level when governments address the wrong policy problem. This happens when they treat unstructured problems as structured or moderately structured, by employing the strategies of depoliticisation by relegating the problem to the domain of experts, or of narrow problem demarcation. These strategies lead citizens to feel that their viewpoints are not taken seriously, which leads to distrust of authorities, non-compliance or protest, and ultimately to intractability. In this context, it is acknowledged more and more that expert knowledge is not purely objective, that it is not infallible, and that lay persons can contribute certain experiential knowledge that is often overlooked by scientific experts. For this reason, Hisschemöller and Hoppe argue that in the case of unstructured problems we need to adopt a learning strategy; we need broad public debate at an early stage involving both lay persons and experts, who have a similar status. The debate needs to focus not only on solutions, but also on problem definition.
Chapter
Full-text available
In this chapter the group of theories that center on preference transformation through deliberation, namely deliberative democracy, is explored in the context of the central question how governments should deal with intractable disagreement regarding novel technologies. The core notion of deliberative democracy is that legitimate political decisions are those that are reached through free and uncoerced debate between equals. This means that, ideally, the debate must be free of power imbalances that give some people better chances than others to influence the decision-making process. Following Jürgen Habermas, many deliberative democrats argue that decisions should be made on the basis of the ‘forceless force of the better argument’. This exploration of deliberative democracy revolves around three questions that are deemed relevant for dealing with intractable disagreement: what is the goal of the deliberation, what arguments are valid, and who should participate? Deliberative democracy is confronted with critiques that have been mounted against it regarding each of these questions. These critiques are put forward by difference democrats, agonistic democrats, and political liberals and focus on the problems of tyranny of the majority, elite domination, representation, pernicious group dynamics, suppresion of dissensus, and the limited role of activism. From this theoretical examination emerge three conditions and a set of criteria that encapsulate what public deliberation should encompass. It is argued that a tension can be discerned in deliberative theory between the goals of consensus, inclusiveness, and quality of debate, and that deliberation serves a different purpose for different types of problems. It is concluded that for unstructured problems, such as the conflict over biotechnology, it is premature to aim for reaching consensus through deliberation. Both inclusiveness and deepening of understanding are important goals in unstructured problems, amongst other reasons because they contribute to opinion transformation. However, while these two goals can co-exist to a certain extent, we should be aware that including more participants and viewpoints is likely to lead to a loss of quality of argument. Therefore, sometimes we need to limit the group of participants, but by the same token deliberation should be regarded as but one avenue for political participation, and other forms, such as protest and activism should be accorded an important function as well. A three-track approach is proposed: an agonal track can function as an agenda-setting space in which anyone can raise concerns and make statements in whatever form they deem necessary. In a deliberative track arguments are exchanged in a more organised and structured fashion, while still aiming to be as inclusive as possible. An institutional track is informed by the former two tracks and here different options are weighed and decisions are made.
ResearchGate has not been able to resolve any references for this publication.