Dual-use research and the H5N1 bird flu: Is restricting publication the solution to biosecurity issues?

 
Science and Public Policy Advance Access published September 27, 2013

Science and Public Policy (2013) pp. 1–14                                                                                         doi:10.1093/scipol/sct064

                      Dual-use research and the H5N1
                     bird flu: Is restricting publication the
                        solution to biosecurity issues?
                                                           Sabrina Engel-Glatter*

                       Institute for Biomedical Ethics, University Basel, Bernoullistrasse 28, 4055 Basel, Switzerland.
                                          *Corresponding author. Email: sabrina.engel@unibas.ch.

                     Recent studies altering the host range of the H5N1 bird flu virus have refueled intense debates
                     over the potential misuse of academic life science research. To curtail the bioterrorism threat,
                     it has been suggested that dissemination of the research results and methodology should be
                     restricted. However, doubts have been raised over the suitability and effectiveness of this
                     measure. Using the H5N1 studies as an example, this paper summarizes the main arguments
                     of the debate. Particular attention is paid to the issue of the tacit knowledge required to replicate
                     published life science research results, which has so far received limited attention. Taking into
                     account the importance of tacit knowledge for life science research, it is argued that preventing
                                publication of the methodology does not decrease the threat of bioterrorism.

                         Keywords: dual-use research of concern; life science research; biosecurity; tacit knowledge;
                                                                 influenza.

1. Introduction                                                                  to include non-state actors in late 2001, raised doubts
                                                                                 over its effectiveness to address the current challenges
Since the anthrax attacks in 2001, the dual-use potential of                     and initiated this controversial debate (McLeish and
life science research has been intensely discussed. Fears of                     Nightingale 2007; Tucker 2002).
published research findings serving as a blueprint for                               The concerns have been publicly discussed after selected
building biological weapons have especially troubled US                          scientific papers on pathogenic viruses were published,
policy-makers (Malakoff 2001). Initially, the term dual-use                      including a paper on an engineered mousepox virus that
applied to engineering and information technologies and                          overcomes vaccine protection (Jackson et al. 2001), a pub-
related knowledge that may be used for both peaceful and                         lication describing the first de novo synthesis of a pathogen
military purposes with little or no modification (Hall 1965;                      (the poliovirus) (Cello et al. 2002), a study identifying
Panel on Scientific Communication and National Security                           virulence factors that distinguish the causative agent of
1982). The rapid advances of life science research in recent                     smallpox, variola virus, from its close relative, vaccina
years have pushed its experiments, results, and related                          virus (Rosengard et al. 2002), a paper characterizing the
technologies into the center of the dual-use debate.                             reconstructed 1918 Spanish influenza pandemic strain
   Long before the misuse potential of life science research                     (Tumpey et al. 2005), and recent studies on mutated
received so much public attention, the development, pro-                         versions of the H5N1 bird flu (Herfst et al. 2012b; Imai
duction and stockpiling by state actors of bacteriological                       et al. 2012). To prevent deliberate misuse of such published
and toxic weapons had been banned internationally by the                         knowledge, there have been calls for tighter regulations
1972 Bioweapons and Toxin Convention (BTWC).                                     and restrictions on academic research and the dissemin-
However, the apparent ease with which life science know-                         ation of research results (Tucker 2002; Wallerstein 2002,
ledge develops and diffuses is perceived to have widened                         Resnik and Shamoo 2004; Gaudioso and Salerno 2004;
the range of actors with the potential to develop bio-                           van Aken 2006). In addition, a variety of international
weapons from state actors to non-state actors. The                               and local policy measures have been implemented. For
anthrax attacks, and the failure to reinforce the BTWC                           example, the US government has defined a list of ‘select

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2 of 14   .   S. E. Glatter

agents’ with the potential to pose a severe threat to both             any attempts to determine the pandemic potential of the
human and animal health, to plant health, or to animal                 virus remain speculative. It is this unknown potential, or
and plant products.1 US government regulations control                 in other words, our ignorance about the implications of
research with, and transfer of, these ‘select agents’.2                releasing the virus into the environment, that leads to the
Further measures include: publication guidelines for                   disagreement amongst virology experts on whether the
journals to pre-screen potentially sensitive publications              mutated H5N1 virus and the related experiments can
(Atlas et al. 2003), US government oversight of research               truly be termed ‘dangerous’ (Palese and Wang 2012;
projects and possible classification of sensitive research,3            Bouvier 2012; Inglesby et al. 2011; Morens et al. 2012).
the implementation of screening guidelines for synthetic                  With this in mind, a fixed list of ‘dangerous technologies
DNA orders from official providers for sequences                        and pathogens’ and ‘experiments of concern’, although
encoding select agents and toxins,4 and the establishment              helpful, appears to be of limited use to define which type
of codes of conduct for scientists.5                                   of research may pose a threat to public health and safety.
  In an attempt to address concerns over life science                  A more flexible perspective on dual-use technology and
research and to find a formal definition of dual-use                     ‘dangerous science’ is needed to ensure that policy
research, the US National Academies published the                      measures keep up with the rapid developments in life
highly influential report ‘Biotechnology Research in an                 science research and secure the benefits of academic
Age of Terrorism’ (National Research Council 2004).                    research. This different perspective on the development
The so-called Fink report6 defines dual-use research of                 of life science research and its impact on the dual-use
concern (DURC) as:                                                     debate has been discussed amongst sociologists (McLeish
                                                                       and Nightingale 2007; Vogel 2008; Tucker 2011).
  . . . research that, based on current understanding, can be
                                                                       However, it has not yet found its way into the public
  reasonably anticipated to provide knowledge, products, or
                                                                       debate over dual-use research. By using the controversially
  technologies that could be directly misapplied to pose a
  threat to public health and safety, agricultural crops and           debated H5N1 studies as a case study, this paper will em-
  other plants, animals, the environment, or material.                 phasize the impact of an alternative perspective on the
                                                                       dominant biosecurity discourse and highlight how an
In addition, the report defined seven categories of ‘experi-            alternative view of ‘dangerous’ life science research may
ments of concern’ to be scrutinized when designing research            alter the prioritization of policy responses.
programs and publishing sensitive results. These include:                 Furthermore, in the light of an alternative perspective,
(1) to render a vaccine ineffective                                    this paper will evaluate the effectiveness of one key policy
(2) to create resistance to therapeutically useful antibi-             measure: restricting dissemination of the research method-
    otics or antiviral agents                                          ology. It has been argued that the potential dangers and
(3) to enhance the virulence of a pathogen or render a                 disastrous consequences of academic research demand the
    non-pathogen virulent                                              implementation of precautionary measures such as restrict-
(4) to increase the transmissibility of a pathogen                     ing publication (Osterholm and Relman 2012; Kuhlau
(5) to alter the host range of a pathogen                              et al. 2011; Resnik 2013). Thus, besides outlining a differ-
(6) to enable the evasion of diagnostic/detection                      ent perspective on the potential dangers of dual-use life
    modalities                                                         science research, this paper will summarize the main argu-
(7) to enable the weaponization of a biological agent or               ments of the dual-use debate around the H5N1 case and
    toxin                                                              make use of the precautionary principle (PCP) to evaluate
                                                                       whether preventing publication of the methodology of
This paper will outline that categorizing and focusing on              DURC is an effective tool to decrease the bioterrorism
‘dangerous technologies and pathogens’ reflects a limited               threat.
perspective on the dual-use dilemma. As McLeish and
Nightingale (2007) pointed out, an unambiguous definition
of ‘dangerous’ cannot be agreed upon as this:                          2. Research on highly virulent, possibly
  . . . is not a descriptive term that denotes the property of some-   human transmissible, H5N1 influenza
  thing but an expressive term that refers to how we think about       virus strains
  the possible implications of the properties of something.
                                                                       Two recent studies on the H5N1 bird flu have intensified
As a result, different people, even experts, will evaluate the         the international debate over DURC. They describe a set
dangerousness of technologies and pathogens differently.               of mutations necessary for the highly virulent H5N1 bird
This is reflected by the current discourse around two                   flu virus to transmit amongst mammals, possibly humans
studies on the highly virulent H5N1 bird flu virus.                     (Herfst et al. 2012b; Imai et al. 2012). The H5N1 case
Researchers have mutated the virus so that it can spread               raised concerns for several reasons: the bird flu virus is
amongst mammals via aerosol (Herfst et al. 2012b; Imai                 highly virulent, it is listed on the select agent and toxin
et al. 2012). However, as no human studies are desirable,              list, and the performed experiments can be allocated to
Dual-use research and the H5N1 bird flu      .   3 of 14

category 5 (to alter the host range of a pathogen) of the      aggressive control programs, and to adapt current
Fink report.                                                   pandemic preparedness plans (Kawaoka 2012; Fouchier
   When submitted to the journals Nature and Science for       et al. 2012a, 2013).
publication, the editors referred the two studies to the          However, the NSABB experts had initially decided that
National Advisory Board for Biosecurity (NSABB).               the benefits of the study would not outweigh the risks of
Established by the US government as a result of the            publication (Berns et al. 2012). The main risks in publish-
Fink report, the NSABB provides advice, guidance and           ing both papers in full were described as twofold. First, the
leadership regarding biosecurity oversight of DURC in          results and methodology of the H5N1 studies, if published,
the USA.7 Its decisions are, however, not legally binding.     could be directly misapplied by others to pose a threat to
For the first time, the NSABB had voted against the pub-        public health and safety (biosecurity risk). In particular,
lication of the methodological details in order to prevent     the possibility of synthesizing the flu mutant strains based
‘those who would seek to do harm’ from replicating the         on published sequences and the identified mutations raised
experiment.8 The board had concluded that the harms of         concern. The NSABB members Osterholm and Relman
fully publishing these results exceeded the benefits of pub-    argued that:
lication (Berns et al. 2012). Two crucial aspect may have
                                                                 . . . reverse engineering and synthesizing a mutant A/H5N1
influenced the board’s so far unique decision: the official
                                                                 virus strain will be easier for many scientists if they have
World Health Organization estimate for the case fatality
                                                                 access to the complete methods and results of the two
rate of H5N1 avian influenza of around 60% (Beigel et al.         research efforts and do not need to surmise the steps of the
2005)9, and misunderstandings of technical details               investigators. (Osterholm and Relman 2012)16
(Morens et al. 2012).10 Hence, fears of potentially disas-
trous consequences for public health resulting from an         Second, research with the virus could result in an uninten-
unintended or intended release of the engineered H5N1          tional release into the environment (biosafety risk).17 In
strains were particularly strong (Berns et al. 2012).          order to mitigate the biosecurity and biosafety risks
   To allow time for evaluating the risks and benefits of the   associated with publication, the board had suggested
research, the influenza research community proposed a           redacting the papers and excluding any description of the
three-month voluntary moratorium11 on research                 methodology (Berns et al. 2012). However, the effective-
involving highly pathogenic avian influenza H5N1.               ness of partially restricting or even preventing publication
During that time, the pros and cons of publishing the          was repeatedly questioned.
manuscripts were intensely discussed by scientific and             The main argument used in favor of publishing the
security experts, the NSABB, the WHO and the US gov-           research in full was the necessity to share the research
ernment. Finally, a majority vote of 6 to 1212, strongly       results in the wider scientific community to ensure free
opposed      by     the    NSABB        member      Michael    and open science. Withholding the methodology has
T. Osterholm,13 led to the revision of the NSABB’s             been criticized as unethical, and as an assault on the
decision resulting in full publication of the two papers       openness, accessibility and quality of scientific research
(Herfst et al. 2012b; Imai et al. 2012). The research mora-    (Bouvier 2012; Racaniello 2012). It was argued that
torium proposed by the influenza community was                  omitting the methods from the manuscripts presents a
extended beyond the originally proposed three months to        barrier for researchers to engage in further research
provide time for further evaluation of biosafety14 and         thereby limiting the scientific output essential to combat
biosecurity15 concerns (Fouchier et al. 2012a). The            the natural pandemic threat of influenza viruses (Palese
research finally commenced one year later in January            and Wang 2012; Morens et al. 2012; Kawaoka 2012;
2013 (Fouchier et al. 2013).                                   Perez 2012; Faden and Karron 2012; Casadevall and
                                                               Shenk 2012). In contrast, it was claimed that, although
                                                               the results are valuable, publishing the results would not
3. To publish or not to publish?                               bring about any additional benefit for pandemic prepared-
Fouchier and Kawaoka, the two corresponding authors            ness as resources to detect the virus and support programs
of the studies, defended conducting, publishing and            for a number of the H5N1 endemic countries are often
continuing the work on mammalian transmissible H5N1            lacking (Osterholm and Relman 2012).
virus strains by emphasizing the benefits of their work            Furthermore, it was argued that publishing the papers
and by stressing the importance of their research for          in full may result in more laboratories working with the
pandemic preparedness. Their proof-of-principle experi-        virus, possibly some with insufficient safety standards,
ments show that few mutations could enable the virus           thereby increasing the chance of an unintentional release
to be transmitted via aerosols amongst mammals,                (Inglesby et al. 2011; Osterholm and Henderson 2012).
possibly humans, while maintaining virulence (Herfst           Other opponents of publishing claimed that sharing the
et al. 2012b; Imai et al. 2012). According to the authors,     results and methodology with a small group of selected
the study highlighted the need to monitor H5N1 outbreaks       experts would be sufficient to secure beneficial outcomes
in poultry with more urgency, to implement more                (Osterholm and Relman 2012; Fouchier et al. 2012b).
4 of 14    .   S. E. Glatter

Table 1.   H5N1 debate: Summary of arguments for and against publication of research methodology

Pro publishing                         Reference                                       Contra publishing                    Reference

Benefits for pandemic                   Fouchier et al. 2012b; Herfst et al. 2012a;     Knowing the results (mutations)      Osterholm and
 preparedness: public health            Perez 2012; Palese and Wang 2012;               is sufficient (no enhancement         Relman 2012
 threat of H5N1 strains                 Kawaoka 2012; Morens et al. 2012                of disease surveillance or
 (mammalian transmission,                                                               countermeasure availability
 maintenance of virulence),                                                             expected in the near future)
 enables monitoring of current
 H5N1 strains for critical
 mutations, need for
 enhancement of current
 preparedness plans ‘Nature is
 more inventive than men’
Accessibility of the methodology       Herfst et al. 2012a; Perez 2012; Palese and     Access to the complete methods       Osterholm and
 through textbooks and other            Wang 2012; Morens et al. 2012                   and results makes it easier for      Relman 2012
 open sources such as published                                                         scientists to synthesize a mutant
 papers                                                                                 A/H5N1 virus strain (increase in
                                                                                        bioterrorism threat through
                                                                                        easier access)
Need for trained experts and           Palese and Wang 2012; Racaniello 2012;          Replication not difficult in          Zimmer 2012
  high-tech research facilities to       Fouchier 2012                                  technological terms
  replicate results
Sharing the results in the wider       Racaniello 2012; Bouvier 2012                   Sufficiency of sharing the results    Osterholm and
  scientific is a basic requirement                                                       with a small group of selected      Relman 2012;
  for scientific endeavor (value                                                          experts, even benefit of that        Fouchier et al.
  of free science)                                                                       is questionable                     2012c; Osterholm
                                                                                                                             and Henderson
                                                                                                                             2012
Prerequisite for ensuring quality      Bouvier 2012
  of scientific research by enabling
  post-publication peer-review and
  replication (value of high quality
  in science)
Barrier for researchers to continue    Perez 2012; Palese and Wang 2012;               Encouragement for more labs          Osterholm and
  the research, need for                 Kawaoka 2012; Morens et al. 2012;              to initiate dual-use research        Henderson 2012;
  publication to ensure                  Bouvier 2012; Faden and Karron 2012;           on H5N1 (increase of the             Inglesby et al.
  further research and                   Casadevall and Shenk 2012                      biosecurity and biosafety threat)    2011
  prospective benefits

This has been rejected for the same reasons as restricting                    when the possible outcomes and their respective
publication (Morens et al. 2012). It was also criticized on                   probabilities are known.
the grounds that, while providing a main barrier to                              With regards to the H5N1 case, especially at the time of
research, the measure would be futile in the long term,                       publication, the likelihood with which the risks and
given that the methodology can be found in virology                           benefits of the research will come to pass is unknown.
textbooks (Palese and Wang 2012; Morens et al. 2012;                          For example, to estimate the likelihood of misuse one
Perez 2012; Herfst et al. 2012a) (for a summary of the                        needs access to information on the degree of training,
arguments see Table 1).                                                       intentions, financial, and personnel resources of potential
                                                                              bioweaponeers. Such knowledge is, however, not publicly
                                                                              available. It will be held by intelligence and security
4. DURC and the precautionary principle
                                                                              experts, if anyone has access to it at all (Selgelid 2009).
Several groups, including the WHO and the NSABB, have                         Furthermore, as Rappert (2008) pointed out, risk and
proposed adopting risk–benefit analysis when addressing                        benefits will be open to a considerable amount of interpret-
DURC issues.18 This recommendation has been followed                          ation. This is reflected in the discourse on the H5N1 case.
throughout the discourse around the H5N1 studies.                             For example, experts do not agree on how ‘dangerous’ the
However, as pointed out by Andrew Stirling, a risk                            mutated virus would be to human health, because data
expert, under conditions of uncertainty and ignorance                         from the ferret model cannot be directly extrapolated to
risk–benefit analysis fails (Klinke et al. 2006; Stirling and                  the human context (Bouvier 2012; Racaniello 2012; Fauci
Scoones 2009). It is traditionally used for routine risks,                    and Collins 2012).
Dual-use research and the H5N1 bird flu          .   5 of 14

  In order to address the challenges associated with                  Along these lines, Resnik (2003) argues that:
DURC, the bioethicists Kuhlau et al. (2011) have
                                                                        . . . the principle can be scientific provided that (1) the threats
proposed to make use of the PCP as a ‘rule of choice’                   addressed by the principle are plausible threats, and (2) the
with regards to DURC:                                                   precautionary measures adopted are reasonable.
  When and where serious and credible concern exists that             He proposes to use epistemic criteria to determine whether
  legitimately intended biological material, technology or know-
                                                                      a threat is plausible and to use practical considerations to
  ledge in the life sciences pose threats of harm to human health
  and security, the scientific community is obliged to develop,
                                                                      determine whether a response to a threat is reasonable.
  implement and adhere to precautious measures to meet the               Considering the ignorance of risks and benefits
  concern.                                                            associated with DURC studies such as the H5N1
                                                                      research, the PCP could be a useful tool to analyze the
Correspondingly, the NSABB members Osterholm and                      reasonableness of preventing or banning the publication
Relman have, in the light of the potentially disastrous               of results and methods as a precautionary measure.
consequences associated with the release of a human trans-            When applying the PCP using Resnik’s and Sandin’s
missible H5N1 virus, suggested to err in favor of ‘do no              framework, there are two main questions to answer.
harm’. They proposed to make:                                         First, how plausible are the threats associated with pub-
                                                                      lishing the H5N1 studies? Second, is censorship a reason-
  . . . use of the precautionary principle when approaching the       able mean to address the threat and prevent possible
  issue of DURC. (Osterholm and Relman 2012)                          negative consequences?
                                                                         In order to determine whether publishing the H5N1
The PCP is designed for making practical decisions under              papers in full presents a reasonable threat, one needs to
uncertainty when no reliable quantitative data is available.          discuss whether the engineered H5N1 strain could, in prin-
It was originally created as a way to respond to environ-             ciple, cause a disastrous pandemic and whether the H5N1
mental risks (Goklany 2001). For example, the PCP has                 publications could easily be misused by those who seek to
been used to address issues such as: global warming, in-              do harm. In this context, the PCP does not specify the
tensive dichlorodiphenyltrichloroethane (DDT)19 use, and              degree of scientific evidence required to determine what
the commercialization of genetically modified food. The                a reasonable threat might be. To solve this issue, Sandin
principle has often been criticized for being too vague,              et al. (2002) proposed to use a degree of evidence in
overly risk-averse and an unscientific approach to                     qualitative terms such as ‘scientifically supported strong
decision-making due to a lack of a scientific basis                    suspicions’ to evaluate the threat.
(Brombacher 1999; Gray and Bewers 1996). Contrasting                     Thus, what is the scientific evidence supporting the sus-
this critique, risk experts argue that under conditions of            picion that engineered H5N1 strains could pose a reason-
uncertainty,20 ignorance21 and ambiguity22 sound scientific            able threat to human health? To begin with, it is true that
methods of risk assessment have in any case little justifica-          the H5N1 virus infects humans, although transmission
tion (Stirling 2007; Hoffman-Riem and Wynne 2002). It is              between humans remains limited (Yang et al. 2007).
under these conditions that the PCP can be viewed as a                Another source of concern is the official mortality rate of
general normative guide for policy-makers to acknowledge              about 60% (Beigel et al. 2005).23 Virology experts, such
the benefit of doubt (Stirling 2007).                                  as Palese, Bouvier, and Taubenberger believe the rate to be
   The critique of the PCP may also be related to the fact            overestimated (Bouvier 2012; Palese and Wang 2012).24
that the principle does not define which types of hazards it           The true case fatality rate of the unmodified H5N1 virus
applies to, what level of (scientific) evidence is required,           is estimated to be between 1% and 33% (Li et al. 2008;
which preventive measures should be taken and with                    Morens et al. 2012). In comparison, the fatality rate of the
what force they are recommended (Sandin et al. 2002).                 1918 pandemic virus was estimated to be 2.5% (Li et al.
However, Sandin, a bioethicist, argues that the PCP does              2008). The worst human influenza pandemic in history so
not contradict science and has recommended establishing               far, raged from 1918 to 1919 and claimed an estimated
the following criteria when deciding whether to use the               50 million lives (Taubenberger and Morens 2006).
PCP (Sandin et al. 2002; Sandin 2009):                                However, even if the true mortality rate of the mutant
                                                                      virus strains was much below the rate of the 1918 virus,
  An action A is precautionary with respect to something              pandemic spread of a deadly H5N1 variant would be a
  undesirable U, if and only if 1) A is performed with the
                                                                      cause for significant public health concern.
  intention of preventing U, 2) the agent does not believe it to
                                                                         Further data comes from the animal model in which
  be very likely that U will occur if A is performed, and 3) the
  agent has externally good epistemic reasons a) for believing        human influenza viruses cause influenza-like illness
  that U might occur, b) for believing that A will in fact at         (Maher and DeStefano 2004). Ferrets are susceptible to
  least contribute to the prevention of U, and c) for not believing   infection with the mutated H5N1 virus. According to the
  that it to be certain or very likely that U will occur if A is      two studies, the virus can be transmitted amongst ferrets
  performed.                                                          via aerosol while maintaining virulence (Herfst et al.
6 of 14   .   S. E. Glatter

2012b; Imai et al. 2012). Hence, the mutant virus has the            reports covering the H5N1 case, for example by the New
potential to infect and spread amongst humans. However,              York Times (Zimmer 2012).
it should be noted that the results of these infection studies          Indeed, as has been pointed out, life science research has
cannot be used directly to predict the transmissibility and          evolved rapidly over the past decades. The emergence of
pathogenicity of the virus in humans (Bouvier 2012;                  gene technology, the development of high-throughput
Morens et al. 2012; Racaniello 2012; Fauci and Collins               DNA synthesis and DNA sequencing machines, the com-
2012).                                                               pletion of the human and other genome projects have sig-
   In conclusion, the threat is plausible: it is possible that       nificantly enhanced research efficiency and opened new
the virus could cause a pandemic that would be devastat-             possibilities. However, by taking this view, two important
ing to the world’s population, although there is no (and             aspects are overlooked. First, it ignores the significant
there will not be) concrete scientific evidence available.            financial means and trained specialists required to operate
Next, the second question needs to be answered: is pre-              these new technologies. For example, to ensure constant
venting or restricting publication a reasonable response             access to this vital scientific and technological expertise
to the threat of misuse? Would it significantly contribute            and to help to rationalize institutional resources, more
to the prevention of the feared consequences?                        and more so-called ‘core service facilities’ are being estab-
                                                                     lished at major universities with a life science focus (Sa
                                                                     2008).25 Those facilities are operated by staff scientists
5. The role of tacit knowledge
                                                                     with various backgrounds and expert training ranging
Many scientists have argued that preventing publication              from bioinformatics to molecular biology, chemistry and
of the results and methodology does not prevent misuse.              engineering.
They argued that even if the methodology was omitted                    Second, the non-technological component of research is
from the paper, an individual with the relevant training             overlooked. In addition to sophisticated machines and
would be able to repeat the experiments. For example,                technologies, there are many more steps involved when
Fouchier and colleagues, stated that their methodology               performing life science research. These often require very
can be found in many virology textbooks (Herfst et al.               specific expertise and technical skills of the individual re-
2012a):                                                              searcher that can only be learned through constant
  Individuals with bad intentions do not need to read the details    practice and observation of peers. Hence, even if ‘labora-
  in our manuscript because the methods for creating similar         tory processes have become more automated’ as Chyba
  viruses have already been published widely.                        (2006) pointed out, it does not follow that ‘less and less
                                                                     tacit knowledge is needed’ to conduct life science research.
A similar argument was used by Wimmer (2006):                        Tacit knowledge was, and still is, an important factor not
  . . . all methods used for the synthesis of poliovirus were pub-   only for the success of life science research, but for science
  lished long before the experiment was conceived. Thus, we          and technology in general.
  neither described new technologies to synthesize DNA nor              The term tacit knowledge was first coined by Polanyi
  invented novel methods to convert cDNA into infectious             who defined it as:
  viral RNA.
                                                                       . . . things that we know but cannot tell. (Polanyi 1962)
This argument contrasts the current discourse about
DURC, which assumes a direct correlation between                     Since the 1960s much research has been done on the
technological advances in the life sciences and an increased         concept of tacit knowledge. Different forms have been
threat of bioterrorism. By focusing on the ease of diffusion         defined including somatic-limit and collective tacit know-
of knowledge and technologies, socio-technical aspects of            ledge,26 which are widely accepted, for example in the field
biotechnology such as tacit knowledge, complexity and                of economics, psychology, and education.
contingency are overlooked and possible challenges are                  Scholars have attempted to describe and measure the
disregarded, thus leading to the perception of an increased          impact of tacit knowledge on the success of academic
threat (Vogel 2008). Moreover, relying on this linear model          endeavors and the translation of academic knowledge into
of technical change may lead to a false prioritization of            industrial applications (Leonard and Insch 2005; Somech
policy measures and an inappropriate focus on high-tech              and Bogler 1999; Zucker et al. 2002). For example, Harry
research (McLeish and Nightingale 2007; Vogel 2008;                  M. Collins, a social scientist, has presented an insightful
Leitenberg 1999).                                                    analysis of the importance of tacit knowledge for scientific
   Chyba (2006) has compared the rapid development of                research in physics (Collins 2001). He described the attempt
life science technologies to the evolution of computer               of Western researchers to repeat experimental results pub-
power. He argued that the pace of development will                   lished by Russian scientists during the Cold War. Only in
make DNA synthesis and other biotechnologies increas-                the 1990s, after closely observing how the experiments were
ingly available to individuals with only basic scientific             performed, did the Western researchers succeed in
skills. This view was repeatedly presented in media                  replicating the results. Collins drew the following
Dual-use research and the H5N1 bird flu        .   7 of 14

conclusions from his field observations: In order to success-           rare? Could the lack of capabilities be a main reason?
fully replicate an experimental result, researchers first have          Previous studies on failed and successful attempts to
to understand and acknowledge the importance of tacit                  develop bioweapons provide possible answers. Two
knowledge. Second, they have to trust the validity of the              studies illustrating the impact of socio-technical aspects
results, and third they need to know how difficult a proced-            on bioweapons have been presented by Ouagrham-
ure is, meaning how much patience with trial and error is              Gormley and Vogel (2010) and by Leitenberg (1999).
required (Collins 2001).                                               Ouagrham-Gormley and Vogel (2010) show that a
   The concept of tacit knowledge has not yet gained much              substantial part of the Soviet smallpox bioweapon devel-
attention in the biosecurity debate within life science                opment program was unable to create a workable biolo-
research. Tucker (2011) and Vogel (2008) are among the                 gical weapon even though they had substantial expertise,
few who have highlighted the importance of tacit know-                 resources, time, infrastructure and even detailed protocols
ledge used by life scientists during experimentation. In the           at their disposal. They highlight:
context of life science research, Tucker (2011) defines ‘tacit
                                                                         . . . the local and personal character of bioweapons know-
knowledge’ as knowledge:
                                                                         ledge, specialized skills, and scientific know-how, which
  . . . that cannot be transmitted in writing but must be gained         cannot be transferred easily from one person to another and
  through years of hands-on experience in the laboratory.                from one location to another. (Ouagrham-Gormley and Vogel
                                                                         2010)
Tacit knowledge plays, as Tucker (2011) recognizes, a
central role when aiming to determine the biosecurity                  They also concluded that depending on the social context,
risks associated with life science research.                           tacit knowledge plays an important role not only on the
   One of the few studies on tacit knowledge in the life               individual, but also on the communal level (collective tacit
sciences has been conducted by Kathleen Vogel. It                      knowledge). As the most effective policy recommendation
involved members of the Wimmer group who published                     to prevent former Soviet weaponeers working in the USA
the first de novo synthesis of a virus (Cello et al. 2002;              from selling their knowledge, they suggested separating
Vogel 2008). The group revealed that the most difficult                 them from one another in order ‘to allow the BW-related
part of the poliovirus synthesis was not the partially auto-           skills to decay over time’.
mated DNA synthesis. Instead, it was the construction of                  Leitenberg, a security expert, reached a similar conclu-
the virus: the production of the virus components, the                 sion on the importance of tacit knowledge for biological
assembly of those components into virus particles, and                 weapons construction. Despite extraordinary financial
finally the incorporation of the virus’ synthetic genetic               resources, access to modern equipment, despite sufficient
material. According to the group, these steps, although                time and the fact that there were individuals with graduate
around for more than 20 years ‘. . . require specialized la-           and postgraduate training amongst their members, the
boratory know-how and practices only obtained by                       religious Japanese Aum Shinrikyo group failed to
training, care, and attention to detail [and are difficult              produce and disperse botulinum toxin or Bacillus anthracis
even for experienced researchers] (Vogel 2008). That the               (Leitenberg 1999; Ballard et al. 2001). Leitenberg
reconstruction or recovery of a pathogen would currently               concluded that:
require someone ‘skilled in the art’ has been supported by               . . . the experience of the Aum is therefore in marked contrast
other experts including the NSABB Working Group on                       to the legion of statements by senior US government officials
Synthetic Genomics.27 In the context of the H5N1                         and other spokesmen claiming that the preparation of biolo-
studies, Palese and Wang argue that the generation of en-                gical agents and weapons could be carried out in ‘kitchens’,
gineered H5N1 based on the published raw sequence                        ‘bathrooms’, ‘garages’, ‘home breweries’, and is a matter of
would require:                                                           relative ease and simplicity.

  . . . (i) access to a sophisticated laboratory setting, (ii) profi-   In a related study from 1995, the sociologists McKenzie
  ciency in relevant concepts of molecular biology, and (iii) ex-      and Spinardi (1995) highlighted the importance of socio-
  perience with laboratory methods related to viruses. (Palese         technological aspects with regards to nuclear weapons
  and Wang 2012)                                                       development. In their analysis based on interviews with
                                                                       nuclear weapons designers and computing experts, they
The author of one of the criticized H5N1 studies has used a
                                                                       emphasized that:
similar argument:
                                                                         . . . tacit knowledge is also crucial to nuclear weapons
  It takes a lot of knowledge, together with perhaps ten years of
                                                                         development.
  training and a well-equipped high containment lab, even to
  reproduce our work. (Fouchier 2012)                                  Thus, the work of Ouagrham-Gormley and Vogel,
                                                                       Leitenberg, and McKenzie and Spinardi indicates that:
  In his simplistic portrait of biotechnology research,
Chyba (2006) nevertheless raised an important question:                  . . . Because tacit knowledge is transmitted person to person,
Why is it that modern bioterrorist attacks28 have been so                there are greater barriers to the spread of competence than
8 of 14   .   S. E. Glatter

  the traditional view might lead us to expect. (McKenzie and      knowledge needed to reproduce the experimental results,
  Spinardi 1995)                                                   the task may pose significant hurdles even for specially
Another aspect to be considered in this context is the             trained individuals.
accessibility of bioweapons material. Rather than buying              Two possible conclusions can be drawn from this
state-of-the-art laboratory equipment and investing great          analysis. Unskilled individuals or groups do not possess
                                                                   the explicit and tacit knowledge currently needed to make
financial resources and time to synthesize a virus from
                                                                   use of the published methodology of the H5N1 studies and
scratch, pathogens more suited for a bioweapon could,
                                                                   reproduce the results. On the other hand, omitting the
for example, be stolen or isolated from the wild and sub-
                                                                   methodology would significantly delay, but not prevent, a
sequently modified to turn it into a category A bioterror-
                                                                   skilled team of specifically trained scientists with the will,
ism agent as defined by the US Center for Disease
                                                                   enough time, the right equipment and sufficient financial
Control29 (Herfst et al. 2012a; Tucker 2003). Moreover,
                                                                   resources from replicating the H5N1 study results. With
a study by Suk et al. (2011) suggests that instead of
                                                                   this in mind, prohibiting dissemination of the methodology
‘high-tech’ activities, ‘low tech’ activities may be especially
                                                                   could be regarded as ineffective in reducing the bioterror-
attractive to bioterrorists:
                                                                   ism threat and as a result may be considered an unreason-
  Contamination of food and water, and direct injection/appli-     able response to the biosecurity threat of DURC.
  cation of a pathogen, all have much lower technical hurdles
  and might be expected to be rather more successfully deployed.
                                                                   6. Discussion
Indeed, in 1984, followers of Bhagwan Shree Rajneeshee,
an Indian guru, deliberately contaminated salad bars at ten        This paper outlines that prohibiting publication of the
restaurants in the USA with salmonella resulting in 754            methodology and results is not a reasonable response to
individuals with food poisoning (Wheelis et al. 2006).             the uncertain biosecurity threat. It contrast a recent
   Furthermore, many scientists have pointed out that              analysis published by Resnik (2013) who argues that:
although ferrets are a good model for human influenza
                                                                     . . . re-dacted publication would have been a reasonable
infection, the results may not be directly applicable to             response to the threats posed by the controversial H5N1
humans as the potential for the transmission and lethality           papers if not for practical and legal problems.
of engineered H5N1 in humans is unknown (Bouvier 2012;
Morens et al. 2012; Racaniello 2012; Fauci and Collins             Resnik seems to support the common assumption that the
2012). Consequently, bioterrorists run the risk of discover-       papers:
ing that the mortality and transmission rates of the engin-          . . . provide terrorists with a recipe for making a bioweapon.
eered strains are comparable to a seasonal influenza after
having invested much time and resources in replicating the         However, I would question that assumption and argue that
H5N1 experiments.                                                  replicating the H5N1 experiments is not very easy for in-
   Thus, it seems that attempting to replicate published           dividuals or groups with minimal training, or even for
dual-use results may pose more challenges than the                 trained specialists. Neither is replicating the H5N1
common discourse reflects. Considering the importance               studies the most suitable and easiest way to obtain a bio-
of tacit knowledge, an individual with only minimal                weapon. However, for individuals with specialty know-
training should not be able to repeat the experiments              ledge in influenza virology, this will not provide a real
even if the methodology was published. The more                    barrier. With enough time and resources at hand, they
pressing question is how easily could a professional virolo-       do not need to rely on the short methods section in the
gist replicate the results and produce sufficient amounts of        H5N1 papers, but will be able to combine their expert
the virus? First, withholding the methodology would likely         knowledge with textbook methodology in order to repli-
result in a need for more time for ‘trial and error’. Another      cate the experiments.
factor that comes into play is the form and length of the             Although replicating the results of the H5N1 studies is
methodology sections in papers. The explanations in such           doable for trained individuals even without access to the
sections are usually short and of limited depth due to space       methodology, omitting this information will provide a
limitations, besides only providing information on explicit        barrier for well-intentioned scientists. As the current
knowledge. Commonly, researchers exchange more                     system of academic research is built on openness and the
detailed protocols or even visit each other in their               exchange of study results, classification of results and
laboratories to be able to replicate published results.            potential funding cuts may divert scientists to other
Furthermore, tacit knowledge may be essential for                  research fields. Prohibiting publication may even impose
translating or adapting technologies to a new environment,         new risks. As Sandin et al. (2002) point out, the PCP
not only on an individual level, but also on a communal            should also:
level (Ouagrham-Gormley and Vogel 2010). In summary,                 . . . be applied to precautionary measures prescribed by the
depending on the degree of training and the tacit                    principle itself.
Dual-use research and the H5N1 bird flu    .   9 of 14

Less scientific research may mean a lack of crucial know-                  This analysis does not conclude that we should ignore
ledge for pandemic preparedness necessary to address                   the DURC problem, as it would not be a reasonable
threats imposed by future natural human H5N1 pandemics.                response to the threat. Preventing terrorists and states
For example, the development of counter-measures (e.g.                 from using bioweapons is important. The DURC
vaccination) may be prevented, thereby precluding society              problem calls for a more detailed investigation of the
from obtaining the benefit of the research. This is especially          biosafety and biosecurity risks associated with DURC
worrisome as the prospective of benefits for public health              that includes a fact- and case-based assessment of the po-
are the motivation of such research and justification for               tential for misuse. In this respect, the H5N1 papers could
public funding. In their analysis of the case, the bioethicists        be regarded as a wake-up call for the scientific community.
Faden and Karron (2012) refer to a:                                    Although the dual-use issues associated with life science
                                                                       research have been discussed for the last decade, the
  . . . moral obligation to ensure that the results of that research
                                                                       H5N1 example illustrates how the restriction of research
  are used to help reduce risks to global health.
                                                                       funding and publication could become a reality in the near
There are further risks from limiting scientific openness. For          future. In response to the H5N1 case, the US government
example, sharing the results is a prerequisite for responsible         has issued a new policy that allows research funding pro-
conduct in science as peer review significantly contributes to          posals sent to government agencies to be screened for
ensuring the quality of the research and the research teams.           DURC. It also allows for the classification of research
Preventing this mechanism might have a negative impact                 results and the restriction of funding of research that
on the quality of the research and thus may increase the               raises concerns.31 However, how research proposals will
likelihood of viral escape from the laboratory.                        be evaluated, that is how risks and benefits will be
   Regarding the biosafety concerns associated with a                  assessed and who will evaluate the proposals, remains
higher number of researchers working with the engineered               unclear.32 Major differences in assessment of the term
strains—this issue may better be solved through enhanced               ‘dangerous’ in association with DURC might either
biosafety regulations than through censoring the research,             result in the underestimation of risks and threats or may
given the potential negative implication of censorship.                lead to the restriction of legitimate academic research.
Although it was discussed that enhanced Biosafety Level                Thus, it has become more important than ever for the
3 (BSL 3) conditions are sufficient (Casadevall aned Shenk              scientific community to address public concerns over
2012; Herfst et al. 2012a), Imperiale and Hanna (2012)                 DURC by establishing a transparent governance sys-
proposed using BSL4 conditions until more evidence is                  tem (see Miller and Selgelid (2008) for an overview of
available on the danger of the virus. A further biosafety              possible options).
measure would be to plan ahead and use a less virulent                    Governance options that restrict and control access to
strain of the H5N1 virus. In fact, one of the two labs, in             research results, as for example proposed by experts from
which the controversial H5N1 studies have been per-                    the Center for International and Security Studies at
formed, did decide to use less virulent strains for their ex-          Maryland (Steinbruner et al. 2007), may not be useful in
periments (Imai et al. 2012).                                          the light of the analysis presented above. For ensuring
   In contrast to censorship, education and personnel                  oversight, the WHO has been suggested as an ideal gov-
screening to identify individuals with malicious intentions            ernance body (Fouchier et al. 2012b). However, based on
may be more reasonable and effective measures to mitigate              decades of experience with regulating smallpox research,
biosecurity risks. For example in the USA, the Public Health           the WHO may not be the ideal choice to prevent deliber-
Security and Bioterrorism Preparedness and Response Act                ate misuse of DURC due to financial and political
(PL107-188) from 2002 requires that persons seeking to                 dependencies and a strong influence of the pro-research
possess, use, or transfer agents and toxins listed on the              fraction (Tucker 2006).
‘select agents and toxins’ list must undergo registration and             Nevertheless, the scientific community has a duty to
must have a legitimate need to handle or use such agents and           consider the negative implications of their research and
toxins.30 Finally, secrecy is an ineffective tool of prevention.       thus must find a way to address and possibly regulate
Before publication, the information on the H5N1 experi-                DURC issues (Kuhlau et al. 2008). As has been repeatedly
ments had been available to many scientists and the editors            suggested, scientists should receive education in bioethics
of the two journals. Even if the US-based journal, Science,            and familiarize themselves with ‘experiments of concern’ as
had been forced to follow the original NSABB recommen-                 defined by the Fink report and the BTWC (Dando et al.
dation to not publish the methodology, the UK-based                    2008; Pearson and Mahaffy 2006; Rappert et al. 2006). If
Nature could have (and did) proceed with publication.                  possible, plans to mitigate potential risks, for example
There are many other journals and editors who do not fall              intensified security measures and personnel training and
under US legislation and may be willing to publish such                screening, must be prepared before the results of DURC
manuscripts. Redaction of the papers would thus not be ef-             are communicated to the public.
fective in reducting the threat as it would not prevent dissem-           However, scientists will not be able to ensure that their
ination of the sensitive knowledge.                                    research will never be misused. Thus, it is important that
10 of 14   .   S. E. Glatter

the research is conducted with the intention of benefitting     7. National Science Advisory Board for Biosecurity
the public. The peer review system of science, which can          (2007), About NSABB         accessed     11
stricted, needs to ensure that only such research is sup-         September 2013.
ported. Furthermore, the potential benefits of the              8. National Institute of Health. Press statement on the
research need to be explained to the public as best as            NSABB review of H5N1 research, 2011  accessed 11
facts. Scientists will need to explain in their papers, and       September 2013.
possibly with accompanying media campaigns, the rele-          9. World Health Organization. FAQs: H5N1 influenza,
vance and potential benefits of their DURC to ensure               Q1: What is H5N1?  accessed 11 September 2013.
                                                              10. The Fouchier lab reported fatal infections of ferrets
Acknowledgments                                                   following ‘intratracheal inoculation’ with the
The author wishes to thank Anna Genske, Bernice Elger             mutated H5N1 virus (Herfst et al. 2012b). However,
and the anonymous reviewers for their valuable input.             intratracheal inoculation is a method that:
                                                                    . . . is not directly relevant to viral transmissibility or
Funding                                                             natural pathogenesis. [. . .] Influenza viruses that are
                                                                    otherwise considered to be of low pathogenicity
This work was supported by the Forschungsfonds                      often induce severe and even fatal disease in
University Basel and the Käthe-Zingg-Schwichtenberg                animals when administered by this route. (Morens
Fonds of the Swiss Academy of Medical Sciences.                     et al. 2012: 336)
                                                              11. A moratorium can be defined as a period of time
Notes                                                             during which a certain activity is not allowed.
 1. The list includes a selection of viral, bacterial and     12. 14 April 2012, statement on NSABB’s recommenda-
    fungal species as well as toxins. An updated list of          tions to the National Institute of Health on H5N1
    select agents is accessible at  accessed 11 September 2013.                     September 2013.
 2. Uniting and Strengthening America by providing            13. See  accessed 11 September 2013.
    Obstruct Terrorism (USA Patriot) Act, 2001 Public         14. Biosafety includes:
    Law 107–56, and the Public Health Security and                  . . . containment principles, facility design, practices
    Bioterrorism Preparedness and Response Act, 2002.               and procedures to prevent occupational infections
 3. National Institute of Health (2012) United States               in the biomedical environment or release of the
    Government Policy for Oversight of Life Sciences                organisms to the environment. (Nordmann 2010)
    Dual Use Research of Concern  accessed 11 September 2013.                                . . . the sum of risk management practices in defense
 4. US Government, Screening Framework Guidance for                 against biological threats’, which includes aversion
    Synthetic     Double-Stranded     DNA       Providers,          of biological terrorism and other disease breakouts.
    Department of Health and Human Services, Office                  (Meyerson and Reaser 2002)
    of the Secretary Federal Register Vol. 74, p. 224         16. The press has also discussed how easily the results
     accessed                2012).
    11 September 2013                                         17. See  accessed 11 September 2013.
    Statement on biosecurity, Trieste, Italy  accessed 11
    September 2013.                                                 Just as scientists should weigh benefits against
 6. The report committee was headed by Professor Gerald             the risks when deciding which projects to pursue,
    R. Fink, Professor of Genetics, Whitehead Institute,            governments should be encouraged to do the same
    MIT, Boston, MA.                                                when deciding which projects to fund.
Dual-use research and the H5N1 bird flu     .   11 of 14

    The NSABB (2007) stated that:                                    Synthetic_Genomics.pdf> accessed 11 September
                                                                     2013.
      The NSABB will [. . .] develop guidelines for the
                                                                 28. According to the US Center for Disease Control:
      oversight of dual use research, including guidelines
      for the risk-benefit analysis of dual use biological              . . . a bioterrorism attack is the deliberate release of
      research and research results.                                   viruses, bacteria, or other germs (agents) used to
                                                                       cause illness or death in people, animals, or plants.
19. DDT was extensively used as an insecticide in agricul-             ( accessed 11 September 2013)
    20th century. Today, due to concerns over its potential
    toxic side effects, intensive use of DDT is banned           29. The US Center for Disease Control separates bioter-
    worldwide.                                                       rorism agents into three categories, depending on how
20. Under the condition of uncertainty, possible outcomes            easily they can be spread and the severity of illness or
    can be characterized, but the available information or           death they cause. Category A agents are considered
    analytical models do not present a definitive basis for           the highest risk, because they can be easily spread or
    assigning probabilities (Stirling 2007).                         transmitted from person to person, they result in high
21. Under ignorance neither probabilities nor outcomes               death rates and have the potential for major public
    can be fully characterized (Stirling 2007; Collinridge           health impact, they might cause public panic and
    1980).                                                           social disruption, and they require special action for
22. Under the condition of ambiguity, outcomes are prone             public health preparedness          accessed       11
    2007).                                                           September 2013. With a few exceptions, there are
23. World Health Organization. FAQs: H5N1 influenza,                  more steps required beyond the synthesis and replica-
    Q1: What is H5N1? (2012)  accessed 11 September 2013.                   ization and dispersal of the pathogenic material
24. The mortality rate is based on diagnostically confirmed           (Tucker 2003). For example, the pathogen Bacillus
    cases of human H5N1 infections in hospitalized                   anthraces could be isolated from the wild as it is still
    patients in Southeast Asia. Due to a lack of epidemio-           endemic amongst cattle, e.g. in Equatorial Africa.
    logic and virologic studies and limited access to health         Infections are also sporadically detected in the USA
    care in rural areas, mild forms of infection may likely          (see  accessed 11 September 2013). However, viru-
    have retrospectively identified previously undetected             lence varies amongst naturally occurring Bacillus
    asymptomatic infections (Beigel et al. 2005).                    anthraces strains, and environmental conditions deter-
25. For example, the Functional Genomics Center Zurich,              mine the stability and hence the infectiousness of
    a joint state-of-the-art research and training facility of       anthrax spores. Bioweaponeers would need to isolate
    the ETH Zurich and the University of Zurich,                     many strains to find a suitable one, and would need to
    Switzerland, provides the latest technologies and                stabilize the spores (Dragon and Rennie 1995). The
    expert support in genomics, transcriptomics, prote-              same would be true for naturally occurring H5N1
    omics, metabolomics, and bioinformatics  accessed 11 September 2013.                        modified to adapt to humans as a host.
26. According to the social scientist Harry M. Collins,          30. According to the Public Health Security and
    somatic limit and collective tacit knowledge are                 Bioterrorism Preparedness and Response Act of
    experienced and acquired by humans through immer-                2002, Public Law 107–188, June 12, 2002, Sec. 351A,
    sion in society and guided practice: Somatic-limit tacit         pp. 637ff.
    knowledge is defined by the limited capacities and                  . . . the Secretary [. . .] shall include provisions to
    particular nature of the human brain and body, and                 ensure that persons seeking to register under such
    collective tacit knowledge                                         regulations have a lawful purpose to possess, use,
      has to be known tacitly, because it is located in                or transfer such agents and toxins. [. . .] The
      human collectivities and, therefore, can never be                Secretary shall maintain a national database that
      the property of the any one individual. (Collins                 includes the names and locations of registered
      2007)                                                            persons, the listed agents and toxins such persons
                                                                       are possessing, using, or transferring, and informa-
27. NSABB. Addressing biosecurity concerns related to                  tion regarding the characterization of such agents
    the synthesis of select agents (2006)
12 of 14   .   S. E. Glatter

       persons [. . .] deny access to such agents and toxins by      Bouvier, N. M. (2012) ‘The science of security versus the
       individuals whom the Attorney General has                       security of science’, Journal of Infectious Diseases, 205/11:
                                                                       1632–5.
       identified as ‘restricted persons.’ Restricted persons         Brombacher, M. (1999) ‘The precautionary principle threatens
       are defined as individuals reasonably suspected of               to replace science’, Pollution Engineering, Summer: 32–4.
       ‘committing a crime [. . .]’, individuals with                Casadevall, A. and Shenk, T. (2012) ‘Mammalian-transmissible
       ‘knowing involvement with an organization that                  H5N1 virus: Containment level and case fatality ratio’, MBio,
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                                                                     Cello, J., Paul, A. V. and Wimmer, E. (2002) ‘Chemical
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    Government Policy for Oversight of Life Sciences                 Chyba, C. F. (2006) ‘Biotechnology and the challenge to arms
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                                                                       Studies, 28: 257–62.
       If the risks posed by the research cannot be                  Collins, H. M. (2001) ‘Tacit knowledge, trust and the Q of
       adequately mitigated with the measures above,                   sapphire’, Social Studies of Science, 31: 71–85.
       Federal departments and agencies will determine               Dragon, D. C. and Rennie, R. P. (1995) ‘The ecology of anthrax
       whether it is appropriate to: [. . .] Classify the              spores: Tough but not invincible’, Canadian Vetinary Journal,
       research [. . .] Not provide or terminate research              36: 295–301.
                                                                     Faden, R. R. and Karron, R. A. (2012) ‘Public health and
       funding.                                                        biosecurity. The obligation to prevent the next dual-use
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32. The policy demands the following action for research             Fauci, A. S. and Collins, F. S. (2012) ‘Benefits and risks of influ-
    that involves certain agents and toxins as listed in the           enza research: Lessons learned’, Science, 336/6088: 1522–3.
    document or/and if the research includes experiments             Fouchier, R. A. (2012) ‘Interview with virologist Dr. Ron
    of concerns as defined by the Fink report. In case of               Fouchier’, BIF Futura, 27/3: 12.
    such research it demands federal departments and                 ——, Garcia-Sastre, A., Kawaoka, Y., Barclay, W. S. et al.
                                                                       (2012a) ‘Pause on avian flu transmission research’, Science,
    agencies to:                                                       335/6067: 400–1.
                                                                     ——, ——, ——, —— et al. (2013) ‘Transmission studies
       Assess the risks and benefits of such projects,
                                                                       resume for avian flu’, Science, 339/6119: 520–1.
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       knowledge, information, products, or technologies               transmission’, Science, 335/6069: 662–3.
       generates risk. (National’ Institute of Health (2012)         ——, Osterhaus, A. B., Steinbruner, J., Yuen, K. Y. et al.
                                                                       (2012c) ‘Preventing pandemics: The fight over flu’, Nature,
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