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The Nurse As Facilitator of Critical Thinking

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The Nurse As Facilitator of Critical Thinking Dual Use Research of Concern: Ethical & Governance Issues Victor Cole Ph.D. (Bioethics) Monash Assistant Professor Singapore Institute of Technology What is ‘Dual Use Research of Concern’? The term ‘Dual use research’ was coined by the U.S. National Research Council in 2003, with the government subsequently proposing the following definition of DURC: ‘Life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.’ National Science Advisory Board for Biosecurity, FAQ 2 What is ‘Dual Use Research of Concern’? The term ‘Dual use research’ was coined by the U.S. National Research Council in 2003, with the government subsequently proposing the following definition of DURC: ‘Life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.’ National Science Advisory Board for Biosecurity, FAQ 3 DURC: good users / bad users The scientist who The criminal, terrorist intends to benefit or state that intends humankind in (or threatens) harm pursuing legitimate goals Legitimate goals could include ‘threat assessment’ 4 The fundamental ethical dilemma Benefits obtained from Risk* of harm resulting the knowledge VS from misuse of the produced by research knowledge produced *Where risk is calculated as probability x disvalue of the harm occurring 5 Experiments of concern The U.S. National Research Council in its 2004 report Biotechnology Research in an Age of Terrorism (the Fink Report) defined experiments of concern as those that would: demonstrate how to render a vaccine ineffective; confer resistance to therapeutically useful antibiotics or antiviral agents; enhance the virulence of a pathogen or render a nonpathogen virulent; increase transmissibility of a pathogen; alter the host range of a pathogen; enable evasion of diagnostic/detection modalities; or enable the weaponization of a biological agent or toxin 6 Experiments of concern Examples from Miller & Selgelid (2008) 7 Demonstrate how to render a vaccine ineffective Project Jefferson A 2001 U.S. biodefence project in which researchers attempted to replicate Russian research which produced a vaccine-resistant strain of anthrax, purportedly for defensive purposes, i.e. to understand and thereby combat what the Russians could use offensively 8 Confer resistance to therapeutically useful antibiotics or antiviral agents Mousepox Australian scientists spliced interleukin-4 (IL-4) gene into a mild mousepox intending to induce sterility in the mouse population but created a super-resistant strain of the virus instead 9 Enhance the virulence of a pathogen or render a nonpathogen virulent Hypervirulent tuberculosis In 2003 PNAS published the findings of scientists who created a more virulent form of TB when modifying the genetic structure of the bacteria 10 Increase transmissibility of a pathogen Mixing H5N1 with human flu strains WHO sponsored research to determine the virulence of such a hybrid form of influenza in order to boost readiness to tackle a pandemic 11 Alter the host range of a pathogen Myxomatosis Scientists have examined genes which if introduced into the genome of the myxoma virus (introduced into the rabbit population in the Australia in the 1950s to reduce numbers) could potentially lead to infection in humans 12 Enable evasion of diagnostic/detection modalities Microencapsulation Shrouding pathogen particles, e.g. in a polymeric agent, could thwart detection by antibodies 13 Enable the weaponization of a biological agent or toxin Aerosolization The use of large-scale aerosols, such as have been used in mass vaccination of animals, could enable the effective delivery of bioweapons agents 14 Miller & Selgelid’s additional categories: Genetic sequencing of pathogens E.g. of anthrax (by Read et al., reported in Nature) Synthesis of pathogenic micro-organisms E.g. of polio (by U.S. Department of Defense) Any experiment with variola virus (smallpox) E.g. WHA Variola Advisory Committee’s reporting on work done on primate model of human smallpox Attempts to recover/revive past pathogens E.g. 1918 flu virus recovered from lungs of victims frozen in permafrost 15 A slightly modified USG list USG Policy for Oversight of Life Sciences DURC (2012) specifies 7 ‘experimental effects’ These broadly map the previously articulated ‘experiments of concern’ except that ‘[enabling] the weaponization of a biological agent or toxin’ has been replaced by ‘[generating] or [reconstituting] an eradicated or extinct agent or toxin’ from among 15 listed in the document 16 USG 2012 list of ‘experimental effects’ Enhances the harmful consequences of the agent or toxin; Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical or agricultural justification; Confers to the agent or toxin resistance to clinically or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates their ability to evade detection methodologies; Increases the stability, transmissibility, or the ability to disseminate the agent or toxin; Alters the host range or tropism of the agent or toxin; Enhances the susceptibility of a host population to the agent or toxin; or Generates or reconstitutes an eradicated or extinct agent or toxin listed in Section (III.1) above. 17 USG 2012 list of agents & toxins a) Avian influenza virus i) Marburg virus (highly pathogenic) j) Reconstructed 1918 b) Bacillus anthracis Influenza virus c) Botulinum neurotoxin k) Rinderpest virus d) Burkholderia mallei l) Toxin-producing strains of e) Burkholderia Clostridium botulinum pseudomallei m) Variola major virus f) Ebola virus n) Variola minor virus g) Foot-and-mouth disease o) Yersinia pestis virus h) Francisella tularensis 18 Identifying ethical issues in DURC Use familiar principles from moral theory as a guide to identifying what is at stake, i.e. Rights (to scientific inquiry / to life) Utility (risks / benefits) Justice (who benefits? / who is at risk?) Virtue (‘culture of responsibility’* – prudence) Duty (‘to uphold the integrity of science and prevent its misuse’*) *2012 and 2014 USG Policies on DURC 19 Regulatory approach to DURC in the U.S. Define the term DURC Establish the scope of DURC, i.e. List specific agents and toxins (non-attenuated forms) List categories of experiment Establish oversight responsibilities Institutional Review Entities to assess risk and benefits and determine if research falls within scope: If it does, develop a risk mitigation plan, which includes how results are disseminated Note: Only federally funded research falls under the purview of the DURC policies and can also be classified 20 Assessing risks and benefits of DURC: USG 2012 Policy guidance RISK BENEFIT Reasonably anticipated Benefit(s) to public health? risks to public health & Benefits to non-human safety? entities? Ease of misuse? Usefulness of info to Threat beyond those scientific community? posed to humans? In what time frame? In what time frame? Scope or magnitude of Magnitude of risk? benefit(s)? Impact on public if info communicated as is? OR, in abridged form? 21 Risk mitigation guidance (USG 2012 Policy) i) Modifying the design or conduct of the research. ii) Applying specific or enhanced biosecurity or biosafety measures. iii) Evaluating existing evidence of medical countermeasures (MCM) efficacy, or conducting experiments to determine MCM efficacy against agents or toxins resulting from DURC, and where effective MCM exist, including that information in publications. iv) Referring the institution to available DURC educational tools such as: http://oba.od.nih.gov/biosecurity/biosecurity.html v) Regularly reviewing, at the institutional level, emerging research findings for additional DURC. vi) Requesting that institutions notify funding departments or agencies if additional DURC is identified, and propose modifications to the risk mitigation plan, as needed. 22 Risk mitigation guidance (USG 2012 Policy) vii) Determining the venue and mode of communication (addressing content, timing, and possibly the extent of distribution of the information) to communicate the research responsibly. viii) Reviewing annual progress reports from Principal Investigators to determine if DURC results have been generated, and if so, flagging them for institutional attention and applying potential mitigation measures as described above, as necessary. ix) If the risks posed by the research cannot be adequately mitigated with the measures above, Federal departments and agencies will determine whether it is appropriate to: (a) Request voluntary redaction of the research publications or communications (b) Classify the research (c) Not provide or terminate research funding 23 Governance challenges How to achieve a dynamic approach that is prudent without being stifling How and whether to control the dissemination of findings produced, both privately and publicly How any kind of international standard can be achieved given differences
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