Emerging and Readily Available Technologies and National Security A Framework for Addressing Ethical, Legal, and Societal Issues (2014) / Chapter Skim
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7 Mechanisms for Addressing Ethical, Legal, and Societal Issues
7 Mechanisms for Addressing Ethical, Legal, and Societal Issues
Pages 230-244
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From page 230... ...
in that they are governed by specified procedures, and their operation and often their existence are backed by law and governmental power. Informal mechanisms are more akin to conversations between colleagues and friends that enlighten and provide information to those who must make decisions about ELSI concerns.
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The integration of technical and STS/policy work is harder to achieve, however, when the institutions involved are separate. One major advantage of a mechanism for addressing ELSI concerns that is integrated with R&D is the easy access to detailed knowledge of the technical work, knowledge that is often integral to the effective pur 1 For example, all research projects involving recombinant DNA if funded by the Na tional Institutes of Health or if conducted at an institution receiving any NIH funding at all must comply with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.
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From page 232... ...
Different mechanisms for addressing ELSI concerns also differ substantially in their financial cost, with formal mechanisms tending to cost more than informal ones. Nevertheless, it is unrealistic to expect that addressing ethical, legal, and societal issues will be cost-free, and investments in mechanisms to address such issues may be cost-effective if they help policy makers to avoid expenses that might be incurred in the future when programmatic changes are harder and more costly to make.
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From page 233... ...
that took both ethical and legal concerns into account.3 The covered research included the "use and derivation of new stem cell lines derived from surplus blastocysts, from blastocysts produced with donated gametes, or from blastocysts produced using nuclear transfer." The study also considered health science policy issues related to the development and use of human embryonic stem cells for eventual therapeutic purposes. As a result of the complexity and novelty of 3 National Research Council and Institute of Medicine, Guidelines for Human Embryonic Stem Cell Research, The National Academies Press, Washington, D.C., 2005, available at https://download.nap.edu/catalog.php?
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• An exercise in the synthetic biology community is underway today to incorporate social science expertise into understanding ELSI dimensions of such research.4 On May 26, 2006, synthetic biologists issued the Declaration of the Second International Meeting on Synthetic Biology, which addressed several widespread challenges in the field, such as commercial providers accepting orders for DNA sequences that may encode hazardous biological agents.5 The declaration called for the synthetic biology community to adopt the use of software tools and best practice to check for DNA sequences that encode hazardous biological agents, as well as to engage in discussions with various stakeholders and policy makers to develop governance options for the community. Some critics have argued against self-regulation.
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Established by federal law, institutional review boards (IRBs) address ELSI issues directly related to the safety of human subjects that arise in the conduct of research (usually of a biomedical, social, or behavioral nature)
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Such services have been established in a number of research environments to help raise awareness of issues related to the ethics of human subjects research and to assist investigators in resolving these issues. Using an "ELSI consultants on call" model, these services provide real-time advice to scientists about how to recognize and address ELSI concerns in ongoing research and at the same may lead those involved to discuss broader ethical, legal, and societal issues.
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As illustrated in Box 7.1, the FDA has developed procedures for addressing ELSI concerns in drug development that are intended to be expert driven, confidential, advisory, predictable, constructive, timely, and efficient. 7.2.3 Existing DARPA Efforts to Manage ELSI Concerns DARPA acknowledges publicly that there is often a tension between research on novel technological concepts and an underdeveloped ethical, legal, and societal framework for addressing the full implications of such research, noting that "[i]
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In February 2011, the panel met with DARPA to discuss "the implications of privacy laws and policies on DARPA programs" and "to help DARPA create an internal privacy accountability process."9 It is the intent that the panel's experts will consult with individual DARPA program managers to help them address privacy concerns that arise early in a program's life cycle and to ensure that each program's privacy implications are understood.
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A second DARPA effort has been to create an advisory committee for the Living Foundries program. As noted in Chapter 2, that committee is modeled on the privacy panel described above, and its purpose is to advise program staff on the inherent ethical and societal issues that might be raised by DARPA's investment in synthetic biology R&D.
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How, if at all, any of these mechanisms might be useful for addressing ethical, legal, and societal issues associated with R&D in a military context is the question that this section explores. Toward characterizing the attributes of a process for addressing ELSI concerns related to R&D with military relevance, the above discussion is a point of departure.
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Some of the mechanisms described above (e.g., IRBs, advisory boards, interdisciplinary ELSI research, research ethics consultation services) are predicated on the idea that addressing ethical, legal, and societal issues requires deep and serious expertise both from the scientific disciplines involved and from specialists in ethics, law, and the social sciences.
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From page 242... ...
The mechanisms described above work best when project and program managers can address ELSI concerns in a cooperative manner early enough to affect the way a project or program is laid out, that is, before addressing ELSI concerns becomes very expensive either in time or financial resources. Depending on their goals, policy makers will have to decide how far to go with respect to any of these attributes in designing an approach for addressing ethical, legal, and societal issues in the context of military R&D.
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Thus, a chosen approach to addressing ethical, legal, and societal issues for military R&D must maintain control over processes for receiving input from individuals who do not share or are not willing to set aside discussion of this premise. In addition, an approach for addressing ELSI concerns with R&D of military relevance must be capable of accommodating the classified dimensions of military research.
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244 ELSI FRAMEWORK FOR EMERGING TECHNOLOGIES AND NATIONAL SECURITY are usually not relevant to research aimed at advancing foundational or enabling technologies; rather, they emerge primarily in the context of specific applications to address urgent needs. Third, nothing in the discussion above limits consideration of ethical, legal, and societal issues after a new application is deployed for use, and indeed policy makers should be prepared for the possibility that actual operational use of a given application will raise ethical, legal, and societal issues that they will have to address.
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