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Appendix D: Established Institutional Mechanisms for Addressing Ethical, Legal, and Societal Issues
Pages 306-328

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From page 306...
... , Additional Protocol I to the Geneva Conventions on the Protection of Victims of International Armed Conflicts, June 8, 1977, available at http://www.icrc.org/ihl.nsf/b466ed681ddfcfd241256739003e6368/f095453e41336b76c12 563cd00432aa1! OpenDocument.
From page 307...
... Weapons do not include devices developed and used for training and practice; aircraft, intercontinental ballistic missiles, and other launch platforms; or electronic warfare devices." 3 W Hays Parks, "Conventional Weapons and Weapons Reviews," Yearbook of International Humanitarian Law 8:55-142, 2005.
From page 308...
... , there is no written guidance known to the committee specifying precisely when in the acquisition process such a review must take place. Parks, who has personally conducted many LOAC reviews of weapons to be acquired, argues that the process has been successful and effective.
From page 309...
... In some cases, these ramifications include those related to matters such as safety and the protection of human subjects; in others, they include those related to the impact of such work on the broader society at large. Professional standards and codes of ethics may be implied or implicit rather than codified or formalized, and may incorporate standards for behavior (what must a responsible practitioner do in providing services to clients)
From page 310...
... See Advisory Committee on Human Radiation Experiments, Part I, Ethics of Human Subjects Research: A Historical Perspective, Final Report, p. 115, Government Printing Office, Washington, D.C., 1995.
From page 311...
... Physicians take some version of the Hippocratic Oath upon graduation from medical school. Further, the medical profession sets education standards through the leadership of the American Medical Association and the Association of American Medical Colleges, both nonprofit member organizations, with the latter especially focused on academic medicine, as well as through licensing requirements through state medical boards.
From page 312...
... However, the engineering fields distinguish between a professional engineer and what is sometimes called a graduate engineer: the professional engineer has to be licensed and must uphold professional standards or risk losing his or her license, whereas the graduate engineer does not. Graduate engineers have earned a degree from an accredited program and do work that draws on their engineering knowledge, but they have no state engineering license.11 In addition to graduate engineers, employees in companies with "engineer" in their job title need not have engineering training that would qualify them for obtaining a license; this is a result of an industrial exemption in the engineering licensure, which allows the use of the term "engineer" but never "professional engineer" in such cases.12 Despite the distinction between professional engineers and graduate engineers, both groups are included in the specialized professional engineering societies.
From page 313...
... Scientists are considered experts with the authority to determine the scientific value of research proposals and results. This autonomy and authority were granted to scientists during 14 Paul Lucier, "The Professional and the Scientist in Nineteenth-Century America," Isis 100(4)
From page 314...
... :208-220, 2001. 17 The American Chemical Society, American Institute of Chemists, American Society for Biochemistry and Molecular Biology, Society for Neuroscience, Ecological Society of America, and International Society of Ethnobiology, "Codes of Ethics Collection," Center for the Study of Ethics in the Professions, Illinois Institute of Technology, available at http:// ethics.iit.edu/ecodes/ethics-area/12.
From page 315...
... 20 For example, the Federal Policy for the Protection of Human Subjects or the Common Rule, was published in 1991 and codified in separate regulations by 15 federal departments and agencies. The Common Rule requires that as a condition of receiving certain federal research funding, researchers and institutions must establish institutional review boards and follow the ethical principles for research involving human subjects research first laid out in the Belmont report in order to receive research funding.
From page 316...
... D.3  RESEARCH ON ELSI D.3.1  Federally Supported ELSI Research National Human Genome Research Institute For a number of years, the National Human Genome Research Institute (NHGRI) has supported a research program in the ethical, legal, and social implications of genetic and genomic research for individuals, families, and communities.22 The individual research program solicits research projects that anticipate, analyze, and address the ethical, legal, and societal implications of the discovery of new genetic technologies and the availability and use of genetic information resulting from human genetics and genomic research.
From page 317...
... . Since its inception at the beginning of the Human Genome Project, the NHGRI's ELSI Research program has supported freestanding research on ELSI concerns, primarily through several standing program announcements.
From page 318...
... Thus, NSF has made relatively few awards in this domain. D.3.2  Centers of ELSI Research A number of centers for research on the ethical, legal, and societal implications of biomedical and behavioral research have been established, some with government support.
From page 319...
... . to enable prompt consideration of the potential risks and benefits of research breakthroughs and to provide perspectives on new research directions," and "developing information resources for ethical and legal issues related to intellectual property and ethical implications of nanotechnology-based patents and trade secrets." To pursue these activities, the NNI has established two independent centers of research on societal implications of nanotechnology research, one at Arizona State University27 and the other at the University of California, Santa Barbara.28 D.4  OVERSIGHT BODIES D.4.1  Institutional Review Boards Institutional review boards (IRBs)
From page 320...
... For example, because IRBs are a localized and flexible review process, different IRBs examining multisite clinical research may come to different conclusions about the same research, which may lead to confusion and frustration among researchers from different institutions.31 Another criticism argues that because of the power of IRBs to control the specifics of research protocols through the rejection or acceptance of the research protocol, IRBs may create an adversarial relationship between researchers and ethicists instead of encouraging communication and collaboration.32 Others worry about the scope of IRB review. Some criticisms suggest 29 Laura Stark, Behind Closed Doors: IRBs and the Making of Ethical Research, University of Chicago Press, 2012, pp.
From page 321...
... For example, a 2003 National Research Council report37 argued that IRBs are often "overloaded and underfunded and so may not be able to adequately protect participants from harm in high-risk research, such as clinical trials of experimental drugs"; are excessively focused on "documenting consent to participate in research so as to satisfy the letter of federal requirements [rather than on] helping individuals reach an informed, voluntary decision about participation"; and have a tendency to "delay research or impair the integrity of research designs, without necessarily improving participant protection, because the type of review is not commensurate with risk." Others argue that IRBs focus too much on protecting their respective institutions from lawsuits and bad press.38 D.4.2  Embryonic Stem Cell Research Oversight Committees In 2004, the National Academies began a project to develop guidelines for responsible and ethical research involving human embryonic 33 Mildred K
From page 322...
... committee to oversee "all issues related to derivation and use of hES cell lines and to facilitate education of investigators involved in hES cell research"39 Of particular significance is the fact that ESCRO committees were supposed to approve the scientific merit of research proposals involving hES cell lines. According to the 2005 report, such committees should include representatives of "the public and persons with expertise in developmental biology, stem cell research, molecular biology, assisted reproduction, and ethical and legal issues in hES cell research" with "suitable scientific, medical, and ethical expertise to conduct its own review." An ESCRO committee was not intended to be explicitly coupled to the IRB mechanism, and its responsibilities went beyond those related to human subject protections.
From page 323...
... informs and advises the NIH on issues related to recombinant DNA research and reviews human gene transfer research. Established by the NIH in the 1970s, the RAC serves two functions, one as a forum for "open, public deliberation on the panoply of scientific, ethical, and legal issues raised by recombinant DNA technology and its basic and clinical research applications" and the other to review and publicly discuss on behalf of the NIH "protocols that raise novel or particularly important scientific, safety or ethical considerations."41 It does so in part by advising the government on potentially controversial areas of genetics research as well as by reviewing novel genetics research proposals that raise new and challenging ELSI concerns.
From page 324...
... According to the NIJ, the panel, consisting of practitioners from the medical, research, legal, and ethical communities, discussed "chemical options, the risk factors associated with their use, potential delivery mechanisms, the empirical studies available from the relevant community, and legal and ethical issues associated with these agents." 44 Advisory boards and committees can and do shed light on important ethical, legal, and societal issues. But by definition and as is true with certain other mechanisms such as ELSI research or research ethics consultation services, they have no actual decision-making authority, and the decision makers to whom they report are free to adopt, disregard, or ignore any or all of the findings, conclusions, or recommendations of these boards and committees.
From page 325...
... in 2002 pursuant to the Homeland Security Act of 2002. The CPO, a senior official in the DHS hierarchy, has responsibilities "to ensure privacy and transparency in government are implemented throughout the Department."48 More specifically, the CPO's responsibilities include assuring that the departmental uses of technologies sustain, and do not erode, privacy protections relating to the use, collection, and disclosure of personal information; assuring that personal information contained in Privacy Act systems of records is handled in full compliance with fair information practices as set out in 46 Roberta M
From page 326...
... But a CPO is also likely to have other responsibilities, such as oversight and/or implementation of policy regarding the Freedom of Information Act. Perhaps more importantly, CPOs may be seen as serving primarily a public relations role rather than actually creating and enforcing policies that protect privacy.49 D.6.3  Environmental Assessments and Environmental Impact Statements Under the National Environmental Policy Act (NEPA)
From page 327...
... As stated in a 2008 NRC report,51 many analysts have argued that broader and more direct participation of both the public and interested or affected groups in the official environmental policy processes will increase the legitimacy and the substantive quality of policy decisions. Melnick argued in 1983 that the National Environmental Policy Act was an important reason for the increasing participation of environmental and other nontraditional groups in administrative decision making.52 Others have argued that public participation is not an unalloyed good, raising issues such as "the accountability and representativeness of self-appointed public participants, the inability of nonexpert communities to understand and process complex scientific relationships, the unlikelihood of reaching a meaningful consensus among conflicting interests, the effects of misdirected pressure to achieve consensus at the expense of achieving other important societal goals, and manipulation of outcomes either by those who frame the questions to be addressed or by those who get a ‘seat at the table.'"53 D.6.4  Drug Evaluation and Approval The Food and Drug Administration (FDA)
From page 328...
... Evaluations add relatively little to overall development dollar costs, benefiting from economies of scope as issues (e.g., equity, special populations) recur in different contexts.


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