Framework for Addressing Ethical Dimensions of Emerging and Innovative Biomedical Technologies A Synthesis of Relevant National Academies Reports (2019) / Chapter Skim
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Framework for Addressing Ethical Dimensions of Emerging and Innovative Biomedical Technologies
Framework for Addressing Ethical Dimensions of Emerging and Innovative Biomedical Technologies
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2019. Framework for addressing ethical dimensions of emerging and innovative biomedical technologies: A synthesis of relevant National Academies reports.
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have convened multiple committees of leading nues of research should be pursued and how studies experts in the biomedical sciences and in ethics to should be conducted or regulated to how biotechnology address ethical challenges related to innovative and should be implemented within a health system. Frameemerging biomedical technologies.1 Some committees works addressing only one piece of this process or the have been specifically charged with addressing ethical ways that these pieces fit together will likely be incomplete issues; others have addressed ethical issues as part of for the purposes of the National Academies and similar a broader scope of work.
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Those providing policy advice and making policy decisions on matters of biomedical science have a special respon BOX 1 sibility to consider the full range of risks and implications Framework for Ethical Dimensions of of innovation when advising scientists, legislators, and the Emerging and Innovative Biomedical nation on research activities. This commitment to rigor Technologies necessitates, as much as possible, an evidence-based approach that considers both the proximate and the long • Promote societal value term impacts of biomedical technology or research while eschewing non-data-driven slippery-slope arguments that • Minimize negative societal impact sometimes characterize discussions of contentious ethical issues.
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Reports addressing ethical implications related ticipants and future patients. Potential negative societal to embryonic stem cell research specifically described the impacts include a broad range of consequences that are potential of this research to address important health particularly important in the context of making policyproblems within society, and potential risks or harms oriented recommendations.
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Though broader distributive justice issues in health care are beyond the scope of work for many policy makers or programs, the identification of potential inequities and how to address them Protect the Interests of Research Participants indicates a commitment to minimizing societal impacts. The report on MRTs specifically addresses the potential The goal of protecting the interests of research particifor the introduction of MRTs to increase health inequities pants focuses specifically on clinical research, an essenbecause MRTs will likely be highly expensive and initially tial stage in the development of innovative biomedical available only to relatively well-off individuals with health technologies.
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. Advance the Interests of Patients In contrast to the protection of research participants' Steps that researchers should take to protect research interests, a commitment to advancing patients' interests participants and their interests are outlined in the 2003 focuses on the clinical application of innovative biomedical IOM report Responsible Research: A Systems Approach technologies, whether in the health system context or othto Protecting Research Participants, which recommends erwise.
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A central ethical commitment is thus adherence to high standards of research conduct and scientific practice. Flawed research designs can harm research participants, waste Engage Relevant Communities resources, fail to generate valuable data for patients National Academies reports have frequently called for a and society, and compromise public support for and commitment to community engagement in multiple forms.
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. sight and review of clinical gene transfer protocols, have focused almost exclusively on assessing the adequacy The National Academies reports on innovative biomedical of oversight mechanisms (IOM, 2014b)
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This example embryonic stem cells, which have been the focus of demonstrates how oversight and regulation change in several National Academies reports, present important response to experience and, in particular, in response to challenges because of differing moral views in American changing public views about the acceptability of specific society concerning the ethical nature of these technolo- forms of research. gies.
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policy recommendations for emerging and innovative bio• Final Report of the National Academies' Human medical technologies, policy makers and others working Embryonic Stem Cell Research Advisory Com- in this area can explain their rationale for balancing the mittee and 2010 Amendments to the National ethical considerations in the manner they did. The bodies Academies' Guidelines for Human Embryonic receiving the recommendations, often federal agencies, Stem Cell Research (2010)
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For work could be helpful more broadly beyond the domain committee members, policy makers, and advisers, this of emerging biomedical technology. The values set forth framework can provide a starting point for determining if within the framework are not highly specific and could be an innovative biomedical technology raises new ethical the starting point for an articulation of values or ethics concerns and also for deliberating about the best ways to considerations across a broad range of issues in biomed- identify and act on the ethical commitments that should icine.
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2010. Final report of the National Academies' Human Embryonic Stem Cell Research Advisory Committee and 2010 amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research.
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