Sci Eng Ethics DOI 10.1007/s11948-014-9567-3 ORIGINAL PAPER

Reengineering Biomedical Translational Research with Engineering Ethics Mary E. Sunderland • Rahul Uday Nayak

Received: 4 April 2014 / Accepted: 27 May 2014 Ó Springer Science+Business Media Dordrecht 2014

Abstract It is widely accepted that translational research practitioners need to acquire special skills and knowledge that will enable them to anticipate, analyze, and manage a range of ethical issues. While there is a small but growing literature that addresses the ethics of translational research, there is a dearth of scholarship regarding how this might apply to engineers. In this paper we examine engineers as key translators and argue that they are well positioned to ask transformative ethical questions. Asking engineers to both broaden and deepen their consideration of ethics in their work, however, requires a shift in the way ethics is often portrayed and perceived in science and engineering communities. Rather than interpreting ethics as a roadblock to the success of translational research, we suggest that engineers should be encouraged to ask questions about the socio-ethical dimensions of their work. This requires expanding the conceptual framework of engineering beyond its traditional focus on ‘‘how’’ and ‘‘what’’ questions to also include ‘‘why’’ and ‘‘who’’ questions to facilitate the gathering of normative, socially-situated information. Empowering engineers to ask ‘‘why’’ and ‘‘who’’ questions should spur the development of technologies and practices that contribute to improving health outcomes. Keywords Engineering  Capstone course  Translational medicine  Translational science  Education  Bioengineering  Value sensitive design

M. E. Sunderland (&) Department of Nuclear Engineering, 4155 Etcheverry Hall, MC 1730, University of California, Berkeley, Berkeley, CA 94720-1730, USA e-mail: [email protected] R. U. Nayak Department of Bioengineering, University of California, Berkeley, Berkeley, CA 94720-1762, USA e-mail: [email protected]

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Introduction Translational science is a relatively novel concept that was introduced to categorize practical, outcome-oriented research. In the biomedical sciences, the concept gained significant momentum in the early twenty-first century when the National Institutes of Health began planning a new ‘‘Roadmap,’’ which featured translation as its core mission (Maienschein et al. 2008). Efforts to promote translational research have since proliferated as evidenced by the creation of multiple academic journals, policy initiatives, educational programs, research institutes, and funding opportunities (Lander and Atkinson-Grosjean 2011). Conceptually, translational medicine, translational research, and translational science are often used interchangeably to refer to efforts that intend to bring society the benefits of biomedical research by bridging the bench to bedside to community divides. Translational research activities are geared towards improving or maintaining health and therefore the term carries strong moral and rhetorical force. It is also a capacious term that includes a wide spectrum of research activities ranging from the discovery and use of biomarkers for accurate detection to the marketing of new medical technologies to the formulation of new clinical guidelines (Van der Laan and Boenink 2012). Describing these activities as translational research matters because doing so implies that they are guided by the ethos of providing the public with a return on their investment in publicly funded research by solving health problems (Maienschein et al. 2008). Engineers have long engaged in the kind of research that bridges discovery and utility, yet much of the translational literature overlooks their role. In part, this is because of the strong bench to bedside metaphor. The ‘‘translational ethics’’ literature, for example, focuses on how scientists, residing at the bench, can be brought into more productive, collaborative relationships with clinicians, at the bedside, while the role of the engineer is unexamined, subsumed, and/or equated with the role of the scientist (Kagarise and Sheldon 2000). Engineers contribute to a broad spectrum of translational research activities, including the building of diagnostic technologies, data analysis programs, and a diversity of medical devices from the nano to the macro scale. In their role as expert problem solvers with the capacity to design and build innovative devices, engineers frequently cross disciplinary and institutional borders, which provides them with opportunities to raise potentially transformative ethical questions, especially regarding product design (van den Hoven 2013). There are value implications to technological designs because new technologies shape our activities and behaviors in ways that promote certain values while undermining others (Van de Poel 2009). It also matters that designing occurs in particular institutional contexts because the design process and its resulting technologies adhere to and reflect formal institutional rules, including laws, standards, regulations and contracts, in addition to informal institutions, such as customs, traditions, and routines. Embedded in these institutions are values, shaped by dynamic social processes (Taebi et al. 2014). Engineers are contributing to translational projects in a diversity of institutional settings, which makes them uniquely positioned to ask value questions and to consider how emphasizing

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different values yields different designs, practices, and devices with the potential to affect health outcomes for better or worse. Despite concerted efforts, translation remains ‘‘slow, expensive, and failureprone’’ (Collins 2011). New educational programs are responding to these challenges by preparing students to meet a diverse range of issues including such diverse topics as technology management, cost/reimbursement analyses, and regulation. These programs recognize that making translation work requires a unique skill set, including the ability to address ethical and social issues (Kurpinski et al. 2014). While no one disputes the relevance of ethics in translational research oriented educational programs, there is no consensus about the best pedagogical practices to do so, especially in the area engineering ethics (Barry and Ohland 2009). In this paper, we offer support for a student-engagement approach to incorporating engineering ethics into translational research (Sunderland 2013). Student engagement considers two key components: (1) how students invest time and effort into their learning, and (2) how institutions allocate resources and organize infrastructure to encourage students to participate in learning activities. We advocate for a student-engagement approach to ethics education because it brings both the student and institutional roles into focus. High levels of student engagement, for example, are often associated with learning activities that incorporate purposeful faculty–student contact and collaborative learning, such as capstone design courses (Wolf-Wendel et al. 2009). We offer an analysis of one of the author’s (Nayak) experiences in a capstone design course to highlight the engineer’s role in the translational research domain. Ethical concerns are at the core of many translational research projects and engineers are well positioned to address these concerns by incorporating non-technical values into their designs. Accomplishing this, however, requires a shift in how ethics is perceived and portrayed within science and engineering communities.

Beyond Regulations, Laws, and Window Dressing Ethics in science and engineering, unfortunately, has earned something of a bad reputation. This is reflected in how engineering students perceive ethics. A recent study of undergraduate engineering students, for example, revealed that they understand ethics to be lists of rules, regulations, laws, and codes that they must memorize and adhere to, rather than a source of rich questions with the potential to fundamentally reshape their research (Holsapple et al. 2012). Conflating ethics with rules and regulations implies that following the rules ensures an ethical course of action. This, however, is far from true. Although we can hope that many laws are indeed ethical, it is the case that new laws are more dependent on legal precedents than overarching moral principles, particularly in the domain of emerging technologies (Lo´pez and Lunau 2012). There are also concerns that science and engineering ethics involves substantial speculation about hypothetical futures. These skeptics argue that imagining and analyzing apocalyptic and/or utopian future

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scenarios wastes scarce resources that could be allocated to support more pressing concerns (Robert et al. 2013). Another widely held concern is that science and engineering ethics is usually nothing more than ‘‘window dressing.’’ This unease, for example, was front and center during the US congressional hearings that were held to authorize the National Nanotech Initiative, during which Langdon Winner warned the government against creating a ‘Nanoethicist Full Employment Act.’ This quip reflects the disdain that surrounds the Human Genome Project’s ethics activities, which many perceive as a job creation program for ethicists, whose primary role was to give the green light and ethical-stamp-of-approval to controversial research activities (Guston 2013). The notion that ethicists are needed to green-light potentially controversial research maps onto the prevalent perception in translational research that ethics is ultimately a hurdle or roadblock (e.g., Sugarman and McKenna 2003). The first roadblock is between the bench and the bedside, which draws attention to the practices and factors that slow the movement of new diagnostic, preventative, and/ or therapeutic methods into their first testing in humans. In this conceptualization, the ethical concerns of Institutional Review Boards (IRBs) are portrayed as ‘‘blocking’’ promising methods from being tested in humans. The second major block is situated between clinical studies and everyday health decision-making, which points out the challenges of successfully moving through and beyond the clinical trial process. The regulatory and ethical concerns of the FDA are implied blocks that must be overcome at this stage of translational research (Woolf 2008). Although it is true that navigating the regulatory landscape of clinical trials is indeed time consuming, and arguably overly and unnecessarily so (Grove 2011); it is also wrong to equate regulatory vigilance with ethical reflection. While adhering to various regulatory frameworks (institutional, national, etc.) requires rule following (albeit there is often room for interpretation), ethical reflection involves considering the different values and moral principles that motivate and justify one course of action over another. The adversarial conceptualization of ethics as a regulatory roadblock can be understood from an institutional perspective because the activities associated with technological progress are generally separated from the activities involved with ethics and governance. Altering this perception therefore requires changes at the institutional level, accompanied by a recognition that asking engineers to actively participate in the ethical dimensions of their research would require a significant shift in the division of moral labor (Fisher and Rip 2013). For although ethics is generally recognized as a component of science and engineering curricula, it is usually portrayed as a non-essential add-on in otherwise highly integrated technical programs (Adams et al. 2011). Both perceptual and practical changes are needed to motivate engineers to engage with ethics. What do we mean by ethics? In engineering, ‘‘ethics’’ research is often used as a catchall term to refer to any and all studies of technologies that are not conducted by scientists or engineers (Calvert and Martin 2009). In the engineering ethics literature, ethics is usually presented as either a decision-making problem or a dilemma; engineers are charged with marshaling evidence that will allow them to break down the problem into specific steps, evaluate different solutions, and

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ultimately make a rational and informed decision (Jonassen et al. 2009). In this paper, we define engineering ethics as a reflective process that involves asking specific kinds of questions (who and why questions). These questions elicit normative responses with the potential to enable an analysis of the value and meaning of engineering and technology to individuals, communities, and societies. Why should engineers care about ethics at all? Aren’t these broad societal questions beyond the engineer’s domain of responsibility? It has been argued that most moral matters in engineering are taken care of by following regular ‘‘business as usual’’ approaches and do not require special ethical reflection (Grunwald 2000, 194). This interpretation is tied to the traditional definition of engineering, which emphasizes that engineering’s purpose is to design solutions that are effective at meeting social needs (Dym et al. 2005). There are, however, many different ways to understand, conceptualize, and articulate social needs and different ways to envision what it would mean to meet them. During their education, engineers learn to cultivate a design perspective, which allows them to identify social needs and corresponding problems in a particular information-oriented way (Atman et al. 2008). In turn, the language of engineering design shapes engineers’ conceptual development (Streveler et al. 2008), including how they incorporate social welfare concerns into their conceptual framework of engineering; for a variety of reasons, students’ interest in the socio-ethical dimensions of engineering appear to decline during the course of their undergraduate education (Cech 2014). Perhaps the language of engineering design, which teaches students to ask particular questions and prioritize certain kinds of information, contributes to this decline. The discourse of engineering design constrains what might and what should be known (Atman et al. 2008). Engineers’ work in translational research is not inherently ethical, but because of engineering’s professional commitment to promoting societal good, many hold the assumption that pursuing technological progress in the name of translation is a virtuous endeavor. We argue that engineers who contribute to translational research projects should be empowered to identify and address ethical questions that will allow them to incorporate values into their designs. By explicitly asking value questions, engineers have the capability to initiate transformative discussions about how projects might be reshaped to better ensure improved health outcomes. Explicit ethical reflection is needed to guide translational research toward its broader humanitarian aims (Robert et al. 2013). Although engineers are trained to provide optimized solutions that maximize efficiency and profit, their unique technological expertise could also be employed in translational design projects to, for example, ameliorate rather than exacerbate existing health disparities. We’re not suggesting that engineers should be held responsible for solving the general ethical problems that are associated with living in a society fraught with health and social inequalities. We want to empower engineers to ask questions that might have previously been dismissed as irrelevant, unsolvable, or beyond their domain of expertise. Rather than asking engineers to add ethics to their list of problems to be solved, we want to instill a comfort with initiating and engaging in open-ended discussions about the socio-ethical

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dimensions of their projects with the aim of developing expertise regarding how certain values are built into their designs. Instead of portraying ethics as a list of rules that engineers must follow, we build on recent efforts to better elucidate the value questions that arise at every stage of translational research (Kelley et al. 2012). Engineers should be encouraged to ask questions about the morally problematic features of translational research, including, but not limited to: (1) its potential to exacerbate health disparities; (2) its risk of fueling a widespread therapeutic misconception by overpromising its potential to solve medical problems; and (3) the complicated conflicts of interest that arise between sponsors, scientists, clinical investigators, and engineers (Sofaer and Eyal 2010). To see how empowering engineers to ask these kinds of socioethical questions can shape translational research projects, we describe one of the author’s (Nayak) experiences in a bioengineering capstone course.

Designing Ethical Translations At the University of California, Berkeley, bioengineering senior undergraduates have the opportunity to take a Design Capstone course. Although ‘‘translational research’’ is not explicitly mentioned in the course, students work together to design products for their clinician clients that can help to solve a problem at the bedside or in the community. For bioengineers, solving biomedical and health problems starts in a clinic or community setting, which is where the design process begins. As a team, students meet with their clinician client to learn about potential health research problems that may be addressed with a creative engineering solution. In discussion with their clients, engineering teams develop needs statements as a strategy to better articulate the problem(s). They prioritize these needs with ranking systems and then begin generating concept designs. After benchmarking existing products, students select a top design to prototype and test. This design process involves continual ethical reflection. We argue that engineers should be encouraged to make this reflection more explicit by initiating and engaging in discussions with a diversity of stakeholders about how incorporating and/or emphasizing different values into the design process leads to the development of different technologies and practices (Van den Hoven 2007, 2013; Shilton 2013). As an approach to engineering, value sensitive design aims to incorporate values into the design process. Implicit in this approach is the idea that values and norms are embedded in technologies and therefore can be imparted into technologies by their designers (van den Hoven 2007). Many recent engineering innovations in electricity monitoring and health care systems could have benefited if nonfunctional values had been incorporated into the designs. For example, electronic record-keeping technologies that promise to reduce costs, meet sustainability goals, and improve efficiency and patient safety have failed to be implemented because they posed a risk to the widely shared value of personal privacy. Similarly, some smart meters have been rejected because they were perceived as spying devices. A value sensitive design approach to engineering seriously considers values, such as

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privacy, as ‘‘non-functional requirements’’ at the earliest stages of development. Doing so, allows engineers to anticipate relevant moral concerns and incorporate them into their designs (van den Hoven 2013). In her ethnographic study of design in a computer science laboratory, Katie Shilton (2013) explores the mechanisms by which these kinds of non-functional values are incorporated into technologies. She suggests that different activities can be added to design practices to act as ‘‘values levers’’ to encourage ethical reflection. Values levers include: working on interdisciplinary teams, advocacy about the relevance of social values by leaders, navigating institutional mandates, gaining funding, and interacting with a values advocate, such as an embedded social scientist. Along these lines, we add that encouraging engineers to consider values throughout the biomedical translational process should allow them to develop products that reflect the clinician’s values in addition to the community’s values, which should ultimately yield better solutions. In the bioengineering capstone course, clinician clients provide the research teams with guidance about what area of medicine or what problem should be solved, and act as a resource to help students to develop strategies for implementing the innovation in the clinic or community setting. It is very important to emphasize that the project that Nayak was involved with, which is further elaborated as an example in this paper, did not involve any prototype testing with humans. It is important to flag this because the project did not undergo IRB approval.1 In addition, we want to make a distinction between the ethical concerns that legally require the attention of an IRB versus the ethical concerns that are at play in value sensitive design. While engineers would rightly feel overwhelmed, unfairly burdened, and also unprepared to take on the responsibilities that are typically the purview of IRBs, they should feel empowered to take responsibility for engaging in value sensitive design, which includes asking value questions about the non-functional aspects of the problem(s) that they are attempting to solve. For Nayak and his team members this meant asking questions about privacy and taking steps to build these values into their design. Students help their clients to explore and redefine the problem and the scope of the project. Project redefinition is usually motivated by two intertwined constraints: (1) the need to complete the project during the semester and, (2) the need to narrowly define a problem that fits the scope of the class while simultaneously meeting the needs of the client. With only a semester to work on the project, articulating a potentially solvable problem is a significant challenge. Team members want to develop a functional prototype and sometimes that involves choosing one small aspect of the problem to solve rather than attempting to solve many problems. Sometimes clinicians present students with a well-defined vision of an end product, which leads them to engage the engineering teams in discussions about the 1

In addition, we want to explain that the example is presented in vague terms because Nayak and his team are continuing to develop their prototype and have plans to submit for a patent. Privacy concerns around patenting therefore prevent us from sharing specific details about examples. Indeed, this lack of access to specific information poses a problem for academics who are interested in studying the translational process. We spent considerable effort searching for capstone projects that had been ‘‘successfully’’ translated (i.e., were functioning as a device in the medical community), but were unable to unearth suitable examples.

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‘‘nuts and bolts’’ of the device development. In the capstone course, students learn that this is where their unique expertise has the potential to really shape the translational process. Rather than creating design plans to realize the clinician’s vision of how to solve the problem, engineers learn that their role is to define and redefine the problems that are underlying and motivating the clinician’s vision. To do this, engineers learn to ask what questions that will allows them to gather concrete information about the client’s problems, which in turn, will allow them to create a ‘‘needs statements’’ that codifies the client’s specific needs (Ulrich and Eppinger 2008). Engineers create these needs statements by learning to ask targeted what design questions, but they are also in a unique position to ask why and who questions that would allow them to gather information about values. Although the epistemology of knowledge classification is beyond the scope of this paper, it is relevant to draw attention to recent taxonomies that divide knowledge into four broad categories: (1) know-what; (2) know-how; (3) knowwhy; and (4) know-who. Know-what knowledge is squarely in the engineer’s domain and is described as the kind of explicit knowledge that is easy to break down and communicate in distinct bits of data, such as a recipe or the date of a specific event. Know-how knowledge is often encountered by engineers because it describes a process or practice (tacit knowledge) that might be used to solve a problem. It refers to the ability to do something. In capstone design courses and textbooks, engineers learn how to distinguish between these two kinds of information and also how to ask question that can turn know-how knowledge into know-what knowledge. In contrast, know-why and know-who knowledge is often perceived as beyond the engineers’ immediate purview and area of expertise. Know-why knowledge refers to explicit and implicit knowledge regarding values, principles, and norms at the individual, community, institutional, societal, or global level. Know-who knowledge refers to information about who knows what and the ability to cooperate and communicate across disciplinary divides (Johnson et al. 2002; Gasson 2005). Knowwhy and know-who knowledge is central to the design process and engineers are in a position to incorporate this kind of information into their needs statements. In the capstone design class, engineers learn that their unique expertise allows them to ask ‘‘what’’ rather than ‘‘how’’ questions of their clients. This emphasis reminds students that their goal is to understand the essence of what their client needs rather than focusing immediately on how to accomplish a specific task. To draw this information out of their clients, students are encouraged to bring props to consultations to stimulate discussion about the client’s needs while also illuminating problems with the existing products. For example, the customer or client might suggest to the engineering team: ‘‘I think that you should install a protective shield around the battery contacts.’’ This is a how statement because it describes how the problem might be solved; the statement is process and practice oriented. Instead, engineers are encouraged to ask what questions that will enable them to express the need specifically as raw data: ‘‘the battery is protected from an accidental shorting.’’2 Learning how to design involves learning how to codify statements into 2

This battery example was used in the capstone course by Professor Amy Herr to illustrate the importance of emphasizing ‘‘what not how’’ during client consultations.

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what knowledge. But what questions and the answers that they generate are situated in a specific context that can only be understood by asking why and who questions. A clinician, for example, may ask for a way to measure oxygen saturation in the blood and suggest how the problem could be solved by creating a variant of a pulse oximeter. In response, engineers learn to initiate a discussion that will allow them to create a list of what the clinician needs. They might ask ‘‘What device are you currently using?’’; ‘‘What level of accuracy does it provide?’’; ‘‘How many times will it be used each day?’’ etc. This line of questioning is meant to prevent the engineering team from prematurely jumping into the design process with a solution, and instead creates a dialogue that guides the design process. Engineers are trained to unpack problems by articulating needs. These needs are then ranked while the team considers different ways that each need might be reframed as a problem to be ‘‘solved.’’ Throughout this process of problem definition, teams consult with their clinician clients to evaluate the utility of different solutions, including ease of implementation in a hospital or community setting. While the emphasis is on developing a useful device or tool, students are also in a position to ask why and who questions that will allow them to consider their projects’ ethical and/or societal dimensions. For example, Nayak was involved in a project that sought to develop a device for implementation in a rural Guatemalan setting.3 The research project sought to understand how maternal and infant exposures to household air pollution from cooking fires contributed to infant birth weight and neurocognitive development. The focus was on a particular research site where there had previously been a randomized stove intervention trials to reduce infant pneumonia (Smith et al. 2011; Thompson et al. 2011). The team was charged with developing a device that could quantitatively measure the behavior that occurred around the cook-stoves because proximity to them increases exposure to harmful air pollutants (Smith et al. 2010). We (the team) considered many why and who questions while designing possible concept solutions to implement. For example, one of our potential design concepts involved using a camera to directly record behavior, which raised normative questions about privacy standards: who would the device record and why might this information be culturally sensitive? Who has a right to privacy and why? Who will have access to the information? Who should have access to the information? Why might other institutions or individuals want access to the information? In addition to privacy, we considered why using a camera to record behaviors might actually cause the research participants to change their behaviors. With this in mind, we set out to develop a device that would help us to understand behavior without altering behavior. Several other ethical questions came up throughout our project, especially regarding how the device would actually operate in rural Guatemala: Who would use it? Why would they be interested in using it? Why might they use it for an alternative activity? Who would monitor it? Why might it require maintenance? Additional ethical concerns arose around the challenge of completing our project by the semester’s end. We had to reprioritize issues in order to focus our attention. 3

It is important to emphasize that the prototypes developed and tested by Nayak and his classmates were not tested with human research subjects because the project did not undergo IRB approval.

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These kinds of resource allocation questions, which were raised throughout the project, are inherently ethical because focusing on one feature of a problem often means ignoring other aspects of the problem, even temporarily. When designing a solution to a clinical or community need, it is critically important to keep the client in focus and evaluate how the solution will work for individuals and in communities. While one might be inclined to focus on how the solution will solve the clinician’s problem, we made an effort to remember that the ultimate end-user is the patient or client, and that the ultimate outcome is to improve health. Because of this, the engineering ethics of translational research encompasses not only the clinician’s concerns but also client and community concerns. An apparently useful technology, no matter how clever and efficient it is, will be unworkable if it violates the values of the clinician or client. In the cook-stove project, for example, we wondered about the practicalities of our device’s power consumption. Who would pay for the power that was required to operate the device? Why might the power consumption of research technologies cause management problems in low-resource settings? Why might certain cultural traditions be important for cooking? One of the course’s core learning objectives was to show the ways in which socio-ethical concerns could lead to different product designs. Unfortunately, ethical and regulatory issues are often bundled together and, by association, equated with one another. However, an FDA-approved product is not necessarily an ethical product. For example, a new designer drug might be safe but it might also seek to create a need for a new drug where none exists (Angell 2004). Furthermore, members of FDA review committees are now permitted to hold financial conflicts of interest (Palmer 2010; Wood and Mador 2013). While regulatory processes and laws are important for ensuring the safety and legality of new products, ethics plays a different role. Cultivating the ability to identify, articulate, and ask ethical questions should enable engineers to make products that are more than just legal and efficient; an ethical awareness should allow engineers to make products that: (1) are comfortable for patients, clinicians, and clients to use; (2) take into consideration the potential discomforts that might arise in different cultural contexts; (3) are accessible to different socio-economic groups; (4) respond to patient’s and communities’ needs rather than the clinician’s needs; and (5) reflect and promote values that are important in the relevant communities and broader society.

Conclusion: Reengineering Translation To justify the establishment of the new National Center for Advancing Translational Sciences (NCATS), Francis Collins argued that the current translational process was broken. Built to facilitate the reengineering of the entire translational process, NCATS is meant to enable the scientific community to promote new ways of innovating (Collins 2011). Engineers are positioned to play a key role in this reengineering endeavor. What if engineers were expected to incorporate ethical questions into their client consultations and non-functional values into their designs? The capstone course example shows that ethical questions are at the core of

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translational endeavors and notably that engineers, including Nayak and his peers, are interested and ready to explore the ethical dimensions of their work. Encouraging and empowering engineers to take on ethical questions in a more explicit and rigorous manner has the potential to transform the success of translational research. Relegating questions of ethics and social responsibility to ethicists marginalizes and compartmentalizes them as non-technical and therefore irrelevant. Explicitly bringing ethics and values into the engineering domain of design enables engineers to ask non-technical questions without the perception that they are overstepping their area of expertise. The various institutions in which translational research occurs therefore need to be aware of how they portray ethics. Rather than depicting ethics as a roadblock in the translational process, we argue that institutions should encourage and facilitate interactions that will allow engineers to consider the social and ethical values that are at play throughout the design process. Empowering engineers to engage with the ethical dimensions of their work has the potential to yield new translational solutions that better reflect and respect the overarching moral goal of translational research to improve human health. Acknowledgments We are grateful to all of the engineering students who candidly shared their ideas. We thank Amy E. Herr, University of California, Berkeley, for the opportunity to explore the Bioengineering Senior Capstone Design Course. We thank Lisa M. Thompson, RN, FNP, PhD, University of California, San Francisco for the opportunity to work with her on the development of a prototype device to monitor cook stove behaviors and for helpful feedback on the manuscript. Thank you to Terry Johnson for many insightful discussions and comments on the manuscript. We also thank Ray Spier and two anonymous reviewers for helpful feedback on an earlier draft. The authors take full responsibility for the views expressed in the paper. This material is based upon work supported by the National Science Foundation (NSF) under Grant No. 1237830.

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Reengineering Biomedical Translational Research with Engineering Ethics.

It is widely accepted that translational research practitioners need to acquire special skills and knowledge that will enable them to anticipate, anal...
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