Ethical, Legal, And Social Implications Research Articles

Funding and Forums for ELSI Research: Who (or What) Is Setting the Agenda?

Background: Discussion of the influence of money on bioethics research seems particularly salient in the context of research on the ethical, legal, and social implications (ELSI) of human genomics, as this research may be financially supported by the ELSI Research Program. Empirical evidence regarding the funding of ELSI research and where such research is disseminated, in relation to the specific topics of the research and methods used, can help to further discussions regarding the appropriate influence of specific institutions and institutional contexts on ELSI and other bioethics research agendas. Methods: We reviewed 642 ELSI publications (appearing between 2003 and 2008) for reported sources of funding, forum for dissemination, empirical and nonempirical methods, and topics of investigation. Results: Most ELSI research is independent of direct grant-based funding sources; 66% reported no such sources of funding. The National Human Genome Research Institute (NHGRI) is the most dominant source of funding; 16% of publications acknowledged at least one source of NHGRI grant funding. Funding is acknowledged more frequently in empirical than nonempirical publications and more frequently in publications in public health journals than in any other ELSI research dissemination forums. Dominant research topics vary by publication forum and by reported funding. Conclusions: ELSI research is surprisingly independent of direct grant-based funding, yet correlations are apparent between this type of funding and publication placement, topics addressed, and methods used, implying a not insignificant influence on ELSI research agenda setting. However, given the relatively low percentage of publications acknowledging external grant-based funding, as well as other significant correlations between publication placement and topics addressed, additional institutional contexts, perhaps related to professional advancement or valuation, may shape research agendas in ways that potentially exceed the direct influences of grant-based funding in this area. In some cases, grant-based funding may actually counter other potentially problematic institutional influences.

Attitudes of university students in Hong Kong about the use of genomic science and technology

Objective: This study aims at exploring university students' attitudes towards the application of genomic science and technology (GST) and the rationales behind their judgments. Background: With the rapid advances in GST, its wide application will become common in the near future. Since understanding the ethical, legal, and social implications (ELSI) of GST is important for its sustained development, understanding public attitude towards GST application is critical for its acceptance in Hong Kong society. Participants: Cantonese speaking undergraduate and postgraduate students of the University of Hong Kong (HKU-students). Methods: The study consisted of two parts. Part 1 was a survey of 400 HKU-students recruited at the library entrance and the written questionnaires were completed immediately. Part 2 comprised semi-structured interviews of 65 of the 400 HKU-students surveyed in Part 1 and each was interviewed individually. Conclusions: In Part 1, HKU-students had “neutral” responses for most themes, and Part 2 showed that the “neutrality” was primarily caused by opposing opinions of proponents and opponents in each theme. HKU-students had a negative attitude towards human genetic enhancement and were worried about GM food, genetic discrimination, and misuses of genetic information. The study did not support “the deficit model” but confirmed the “particularistic” view that endorsement of a GST application is determined by specific contextual factors.

ELSIfication in Canada: Legal Modes of Reasoning

ELSI (Ethical, Legal and Social Implications) initiatives are frequently attached to major science programmes. The expectation is that ELSI research will produce a practical advanced assessment of the impacts of technological development. Williams' overview of the field demonstrates that this encourages a mechanistic understanding of technological development leading to compressed foresight, i.e. the notion that the future is imminent in the present. The development of the ELSI domain in Canada has been characterised by an affinity between the types of knowledge valorised by the field and modes of legal reasoning, suggesting a legal variant of compressed foresight. The concept of juridification and an analysis of two related modes of legal reasoning (analogy and reflective equilibrium) shed light on the connection between legal reasoning and the ELSI field in Canada. The deployment of the aforementioned modes of legal reasoning enables law to define and operationalise difficult questions by drawing on currently existing principles and precedents. Thus, when legal modes of reasoning are brought to bear on ELSI questions, the future is made a calculable and manageable extension of the present, dovetailing with the ELSI field's requirement of pragmatic, advanced assessment.

Catching Education Up with Technology: Preparing the Public to Make Informed Choices about Personal Genetics

Dear Editor: As we approach an era in which personal genome sequencing will be inexpensive and rapid enough for routine use in the clinic, genetic information will play an increasingly prominent role in healthcare. Therefore, the fields of personalized medicine and pharmacogenomics seek to utilize personal genetic information to develop individualized diagnostic and therapeutic strategies. For their potentially transformative effects to be fully realized, a public that is informed about genetics is essential. In their recent article, Dougherty and colleagues (2011) highlight this critical educational need. They demonstrate that statewide standards for genetics education at the high school level are largely inadequate, particularly for concepts related to complex traits, which are fundamental for comprehending the potential and the intricacies of interpreting personal genetic information. This report is alarming, as it is critical that upcoming generations know about the promise of personalized medicine, our current ability to interpret genome sequences, and the limitations of what this information can predict about future health. To complement the improvements in genetics education recommended by Dougherty and colleagues, our society must also be made aware of the complex ethical, legal, and social implications (ELSI) of the choices we will face. Therefore, the most effective preparation of our society for the benefits and challenges of modern genetics should include a comprehensive program addressing the ELSI of personal genetics. To make informed decisions about obtaining and sharing personal genetic information, individuals will also need to consider many complex questions, such as: What do you want to learn from your genome sequence? Predictions about your health? Predictions about your behavior? Would you ask your family's permission before having your genome analyzed, since it may potentially reveal information about the genetic makeup of your relatives? Would a person's genetic predisposition to a disease affect your decision to date that individual? How private is your genetic information? How are you protected against genetic discrimination? As the cost of personal genome sequencing rapidly declines, we must act quickly to integrate these and other important topics into the curriculum. At the Personal Genetics Education Project (pgEd), we suggest that educating high school students offers a cost-effective and comprehensive strategy to broadly reach a generation of young adults who will become independent healthcare consumers just as genome sequencing becomes a low-cost, widely available option. Issues in personal genetics involve multiple fields, including genetics, ethics, sociology, policy, and health. Determining what students should learn will require interdisciplinary dialogue and will yield opportunities to include units on personal genetics in multiple classrooms, including those of biology, health, social studies, psychology, and law. A program that incorporates ELSI discussions across the curriculum is likely to have the broadest impact, reaching students regardless of their inclination toward science. Promoting a coordinated national effort to incorporate personal genetics education into high school curricula is precisely our mission at pgEd. Our curriculum is freely available on our website (www.pgEd.org) to help teachers start discussions about personal genetics in their classrooms. We envision that efforts such as these will help to cultivate a community of informed individuals prepared to face highly personal choices about their genetic information and therefore optimally poised to benefit from this new era in science and medicine.

Charting ELSI’s future course: lessons from the recent past

PurposeWe sought to examine the ethical, legal, and social implications (ELSI) literature research and scholarship types, topics, and contributing community fields of training as a first step to charting the broader ELSI community’s future priorities and goals. MethodsWe categorized 642 articles and book chapters meeting inclusion criteria for content in both human genetics or genomics and ethics or ELSI during a 5-year period (2003–2008) according to research and scholarship types, topics, and the area of advanced training of the first-listed author. Research and scholarship type categories were developed and characterized through in-depth review of 95 randomly sampled publications from the larger group. ResultsThere is a single dominant approach to ELSI, which focuses on ethical and other social issues “downstream” of advances in genomics, the contributors to which predominately have advanced training in medicine or science fields other than social science. A comparatively low percentage of publications primarily offer policy recommendations, and these are much more likely to be written by those with advanced training in law than is the case for the literature as a whole. Social science studies predominately employ qualitative methods and vary significantly with respect to the extent and types of recommendations offered. Two further types of ELSI research and scholarship offer alternative models for so-called “normative” work in this field. ConclusionConsidering topics, training, and types of ELSI research and scholarship from the most recent past allows for a baseline perspective that is sorely needed in charting this field’s future course.Genet Med 2012:14(2):259–267

Genes and plays: bringing ELSI issues to life

AbstractEthical complexities surround the promise of genomic technology and the power of genetic information as they alter conceptions of identity and dynamics within personal and professional relationships. Creative approaches such as dramatic vignettes offer a unique analytical stage for imagining the bioethical past and future. Dramatic narratives can bring to life images of differing perspectives and values when experiencing innovations in medicine. Although the scientific landscape shifts, concerns expressed in theatre from 50 years ago parallel many contemporary ELSI (ethical, legal, and social implications) issues, highlighting the ongoing struggle to appreciate the impact of emerging genetic technologies on relationships. To illuminate these enduring concerns, we explore how perceptions and relationships have influenced—and been influenced by—genetics as portrayed through dramatic vignettes. We build on the legacy of using case vignettes as a clinical teaching modality, and believe similar value exists within the research ethics domain. The selection of dialogue discussed encompasses abbreviated excerpts from two existing and one original vignette that we staged at the ELSI 2011 Congress and various academic and health institutions.Genet Med 2012:14(2):274–277

What Research Ethics Should Learn from Genomics and Society Research: Lessons from the ELSI Congress of 2011

Research on the ethical, legal, and social implications (ELSI) of human genomics has devoted significant attention to the research ethics issues that arise from genomic science as it moves through the translational process. Given the prominence of these issues in today's debates over the state of research ethics overall, these studies are well positioned to contribute important data, contextual considerations, and policy arguments to the wider research ethics community's deliberations, and ultimately to develop a research ethics that can help guide biomedicine's future. In this essay, we illustrate this thesis through an analytic summary of the research presented at the 2011 ELSI Congress, an international meeting of genomics and society researchers. We identify three pivotal factors currently shaping genomic research, its clinical translation, and its societal implications: (1) the increasingly blurred boundary between research and treatment; (2) uncertainty--that is, the indefinite, indeterminate, and incomplete nature of much genomic information and the challenges that arise from making meaning and use of it; and (3) the role of negotiations between multiple scientific and non-scientific stakeholders in setting the priorities for and direction of biomedical research, as it is increasingly conducted "in the public square."

Untapped ethical resources for neurodegeneration research

BackgroundThe research community has a mandate to discover effective treatments for neurodegenerative disorders. The ethics landscape surrounding this mandate is in a constant state of flux, and ongoing challenges place ever greater demands on investigators to be accountable to the public and to answer questions about the implications of their work for health care, society, and policy.MethodsWe surveyed US-based investigators involved in neurodegenerative diseases research about how they value ethics-related issues, what motivates them to give consideration to those issues, and the barriers to doing so. Using the NIH CRISP database we identified 1,034 researchers with relevant, active grants and invited them to complete an online questionnaire. We received 193 responses. We used exploratory factor analysis to transform individual survey questions into a smaller set of factors, and linear regression to understand the effect of key variables of interest on the factor scores.ResultsEthics-related issues clustered into two groups: research ethics and external influences. Heads of research groups viewed issues of research ethics to be more important than the other respondents. Concern about external influences was related to overall interest in ethics. Motivators clustered into five groups: ensuring public understanding, external forces, requirements, values, and press and public. Heads of research groups were more motivated to ensure public understanding of research than the other respondents. Barriers clustered into four groups: lack of resources, administrative burden, relevance to the research, and lack of interest. Perceived lack of ethics resources was a particular barrier for investigators working in drug discovery.ConclusionsThe data suggest that senior level neuroscientists working in the field of neurodegeneration (ND), and drug discovery specifically, are motivated to consider ethics issues related to their work, but the perceived lack of ethics resources thwarts their efforts. With bioethics centres at more than 50% of the institutions at which these respondents reside, the neuroscience and bioethics communities appear to be disconnected. Dedicated ethical, legal and social implications (ELSI) programs, such as those fully integrated into genetics and regenerative medicine, provide models for achieving meaningful partnerships not yet adequately realized for scholars and trainees interested in drug discovery for ND.

Using Critical Literacy to Explore Genetics and its Ethical, Legal, and Social Issues with In-Service Secondary Teachers

The described interdisciplinary course helped a mixed population of in-service secondary English and biology teacher-participants increase their genetics content knowledge and awareness of Ethical, Legal, and Social Implications (ELSI) that arose from discoveries and practices associated with the Human Genome Project. This was accomplished by applying a critical literacy approach that allows people develop cognitive skills such that they are able to “read the world” (Wink, 2004). The approach is one that permits readers to go beyond the literal text to examine what is present as well as what is missing as it relates to issues of equity and fairness. Becoming critically literate enabled these teacher-participants to challenge the subtle attitudes, values, and beliefs conveyed by a range of written and oral texts. The teacher-participants in this course improved their critical literacy skills by actively reading, critically writing about, and using evidence to support their conclusions about issues arising from advances in human genetics. A biologist, a linguist, and an educator collaboratively designed and taught the course. The personalized focus on the integration of thoughtful reading and writing in this class enhanced the teacher-participants' (n = 16) professional and intellectual development and will potentially improve learning in their biology and English classrooms in the future.

The Establishment of an Ethical Guideline for Genetic Testing Through Citizen Consensus via the Internet in Taiwan

BackgroundWith the rapid advance of genetics, the application of genetic testing has become increasingly popular. Test results have had a tremendous impact on individuals who receive the test and his or her family. The ethical, legal, and social implications (ELSI) of genetic testing cannot be overlooked. The Internet is a potential tool for public engagement.ObjectivesThis study aimed at establishing ethical guidelines for genetic testing in Taiwan through a participatory citizen consensus approach via the Internet.MethodsThe research method used was a citizen consensus conference modified by an Internet application and the Delphi technique. The citizen consensus conference is one of the public participation mechanisms. The draft ethical guidelines for genetic testing were written by an expert panel of 10. The Delphi technique was applied to a citizen panel recruited via the Internet until a consensus was reached. Our research population was restricted to people who had Internet access.ResultsIncluded in the citizen panel were 100 individuals. A total of 3 individuals dropped out of the process. The citizen panel was exposed to the issues through Internet learning and sharing. In all, 3 rounds of anonymous questionnaires were administered before a consensus was reached in terms of importance and feasibility. The result was ethical guidelines composed of 4 categories and 25 items. The 4 categories encompassed decision making (6 items), management of tissue samples (5 items), release of results (8 items), and information flow (6 items). On a scale of 1 to 10, the average (SD) importance score for the decision-making category was 9.41 (SD 0.58); for the management of tissue samples category, the average score was 9.62 (SD 0.49); for the release of results category, the average score was 9.34 (SD= 0.59); and for the information flow category, the average score was 9.6 (SD = 0.43). Exploratory analyses indicated that participants with higher education tended to attribute more importance to these guidelines.ConclusionsThe resulting recommended ethical guidelines had 4 categories and 25 items. We hope through the implementation of these guidelines that mutual trust can be established between health care profession and the general public with respect to genetic tests.

To ELSI or Not to ELSI Neuroscience: Lessons for Neuroethics from the Human Genome Project

The Ethical, Legal, and Social Implications (ELSI) program of the Human Genome Project stands as a model for how to organize bioethical inquiry for a rapidly changing field. Neuroscience has experienced significant growth in recent years and there is increasing interest in organizing critical reflection on this field, as evidenced by the creation of “neuroethics.” A nascent framework for reflection on the implications of neuroscience is emerging but significant work remains, given the pace and scope of neuroscientific developments. The adoption of an ELSI program, modeled on that of the ELSI program of the Human Genome Project, promises a way for neuroscience to meet important organizational, educational, and policy objectives. Review of recent criticisms of the HGP ELSI program suggests that an ELSI program for neuroscience would face certain obstacles. Those interested in a neuroscience ELSI program will need to develop appropriate resources to overcome these obstacles.

An Ethical, Legal, and Social Implications (ELSI) Program for Neuroscience: Heuristics and the Lay Public

An ethical, legal, and social implications (ELSI) program that follows the model of the Human Genome Project will not likely provide a coordinated program of research to address the implications of...

The Challenges of Governing Biotechnology in Korea

This paper explores the development of biotechnology governance and current challenges to its improvement in Korea. It aims to identify what element would be crucial to foster an effectively working system of biotechnology governance in Korea. The analysis is focused on two cases, the legislation of the Bioethics and Biosafety Act, and the development of ethical, legal, and social implications (ELSI) research. Our analysis finds that communication and consensus building between scientists and bioethics advocates in a broader sense is critical for improved governance. During the prolonged dispute over this legislation, the stakeholders advocating scientific advancements and those emphasizing the importance of ethics did not reach an agreement, which was reflected in the limitations of the act. The nascent ELSI research attempted to facilitate interdisciplinary communication and understanding between biotechnology scientists and those in humanities and social sciences, but was met with only limited success. Good governance of biotechnology requires scientists and other stakeholders to willingly comply with regulations and internalize certain norms. Based on our experience in ELSI research, a few suggestions are made to contribute to this end.

The Challenges of Governing Biotechnology in Korea

This paper explores the development of biotechnology governance and current challenges to its improvement in Korea. It aims to identify what element would be crucial to foster an effectively working system of biotechnology governance in Korea. The analysis is focused on two cases, the legislation of the Bioethics and Biosafety Act, and the development of ethical, legal, and social implications (ELSI) research. Our analysis finds that communication and consensus building between scientists and bioethics advocates in a broader sense is critical for improved governance. During the prolonged dispute over this legislation, the stakeholders advocating scientific advancements and those emphasizing the importance of ethics did not reach an agreement, which was reflected in the limitations of the act. The nascent ELSI research attempted to facilitate interdisciplinary communication and understanding between biotechnology scientists and those in humanities and social sciences, but was met with only limited success. Good governance of biotechnology requires scientists and other stakeholders to willingly comply with regulations and internalize certain norms. Based on our experience in ELSI research, a few suggestions are made to contribute to this end.

Effectiveness of an online curriculum for medical students on genetics, genetic testing and counseling

Background: It is increasingly important that physicians have a thorough understanding of the basic science of human genetics and the ethical, legal and social implications (ELSI) associated with genetic testing and counseling.Methods: The authors developed a series of web-based courses for medical students on these topics. The course modules are interactive, emphasize clinical case studies, and can easily be incorporated into existing medical school curricula.Results: Results of a ‘real world’ effectiveness trial indicate that the courses have a statistically significant effect on knowledge, attitude, intended behavior and self-efficacy related to genetic testing (p<0.001; N varies between 163 and 596 for each course).Conclusions: The results indicate that this curriculum is an effective tool for educating medical students on the ELSI associated with genetic testing and for promoting positive changes in students’ confidence, counseling attitudes and behaviors.

OUTLINING ETHICAL ISSUES IN NANOTECHNOLOGIES

Nanotechnologies are an expression of the human ability to control and manipulate matter on a very small scale. Their use will enable an even and constant monitoring of human organisms, in a new and perhaps less invasive way. Debates at all levels--national, European and international--have pointed out the common difficulty of giving a complete, clear definition of nanotechnologies. This is primarily due to the variety of their components, to the fact that there is not just one technology but several. The most significant medical applications of nanotechnologies are in the diagnostic and the therapeutic fields, eg biosensors and molecular imaging, providing diagnosis and drug delivery with no invasive methods involved. Like any other emerging field, such technologies imply new possibilities for improving health but, on the other hand, they are still at an experimental stage and therefore should be implemented under rigorous safety testing before going on general release. For this purpose, the ethical, legal and social implications (ELSI) of nanotechnologies have been elaborated by study groups, in order to develop solutions before the results of the tests are diffused into medical practice. The aim of this paper is to define some of the ethical issues concerning biomedical applications and to evaluate whether there is a need for new or additional guidelines and regulations.

Moral Agendas for Genomics: How to Find the Blind Spots?

In evaluating patterns of attention, the hard part is to identify blind spots. This essay focuses on the moral agenda for genomics, arguing that this agenda is framed differently through different metaphors on the relation between science and society. It is argued that moral agendas on genomics are dominated by the ELSI (Ethical, Legal and Social Implications) frame, that a global ethics framing deserves more prominence, and that the frames need one another for the identification of blind spots.

Introducing Social and Ethical Perspectives on Gene—Environment Research

Sociologists are increasingly involved with the design and execution of studies that examine the interplay between genes and environment, requiring expertise in measurement of both genetic and nongenetic factors. In addition, there are important lessons from a literature, heretofore directed primarily at medical geneticists and clinical researchers, that examines the ethical, legal, and social implications (ELSI) of the genomic revolution. This article introduces ELSI perspectives on the challenges that confront investigators who undertake gene—environment research and offers nine recommendations based on this literature. These challenges include assessing how genetic information is understood; minimizing potential risks of harm from participation in gene—environment research; and considering ethical aspects of variable selection, study design, dissemination of study findings, and whether to disclose genetic results to individual participants.

BEGIN Partnership: Using Problem-Based Learning To Teach Genetics &amp; Bioethics

A science education center at a university medical school had grant funding to develop a genetics curriculum unit but needed a dissemination plan. A statewide science teacher organization that provided professional development training was facing decreased funding. These two groups combined their efforts, and created a unique partnership, called BEGIN (Biotechnology, Ethics and Genetics Instructional Network) that has brought together university medical and science faculty and high school biology teachers. The main goal of this partnership is to provide high school biology teachers with new instructional tools to face the challenges of teaching genetics and bioethics in a manner that is content-rich, research and standards-based, and relevant to students' lives. This article describes the BEGIN partnership and summarizes the tiered approach used for designing, pilot-testing, and disseminating a new problem-based learning (PBL) curriculum module on the bioethics of DNA testing for Huntington's disease. The article also provides some preliminary data on the effectiveness of this approach in transforming teacher practice. BEGIN: A Unique Partnership Between University Faculty & Science Teachers BEGIN was launched in 2003 using grant funding from the National Institutes of Health's National Human Genome Research Institute (NHGRI). This collaborative partnership brings together faculty and staff of the Life Sciences Learning Center (a hands-on science education laboratory located at the University of Rochester School of Medicine and Dentistry) and science educators from the New York State Biology-Chemistry Professional Development Network. The goal of this project is to develop and disseminate PBL-based activities that introduce high school students to the ethical, legal, and social implications (ELSI) of genetic testing. BEGIN focuses on curriculum and professional development, working primarily with high school teachers who teach biology courses based on the New York State Living Environment core curriculum (NYSED). In order to increase the likelihood that teachers will adopt new curricula and instructional practices, BEGIN uses an ongoing, multi-year process of curriculum development and professional development with teachers from the New York State Biology-Chemistry Professional Development Network. The process introduces PBL and other instructional strategies that are based on current educational research on effective, best practices. The centerpiece of the BEGIN partnership is a five-part PBL curriculum module called Family Secrets (Markowitz et al., 2006). This module engages students in constructing knowledge about DNA testing, Huntington's disease, and the bioethics of genetic testing. Using PBL strategies, students access and interpret relevant scientific information and data, collaborate with other students, and develop ownership of their solution to a real-life problem. These skills are all key characteristics of science inquiry, and correlate with the inquiry skills found in the National Science Education Standards (NRC, 1996). Family Secrets is the result of a three-year process of curriculum development, statewide pilot-testing, dissemination, and feedback. Family Secrets was created by a Development Team of master teachers from the New York State BiologyChemistry Professional Development Network, and scientists, a pediatric geneticist, and a bioethicist from the University of Rochester. A group of ten biology Pilot Mentors from throughout New York State pilot-tested the initial version of Family Secrets in their classrooms, and provided year-long feedback to the Development Team. A revised version of Family Secrets was then introduced to 62 statewide Biology Mentors at a four-day summer institute at the University of Rochester Medical Center. Mentors field-tested the revised curriculum, and provided the Development Team with preliminary evaluation data to assess the impact of Family Secrets and the PBL process on classroom instruction and student learning. …

GINA, GENISM, AND CIVIL RIGHTS

Culminating its 13-year legislative gestation, The Genetic Information Nondiscrimination Act (GINA), was signed by President George W. Bush on May 21, 2008. GINA is the first major federal law to come out of the Ethical, Legal and Social Implications (ELSI) portion of the Human Genome Project. The passage of GINA has been widely celebrated. For the genetic research community, the act was sought to encourage people to become research subjects by providing them with some assurance that genetic research results would not be used against them by health insurance companies or employers. For Francis Collins, the project's leader, the long gestation period was a ‘silver lining’ in that it provided many opportunities ‘to educate policymakers about the potential of genomic medicine and the challenges that must be addressed if we are to realize that potential’.1