Public Health Public Health Genomics
by
W. David Dotson, Muin J. Khoury
  • LAST REVIEWED: 04 October 2016
  • LAST MODIFIED: 29 November 2011
  • DOI: 10.1093/obo/9780199756797-0013

Introduction

In the wake of the Human Genome Project’s completion in 2003, the pace of biological discovery and the rate of translation of molecular research findings along the path from “bench” research to clinical “bedside” application continue to accelerate. A plethora of health-related applications of genomic technology have arisen alongside basic research findings and are being adopted into the emerging field of personalized medicine. Public health genomics is a multidisciplinary field that seeks to translate genome-based discoveries into improved population health. It involves application of techniques of classical genetics, as well as more recent advances in molecular biology and biotechnology (including genomic, proteomic, epigenetic, and other methodologies), toward disease prevention and health promotion. Personalized medicine embodies hope, fueled largely by exciting findings in basic research, that genomic discoveries can be applied toward customizing and optimizing aspects of health care (e.g., therapeutics, diagnosis, and/or prediction of risk of particular diseases and informing disease prevention and health promotion strategies) for patients on an individual level. While sharing many similarities in subject matter with the field of personalized medicine, public health genomics differs markedly in taking a population health perspective. Moreover, the heightened expectations for personalized medicine that have emerged alongside growth in basic genomic research necessitate the development of a coordinated and balanced research agenda. This will help ensure responsible translation of applications of genomic technology from bench to bedside and allow evidence-based processes to be applied to the evaluation of genomic applications where necessary to determine their safest and most effective uses in clinical care. This need is all the more pressing, given that the field of genetic testing alone has grown rapidly to include tests for more than 2,000 conditions, according to the GeneTests website (see Journals, Serials, and Other Publications). While most of these may correspond to rare, single-gene disorders, tests for predicting risk of more common and complex diseases and individual physiological responses to specific drugs are also available. Increasingly, tests such as these have become available directly to consumers, opening up the possibility for people to be tested with no involvement of health care providers.

General Overviews

Genomics—and its implications in public health and clinical medicine—can be an extremely confusing topic that is often poorly understood even among clinicians. Mikail 2008 is a beginning-level textbook outlining many facets of public health genomics, while the slightly more advanced level text of Stewart, et al. 2007 covers the fundamentals, with emphasis on policy from a UK health care delivery perspective. A more advanced level text is Khoury, et al. 2000. Excellent descriptive overviews of the basics of genomic science appropriate for general clinician readership, including applications of genomic technology in health care, are provided in Feero, et al. 2010. This review is part of a series on genomic medicine in the New England Journal of Medicine. More expansive coverage of similar information, designed for readability among laypersons, can be found on the Genetics Home Reference website. The Human Genome Project, which revolutionized our thinking about genomics in many respects, was completed in 2003. Human Genome Project results have sometimes defied our expectations, for example, in showing that humans possess far fewer genes than were originally anticipated. Detailed information on the Human Genome Project is available through the National Human Genome Research Institute’s (NHGRI) All About the Human Genome Project website and the US Department of Energy’s Human Genome Project Information website. Ginsberg and Willard 2009 provides a relatively brief overview of the present state of genomic and personalized medicine, whereas the two-volume Willard and Ginsberg 2009a and Willard and Ginsberg 2009b covers the field in extraordinary depth. A perspective on personalized medicine that is highly accessible to a broad range of readers is available in Collins 2010.

  • All About the Human Genome Project (HGP). National Human Genome Research Institute, National Institutes of Health.

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    Fact sheets, general information, and educational tools covering aspects of the Human Genome Project are available through this website.

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    • Collins, Francis S. 2010. The language of life: DNA and the revolution in personalized medicine. New York: HarperCollins.

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      Written by the former director of NHGRI, now the director of the National Institutes of Health (NIH), this book provides a perspective on the promise of personalized medicine that is highly accessible to a broad range of readers.

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      • Feero, W. Gregory, Alan E. Guttmacher, and Francis S. Collins. 2010. Genomic medicine—An updated primer. New England Journal of Medicine 362:2001–2011.

        DOI: 10.1056/NEJMra0907175Save Citation »Export Citation »E-mail Citation »

        More than simply an update of Guttmacher and Collins’s 2002 article “Genomic Medicine: A Primer” (New England Journal of Medicine 347:1512–1520), this basic overview of genomics in medicine ventures into an expanded territory, touching on the regulation of gene expression, microarray technologies, the HapMap Project, genome-wide association studies (GWAS), and next-generation sequencing. As with its predecessor, a helpful glossary of terms is included.

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        • Genetics Home Reference.

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          Designed with consumer or lay readership in mind, this website offers numerous resources that are also informative and interesting to clinical and scientific audiences. Fact sheets on the genetics of hundreds of conditions are provided, along with a catalog of information on specific genes, an expansive glossary of terms, and a handbook that offers a virtual education in genetics and molecular biology.

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          • Ginsburg, Geoffrey S., and Huntington F. Willard. 2009. Genomic and personalized medicine: Foundations and applications. Translation Research 154:277–287.

            DOI: 10.1016/j.trsl.2009.09.005Save Citation »Export Citation »E-mail Citation »

            This thorough review addresses what genomic medicine and personalized medicine are, discusses family history and genomic information as tools for risk prediction and risk assessment, outlines categories of applications for genomic and personalized medicine (disease susceptibility, diagnostic/prognostic applications, pharmacogenomics, and monitoring) with examples, addresses future prospects for personal genome sequencing, and considers policy issues involved in bringing genomics into clinical practice. Available online by subscription.

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            • Human Genome Project Information. Genome Science Program, US Department of Energy Office of Science.

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              This authoritative website contains information on the history, goals, and results of the Human Genome Project. Additionally, links to a wide variety of resources, including key publications from the project; sequence databases; a Gene Gateway Workbook to guide users through freely accessible genomics web tools such as GeneReviews; and information on ethical, legal, and social issues associated with genomics are included.

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              • Khoury, Muin J., Wylie Burke, and Elizabeth J. Thomson, eds. 2000. Genetics and public health in the 21st century: Using genetic information to improve health and prevent disease. Oxford Monographs on Medical Genetics 40. New York: Oxford Univ. Press.

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                An intermediate- to advanced-level text on public health genomics, this book offers an overview of genetics in the field of public health and then covers public health assessment; the evaluation of genetic tests; interventions on a population level; education; and health communication along with ethical, legal, and social questions surrounding genomics in public health.

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                • Mikail, Claudia N. 2008. Public health genomics: The essentials. San Francisco: Jossey-Bass.

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                  An introductory overview of public health genomics, this text offers an extensive breadth of coverage. The role of government in genomics is presented from a US perspective, and background on basic genetic science is presented before delving into health-related applications of genomics. Overall, it would be difficult, if not impossible, to find more basic information on public health genomics in a single source than is presented in this introduction.

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                  • Stewart, Alison, Philippa Brice, Hilary Burton, Paul Pharoah, Simon Sanderson, and Rod Zimmern. 2007. Genetics, health care and public policy: An introduction to public health genetics. Cambridge, UK: Cambridge Univ. Press.

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                    This is another fine introductory textbook covering all the fundamentals of public health genomics while giving unique and helpful emphasis on policy from a UK perspective.

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                    • Willard, Huntington F., and Geoffrey S. Ginsburg, eds. 2009a. Genomic and personalized medicine. Vol. 1. Boston: Elsevier/Academic Press.

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                      Volume 1 of a two-volume set that is practically exhaustive in covering the present state of personalized and genomic medicine. Beginning with basic human genomics, this volume goes on to cover genomic technology platforms and informatic issues in genomics before introducing translation of genome-based technologies into clinical practice. Five chapters are devoted to public health genomics.

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                      • Willard, Huntington F., and Geoffrey S. Ginsburg, eds. 2009b. Genomic and personalized medicine. Vol. 2. Amsterdam and Boston: Elsevier/Academic Press.

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                        Volume 2 of the nearly exhaustive two-volume set on the state of personalized and genomic medicine. This volume is devoted to clinical applications of genomic technology, with several chapters under each of the following headings: Cardiovascular Disease, Cancer, Inflammatory Disease, Metabolic Disorders, Neuropsychiatric Disorders, and Infectious Disease.

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                        Journals, Serials, and Other Publications

                        It is often quite difficult for those new to public health genomics to identify specialty journals, serials, and other publications that cater to this emerging field. Those entering the field may find the following publications extremely useful for their concentration of relevant content: Public Health Genomics, Genetics in Medicine, BMC Medical Genomics, Human Genomics, American Journal of Human Genetics, Human Genetics, Genetic Epidemiology, Annual Reviews, PLoS Currents: Evidence on Genomic Tests, and the GeneReviews at GeneTests.

                        Genetic Epidemiology

                        Understanding genetic epidemiology requires, first and foremost, a basic grasp of the relation between genes and clinical disorders. Wright and Hastie 2007 provides an overview of genetics and many common diseases, while Genes and Disease covers both common and rare disorders. References containing more detailed information on how genetic epidemiology is done can be found in the sections on Methods and Studies and International Collaborations.

                        • Genes and Disease. National Center for Biotechnology Information.

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                          Genes and Disease is a freely available online collection containing descriptions of genes and associated diseases. Although information on some common diseases is included, there is broader coverage of rare, single-gene disorders.

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                          • Wright, Alan, and Nicholas Hastie, eds. 2007. Genes and common diseases: Genetics in modern medicine. Cambridge, UK: Cambridge Univ. Press.

                            DOI: 10.1017/CBO9780511543555Save Citation »Export Citation »E-mail Citation »

                            This textbook provides a background on basic and population genetics before giving way to chapters on what is known about the genetic influences on numerous common, complex diseases. Written at an intermediate level, the information should be highly accessible to those with knowledge equivalent to what might be obtained through a university-level introduction to genetics course.

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                            Methods and Studies

                            The principles of human genome epidemiology, along with its astounding breadth, can be appreciated in Khoury, et al. 2010, whereas Reid-Lombardo and Peterson 2010 provides a brief but useful presentation of the fundamentals of association studies in genetic epidemiology geared toward a more general readership. Kere 2010 details the evolution of methodologies that have led to our present ability to investigate multifactorial diseases through genome-wide association studies (GWAS) and other approaches. A decade following release of the draft sequence of the human genome, results from GWAS continue to be useful in identifying scores of single nucleotide polymorphisms (SNPs) associated with an impressive assortment of common and rare disorders. A review of the technologies and strategies involved in GWAS, along with challenges associated with these studies, can be found in Manolio 2010. Thomas 2010 reviews basic approaches for assessing gene-environment interactions in GWAS and pathway-based study designs, while Kraft and Hunter 2005 makes a case for the benefits of planned collaborations toward increased sample sizes for increasing power and minimizing false positives.

                            • Kere, Juha. 2010. Genetics of complex disorders. In Special issue: Recent progress in molecular sciences: Reviews from Karolinska Institutet at its 200-year anniversary. Edited by Sten Orrenius and Hans Jörnvall. Biochemical and Biophysical Research Communications 396:143–146.

                              DOI: 10.1016/j.bbrc.2010.04.013Save Citation »Export Citation »E-mail Citation »

                              Citations for key publications describing relevant analytic techniques from DNA blotting and restriction fragment length polymorphism (RFLP) analysis all the way through haplotype mapping and GWAS are presented chronologically. Strategies covered include candidate gene studies, chromosomal markers, linkage studies, positional cloning, the HapMap Project, and GWAS. Continuing reductions in the cost of whole genome sequencing and implications for personal genome sequencing are also considered. Available online for purchase or by subscription.

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                              • Khoury, Muin J., Sara R. Bedrosian, Marta Gwinn, Julian P. T. Higgins, Julian Little, and John P. A. Ioannidis, eds. 2010. Human genome epidemiology: Building the evidence for using genetic information to improve health and prevent disease. 2d ed. New York: Oxford Univ. Press.

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                                The second edition of Human Genome Epidemiology provides a broad overview of genetic epidemiology and its foundational role in public health genomics. Fundamental aspects of genetic epidemiology are presented, along with data collection, analytic methods, and numerous case studies. Although this is an advanced text, most chapters should be easily understood by those with limited exposure to genetics or statistical methods.

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                                • Kraft, Peter, and David Hunter. 2005. Integrating epidemiology and genetic association: The challenge of gene–environment interaction. Philosophical Transactions of the Royal Society London, Series B: Biological Sciences 360.1460: 1609–1616.

                                  DOI: 10.1098/rstb.2005.1692Save Citation »Export Citation »E-mail Citation »

                                  This article presents methods for the study of gene–environment interactions, including study designs and analytical considerations. The authors make a case for collaborative efforts to increase sample size and power to detect effects of interactions.

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                                  • Manolio, Teri A. 2010. Genomewide association studies and assessment of the risk of disease. New England Journal of Medicine 363:166–176.

                                    DOI: 10.1056/NEJMra0905980Save Citation »Export Citation »E-mail Citation »

                                    This review article briefly describes GWAS and how they are carried out. The question of how GWAS can be used in risk prediction, and thus in clinical practice, is considered. Attention is also given to meta-analysis of GWAS, area under the receiver-operator-characteristic curve, and risk reclassification.

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                                    • Reid-Lombardo, Kay M., and Gloria M. Petersen. 2010. Understanding genetic epidemiologic association studies, Part 1: Fundamentals. Surgery 147:469–474.

                                      DOI: 10.1016/j.surg.2009.10.026Save Citation »Export Citation »E-mail Citation »

                                      This brief review defines genetic epidemiology and goes on to describe genetic variation, GWAS, and candidate gene association studies. Although written with a clinical audience in mind, the clear and concise descriptions make this article equally informative for lay readers as well. Available online for purchase or by subscription.

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                                      • Thomas, Duncan. 2010. Methods for investigating gene–environment interactions in candidate pathway and genome-wide association studies. Annual Review of Public Health 31:21–36.

                                        DOI: 10.1146/annurev.publhealth.012809.103619Save Citation »Export Citation »E-mail Citation »

                                        A review of methods for studying gene–environment interactions with an emphasis on recent developments. Study designs and some statistical/analytical considerations are covered. Available online for purchase or by subscription.

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                                        International Collaborations

                                        Large international projects such as HapMap, yielding a haplotype map of the human genome, and the 1000 Genomes Project have emerged in the wake of the Human Genome Project, impacting the course of genomic research far beyond expectation. Descriptions of these projects can be found on the International HapMap Project website; in Manolio, et al. 2008; from International HapMap Consortium 2005; and on the 1000 Genomes Project website. Putting diverse results together from projects such as these into a context that can be used to evaluate the potential benefits and harm that could ensue from their application in population health falls under the rubric of genetic epidemiology. Little, et al. 2009 assembles the STREGA recommendations to facilitate these efforts through increased transparency in reporting of association study results. A collection of tools useful in the practice of genetic epidemiology can be found on the HuGE Navigator website.

                                        Applications of Genomic Technologies

                                        Genomic technologies and genetic tests can be applied in many clinical contexts involving diagnosis, prognosis, risk prediction through family history, pharmacogenomics, disease susceptibility, and monitoring, all of which are outlined in Ginsburg and Willard 2009. Additional information on the wide array of available pharmacogenomic applications can be found on the PharmGKB website, while the Genetic Alliance website provides examples and links to family health history applications. Perhaps the most well-known and successful application of genetic technology in population health is newborn screening, which is reviewed in Hiraki and Green 2010. Examples of applications of all types can be found on the GeneTests website and on GAPPKB. An emerging resource that holds tremendous promise in the field is the NIH Genetic Testing Registry, which is currently in development. More information is provided in the Information on Evidence-Based Evaluation of Genetic Tests and Additional Applications and Issues Surrounding Genomic Technologies in Health Care sections.

                                        • GeneTests.

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                                          GeneTests is an expansive online repository of information on medical genetics that includes laboratory and clinic directories for specific genetic tests as well as educational materials. Also contained within GeneTests is GeneReviews, which is a collection of peer-reviewed articles covering specific genetic tests. The entire website is very well organized and both easily usable and understandable by practically any audience.

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                                          • Genetic Alliance: Family Health History Programs.

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                                            The Genetic Alliance is a nonprofit health advocacy organization focused on health-related aspects of genetics and genomics. The family health history page briefly describes the use of family history as a tool in health care and provides links to relevant projects and events. The link to family health resources is especially interesting. Content is easily understandable for both experts and novices in genomics.

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                                            • Genomic Applications in Practice and Prevention Network Knowledge Base (GAPPKB).

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                                              GAPPKB is a resource designed for use by researchers, public health professionals, policy makers, and health care providers. GAPPKB includes a GAPPFinder tool that allows users to access a curated database of new and emerging genetic tests.

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                                              • Ginsburg, Geoffrey S., and Huntington F. Willard. 2009. Genomic and personalized medicine: Foundations and applications. In Special Issue on Personalized Medicine. Edited by Jeffrey Laurence. Translation Research 154:277–287.

                                                DOI: 10.1016/j.trsl.2009.09.005Save Citation »Export Citation »E-mail Citation »

                                                This review discusses family history and genomic information as tools for risk prediction and risk assessment and outlines categories of applications for genomic and personalized medicine (disease susceptibility, diagnostic/prognostic applications, pharmacogenomics, and monitoring) with examples. Available online for purchase or by subscription.

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                                                • Hiraki, Susan, and Nancy S. Green. 2010. Newborn screening for treatable genetic conditions: Past, present and future. Obstetric and Gynecologic Clinics of North America 37:11–21.

                                                  DOI: 10.1016/j.ogc.2010.01.002Save Citation »Export Citation »E-mail Citation »

                                                  This review highlights the past and present state of newborn screening as a public health mandate. Although this article may be designed for specialists in obstetrics and gynecology, it is certainly accessible to general clinicians and probably easily understandable by most lay readers as well. Available online for purchase or by subscription.

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                                                  • Introduction to the Genetic Testing Registry.

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                                                    This website gives information on the timeline for development of NIH’s Genetic Testing Registry (GTR), which is expected to be available for use by the public sometime in 2011. Especially useful links on this page include background reading and FAQs, among others. The GTR is an extremely important and much needed tool, and researchers in particular will want to follow events related to its development.

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                                                    • Pharmacogenomics Knowledge Base (PharmGKB).

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                                                      PharmGKB is a curated database containing information on the effects of human genetic variants on drug response. The database is searchable for names of genes, variants, drugs, and metabolic pathways and contains a variety of external links to information pertinent to pharmacogenomics. Although some of the contents of the database may be confusing to novices in the field, exploring this resource can be an almost addictive way to learn more about pharmacogenomics.

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                                                      Evidence-Based Evaluation of Genetic Tests

                                                      Evidence-based assessment of genetic tests, as applied in specific clinical scenarios, is a relatively new but much needed endeavor. The Centers for Disease Control and Prevention (CDC) funded the ACCE (analytic validity, clinical validity, clinical utility, and ethical, legal, and social issues) model project in 2000, described on the CDC Public Health Genomics: Genetic Testing website, which led to the development of a framework systematic review of genetic tests based on analytic validity, clinical validity, and clinical utility, with ethical legal and social considerations incorporated in each step of the process. The ACCE model has been utilized by other groups and has formed the basis of modified frameworks, as in Burke and Zimmern 2007. The US Preventive Services Task Force (USPSTF) commissioned evidence reviews and subsequently released evidence-based recommendation statements on BRCA mutation testing and screening for hemochromatosis (US Preventive Services Task Force 2005, US Preventive Services Task Force 2006. The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group developed methods described in Teutsch, et al. 2009 based on the ACCE framework, along with methods of the USPSTF and other groups involved in evidence-based technology assessments. The EGAPP website contains links to six recommendation statements developed by the EGAPP Working group, utilizing these methods. While the EGAPP Working Group focuses primarily on common, complex diseases, the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) has developed similar methods, described in Calonge, et al. 2010, for evaluations that mainly involve newborn screening for rare, single-gene disorders. In addition to these groups, the American College of Medical Genetics develops evidence-based recommendations on genetic tests that are freely available through its website. The Cochrane Cystic Fibrosis and Genetic Disorders Group website provides information on this international collaborative review group dedicated to evidence-based assessment in genetics. The Agency for Healthcare Research and Quality’s National Guideline Clearinghouse website contains guidelines from around the world covering all aspects of health care; however, at present, few are relevant to genomics. The GeneTests website contains a graphic illustrating just how quickly the field of clinically available genetic tests has been expanding; in light of this, many more systematic reviews and evidence-based guidelines will be needed to even approach the ideal of informed translation of these technologies from bench to bedside.

                                                      Additional Applications and Issues Surrounding Genomic Technologies in Health Care

                                                      While in many respects genetic tests can be considered similar to traditional diagnostic and laboratory tests, additional factors can complicate the evidence-based assessment of the utility of genomic applications. Although family history is a genetic test, it differs in some respects from the laboratory-based testing considered in the previous section. Valdez, et al. 2010 reviews family history in public health practice and discusses application of the ACCE framework to the evaluation of family history. Direct-to-consumer (DTC) marketing of genetic tests is an issue that requires consideration in evidence-based evaluations. US Government Accountability Office 2010 highlights many issues of concern surrounding the current landscape of DTC genetic testing. McBride, et al. 2008 describes the challenges of evaluating the clinical impact of genetic testing in the face of DTC marketing and outlines the Multiplex Initiative, which investigates behavioral characteristics of those who choose to undergo genetic susceptibility testing, along with their responses to the results. In addition to tests for estimating susceptibility to common diseases, “nutrigenomic” tests are often marketed DTC. US Government Accountability Office 2006 investigates how misleading the results of some of these tests can be to consumers. Simopoulos 2010 reviews the field of nutrigenomics with a focus on future prospects and directions. Additional considerations are typically needed to address bioethical dimensions of the application of genomic technologies on population levels. The NHGRI Issues in Genetics website offers links to a wide spectrum of areas of bioethical concern, including genetic discrimination, intellectual property rights, and informed consent, among others. Although the United States has passed the Genetic Information Nondiscrimination Act of 2008 (GINA), as discussed in McGuire and Majumder 2009, its coverage is not without limitations.

                                                      Bringing Evidence to Practice

                                                      The development of a coordinated and balanced research agenda that facilitates evidence-based evaluation is needed to ensure responsible translation of applications of genomic technology from bench to bedside. Informal networks may prove to be key catalysts in the development and coordination of such an agenda. Khoury, et al. 2007 describes four phases of translation research in genomics, leading from discovery to population health impact, which differs somewhat from the more generalized model outlined in Westfall, et al. 2007 and utilized by the National Institutes of Health (NIH). An international collaboration to promote effective translation through these four phases (GAPPNet) has recently been launched. Khoury, et al. 2009 describes the GAPPNet framework as composed of four pillars: (1) knowledge synthesis and dissemination, (2) evidence-based recommendations, (3) translation research, and (4) translation programs. The Genome-Based Research and Population Health International Network (GRaPH-Int) website, as well as Burke, et al. 2006, describe an international collaboration with goals similar to those of GAPPNet but with more specific emphasis placed on promoting education and informing policy. Resources devoted to education and training in genomics can be found on the National Coalition for Health Professional Education in Genetics(NCHPEG) website. Stewart, et al. 2007 is a recent textbook that covers the fundamentals of public health genomics while remaining grounded in policy from a UK health care delivery perspective. The role of policy and regulation in public health genomics is exemplified through content on the websites of the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) and Genetics and Public Policy Center (from a US perspective) and the PHG Foundation and World Health Organization’s Human Genetics Programme (from an international perspective).

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