Genetics and Public Policy Center Collection

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    Regulatory approaches to reproductive testing
    (Genetics and Public Policy Center, 2004-09-23) Knoppers, Bartha M.; Isasi, Rosario M.
    This report analyses the ethical and legal aspects of reproductive genetic testing in 11 countries (Australia, Austria, Canada, France, Germany, India, Israel, Japan, The Netherlands, Switzerland and the UK). The legal status of reproductive genetic testing in the countries under analysis is difficult to generalize due to the different regulatory systems adopted. These approaches are a reflection of the legal traditions and cultural and socio-religious beliefs which inform and shape public policy on assisted reproductive technologies and genetic testing. We divide approaches into two groups: public ordering (legislative, top-down approach) and private ordering (non-legislative, bottom-up approach). Even limiting our analysis to a number of countries that span the range from restrictive to pragmatic approaches, there is remarkable symmetry in both the (i) substantive requirements (i.e. gravity, health indications generally) and (ii) procedural safeguards (i.e. informed consent, counselling, confidentiality, civil status, oversight and accreditation) surrounding reproductive genetic testing. Indeed, irrespective of whether a country adopts a prohibitive or a permissive approach through legislation or self-regulation or a mix of both, the ultimate decision is--and should continue to be--a medical one. Nowhere is this more evident than in the substantive requirements.
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    Reproductive genetics: Conceiving new wrongs?
    (Genetics and Public Policy Center, 2005) Crockin, S. L.
    Genetic testing ought to make it easier for couples to make informed reproductive choices. But when mistakes occur, or communication falters, lawsuits soon follow.
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    Reproduction, genetics and the law
    (Genetics and Public Policy Center, 2005-06) Crockin, S. L.
    Both reproductive medicine and genetics are seeing rapid, and in some instances, revolutionary medical and scientific advances. Courts have been called upon to resolve a variety of novel disputes arising from these areas, and more can be anticipated as these technologies continue to develop and their use becomes more widespread. This article discusses some of the most relevant areas of the law and litigation that currently bear on reproduction and genetics or that may be anticipated to do so in the future. Specific developments and judicial decisions addressing them include: legal theories of wrongful birth and wrongful life and their application to children born with genetic impairments; a physician’s duty to warn family members about a relative’s genetic disease; disputes over reproductive materials and non-reproductive cells and tissues; unauthorized genetic testing in the workplace; and genetic discrimination. It is hoped that this discussion will be of value to medical and legal professionals and policy makers who work with these concepts in the increasingly inter-related fields of law and medicine.
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    Regulating reproductive genetics: A review of American bioethics commissions and comparison to the British Human Fertilization and Embryology Authority
    (Genetics and Public Policy Center, 2005-08-25) Riley, M. F.; Merrill, R.
    Many people are now advocating expanded government regulation of research and clinical use of reproductive technologies. Although many of these technologies have been in use or anticipated for more than twenty-five years, and a number of bioethics commissions have considered regulation of them, efforts to develop broad national regulation have largely failed. This article examines the role that government institutions can play and have played in designing regulation of assisted reproduction and reproductive technologies. We review the history of national commissions as proponents and architects of regulation and explore how their structure, mission, and political placement have influenced their success or failure. We then compare the experience of the United States to that of Great Britain which established the Human Fertilization and Embryology Authority (HFEA) in 1990 and consider whether the HFEA might be a model for future regulation in the United States. We conclude that bioethics commissions can play an important role in formulating policy but they cannot create necessary political consensus if that consensus is lacking. Moreover, while the United States can glean important lessons from the British experience, the two countries' political, legal, and medical cultures differ in ways that suggest importation of the British model would be difficult and perhaps unwise.
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    Center director Kathy Hudson testifies before the President's Council on Bioethics
    (Genetics and Public Policy Center, 2004-06-12) Hudson, K
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    Statement of Kathy Hudson, Ph.D Re: New Research on Derivation of Embryonic Stem Cells
    (Genetics and Public Policy Center, 2005-09-16) Hudson, K
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    At-Home DNA Tests: Marketing Scam or Medical Breakthrough
    (Genetics and Public Policy Center, 2006-07-27) Hudson, K
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    Embryo Biopsy for Stem Cells: Trading Old Problems for New
    (Genetics and Public Policy Center, 2006) Hudson, K
    Embryo biopsy for stem cells: trading old problems for new.
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    Genetic tests are testing the law
    (Genetics and Public Policy Center, 2006) Crockin, SL; Javitt, G; Baruch, S.; Bloom, E. M.
    Genetic testing technology has brought new hope—and reproductive options—to would-be parents. But when a testing error occurs or the results are misread or miscommunicated, children may be born with severe, lifelong disabilities. Attorneys can help families of disabled children get the compensation they need to secure their future.
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    Public Awareness and Attitudes about Reproductive Genetic Technology
    (Genetics and Public Policy Center, 2002) Hudson, K; Scott, J.; Kalfoglou, A
    Americans are both hopeful and fearful about the rapidly advancing power of scientists to manipulate human reproduction, according to a new survey released today by the Genetics and Public Policy Center, a Johns Hopkins effort funded by The Pew Charitable Trusts. The survey explored the knowledge and attitudes of 1,211 respondents about reproductive cloning, genetic testing, and genetic modification and preferences about government regulation. "These technologies give us the power to manipulate the most personal and profound of human activities -beginning a new human life," said Kathy Hudson, Ph.D., director of the Center. Highlights of the survey: * Most Americans oppose (76 percent) scientists working on ways to clone humans. Of those who support human cloning research, men outnumber women by more than two to one (26 percent; 11 percent). * Twenty-two percent of respondents believe a human has already been cloned, with young men most likely to believe it (31 percent). * The public draws clear distinctions between health and non-health related applications of these technologies. Two thirds of respondents approve of using reproductive genetic testing to help parents have a baby free of a serious genetic disease. An even larger number, over 70 percent, disapprove of trying to use these technologies to identify or select traits such as strength or intelligence. * Overall, men were twice as likely as women to be highly supportive of reproductive genetic technologies (25 percent; 12 percent). * Most respondents think the government should regulate the quality and safety of reproductive genetic technologies and limit human reproductive cloning. Notably, the majority of Republicans, Democrats and Independents support government regulation of these technologies. * Fifty-four percent think about these technologies primarily in terms of health and safety while 33 percent view them in religious or moral terms. Of the variables explored in the survey, this viewpoint is most strongly correlated with approval or disapproval of reproductive genetic technologies. Those who view these technologies in terms of religion and morality are more likely to disapprove of reproductive genetic technologies * The biggest fears are that using these technologies is too much like "playing God," (34 percent) or that they can be easily used for the wrong purposes (35 percent). The greatest benefits are being able "to wipe out certain genetic diseases forever" (41 percent) and improving parent's chances their baby will be healthy (27 percent). * The public's knowledge about these technologies is not keeping pace with the steep growth in genetic science. Only 18 percent of respondents were able to correctly answer 6 or more of the 8 knowledge questions. "As decision-makers struggle with how to guide the development and use of these powerful technologies, the options they consider must reflect society's values and priorities," said Hudson, who is former assistant director of the Human Genome Project of the National Institutes of Health. According to Hudson, the Center will not advocate for particular policies, but rather will provide objective, credible policy analysis and information to a wide range of professional and lay audiences. The Center is already exploring the survey findings in greater detail and reaching out to scientists, religious leaders, health professionals, and patients.
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    Preimplantation Genetic Diagnosis: A Discussion of Challenges, Concerns, and Preliminary Policy Options Related to the Genetic Testing of Human Embryos
    (Genetics and Public Policy Center, 2004) Baruch, S.; Javitt, G; Scott, J; Hudson, K
    A report by the Genetics and Public Policy Center at Johns Hopkins University outlines policy options to address the scientific and ethical challenges raised by genetic testing of human embryos. The report will be released at a public forum, "Custom Kids?" Genetic Testing of Embryos, to be held on January 8 in Washington, DC. At the forum, an independent panel including former House Speaker Newt Gingrich, Former Clinton White House Chief of Staff John Podesta and former National Institutes of Health Director Bernadine Healy will discuss the issues raised by genetic testing of embryos. "New biomedical technologies have a tendency to sneak up on us", said Kathy Hudson, Director of the Genetics and Public Policy Center. "This report and the Policy Forum are tools to catalyze broad public discussion about this profound use of genetic testing and aid decision makers as they consider what policies can best keep pace with the rapid advances in reproductive genetics" she said. The confluence of advances in human genetics and reproductive science has resulted in the ability to perform genetic tests on embryos produced by in vitro fertilization. This type of testing, known as preimplantation genetic diagnosis, involves the removal of one or two cells from the fertilized egg or embryo and analysis of the genetic material. Test results are then used to select the embryos to transfer to a woman's womb to initiate a pregnancy. Preimplantation genetic diagnosis (PGD) is used currently by families seeking to have a child free from a specific inherited genetic disease or, less often, to have a child with specific genetic characteristics. By testing embryos before a pregnancy has begun, PGD can reduce the need to terminate a pregnancy in which a fetus is found to have a genetic mutation. PGD has been used to test for dozens of inherited diseases, to select embryos that will be a matched tissue donor for an ailing sibling and to select embryos based on sex. PGD raises a number of scientific, ethical and policy issues. First, there are questions about the safety of the in vitro fertilization and embryo manipulation required for PGD and about the accuracy of the genetic tests that are used. Second, some find PGD, or its uses, morally unacceptable because it involves the creation, selection and destruction of human embryos. Third, there are questions of equity: many cannot afford PGD and it is not clear whether and to what extent health insurers will cover it. Finally, there are broad ethical questions about the impact of PGD on family relationships, people living with disabilities, and society as a whole. The Center's report, Preimplantation Genetic Diagnosis: A Discussion of Challenges, Concerns, and Preliminary Policy Options Related to the Genetic Testing of Human Embryos, details the concerns in each of these areas and presents an array of possible policy options. These options include leaving decisions about PGD to individuals and their health care providers, government restrictions on PGD's use and availability, voluntary regulation by professional groups, and an outright ban on PGD. PGD sits at the intersection of two technologies with a confusing regulatory status: assisted reproduction and genetic testing. In the United States oversight of assisted reproductive technologies (ART) has been left primarily in the hands of the individual physicians and there is no uniform and comprehensive system to assure the accuracy and reliability of new genetic tests before they are offered in the clinic. Although there have been calls for heightened oversight of PGD, this report is the first to outline the full range of policy alternatives and consider the potential effects, good and bad, of distinctly different choices. The report is designed to catalyze informed public discussion about PGD, its implications and what, if any, policy process should be put in place to guide the development and use of this potent technology. Over the coming months, the Center will organize meetings across the country to discuss PGD and actively seek out the informed attitudes and policy preferences of a representative sample of Americans. The Center will also convene meetings of stakeholders and experts in order to gain their feedback and input. The Center will then use input from all these sources to refine our PGD policy options and issue a complete set of options and public opinion data for consideration by policy makers. The Center does not advocate for or against preimplantation genetic diagnosis or a particular policy approach. Instead, the Center is committed to providing objective information and analysis and encouraging an informed dialogue among a diverse array of interests. The goal is to ensure that policy decisions, even decisions to maintain the status quo, have been undertaken with a clear-eyed understanding of their potential impact. In developing the options, the Center was aided by its Reproductive Genetics Advisory Committee.
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    Reproductive Genetic Testing: Issues and Options for Policymakers
    (Genetics and Public Policy Center, 2005) Baruch, S.; Javitt, G; Scott, J.; Hudson, K
    Reproductive genetic testing offers prospective parents information about their risk of having a child with a genetic disease or characteristic. This information can be used to help prospective parents make reproductive decisions both before and during a pregnancy. Before pregnancy, prospective parents who know they have a risk of bearing a child with a genetic disease may choose to avoid pregnancy; use donated eggs, sperm or embryos; adopt, use in vitro fertilization followed by preimplantation genetic diagnosis to select those embryos free of a particular genetic mutation or pursue pregnancy better informed and prepared for the possibility of bearing an affected child. After pregnancy has begun, genetic testing can provide reassurance if tests are negative. Positive prenatal genetic test results can give parents time to prepare for the birth of a child with a particular disorder, or be used as the basis for a decision to terminate the pregnancy. Reproductive genetic testing raises a variety of concerns. Some care most that the tests are accurate and reliable. Yet, unlike drugs and medical devices, genetic tests - including those to test embryos and fetuses - are not required to meet standards of accuracy and reliability before they are marketed. Some agencies within the federal government regulate certain limited aspects of genetic testing, but there are gaps in the regulatory process. A genetic test can only identify the presence of a particular mutation or characteristics. It cannot ascribe social significance to that finding. Some worry about the potential uses of genetic tests. For example, they fear a world in which parents choose their child's height, eye color, intelligence level or other non-health-related trait. While these possibilities are all hypothetical, it is currently possible to choose the sex of one's child, and some believe this use of testing is inappropriate. Some also fear that as testing becomes increasingly available, people will face increased pressure to test, both to have the "very best baby" possible and to avoid the birth of an "unhealthy" child. Some people feel there should be limits on reproductive genetic testing. But what should those limits be? Who should set them? These questions raise ethical, social and legal issues that cannot be resolved by science and technology alone. Finally, concerns have been raised that access to genetic tests is not equitable, and that tests are not being delivered at the right time and with the appropriate context and counseling. To help inform public discussion and facilitate policymaking around these issues, the Genetics and Public Policy Center - funded by The Pew Charitable Trusts - has produced a report, Reproductive Genetic Testing: Issues and Options for Policymakers. This report presents a range of policy options that address genetic testing; it is supported by expert analysis that considers the potential effects, positive and negative, of a variety of different policy directions. The report develops policy options around four key areas of concern: (1) use of tests, (2) safety and accuracy, (3) access and (4) delivery. The options present a range of possible roles that federal and state governments and private entities could play in overseeing the development and use of these technologies, and describe the strengths and weaknesses of each approach. The options were developed by the Center through expert analysis and consultation with a variety of experts representing a wide range of political and religious viewpoints; the options were also informed by the results of the Center's extensive public opinion research. A companion report, Reproductive Genetic Testing: What America Thinks, reveals opinions about how regulation should be implemented and who should control regulation, ranging from no regulation at all to government regulation of both the safety and ethics surrounding the use of these tests.
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    Reproductive Genetic Testing: What America Thinks
    (Genetics and Public Policy Center, 2004) Kalfoglou, A; Suthers, K.; Scott, J.; Hudson, K
    Advances in reproductive genetic technologies offer prospective parents an increasing array of options to help them have healthy babies, but these same advances also can raise troubling questions about the extent to which parents can or should choose the characteristics of their children. Parents today can be tested to see if they carry a mutation in a gene that puts them at risk to have a child with a serious genetic disorder. Parents who are at risk can test embryos created through in vitro fertilization (IVF) and select which embryos to transfer to the mother's womb, or test a fetus during pregnancy to see if it is affected. Today we test for serious genetic disorders. In the future, as we learn more about genes, it may be possible to test for less serious disorders, or even characteristics such as behavior and intelligence. This report presents the first look at the largest ever series of social science research studies to learn what Americans know, think and feel about the use and regulation of reproductive genetic testing - carrier testing, prenatal genetic diagnosis and preimplantation genetic diagnosis (PGD). These studies, funded by The Pew Charitable Trusts and conducted by the Genetics and Public Policy Center between October 2002 and August 2004, include 21 focus groups, 62 in-depth interviews, two surveys with a combined sample size of over 6000 people, and both in-person and online Genetic Town Halls. The focus group and interview responses provide a detailed and textured portrait of peoples' attitudes. Participants were asked a series of questions about: awareness and knowledge of reproductive genetic tests; whether they approve or disapprove of using these technologies for purposes ranging from diagnosing a baby with a fatal childhood disease to knowing a baby's sex; thoughts and concerns about the future use of these technologies, including the potential for discrimination, the potential for treating children like products and who will have access to these technologies; and how they would like to see reproductive genetic tests regulated. Survey participants were asked a series of similar questions about their beliefs concerning the appropriate uses of these technologies and whether and how they might be regulated. They were also asked a series of questions about themselves - sex, age, race and ethnicity, religious affiliation, income level, education level, political affiliation - determine whether any significant patterns or trends in attitudes align with any particular demographic groups. Americans' awareness of genetic technologies varies; 90 percent have heard about IVF but only 40 percent have heard about PGD - screening of IVF embryos for genetic diseases or characteristics in order to select which embryos to transfer into the woman's womb. In general, Americans approve of using reproductive genetic tests to prevent fatal childhood disease, but do not approve of using the same tests to identify or select for traits like intelligence or strength. Using reproductive genetic tests to identify increased risks for adult-onset diseases generates mixed approval levels. Survey participants were asked to rank the moral worth of embryos and fetuses. Forty-seven percent of Americans assigned an embryo in the womb maximal moral worth (on a five-point scale), while only 19 percent assigned maximal moral worth to a human embryo frozen in an IVF clinic. The definition of "moral worth" was left to the survey participant. More than 53 percent of all respondents strongly agree with the statement "reproductive genetic technology is potentially the next step in human evolution." In general, Americans would like to see more oversight in the area of reproductive genetic testing. Opinions about how regulation should be implemented and who should control regulation, however, range from no government regulation at all to government regulation of both safety of and ethics surrounding the use of these tests. A companion report, Reproductive Genetic Testing: Issues and Options for Policymakers, presents an update on the science behind reproductive genetic testing, outlines key scientific and medical facts, provides a description of the current policy landscape, assesses current oversight for the development and use of reproductive genetic tests and offers a comprehensive description of possible policy options to guide the development and use of reproductive genetic testing.
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    IMAGN! Increasing Minority Awareness of Genetics Now!
    (Genetics and Public Policy Center, 2005) Genetics and Public Policy Center
    The Human Genome Project revealed that any two humans are 99.9 percent genetically identical to each other. Yet by looking around you, it’s apparent that the 0.1 percent by which we all differ in our DNA can lead to significant differences in physical appearance. That our outward appearance can vary so dramatically has scientists wondering if our insides vary that much as well. Scientists believe that biology and genetics do play a significant role in disease susceptibility. The current research effort at the National Human Genome Research Institute called the HapMap Project aims to identify and study the 0.1 percent difference in the human genome with the goal of trying to figure out who is more likely to develop what disease. To do this, researchers are comparing the differences in genomes between people of three major continental groups: Asian, African, and European. This intersection of genetics and race has a long and volatile history. From the American eugenics movement in the early 20th century, to the Holocaust, to the more recent Sickle Cell Control Act of the 1970s, studying the genetics of different populations often has led to discrimination. This new age of genetic medicine holds promise to predict, treat, and cure human disease better than ever before, but will we be able to avoid its misinterpretation and potential misuses? Increasing dialogue between scientists and community leaders may help avoid repeating history, while making the most of what genetic technologies have to offer. With funding from the National Institutes of Health and the U.S. Department of Energy, the Genetics and Public Policy Center, funded by The Pew Charitable Trusts at Johns Hopkins University, and the Congressional Black Caucus co-sponsored a conference to foster this type of dialogue. The one-day conference, entitled IMAGN! – Increasing Minority Awareness of Genetics Now! – brought together 150 political, community, business, religious and opinion leaders, mostly from the African American community, and scientists and policy leaders to discuss the impact of the new genetics on the black community. Participants were charged with addressing the following two questions: How can advances in human genetics be harnessed to improve the health and well-being of African Americans? And how can we protect against inequitable and unjust uses of genetic information?