The HIV/AIDS 1 pandemic is one of the defi ning issues of the 21 st century. 2 AIDS is the leadin... more The HIV/AIDS 1 pandemic is one of the defi ning issues of the 21 st century. 2 AIDS is the leading cause of death in Africa and the fourth-leading cause of death globally. 3 UNAIDS estimated that 33.2 million people were living with HIV in 2007. 4 More than twenty million people have already died from AIDS and sixty-fi ve million will face death over the next twenty years. 5 The majority of these live in the developing world among the world's poor, powerless and marginalized.
Although genetic medicine has been subject to governmental regulation, reproductive medicine: has... more Although genetic medicine has been subject to governmental regulation, reproductive medicine: has been largely unregulated. Not only does this leave larger issues of well-being unexplored, it also raises more straightforward concerns about safety for women and children. The problem is that there is considerable overlap between "clinical innovation" and "research" in fertility clinics. The overlap is troubling because the clinics function free from oversight. For example, research has shown that a technique used to inject sperm directly into eggs in fertility treatments can cause damage to the egg's chromosomes. This technique was used and the resulting embryos implanted in women before rigorous safety testing. Recent articles have indicated that there may be long-term health impacts for children conceived by in vitro fertilization--a technique that has become part of the reproductive medicine "mainstream." Although reproductive and genetic technologies are frequently combined in the clinic, what regulation there is does not reflect their combined use, but proceeds in isolation. Because there are no integrated moral and policy conversations, we have little ability to explore the appropriate applications of future technology and develop policy to control it before it hits the market. With the advent of cloning techniques, many policymakers and scientists have acknowledged that we cannot leave the oversight of these techniques to the whim of individuals in the private sector. We need to think about how to regulate these technologies in a way that al lows valid research to continue, protects individuals, and promotes the well-being of individuals and of our society. This is the background for "Reprogenetics: A Blueprint for Meaningful Moral Debate and Responsible Public Policy." This two-year research project, conducted at The Hastings Center and funded by the Greenwall Foundation, brings together experts in reproductive and genetic science, ethics, medicine, public policy, and law to address issues raised by the intersection of genetic and reproductive technologies in the clinical setting. The union of genetics and reproduction has moved us toward an era in which parents will have an astonishing variety of techniques available to conceive and gestate children and to select the attributes their children may have. The expanding use of "reprogenetic" technologies challenges our concepts of who we are, who we should be, and the kind of society in which we want to live. Clearly we should be talking about these issues. Our project group has been doing just that. …
To the Editor — A US law aimed at preventing the gene editing of human embryos has had the broade... more To the Editor — A US law aimed at preventing the gene editing of human embryos has had the broader effect of banning an intervention that seeks to prevent mitochondrial diseases. Each year, 700–1,000 children are born in the United States with mitochondrial DNA mutations that cause neuromuscular and developmental diseases for which no fully effective treatments exist. While disease severity varies, in some cases affected children experience premature, agonizing deaths. Mitochondrial replacement therapy (MRT) is a promising intervention that could allow couples to avoid transmitting these diseases to their children. In MRT, mitochondrial DNA from an egg (oocyte) of an unaffected donor is combined with nuclear DNA from an egg (oocyte) of an at-risk prospective (or intending) mother. This intervention has been the topic of thoughtful public discussion in both the United States and the United Kingdom (where it is known as mitochondrial donation). The science, clinical scenarios and ethical issues were directly addressed in four scientific reviews commissioned by the United Kingdom’s Human Fertilisation and Embryology Authority (HFEA), a report by the Nuffield Council on Bioethics and United Kingdom parliamentary debates and actions1–8. The issues involved in MRT were also evaluated at a 2014 hearing by an advisory committee of the US Food and Drug Administration (FDA) and in a 2016 report of the US National Academies of Science, Engineering and Medicine9,10. In the United Kingdom, a public consultation revealed widespread support for MRT11,12, and in 2015, the UK Parliament voted to permit the Human Fertilisation and Embryology Authority (HFEA) to license MRT. Pursuant to this parliamentary authorization, the HFEA in 2016 resolved to grant licenses to perform MRT on a caseby-case basis. In February 2017, the HFEA issued the first license to a UK fertility clinic to undertake an MRT clinical trial. That trial is currently in progress13–15. Several research groups in the United States are well qualified to carry out clinical trials of MRT, if the FDA could review their investigational new drug (IND) applications. However, a rider that Congress has attached to every annual FDA appropriation since 2015 may preclude FDA review of applications to perform MRT in the United States. The rider, currently found in section 734 of the US Consolidated Appropriations Act, 2018, stipulates that
The primary extrinsic concerns regarding synthetic organisms are to do with their human health an... more The primary extrinsic concerns regarding synthetic organisms are to do with their human health and environmental risks. One reason for this is that they are (for now, at least) microorganisms, and many microorganisms cause illnesses in humans (and nonhumans) and are ecological disruptive. Another reason is the growth of “DIY (do-it-yourself) biotech” and “garage biotech” — i.e. people who are exploring synthetic biology on their own or outside of institutional structures such as academic, government, and corporate labs. In this chapter, Michele Garfinkle and Lori Knowles present and evaluate governance strategies, both hard law and soft law, for managing the risks associated with synthetic genomics, while also fostering innovation and realizing its potential benefits. They believe that it is possible to develop synthetic biology in biosecure and biosafe ways.
The excitement over the potential medical uses of embryonic stem cells (hES cells) obscures impor... more The excitement over the potential medical uses of embryonic stem cells (hES cells) obscures important issues about the scientific use and commercial exploitation of human tissue. Geron financed research that derived stem cells from aborted fetuses and from donated human embryos left over from in vitro fertilization. The nature of this tissue naturally raises concerns about classification, control, and commercialization. Unfortunately, the "reflection article" by Geron's ethics advisory board (EAB) does little to advance our thinking on these three issues. In fact, the article only highlights the tension between the altruism individuals are supposed to exhibit by donating their tissue for research and the current patent system, which encourages companies to stake lucrative property claims in that research. Classification and Control In this day and age one rarely discovers new things requiring legal classification, but since human embryos were first created and stored outside the human body, the law has been trying, with some difficulty, to categorize them. In law, a tangible thing is either a person or property, and if it is one it cannot be the other. From this classification flow rights and responsibilities: a person's rights in his or her property permit a degree of control over it, indeed the ability to decide its fate within limits set by the law. Whether a person has property rights in tissues removed from his or her body has been hotly debated, especially when reproductive tissue is involved. Plainly, determining whose property the tissue is, if anybody's, would also determine who controls its use. Pro-choice advocates have strongly argued that the location of a fetus or embryo inside the woman is crucial for resolving these issues. Nearly every common law country in the world has ruled that a man can neither block nor force a woman's decision to abort simply by virtue of his genetic connection to the embryo or fetus. After an abortion the woman's consent must be sought before fetal tissue may be used in research. The connection between the woman and this tissue, which has come from her body, is the basis for such a requirement. The case of the frozen embryo is different, however, because of its different location. When the embryo is outside the woman's body, there is little reason to argue that she should have greater dispositional authority over the embryo than the man. A woman should have control over the use and destination of her ova just as a man should over his sperm, and they should share decisional authority over frozen embryos. A number of cases in the United States have acknowledged that couples should decide what happens to their frozen embryos.[1] Most courts have tried to avoid making an explicit determination of whether the embryo is person or property, but they have vested dispositional authority in the couple, which implies property rights. The Geron EAB takes a similar approach. It vests decisionmaking authority in the couple; they can use, store, give away, or destroy their embryos. Such control seems to imply the couple's property interest in their embryos, although the EAB does not explicitly address the legal classification of the embryo. Since the EAB rejects the position that an embryo is a moral person, it is not likely that it would regard the frozen embryo as a legal person. If it is not a person, one assumes it must be property: the property of the donors by virtue of their genetic connection to the tissue. The EAB states, however, that embryonic tissue is not analogous to other tissue from a person's body and that it may be regarded as "potential progeny." This seems to swing us back toward viewing the embryo as a "person." But the EAB also states that donors should be advised as to whether they have property rights in stem cells derived from their embryos, and this claim suggests the "property" view. If the embryos are not the property of the couple, where would their property rights in the stem cells originate? …
Stem cells are very special, powerful cells found in both humans and non-human animals. They have... more Stem cells are very special, powerful cells found in both humans and non-human animals. They have been called the centrepieces of regenerative medicine – medicine that involves growing new cells, tissues and organs to replace or repair those damaged by injury, disease or aging. Stem cells are the precursors of all cells in the human body. What makes stem cells special is that they are regenerative and malleable. They have the ability to replicate themselves and to repair and replace other tissues in the human body. Some tissues, like skin, need constant renewal, which could not take place without skin stem cells. Other stem cells repair damage to the body’s tissues, for example, rebuilding damaged or degenerating muscle tissue. New research also indicates that stem cell malfunction or damage may be responsible for certain
... Under ancient law, wild animals belong to no one until captured, and pets and research animal... more ... Under ancient law, wild animals belong to no one until captured, and pets and research animals are a limited form of private property, as they are given special legislative protections. So how should the law deal with engineered versions of higher life forms? ...
Although genetic medicine has been subject to governmental regulation, reproductive medicine: has... more Although genetic medicine has been subject to governmental regulation, reproductive medicine: has been largely unregulated. Not only does this leave larger issues of well-being unexplored, it also raises more straightforward concerns about safety for women and children. The problem is that there is considerable overlap between "clinical innovation" and "research" in fertility clinics. The overlap is troubling because the clinics function free from oversight. For example, research has shown that a technique used to inject sperm directly into eggs in fertility treatments can cause damage to the egg's chromosomes. This technique was used and the resulting embryos implanted in women before rigorous safety testing. Recent articles have indicated that there may be long-term health impacts for children conceived by in vitro fertilization--a technique that has become part of the reproductive medicine "mainstream." Although reproductive and genetic technologies are frequently combined in the clinic, what regulation there is does not reflect their combined use, but proceeds in isolation. Because there are no integrated moral and policy conversations, we have little ability to explore the appropriate applications of future technology and develop policy to control it before it hits the market. With the advent of cloning techniques, many policymakers and scientists have acknowledged that we cannot leave the oversight of these techniques to the whim of individuals in the private sector. We need to think about how to regulate these technologies in a way that al lows valid research to continue, protects individuals, and promotes the well-being of individuals and of our society. This is the background for "Reprogenetics: A Blueprint for Meaningful Moral Debate and Responsible Public Policy." This two-year research project, conducted at The Hastings Center and funded by the Greenwall Foundation, brings together experts in reproductive and genetic science, ethics, medicine, public policy, and law to address issues raised by the intersection of genetic and reproductive technologies in the clinical setting. The union of genetics and reproduction has moved us toward an era in which parents will have an astonishing variety of techniques available to conceive and gestate children and to select the attributes their children may have. The expanding use of "reprogenetic" technologies challenges our concepts of who we are, who we should be, and the kind of society in which we want to live. Clearly we should be talking about these issues. Our project group has been doing just that. …
From the cloning of Dolly the sheep a decade ago to more recent advances in embryonic stem cell r... more From the cloning of Dolly the sheep a decade ago to more recent advances in embryonic stem cell research, new genetic technologies have often spurred polemical, ill-informed debates. Perhaps nowhere is this more evident than in the field of reproductive genetics, where difficult bioethical issues are distilled into sound bites and far-fetched claims for easy public consumption. The underlying complexities of reprogenetic research and practice are often drowned out by the noise. In this thoughtful and informed collection, Lori P. Knowles and Gregory E. Kaebnick bring together bioethicists from the United States, Canada, and the United Kingdom to examine the ethical and policy quandaries created by new genetic technologies. Featuring an overview of the field's history (including lessons to be learned from eugenics), comparisons of international and domestic governmental regulations, and discussions of how the market and public opinion affect research, this book considers both the risks and the benefits of combining genetic and reproductive technologies. Concluding with a cautionary call for increased regulation, Reprogenetics introduces fact, history, and reason into a public discussion of complex and vexing issues.
The HIV/AIDS 1 pandemic is one of the defi ning issues of the 21 st century. 2 AIDS is the leadin... more The HIV/AIDS 1 pandemic is one of the defi ning issues of the 21 st century. 2 AIDS is the leading cause of death in Africa and the fourth-leading cause of death globally. 3 UNAIDS estimated that 33.2 million people were living with HIV in 2007. 4 More than twenty million people have already died from AIDS and sixty-fi ve million will face death over the next twenty years. 5 The majority of these live in the developing world among the world's poor, powerless and marginalized.
Although genetic medicine has been subject to governmental regulation, reproductive medicine: has... more Although genetic medicine has been subject to governmental regulation, reproductive medicine: has been largely unregulated. Not only does this leave larger issues of well-being unexplored, it also raises more straightforward concerns about safety for women and children. The problem is that there is considerable overlap between "clinical innovation" and "research" in fertility clinics. The overlap is troubling because the clinics function free from oversight. For example, research has shown that a technique used to inject sperm directly into eggs in fertility treatments can cause damage to the egg's chromosomes. This technique was used and the resulting embryos implanted in women before rigorous safety testing. Recent articles have indicated that there may be long-term health impacts for children conceived by in vitro fertilization--a technique that has become part of the reproductive medicine "mainstream." Although reproductive and genetic technologies are frequently combined in the clinic, what regulation there is does not reflect their combined use, but proceeds in isolation. Because there are no integrated moral and policy conversations, we have little ability to explore the appropriate applications of future technology and develop policy to control it before it hits the market. With the advent of cloning techniques, many policymakers and scientists have acknowledged that we cannot leave the oversight of these techniques to the whim of individuals in the private sector. We need to think about how to regulate these technologies in a way that al lows valid research to continue, protects individuals, and promotes the well-being of individuals and of our society. This is the background for "Reprogenetics: A Blueprint for Meaningful Moral Debate and Responsible Public Policy." This two-year research project, conducted at The Hastings Center and funded by the Greenwall Foundation, brings together experts in reproductive and genetic science, ethics, medicine, public policy, and law to address issues raised by the intersection of genetic and reproductive technologies in the clinical setting. The union of genetics and reproduction has moved us toward an era in which parents will have an astonishing variety of techniques available to conceive and gestate children and to select the attributes their children may have. The expanding use of "reprogenetic" technologies challenges our concepts of who we are, who we should be, and the kind of society in which we want to live. Clearly we should be talking about these issues. Our project group has been doing just that. …
To the Editor — A US law aimed at preventing the gene editing of human embryos has had the broade... more To the Editor — A US law aimed at preventing the gene editing of human embryos has had the broader effect of banning an intervention that seeks to prevent mitochondrial diseases. Each year, 700–1,000 children are born in the United States with mitochondrial DNA mutations that cause neuromuscular and developmental diseases for which no fully effective treatments exist. While disease severity varies, in some cases affected children experience premature, agonizing deaths. Mitochondrial replacement therapy (MRT) is a promising intervention that could allow couples to avoid transmitting these diseases to their children. In MRT, mitochondrial DNA from an egg (oocyte) of an unaffected donor is combined with nuclear DNA from an egg (oocyte) of an at-risk prospective (or intending) mother. This intervention has been the topic of thoughtful public discussion in both the United States and the United Kingdom (where it is known as mitochondrial donation). The science, clinical scenarios and ethical issues were directly addressed in four scientific reviews commissioned by the United Kingdom’s Human Fertilisation and Embryology Authority (HFEA), a report by the Nuffield Council on Bioethics and United Kingdom parliamentary debates and actions1–8. The issues involved in MRT were also evaluated at a 2014 hearing by an advisory committee of the US Food and Drug Administration (FDA) and in a 2016 report of the US National Academies of Science, Engineering and Medicine9,10. In the United Kingdom, a public consultation revealed widespread support for MRT11,12, and in 2015, the UK Parliament voted to permit the Human Fertilisation and Embryology Authority (HFEA) to license MRT. Pursuant to this parliamentary authorization, the HFEA in 2016 resolved to grant licenses to perform MRT on a caseby-case basis. In February 2017, the HFEA issued the first license to a UK fertility clinic to undertake an MRT clinical trial. That trial is currently in progress13–15. Several research groups in the United States are well qualified to carry out clinical trials of MRT, if the FDA could review their investigational new drug (IND) applications. However, a rider that Congress has attached to every annual FDA appropriation since 2015 may preclude FDA review of applications to perform MRT in the United States. The rider, currently found in section 734 of the US Consolidated Appropriations Act, 2018, stipulates that
The primary extrinsic concerns regarding synthetic organisms are to do with their human health an... more The primary extrinsic concerns regarding synthetic organisms are to do with their human health and environmental risks. One reason for this is that they are (for now, at least) microorganisms, and many microorganisms cause illnesses in humans (and nonhumans) and are ecological disruptive. Another reason is the growth of “DIY (do-it-yourself) biotech” and “garage biotech” — i.e. people who are exploring synthetic biology on their own or outside of institutional structures such as academic, government, and corporate labs. In this chapter, Michele Garfinkle and Lori Knowles present and evaluate governance strategies, both hard law and soft law, for managing the risks associated with synthetic genomics, while also fostering innovation and realizing its potential benefits. They believe that it is possible to develop synthetic biology in biosecure and biosafe ways.
The excitement over the potential medical uses of embryonic stem cells (hES cells) obscures impor... more The excitement over the potential medical uses of embryonic stem cells (hES cells) obscures important issues about the scientific use and commercial exploitation of human tissue. Geron financed research that derived stem cells from aborted fetuses and from donated human embryos left over from in vitro fertilization. The nature of this tissue naturally raises concerns about classification, control, and commercialization. Unfortunately, the "reflection article" by Geron's ethics advisory board (EAB) does little to advance our thinking on these three issues. In fact, the article only highlights the tension between the altruism individuals are supposed to exhibit by donating their tissue for research and the current patent system, which encourages companies to stake lucrative property claims in that research. Classification and Control In this day and age one rarely discovers new things requiring legal classification, but since human embryos were first created and stored outside the human body, the law has been trying, with some difficulty, to categorize them. In law, a tangible thing is either a person or property, and if it is one it cannot be the other. From this classification flow rights and responsibilities: a person's rights in his or her property permit a degree of control over it, indeed the ability to decide its fate within limits set by the law. Whether a person has property rights in tissues removed from his or her body has been hotly debated, especially when reproductive tissue is involved. Plainly, determining whose property the tissue is, if anybody's, would also determine who controls its use. Pro-choice advocates have strongly argued that the location of a fetus or embryo inside the woman is crucial for resolving these issues. Nearly every common law country in the world has ruled that a man can neither block nor force a woman's decision to abort simply by virtue of his genetic connection to the embryo or fetus. After an abortion the woman's consent must be sought before fetal tissue may be used in research. The connection between the woman and this tissue, which has come from her body, is the basis for such a requirement. The case of the frozen embryo is different, however, because of its different location. When the embryo is outside the woman's body, there is little reason to argue that she should have greater dispositional authority over the embryo than the man. A woman should have control over the use and destination of her ova just as a man should over his sperm, and they should share decisional authority over frozen embryos. A number of cases in the United States have acknowledged that couples should decide what happens to their frozen embryos.[1] Most courts have tried to avoid making an explicit determination of whether the embryo is person or property, but they have vested dispositional authority in the couple, which implies property rights. The Geron EAB takes a similar approach. It vests decisionmaking authority in the couple; they can use, store, give away, or destroy their embryos. Such control seems to imply the couple's property interest in their embryos, although the EAB does not explicitly address the legal classification of the embryo. Since the EAB rejects the position that an embryo is a moral person, it is not likely that it would regard the frozen embryo as a legal person. If it is not a person, one assumes it must be property: the property of the donors by virtue of their genetic connection to the tissue. The EAB states, however, that embryonic tissue is not analogous to other tissue from a person's body and that it may be regarded as "potential progeny." This seems to swing us back toward viewing the embryo as a "person." But the EAB also states that donors should be advised as to whether they have property rights in stem cells derived from their embryos, and this claim suggests the "property" view. If the embryos are not the property of the couple, where would their property rights in the stem cells originate? …
Stem cells are very special, powerful cells found in both humans and non-human animals. They have... more Stem cells are very special, powerful cells found in both humans and non-human animals. They have been called the centrepieces of regenerative medicine – medicine that involves growing new cells, tissues and organs to replace or repair those damaged by injury, disease or aging. Stem cells are the precursors of all cells in the human body. What makes stem cells special is that they are regenerative and malleable. They have the ability to replicate themselves and to repair and replace other tissues in the human body. Some tissues, like skin, need constant renewal, which could not take place without skin stem cells. Other stem cells repair damage to the body’s tissues, for example, rebuilding damaged or degenerating muscle tissue. New research also indicates that stem cell malfunction or damage may be responsible for certain
... Under ancient law, wild animals belong to no one until captured, and pets and research animal... more ... Under ancient law, wild animals belong to no one until captured, and pets and research animals are a limited form of private property, as they are given special legislative protections. So how should the law deal with engineered versions of higher life forms? ...
Although genetic medicine has been subject to governmental regulation, reproductive medicine: has... more Although genetic medicine has been subject to governmental regulation, reproductive medicine: has been largely unregulated. Not only does this leave larger issues of well-being unexplored, it also raises more straightforward concerns about safety for women and children. The problem is that there is considerable overlap between "clinical innovation" and "research" in fertility clinics. The overlap is troubling because the clinics function free from oversight. For example, research has shown that a technique used to inject sperm directly into eggs in fertility treatments can cause damage to the egg's chromosomes. This technique was used and the resulting embryos implanted in women before rigorous safety testing. Recent articles have indicated that there may be long-term health impacts for children conceived by in vitro fertilization--a technique that has become part of the reproductive medicine "mainstream." Although reproductive and genetic technologies are frequently combined in the clinic, what regulation there is does not reflect their combined use, but proceeds in isolation. Because there are no integrated moral and policy conversations, we have little ability to explore the appropriate applications of future technology and develop policy to control it before it hits the market. With the advent of cloning techniques, many policymakers and scientists have acknowledged that we cannot leave the oversight of these techniques to the whim of individuals in the private sector. We need to think about how to regulate these technologies in a way that al lows valid research to continue, protects individuals, and promotes the well-being of individuals and of our society. This is the background for "Reprogenetics: A Blueprint for Meaningful Moral Debate and Responsible Public Policy." This two-year research project, conducted at The Hastings Center and funded by the Greenwall Foundation, brings together experts in reproductive and genetic science, ethics, medicine, public policy, and law to address issues raised by the intersection of genetic and reproductive technologies in the clinical setting. The union of genetics and reproduction has moved us toward an era in which parents will have an astonishing variety of techniques available to conceive and gestate children and to select the attributes their children may have. The expanding use of "reprogenetic" technologies challenges our concepts of who we are, who we should be, and the kind of society in which we want to live. Clearly we should be talking about these issues. Our project group has been doing just that. …
From the cloning of Dolly the sheep a decade ago to more recent advances in embryonic stem cell r... more From the cloning of Dolly the sheep a decade ago to more recent advances in embryonic stem cell research, new genetic technologies have often spurred polemical, ill-informed debates. Perhaps nowhere is this more evident than in the field of reproductive genetics, where difficult bioethical issues are distilled into sound bites and far-fetched claims for easy public consumption. The underlying complexities of reprogenetic research and practice are often drowned out by the noise. In this thoughtful and informed collection, Lori P. Knowles and Gregory E. Kaebnick bring together bioethicists from the United States, Canada, and the United Kingdom to examine the ethical and policy quandaries created by new genetic technologies. Featuring an overview of the field's history (including lessons to be learned from eugenics), comparisons of international and domestic governmental regulations, and discussions of how the market and public opinion affect research, this book considers both the risks and the benefits of combining genetic and reproductive technologies. Concluding with a cautionary call for increased regulation, Reprogenetics introduces fact, history, and reason into a public discussion of complex and vexing issues.
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Papers by Lori Knowles