Lainie Friedman Ross
- Published in print:
- 2006
- Published Online:
- May 2006
- ISBN:
- 9780199273287
- eISBN:
- 9780191603655
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/0199273286.003.0010
- Subject:
- Philosophy, Moral Philosophy
This chapter examines the arguments for and against conducting biomedical and behavioral research in schools; whether additional human subject protections are necessary; and whose consent is ...
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This chapter examines the arguments for and against conducting biomedical and behavioral research in schools; whether additional human subject protections are necessary; and whose consent is necessary and how it should be procured. It is argued that while schools are a tempting venue to do biomedical and behavioral research, parents, students, teachers, school officials, researchers, and institutional review boards need to be sensitive to the unique problems that such research may raise. Schools should have written policies that address the need to protect human subjects when research is done in the school setting. Minimum guidelines for schools are presented.Less
This chapter examines the arguments for and against conducting biomedical and behavioral research in schools; whether additional human subject protections are necessary; and whose consent is necessary and how it should be procured. It is argued that while schools are a tempting venue to do biomedical and behavioral research, parents, students, teachers, school officials, researchers, and institutional review boards need to be sensitive to the unique problems that such research may raise. Schools should have written policies that address the need to protect human subjects when research is done in the school setting. Minimum guidelines for schools are presented.
Chloe Silverman
- Published in print:
- 2011
- Published Online:
- October 2017
- ISBN:
- 9780691150468
- eISBN:
- 9781400840397
- Item type:
- chapter
- Publisher:
- Princeton University Press
- DOI:
- 10.23943/princeton/9780691150468.003.0001
- Subject:
- Anthropology, Social and Cultural Anthropology
This book examines the evolution of the diagnostic category of autism as people have understood it in different places and times, with a particular focus on the importance of affect in biomedical ...
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This book examines the evolution of the diagnostic category of autism as people have understood it in different places and times, with a particular focus on the importance of affect in biomedical research during the second half of the twentieth century and the first few years of the twenty-first. It considers the degree to which representation of autism depends on particular institutional and epistemological arrangements; shifts the focus from psychiatrists, epidemiologists, and geneticists to parents, counselors, diagnosticians, and lawyers, as they try to make sense of and apply systematic, authoritative knowledge in their daily lives and work; and highlights the centrality of love as a way of knowing about bodies, persons, and relationships in biomedicine. This introduction provides an overview of theories of love in biomedicine, the ethics of treating autism and how it relates to the question of moral personhood, the history of diagnosis of autism, biosociality and contested illnesses, and the book's methodology.Less
This book examines the evolution of the diagnostic category of autism as people have understood it in different places and times, with a particular focus on the importance of affect in biomedical research during the second half of the twentieth century and the first few years of the twenty-first. It considers the degree to which representation of autism depends on particular institutional and epistemological arrangements; shifts the focus from psychiatrists, epidemiologists, and geneticists to parents, counselors, diagnosticians, and lawyers, as they try to make sense of and apply systematic, authoritative knowledge in their daily lives and work; and highlights the centrality of love as a way of knowing about bodies, persons, and relationships in biomedicine. This introduction provides an overview of theories of love in biomedicine, the ethics of treating autism and how it relates to the question of moral personhood, the history of diagnosis of autism, biosociality and contested illnesses, and the book's methodology.
Mary Briody Mahowald
- Published in print:
- 2006
- Published Online:
- September 2006
- ISBN:
- 9780195176179
- eISBN:
- 9780199786558
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/0195176170.003.0013
- Subject:
- Philosophy, Feminist Philosophy
Cases illustrating the exclusion of women in biomedical research, experimental treatment and maternal fetal surgery, human reproductive cloning, and embryonic stem cell research are presented. For ...
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Cases illustrating the exclusion of women in biomedical research, experimental treatment and maternal fetal surgery, human reproductive cloning, and embryonic stem cell research are presented. For each topic, empirical and theoretical factors are discussed from an “egalitarian perspective” that imputes privileged status to the standpoint of those who are “nondominant”. Implications of different positions about moral status of embryos and fetuses, and about people born with disabilities are also considered.Less
Cases illustrating the exclusion of women in biomedical research, experimental treatment and maternal fetal surgery, human reproductive cloning, and embryonic stem cell research are presented. For each topic, empirical and theoretical factors are discussed from an “egalitarian perspective” that imputes privileged status to the standpoint of those who are “nondominant”. Implications of different positions about moral status of embryos and fetuses, and about people born with disabilities are also considered.
Jason E. Glenn
- Published in print:
- 2015
- Published Online:
- May 2016
- ISBN:
- 9781781381724
- eISBN:
- 9781781382257
- Item type:
- chapter
- Publisher:
- Liverpool University Press
- DOI:
- 10.5949/liverpool/9781781381724.003.0005
- Subject:
- Literature, Criticism/Theory
This chapter traces and analyzes the history of human subject research and its role in the production of knowledge for biomedical use. It argues that the historic use of subjugated/condemned and ...
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This chapter traces and analyzes the history of human subject research and its role in the production of knowledge for biomedical use. It argues that the historic use of subjugated/condemned and dehumanized populations by clinicians for biomedical research helped produce a dehumanized field of knowledge. It offers a new and far-reaching interpretive framework that replaces Michel Foucault's thesis that the detachment of biomedical practitioners from their human research subjects resulted purely from a natural-scientific ‘clinical gaze’. This ‘gaze’ can be understood in more comprehensive terms as also the ‘symbolic gaze’ derived from the sociogenic code of a specific genre of ‘being’ human, including that of the late modern, purely biocentric variant of secular Western Man. And it is within the terms of this dual-perspectived ‘gaze’ that the biological bodies of dehumanized/subjugated populations were perceived first and foremost as the embodiment of symbolic death — as lives having no human value — in opposition to that of the clinician/practitioner as the self- and societally-represented embodiment of symbolic life.Less
This chapter traces and analyzes the history of human subject research and its role in the production of knowledge for biomedical use. It argues that the historic use of subjugated/condemned and dehumanized populations by clinicians for biomedical research helped produce a dehumanized field of knowledge. It offers a new and far-reaching interpretive framework that replaces Michel Foucault's thesis that the detachment of biomedical practitioners from their human research subjects resulted purely from a natural-scientific ‘clinical gaze’. This ‘gaze’ can be understood in more comprehensive terms as also the ‘symbolic gaze’ derived from the sociogenic code of a specific genre of ‘being’ human, including that of the late modern, purely biocentric variant of secular Western Man. And it is within the terms of this dual-perspectived ‘gaze’ that the biological bodies of dehumanized/subjugated populations were perceived first and foremost as the embodiment of symbolic death — as lives having no human value — in opposition to that of the clinician/practitioner as the self- and societally-represented embodiment of symbolic life.
Renée C. Fox and Judith P. Swazey
- Published in print:
- 2008
- Published Online:
- October 2011
- ISBN:
- 9780195365559
- eISBN:
- 9780199851881
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195365559.003.0012
- Subject:
- Philosophy, Philosophy of Science
Bioethics has been argued to be not only about intellectual or biomedical ethical issues, but also about biomedical research, health care, and the values and beliefs of the American society. However ...
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Bioethics has been argued to be not only about intellectual or biomedical ethical issues, but also about biomedical research, health care, and the values and beliefs of the American society. However culture wars between the liberals and conservatives have inched their way into bioethics. This chapter discusses the association of culture wars to bioethics.Less
Bioethics has been argued to be not only about intellectual or biomedical ethical issues, but also about biomedical research, health care, and the values and beliefs of the American society. However culture wars between the liberals and conservatives have inched their way into bioethics. This chapter discusses the association of culture wars to bioethics.
Philip Bielby
- Published in print:
- 2009
- Published Online:
- September 2009
- ISBN:
- 9780199231461
- eISBN:
- 9780191723858
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780199231461.003.0009
- Subject:
- Public Health and Epidemiology, Public Health, Epidemiology
A particular challenge for consent in biomedical research is the participation of adults with mental disorder or intellectual disability to a degree that impinges on but does not necessarily erode ...
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A particular challenge for consent in biomedical research is the participation of adults with mental disorder or intellectual disability to a degree that impinges on but does not necessarily erode decisional competence. This challenge is emphasized by recent developments in neuroscience which have reinvigorated interest in biomedical research with cognitively vulnerable human participants, particularly research into the origins and treatment of mental disorder. This chapter argues that we can best understand the scope and limits of consent as a ‘procedural’ principle of empowerment. It grounds this argument in a rationalist moral theory of human (or agency) rights devised by Alan Gewirth (1978). Drawing on the recent work of Gewirthian legal theorists Beyleveld and Brownsword (2004 and 2007), it offers a defence of the ethical significance of consent as a procedural human rights value, which does not in itself constitute a substantive human right.Less
A particular challenge for consent in biomedical research is the participation of adults with mental disorder or intellectual disability to a degree that impinges on but does not necessarily erode decisional competence. This challenge is emphasized by recent developments in neuroscience which have reinvigorated interest in biomedical research with cognitively vulnerable human participants, particularly research into the origins and treatment of mental disorder. This chapter argues that we can best understand the scope and limits of consent as a ‘procedural’ principle of empowerment. It grounds this argument in a rationalist moral theory of human (or agency) rights devised by Alan Gewirth (1978). Drawing on the recent work of Gewirthian legal theorists Beyleveld and Brownsword (2004 and 2007), it offers a defence of the ethical significance of consent as a procedural human rights value, which does not in itself constitute a substantive human right.
Adrian R. Morrison
- Published in print:
- 2009
- Published Online:
- March 2012
- ISBN:
- 9780195374445
- eISBN:
- 9780199847938
- Item type:
- book
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195374445.001.0001
- Subject:
- Psychology, Social Psychology
The relationship between animals and humans is more complex today than ever before. Animal–human interaction has engendered a bitter enmity between animal rights activists and the biomedical ...
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The relationship between animals and humans is more complex today than ever before. Animal–human interaction has engendered a bitter enmity between animal rights activists and the biomedical researchers whose work depends on the use (and oftentimes the killing) of laboratory animals. This book—which argues that humane animal use in biomedical research is an indispensable tool of medical science, and that efforts to halt such use constitute a grave threat to human health and wellbeing— is the culmination of the author's years spent negotiating the treacherous divide between a legitimate concern for animals and the importance of biomedical research. Drawing on the disciplines of philosophy, history, biology, and animal behavior, he crafts a multi-faceted argument in favor of using animals humanely in research, the center of which is his staunch belief that human interests must be the primary concern of science and society. Along the way, he delves into other human uses of animals in domains such as agriculture, hunting, and education, examining each use along with its philosophical, moral, and ecological implications. The result is a thought-provoking, intelligent and fair-minded discussion of a charged subject—of the past and present of animals' relationships with humans, and how and why we should be able to use them as we do.Less
The relationship between animals and humans is more complex today than ever before. Animal–human interaction has engendered a bitter enmity between animal rights activists and the biomedical researchers whose work depends on the use (and oftentimes the killing) of laboratory animals. This book—which argues that humane animal use in biomedical research is an indispensable tool of medical science, and that efforts to halt such use constitute a grave threat to human health and wellbeing— is the culmination of the author's years spent negotiating the treacherous divide between a legitimate concern for animals and the importance of biomedical research. Drawing on the disciplines of philosophy, history, biology, and animal behavior, he crafts a multi-faceted argument in favor of using animals humanely in research, the center of which is his staunch belief that human interests must be the primary concern of science and society. Along the way, he delves into other human uses of animals in domains such as agriculture, hunting, and education, examining each use along with its philosophical, moral, and ecological implications. The result is a thought-provoking, intelligent and fair-minded discussion of a charged subject—of the past and present of animals' relationships with humans, and how and why we should be able to use them as we do.
Rebecca Dresser
- Published in print:
- 2000
- Published Online:
- March 2012
- ISBN:
- 9780198299189
- eISBN:
- 9780191685644
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780198299189.003.0024
- Subject:
- Law, Philosophy of Law, Medical Law
During the 1990s, US government priorities for biomedical research funding became the focus of heated debate. Some members of Congress joined with organizations advocating on behalf of persons with ...
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During the 1990s, US government priorities for biomedical research funding became the focus of heated debate. Some members of Congress joined with organizations advocating on behalf of persons with various health problems to raise questions concerning how funds are allocated at the National Institutes of Health (NIH), the major government agency supporting biomedical research. In turn, NIH officials produced a document setting forth the substantive criteria used to determine funding allocation. The agency also took steps to increase opportunities for members of the public to provide input on funding priorities. Yet the underlying debate remains unsettled. This chapter analyzes distributive and procedural justice issues raised by research priority setting, with the goal of clarifying the values, choices, and trade-offs at stake in this policy context. It also examines difficulties inherent in assigning priorities based on factors such as disease incidence, disease severity, prevention versus treatment, and age, gender, and ethnicity of affected populations. Lastly, it considers the potential roles of laypersons and experts in establishing priorities for publicly-funded health research.Less
During the 1990s, US government priorities for biomedical research funding became the focus of heated debate. Some members of Congress joined with organizations advocating on behalf of persons with various health problems to raise questions concerning how funds are allocated at the National Institutes of Health (NIH), the major government agency supporting biomedical research. In turn, NIH officials produced a document setting forth the substantive criteria used to determine funding allocation. The agency also took steps to increase opportunities for members of the public to provide input on funding priorities. Yet the underlying debate remains unsettled. This chapter analyzes distributive and procedural justice issues raised by research priority setting, with the goal of clarifying the values, choices, and trade-offs at stake in this policy context. It also examines difficulties inherent in assigning priorities based on factors such as disease incidence, disease severity, prevention versus treatment, and age, gender, and ethnicity of affected populations. Lastly, it considers the potential roles of laypersons and experts in establishing priorities for publicly-funded health research.
Morrison Adrian R.
- Published in print:
- 2009
- Published Online:
- March 2012
- ISBN:
- 9780195374445
- eISBN:
- 9780199847938
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195374445.003.0005
- Subject:
- Psychology, Social Psychology
This chapter addresses biomedical research in a larger context, and examines how science works in general. It focuses on the contributions that animals have made to the health and welfare of humans. ...
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This chapter addresses biomedical research in a larger context, and examines how science works in general. It focuses on the contributions that animals have made to the health and welfare of humans. Humans owe a large debt to laboratory animals for developing the health of humans despite some claims to the contrary, some of them from rather unexpected quarters. It also provides a discussion of the use of animals in education. In addition, it presents a remarkable survey showing how far removed from a particular clinical condition basic research can be and still lead to a major advance. It then describes a real-life example of applied research—how one surgeon sought to keep his surgical patients from dying of malnutrition. Utilization of animals in research should be controlled.Less
This chapter addresses biomedical research in a larger context, and examines how science works in general. It focuses on the contributions that animals have made to the health and welfare of humans. Humans owe a large debt to laboratory animals for developing the health of humans despite some claims to the contrary, some of them from rather unexpected quarters. It also provides a discussion of the use of animals in education. In addition, it presents a remarkable survey showing how far removed from a particular clinical condition basic research can be and still lead to a major advance. It then describes a real-life example of applied research—how one surgeon sought to keep his surgical patients from dying of malnutrition. Utilization of animals in research should be controlled.
Thomas Banchoff
- Published in print:
- 2011
- Published Online:
- August 2016
- ISBN:
- 9780801449574
- eISBN:
- 9780801460593
- Item type:
- chapter
- Publisher:
- Cornell University Press
- DOI:
- 10.7591/cornell/9780801449574.003.0001
- Subject:
- Political Science, Public Policy
This chapter traces the emergence of the human embryo as an object of ethical controversy from 1968 through the early 1990s. This trajectory can be divided into three phases. The first phase, roughly ...
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This chapter traces the emergence of the human embryo as an object of ethical controversy from 1968 through the early 1990s. This trajectory can be divided into three phases. The first phase, roughly the decade following from the first fertilization of an egg outside the womb in Cambridge, England, in 1968, centered on concerns about eugenics, safety, and human sexuality. The focus was on the development of IVF as an infertility treatment and the race to produce the first “test-tube” baby. The moral status of the embryo was a subordinate issue. During a second phase, as IVF was gradually established as an infertility treatment, from 1978 to 1986, national ethics committees took up the problem of the respect due to the embryo, on the one hand, and the imperative of biomedical research, on the other. During a third phase, from 1987 to 1994, which coincided with the onset of political and policy struggles, the ethical debate became more polarized. The Catholic Church and its pro-life allies fused the embryo research and abortion issues, and scientists and their allies in the bioethics community increasingly emphasized the healing power of research for infertility and other conditions.Less
This chapter traces the emergence of the human embryo as an object of ethical controversy from 1968 through the early 1990s. This trajectory can be divided into three phases. The first phase, roughly the decade following from the first fertilization of an egg outside the womb in Cambridge, England, in 1968, centered on concerns about eugenics, safety, and human sexuality. The focus was on the development of IVF as an infertility treatment and the race to produce the first “test-tube” baby. The moral status of the embryo was a subordinate issue. During a second phase, as IVF was gradually established as an infertility treatment, from 1978 to 1986, national ethics committees took up the problem of the respect due to the embryo, on the one hand, and the imperative of biomedical research, on the other. During a third phase, from 1987 to 1994, which coincided with the onset of political and policy struggles, the ethical debate became more polarized. The Catholic Church and its pro-life allies fused the embryo research and abortion issues, and scientists and their allies in the bioethics community increasingly emphasized the healing power of research for infertility and other conditions.
Zachary M. Schrag
- Published in print:
- 2014
- Published Online:
- January 2015
- ISBN:
- 9780262027465
- eISBN:
- 9780262320825
- Item type:
- chapter
- Publisher:
- The MIT Press
- DOI:
- 10.7551/mitpress/9780262027465.003.0024
- Subject:
- Biology, Bioethics
This chapter explores various ways of distinguishing research that should and should not be covered by human subjects regulations. Aligning regulations to the underlying statute, which only covers ...
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This chapter explores various ways of distinguishing research that should and should not be covered by human subjects regulations. Aligning regulations to the underlying statute, which only covers “biomedical and behavioral research,” would return scrutiny to the areas of concern identified by Congress. Alternatively, defining “human subjects” more narrowly as those people in the power of an investigator might focus energy on the prevention of the abuse of power. By contrast, relying on distinctions between generalizable knowledge and nongeneralizable knowledge is the very worst strategy, for in three decades policy makers have proved unable to agree on what this distinction means.Less
This chapter explores various ways of distinguishing research that should and should not be covered by human subjects regulations. Aligning regulations to the underlying statute, which only covers “biomedical and behavioral research,” would return scrutiny to the areas of concern identified by Congress. Alternatively, defining “human subjects” more narrowly as those people in the power of an investigator might focus energy on the prevention of the abuse of power. By contrast, relying on distinctions between generalizable knowledge and nongeneralizable knowledge is the very worst strategy, for in three decades policy makers have proved unable to agree on what this distinction means.
Doogab Yi
- Published in print:
- 2015
- Published Online:
- September 2015
- ISBN:
- 9780226143835
- eISBN:
- 9780226216119
- Item type:
- chapter
- Publisher:
- University of Chicago Press
- DOI:
- 10.7208/chicago/9780226216119.003.0002
- Subject:
- History, History of Science, Technology, and Medicine
Chapter 2 examines these changing dynamics, and the scientific and political genealogy of recombinant DNA technology. I argue that recombinant DNA technology derived from particular experimental ...
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Chapter 2 examines these changing dynamics, and the scientific and political genealogy of recombinant DNA technology. I argue that recombinant DNA technology derived from particular experimental opportunities, and from commitments to the biology of higher organisms; this occurred in the late 1960s and early 1970s, when molecular biology was experiencing an intellectual and political “crisis.”Less
Chapter 2 examines these changing dynamics, and the scientific and political genealogy of recombinant DNA technology. I argue that recombinant DNA technology derived from particular experimental opportunities, and from commitments to the biology of higher organisms; this occurred in the late 1960s and early 1970s, when molecular biology was experiencing an intellectual and political “crisis.”
Sheldon Krimsky
- Published in print:
- 2014
- Published Online:
- November 2015
- ISBN:
- 9780231162999
- eISBN:
- 9780231531276
- Item type:
- chapter
- Publisher:
- Columbia University Press
- DOI:
- 10.7312/columbia/9780231162999.003.0001
- Subject:
- Public Health and Epidemiology, Public Health
This chapter considers how and where race enters modern biomedicine, with an emphasis on the role of federal regulatory frameworks and mandates in incentivizing the introduction of racial categories ...
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This chapter considers how and where race enters modern biomedicine, with an emphasis on the role of federal regulatory frameworks and mandates in incentivizing the introduction of racial categories in research and practice. Foremost among these are initiatives such as the National Institutes of Health Revitalization Act of 1993 and the Food and Drug Modernization Act (FDMA) of 1997. This chapter also considers the implications of how federally sponsored biobanks, which compile genetic data from around the world, frequently organize their vast data sets using population groupings that often become collapsed into racial categories reflecting the U.S. Office of Management and Budget (OMB) mandate. This sets the stage for exploring what happens to race after it enters biomedical research and practice by looking for where it travels, how and by whom it is taken up, and what diverse purposes it serves—both intentional and unintentional.Less
This chapter considers how and where race enters modern biomedicine, with an emphasis on the role of federal regulatory frameworks and mandates in incentivizing the introduction of racial categories in research and practice. Foremost among these are initiatives such as the National Institutes of Health Revitalization Act of 1993 and the Food and Drug Modernization Act (FDMA) of 1997. This chapter also considers the implications of how federally sponsored biobanks, which compile genetic data from around the world, frequently organize their vast data sets using population groupings that often become collapsed into racial categories reflecting the U.S. Office of Management and Budget (OMB) mandate. This sets the stage for exploring what happens to race after it enters biomedical research and practice by looking for where it travels, how and by whom it is taken up, and what diverse purposes it serves—both intentional and unintentional.
Morrison Adrian R.
- Published in print:
- 2009
- Published Online:
- March 2012
- ISBN:
- 9780195374445
- eISBN:
- 9780199847938
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195374445.003.0006
- Subject:
- Psychology, Social Psychology
This chapter provides a number of examples of misrepresentations of medical history. It specifically shows that the claims made against the role of animals in biomedical research are simply false. It ...
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This chapter provides a number of examples of misrepresentations of medical history. It specifically shows that the claims made against the role of animals in biomedical research are simply false. It also considers the animal-rightist claims of those who really should know better, the medically trained. Ray and Jean Greek highlight in their book that they are not interested in animal rights but only in demonstrating that using animals in research endangers human health. They present the same distortions of medical history as those presented by other individuals discussed in this chapter. In addition, Brandon Reines specializes in advancing the thesis that significant medical advances are primarily due to observations made on human patients.Less
This chapter provides a number of examples of misrepresentations of medical history. It specifically shows that the claims made against the role of animals in biomedical research are simply false. It also considers the animal-rightist claims of those who really should know better, the medically trained. Ray and Jean Greek highlight in their book that they are not interested in animal rights but only in demonstrating that using animals in research endangers human health. They present the same distortions of medical history as those presented by other individuals discussed in this chapter. In addition, Brandon Reines specializes in advancing the thesis that significant medical advances are primarily due to observations made on human patients.
Oonagh Corrigan, John McMillan, Kathleen Liddell, Martin Richards, and Charles Weijer (eds)
- Published in print:
- 2009
- Published Online:
- September 2009
- ISBN:
- 9780199231461
- eISBN:
- 9780191723858
- Item type:
- book
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780199231461.001.0001
- Subject:
- Public Health and Epidemiology, Public Health, Epidemiology
Since its inception as an international requirement to protect patients and healthy volunteers taking part in medical research, informed consent has become the primary consideration in research ...
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Since its inception as an international requirement to protect patients and healthy volunteers taking part in medical research, informed consent has become the primary consideration in research ethics. Despite the ubiquity of consent, however, scholars have begun to question its adequacy for contemporary biomedical research. This book explores this issue, reviewing the application of consent to genetic research, clinical trials, and research involving vulnerable populations. For example, in genetic research, information obtained from an autonomous research participant may have significant bearing on the interests of family members who have not consented to the study. This casts doubt on the adequacy of consent for such studies. This book also questions the assumptions that informed consent is essential and that it satisfactorily protects the principle of individual autonomy. It reviews recent empirical studies that challenge the possibility of truly informed consent and highlights the extent to which consent is governed by social norms and expectations. It also investigates how consent might be of secondary importance in some circumstances, for example when a research project appears to protect a public or community interest.Less
Since its inception as an international requirement to protect patients and healthy volunteers taking part in medical research, informed consent has become the primary consideration in research ethics. Despite the ubiquity of consent, however, scholars have begun to question its adequacy for contemporary biomedical research. This book explores this issue, reviewing the application of consent to genetic research, clinical trials, and research involving vulnerable populations. For example, in genetic research, information obtained from an autonomous research participant may have significant bearing on the interests of family members who have not consented to the study. This casts doubt on the adequacy of consent for such studies. This book also questions the assumptions that informed consent is essential and that it satisfactorily protects the principle of individual autonomy. It reviews recent empirical studies that challenge the possibility of truly informed consent and highlights the extent to which consent is governed by social norms and expectations. It also investigates how consent might be of secondary importance in some circumstances, for example when a research project appears to protect a public or community interest.
Carl E. Schneider
- Published in print:
- 2015
- Published Online:
- September 2015
- ISBN:
- 9780262028912
- eISBN:
- 9780262328784
- Item type:
- chapter
- Publisher:
- The MIT Press
- DOI:
- 10.7551/mitpress/9780262028912.003.0001
- Subject:
- Biology, Bioethics
How much good IRB regulation can do depends on how much risk research subjects run. Biomedical research can harm subjects, but much of it needs no physical contact with patients, and most contact ...
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How much good IRB regulation can do depends on how much risk research subjects run. Biomedical research can harm subjects, but much of it needs no physical contact with patients, and most contact cannot cause serious injury. Even truly ill patients are, if anything, safer in than out of research. Social-science research cannot injure people physically, and its risks are trivial compared with the chances free people take daily In short, research harm “has been far less than the harm arising from many entirely ordinary activities” like walking. So the IRB system has less scope to do good than its severity suggests because research is safer than its rhetoric implies.Less
How much good IRB regulation can do depends on how much risk research subjects run. Biomedical research can harm subjects, but much of it needs no physical contact with patients, and most contact cannot cause serious injury. Even truly ill patients are, if anything, safer in than out of research. Social-science research cannot injure people physically, and its risks are trivial compared with the chances free people take daily In short, research harm “has been far less than the harm arising from many entirely ordinary activities” like walking. So the IRB system has less scope to do good than its severity suggests because research is safer than its rhetoric implies.
Hugo Rüdiger, Michael Nasterlack, Andreas Zober, and Tee L. Guidotti
- Published in print:
- 2011
- Published Online:
- May 2011
- ISBN:
- 9780195380002
- eISBN:
- 9780199893881
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195380002.003.0019
- Subject:
- Public Health and Epidemiology, Public Health
Although there are hazards that may be characteristic to a particular industry or workplace, individual workers may be primarily exposed to hazards that are not common to the industry as a whole. For ...
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Although there are hazards that may be characteristic to a particular industry or workplace, individual workers may be primarily exposed to hazards that are not common to the industry as a whole. For example, welders in a mine or in a chemical industry are more often exposed to the hazards of welding, not those of mining and chemicals. Another is that in every industry, there are many jobs, such as boxing products and shipping, that have the same hazards. In occupational health that old hazards, even when they are controlled in one industry, never disappear for long: they reappear in new industries and new technologies, where professionals are unfamiliar with them and do not expect them. Among the industries discussed are biomedical research and biotechnology, pharmaceuticals, chemicals, electronics, energy, heavy manufacturing, light manufacturing, metal fabrication, mining and smelting, paper and pulp manufacturing, plastics, rubber, steel, shipyards, transportation, and wood products.Less
Although there are hazards that may be characteristic to a particular industry or workplace, individual workers may be primarily exposed to hazards that are not common to the industry as a whole. For example, welders in a mine or in a chemical industry are more often exposed to the hazards of welding, not those of mining and chemicals. Another is that in every industry, there are many jobs, such as boxing products and shipping, that have the same hazards. In occupational health that old hazards, even when they are controlled in one industry, never disappear for long: they reappear in new industries and new technologies, where professionals are unfamiliar with them and do not expect them. Among the industries discussed are biomedical research and biotechnology, pharmaceuticals, chemicals, electronics, energy, heavy manufacturing, light manufacturing, metal fabrication, mining and smelting, paper and pulp manufacturing, plastics, rubber, steel, shipyards, transportation, and wood products.
Thomas Banchoff
- Published in print:
- 2011
- Published Online:
- August 2016
- ISBN:
- 9780801449574
- eISBN:
- 9780801460593
- Item type:
- chapter
- Publisher:
- Cornell University Press
- DOI:
- 10.7591/cornell/9780801449574.003.0005
- Subject:
- Political Science, Public Policy
This concluding chapter first discusses three overarching trends revealed by the comparison of embryo politics in United States, United Kingdom, France, Germany from 1968–96 and 1997–2008. These are ...
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This concluding chapter first discusses three overarching trends revealed by the comparison of embryo politics in United States, United Kingdom, France, Germany from 1968–96 and 1997–2008. These are the rise and decline of a structured public debate about the moral status of the embryo and the value of biomedical research; the fading of deeper historical legacies and the rise of more recent institutional constraints as frames for policy struggles; and increasing political salience of embryo, stem cell, and cloning research amid electoral and interest group mobilization. The intersection of these related trends has shaped the evolution of research regimes in all four countries and transformed the shape of embryo politics over time. The chapter then details two controversial areas moving onto the policy agenda: preimplantation genetic diagnosis and genetic enhancement. It concludes by considering the future paths of embryo politics.Less
This concluding chapter first discusses three overarching trends revealed by the comparison of embryo politics in United States, United Kingdom, France, Germany from 1968–96 and 1997–2008. These are the rise and decline of a structured public debate about the moral status of the embryo and the value of biomedical research; the fading of deeper historical legacies and the rise of more recent institutional constraints as frames for policy struggles; and increasing political salience of embryo, stem cell, and cloning research amid electoral and interest group mobilization. The intersection of these related trends has shaped the evolution of research regimes in all four countries and transformed the shape of embryo politics over time. The chapter then details two controversial areas moving onto the policy agenda: preimplantation genetic diagnosis and genetic enhancement. It concludes by considering the future paths of embryo politics.
Frank R. Lichtenberg
- Published in print:
- 2001
- Published Online:
- February 2013
- ISBN:
- 9780226132266
- eISBN:
- 9780226132303
- Item type:
- chapter
- Publisher:
- University of Chicago Press
- DOI:
- 10.7208/chicago/9780226132303.003.0016
- Subject:
- Economics and Finance, Econometrics
In the last century, the average health of the American people has improved dramatically. The mean life expectancy of Americans has increased almost twenty years, or two years per decade, since the ...
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In the last century, the average health of the American people has improved dramatically. The mean life expectancy of Americans has increased almost twenty years, or two years per decade, since the turn of the century. Just from 1979 to 1988, the age-adjusted mortality rate declined 7.2 percent. An important part of this enormous progress in health is probably due to large private and public investments in biomedical research. In 1993, research and development (R&D) in the health care sector accounted for 18 percent of total R&D expenditure in the United States. The National Institutes of Health (NIH) administer about 80 percent of federal health R&D and places a high priority on funding basic research. This chapter describes a simple theoretical model of the allocation of the applied component of public biomedical research expenditure — the approximately 50 percent of expenditure that is of direct, near-term relevance to specific diseases — and presents some empirical evidence about the determinants of this budget allocation.Less
In the last century, the average health of the American people has improved dramatically. The mean life expectancy of Americans has increased almost twenty years, or two years per decade, since the turn of the century. Just from 1979 to 1988, the age-adjusted mortality rate declined 7.2 percent. An important part of this enormous progress in health is probably due to large private and public investments in biomedical research. In 1993, research and development (R&D) in the health care sector accounted for 18 percent of total R&D expenditure in the United States. The National Institutes of Health (NIH) administer about 80 percent of federal health R&D and places a high priority on funding basic research. This chapter describes a simple theoretical model of the allocation of the applied component of public biomedical research expenditure — the approximately 50 percent of expenditure that is of direct, near-term relevance to specific diseases — and presents some empirical evidence about the determinants of this budget allocation.
Thom van Dooren
- Published in print:
- 2014
- Published Online:
- November 2015
- ISBN:
- 9780231162999
- eISBN:
- 9780231531276
- Item type:
- chapter
- Publisher:
- Columbia University Press
- DOI:
- 10.7312/columbia/9780231162999.003.0008
- Subject:
- Public Health and Epidemiology, Public Health
This concluding chapter presents preliminary recommendations about how best to approach the use of racial categories in biomedical theory and practice, given that biomedical progress has always been ...
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This concluding chapter presents preliminary recommendations about how best to approach the use of racial categories in biomedical theory and practice, given that biomedical progress has always been inextricably bound up with commerce in the U.S. The issue, however, is not whether commerce should affect biomedical research or practice, but what the proper balance between commerce and science is. New drug applications should be guided by a strict scrutiny framework similar to that employed in constitutional jurisprudence. Similarly, whenever an applicant uses race in relation to biology before an agent of the state, a justification for the use should be required. Demanding a clear and full articulation of the basis and justification for developing and employing such correlations should be considered an essential starting point for confronting the challenges to come.Less
This concluding chapter presents preliminary recommendations about how best to approach the use of racial categories in biomedical theory and practice, given that biomedical progress has always been inextricably bound up with commerce in the U.S. The issue, however, is not whether commerce should affect biomedical research or practice, but what the proper balance between commerce and science is. New drug applications should be guided by a strict scrutiny framework similar to that employed in constitutional jurisprudence. Similarly, whenever an applicant uses race in relation to biology before an agent of the state, a justification for the use should be required. Demanding a clear and full articulation of the basis and justification for developing and employing such correlations should be considered an essential starting point for confronting the challenges to come.
