Franklin G. Miller and Joseph J. Fins
- Published in print:
- 2004
- Published Online:
- September 2009
- ISBN:
- 9780198567219
- eISBN:
- 9780191724084
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780198567219.003.0009
- Subject:
- Neuroscience, Behavioral Neuroscience
This chapter elucidates ethical considerations in designing and carrying out clinical research on people with brain disorders based on an approach to research ethics derived from American ...
More
This chapter elucidates ethical considerations in designing and carrying out clinical research on people with brain disorders based on an approach to research ethics derived from American philosophical pragmatism. Focusing on placebo-controlled trials of pharmacological treatments and deep-brain stimulation for psychiatric and neurological disorders, the chapter reflects how moral principles and standards can conflict when applied to contextually complex situations. To guide ethical judgment, it calls for a careful balancing of morally relevant considerations and an understanding of moral norms rather than categorical or absolute rules.Less
This chapter elucidates ethical considerations in designing and carrying out clinical research on people with brain disorders based on an approach to research ethics derived from American philosophical pragmatism. Focusing on placebo-controlled trials of pharmacological treatments and deep-brain stimulation for psychiatric and neurological disorders, the chapter reflects how moral principles and standards can conflict when applied to contextually complex situations. To guide ethical judgment, it calls for a careful balancing of morally relevant considerations and an understanding of moral norms rather than categorical or absolute rules.
Franklin G. Miller
- Published in print:
- 2009
- Published Online:
- February 2010
- ISBN:
- 9780195335149
- eISBN:
- 9780199866335
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195335149.003.0015
- Subject:
- Philosophy, Moral Philosophy
This chapter considers the scope and limits of consent to participate in research. Following discussion of a famous historical case of clinical research without informed consent, it examines the ...
More
This chapter considers the scope and limits of consent to participate in research. Following discussion of a famous historical case of clinical research without informed consent, it examines the therapeutic misconception and the justifiability of research without consent.Less
This chapter considers the scope and limits of consent to participate in research. Following discussion of a famous historical case of clinical research without informed consent, it examines the therapeutic misconception and the justifiability of research without consent.
Steven Epstein
- Published in print:
- 2010
- Published Online:
- September 2010
- ISBN:
- 9780195388299
- eISBN:
- 9780199866519
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195388299.003.0006
- Subject:
- Political Science, American Politics
Epstein considers collective efforts to transform federal health regulations guiding clinical research. Since 1986, federal laws, policies, and guidelines have either required or encouraged ...
More
Epstein considers collective efforts to transform federal health regulations guiding clinical research. Since 1986, federal laws, policies, and guidelines have either required or encouraged researchers to include women, racial and ethnic minorities, children, the elderly, and other groups within clinical research populations. This chapter analyzes the rise of the “anti‐standardization resistance movement” that led to these institutional changes in law and policy. Epstein argues that the success of this effort depended in part on the hybrid character of the reformers' work. Specifically, the reform project was hybrid in its formal composition (consisting of a tacit coalition of numerous overlapping health movements); in its social basis (combining disease‐specific activism with activism organized around social identities); in its knowledge politics (crossing the lines that supposedly divide laypeople from experts); in its power politics (encompassing ordinary people as well as elites, and biomedical outsiders as well as insiders); in its social location (crossing boundaries between civil society, market institutions, and the state); and in its tactics (combining reformist and radical approaches). While the hybrid character of the reform effort created a risk of internal conflict, Epstein argues that it also created important opportunities for the successful framing of the political project.Less
Epstein considers collective efforts to transform federal health regulations guiding clinical research. Since 1986, federal laws, policies, and guidelines have either required or encouraged researchers to include women, racial and ethnic minorities, children, the elderly, and other groups within clinical research populations. This chapter analyzes the rise of the “anti‐standardization resistance movement” that led to these institutional changes in law and policy. Epstein argues that the success of this effort depended in part on the hybrid character of the reformers' work. Specifically, the reform project was hybrid in its formal composition (consisting of a tacit coalition of numerous overlapping health movements); in its social basis (combining disease‐specific activism with activism organized around social identities); in its knowledge politics (crossing the lines that supposedly divide laypeople from experts); in its power politics (encompassing ordinary people as well as elites, and biomedical outsiders as well as insiders); in its social location (crossing boundaries between civil society, market institutions, and the state); and in its tactics (combining reformist and radical approaches). While the hybrid character of the reform effort created a risk of internal conflict, Epstein argues that it also created important opportunities for the successful framing of the political project.
Katherine Wade
- Published in print:
- 2016
- Published Online:
- May 2016
- ISBN:
- 9780719099465
- eISBN:
- 9781526104410
- Item type:
- chapter
- Publisher:
- Manchester University Press
- DOI:
- 10.7228/manchester/9780719099465.003.0012
- Subject:
- Sociology, Culture
This chapter focuses on two key areas which require further clarity and elaboration in the context of research with children, namely, the requirements for research which does not offer the child the ...
More
This chapter focuses on two key areas which require further clarity and elaboration in the context of research with children, namely, the requirements for research which does not offer the child the prospect of a direct benefit and the provisions around child assent and parental consent. The chapter examines legal and ethical guidance regarding these issues, setting out areas of uncertainty and ambiguity between the various governing instruments. It argues that the lack of clarity in these areas needs to be addressed in order to provide a robust system of protection for children, parents and those involved in clinical research with children. It makes proposals for reform drawing on the legal, ethical and academic guidance in the area and best practice in other countries.Less
This chapter focuses on two key areas which require further clarity and elaboration in the context of research with children, namely, the requirements for research which does not offer the child the prospect of a direct benefit and the provisions around child assent and parental consent. The chapter examines legal and ethical guidance regarding these issues, setting out areas of uncertainty and ambiguity between the various governing instruments. It argues that the lack of clarity in these areas needs to be addressed in order to provide a robust system of protection for children, parents and those involved in clinical research with children. It makes proposals for reform drawing on the legal, ethical and academic guidance in the area and best practice in other countries.
Jack Morrell
- Published in print:
- 1997
- Published Online:
- October 2011
- ISBN:
- 9780198206576
- eISBN:
- 9780191677229
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780198206576.003.0006
- Subject:
- History, British and Irish Modern History, History of Science, Technology, and Medicine
This chapter examines the developments in the teaching of biomedical sciences at Oxford University in England from 1914 to 1939. Though the medical faculty was established in 1885, its teaching and ...
More
This chapter examines the developments in the teaching of biomedical sciences at Oxford University in England from 1914 to 1939. Though the medical faculty was established in 1885, its teaching and research had little to do with the care and the cure of patients in local hospitals. The objective of the medical school was to give a broad and liberal education in biomedical sciences while avoiding the vocational element in teaching. In 1930, Oxford's first college fellow in medicine acknowledged that preclinical scientific studies pursued at Oxford tended to be divorced from actual clinical experience.Less
This chapter examines the developments in the teaching of biomedical sciences at Oxford University in England from 1914 to 1939. Though the medical faculty was established in 1885, its teaching and research had little to do with the care and the cure of patients in local hospitals. The objective of the medical school was to give a broad and liberal education in biomedical sciences while avoiding the vocational element in teaching. In 1930, Oxford's first college fellow in medicine acknowledged that preclinical scientific studies pursued at Oxford tended to be divorced from actual clinical experience.
Gillian Currie, Sarah Curtis, and Terry Klassen
- Published in print:
- 2009
- Published Online:
- February 2010
- ISBN:
- 9780199547494
- eISBN:
- 9780191720055
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780199547494.003.14
- Subject:
- Public Health and Epidemiology, Public Health, Epidemiology
Health economics plays an important part in the clinical research and knowledge translation phases of the research process, as well as having a role in health care prioritization and accountability. ...
More
Health economics plays an important part in the clinical research and knowledge translation phases of the research process, as well as having a role in health care prioritization and accountability. This chapter begins by introducing a conceptual framework which depicts the generation and implementation of research evidence as an iterative process comprising clinical research, knowledge translation, and engagement with key stakeholders. Secondly, key aspects of the generation of evidence through clinical research that impact upon decision-making are highlighted. Pediatric research poses unique challenges distinct from that of adult research and the history and complexities of research in this population are discussed. The third section of the chapter presents the role of economics within decision-making. The chapter concludes with ideas for further strengthening decision-making in child health.Less
Health economics plays an important part in the clinical research and knowledge translation phases of the research process, as well as having a role in health care prioritization and accountability. This chapter begins by introducing a conceptual framework which depicts the generation and implementation of research evidence as an iterative process comprising clinical research, knowledge translation, and engagement with key stakeholders. Secondly, key aspects of the generation of evidence through clinical research that impact upon decision-making are highlighted. Pediatric research poses unique challenges distinct from that of adult research and the history and complexities of research in this population are discussed. The third section of the chapter presents the role of economics within decision-making. The chapter concludes with ideas for further strengthening decision-making in child health.
Claire Snowdon, Diana Elbourne, and Jo Garcia
- Published in print:
- 2009
- Published Online:
- September 2009
- ISBN:
- 9780199231461
- eISBN:
- 9780191723858
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780199231461.003.0004
- Subject:
- Public Health and Epidemiology, Public Health, Epidemiology
This chapter examines the decisions of parents of critically ill babies who had not consented to take part in research. Their decisions were based on a misunderstanding of the information they had ...
More
This chapter examines the decisions of parents of critically ill babies who had not consented to take part in research. Their decisions were based on a misunderstanding of the information they had been given. It is suggested that patients may be overburdened with information and perhaps in this kind of case better decisions could be facilitated by providing less information rather than more.Less
This chapter examines the decisions of parents of critically ill babies who had not consented to take part in research. Their decisions were based on a misunderstanding of the information they had been given. It is suggested that patients may be overburdened with information and perhaps in this kind of case better decisions could be facilitated by providing less information rather than more.
Cicely Saunders, Mary Baines, and Robert Dunlop
- Published in print:
- 1995
- Published Online:
- November 2011
- ISBN:
- 9780192625144
- eISBN:
- 9780191730009
- Item type:
- book
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780192625144.001.0001
- Subject:
- Palliative Care, Patient Care and End-of-Life Decision Making, Pain Management and Palliative Pharmacology
The new edition of this book has been updated to incorporate recent advances in both the approach to, and treatment of, the terminally ill. Based on many years of monitoring clinical practice and ...
More
The new edition of this book has been updated to incorporate recent advances in both the approach to, and treatment of, the terminally ill. Based on many years of monitoring clinical practice and research at St Christopher's Hospice, the author presents practical, balanced advice on the general ethical and medical principles of caring for dying patients. This will continue to be an invaluable handbook for all hospice physicians and nurses as a compassionate source of factual information.Less
The new edition of this book has been updated to incorporate recent advances in both the approach to, and treatment of, the terminally ill. Based on many years of monitoring clinical practice and research at St Christopher's Hospice, the author presents practical, balanced advice on the general ethical and medical principles of caring for dying patients. This will continue to be an invaluable handbook for all hospice physicians and nurses as a compassionate source of factual information.
Lorene M. Nelson, Caroline M. Tanner, Stephen Van Den Eeden, and Valarie M. McGuire (eds)
- Published in print:
- 2004
- Published Online:
- September 2009
- ISBN:
- 9780195133790
- eISBN:
- 9780199863730
- Item type:
- book
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195133790.001.0001
- Subject:
- Public Health and Epidemiology, Public Health, Epidemiology
This book provides the foundation for conducting rigorous epidemiologic and clinical research on neurologic disorders. The book has three parts, each emphasizing the unique aspects of studying ...
More
This book provides the foundation for conducting rigorous epidemiologic and clinical research on neurologic disorders. The book has three parts, each emphasizing the unique aspects of studying neurologic disorders. The first focuses on classic principles of epidemiologic and clinical research, including study design, sources of study bias, and methods for assessing the role of environmental and genetic factors in neurologic disorders. The second part covers each of the major neurologic disorders, with an emphasis on the methodologic aspects of studying these disorders and discussion of future research directions. The third part is devoted to clinical and translational research methods, including the design and conduct of clinical trials and prognostic studies, as well as the principles of health services research and evidence-based medicine. Throughout the book, the principles of neuroepidemiology are illustrated with examples from published studies.Less
This book provides the foundation for conducting rigorous epidemiologic and clinical research on neurologic disorders. The book has three parts, each emphasizing the unique aspects of studying neurologic disorders. The first focuses on classic principles of epidemiologic and clinical research, including study design, sources of study bias, and methods for assessing the role of environmental and genetic factors in neurologic disorders. The second part covers each of the major neurologic disorders, with an emphasis on the methodologic aspects of studying these disorders and discussion of future research directions. The third part is devoted to clinical and translational research methods, including the design and conduct of clinical trials and prognostic studies, as well as the principles of health services research and evidence-based medicine. Throughout the book, the principles of neuroepidemiology are illustrated with examples from published studies.
Lorene M. Nelson, Caroline M. Tanner, Stephen K. Van Den Eeden, and Valerie M. McGuire
- Published in print:
- 2004
- Published Online:
- September 2009
- ISBN:
- 9780195133790
- eISBN:
- 9780199863730
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195133790.003.01
- Subject:
- Public Health and Epidemiology, Public Health, Epidemiology
This chapter provides a review of essential concepts, including an overview of the nervous system and methods for diagnosing neurologic disease. Knowledge of the unique characteristics of the nervous ...
More
This chapter provides a review of essential concepts, including an overview of the nervous system and methods for diagnosing neurologic disease. Knowledge of the unique characteristics of the nervous system is essential to the design and conduct of studies of neurologic diseases. The chapter provides an overview of epidemiologic study design, emphasizing aspects that are particularly important in the investigation of neurologic disease. These sections emphasize the importance of defining the research question, choosing the study population, and defining study outcomes. A particular focus is the unique methodological considerations for studying neurological conditions.Less
This chapter provides a review of essential concepts, including an overview of the nervous system and methods for diagnosing neurologic disease. Knowledge of the unique characteristics of the nervous system is essential to the design and conduct of studies of neurologic diseases. The chapter provides an overview of epidemiologic study design, emphasizing aspects that are particularly important in the investigation of neurologic disease. These sections emphasize the importance of defining the research question, choosing the study population, and defining study outcomes. A particular focus is the unique methodological considerations for studying neurological conditions.
- Published in print:
- 2010
- Published Online:
- March 2013
- ISBN:
- 9780226101644
- eISBN:
- 9780226101668
- Item type:
- chapter
- Publisher:
- University of Chicago Press
- DOI:
- 10.7208/chicago/9780226101668.003.0004
- Subject:
- Law, Environmental and Energy Law
This chapter discusses how and why the government and universities got involved in regulating clinical research. It also explains the five types of rules that govern research involving human ...
More
This chapter discusses how and why the government and universities got involved in regulating clinical research. It also explains the five types of rules that govern research involving human subjects: (i) the common law; (ii) the Common Rule; (iii) the special Food and Drug Administration (FDA) rules that apply when studying an unapproved new drug, biologic, or device in a human; (iv) federal privacy laws; and (v) special federal guidelines affecting the manipulation of genes. Case studies are included at the end of the chapter.Less
This chapter discusses how and why the government and universities got involved in regulating clinical research. It also explains the five types of rules that govern research involving human subjects: (i) the common law; (ii) the Common Rule; (iii) the special Food and Drug Administration (FDA) rules that apply when studying an unapproved new drug, biologic, or device in a human; (iv) federal privacy laws; and (v) special federal guidelines affecting the manipulation of genes. Case studies are included at the end of the chapter.
Holger Schünemann, Davina Ghersi, Julia Kreis, Gerd Antes, and Jean Bousquet
- Published in print:
- 2011
- Published Online:
- May 2016
- ISBN:
- 9780262016032
- eISBN:
- 9780262298957
- Item type:
- chapter
- Publisher:
- The MIT Press
- DOI:
- 10.7551/mitpress/9780262016032.003.0006
- Subject:
- Psychology, Health Psychology
Logical arguments support the view that complete, transparent, and objective reporting of research results avoids systematic error, misinformation, and unrealistic expectations. Evidence about ...
More
Logical arguments support the view that complete, transparent, and objective reporting of research results avoids systematic error, misinformation, and unrealistic expectations. Evidence about publication bias (selective publication of research results on the basis of the obtained results), selective outcome reporting bias (reporting on outcomes research depending on the obtained results), increased demand for information by consumers, and ethical considerations supports these logical arguments. Should there be a requirement to publish or report all results? If so, who or what should require the results to be published? What protocols and standards exist for publication and reporting, and how can they help to address the problem? Is the problem solvable? We conclude by summarizing whether the current suggestions are real solutions.Less
Logical arguments support the view that complete, transparent, and objective reporting of research results avoids systematic error, misinformation, and unrealistic expectations. Evidence about publication bias (selective publication of research results on the basis of the obtained results), selective outcome reporting bias (reporting on outcomes research depending on the obtained results), increased demand for information by consumers, and ethical considerations supports these logical arguments. Should there be a requirement to publish or report all results? If so, who or what should require the results to be published? What protocols and standards exist for publication and reporting, and how can they help to address the problem? Is the problem solvable? We conclude by summarizing whether the current suggestions are real solutions.
Charles F. Manski
- Published in print:
- 2019
- Published Online:
- May 2020
- ISBN:
- 9780691194738
- eISBN:
- 9780691195360
- Item type:
- book
- Publisher:
- Princeton University Press
- DOI:
- 10.23943/princeton/9780691194738.001.0001
- Subject:
- Economics and Finance, Econometrics
Although uncertainty is a common element of patient care, it has largely been overlooked in research on evidence-based medicine. This book strives to correct this glaring omission. Applying the tools ...
More
Although uncertainty is a common element of patient care, it has largely been overlooked in research on evidence-based medicine. This book strives to correct this glaring omission. Applying the tools of economics to medical decision making, the book shows how uncertainty influences every stage, from risk analysis to treatment, and how this can be reasonably confronted. In the language of econometrics, uncertainty refers to the inadequacy of available evidence and knowledge to yield accurate information on outcomes. In the context of health care, a common example is a choice between periodic surveillance or aggressive treatment of patients at risk for a potential disease, such as women prone to breast cancer. While these choices make use of data analysis, the book demonstrates how statistical imprecision and identification problems often undermine clinical research and practice. Reviewing prevailing practices in contemporary medicine, the book discusses the controversy regarding whether clinicians should adhere to evidence-based guidelines or exercise their own judgment. It also critiques the wishful extrapolation of research findings from randomized trials to clinical practice. Exploring ways to make more sensible judgments with available data, to credibly use evidence, and to better train clinicians, the book helps practitioners and patients face uncertainties honestly. It concludes by examining patient care from a public health perspective and the management of uncertainty in drug approvals. The book explains why predictability in the field has been limited and furnishes criteria for more cogent steps forward.Less
Although uncertainty is a common element of patient care, it has largely been overlooked in research on evidence-based medicine. This book strives to correct this glaring omission. Applying the tools of economics to medical decision making, the book shows how uncertainty influences every stage, from risk analysis to treatment, and how this can be reasonably confronted. In the language of econometrics, uncertainty refers to the inadequacy of available evidence and knowledge to yield accurate information on outcomes. In the context of health care, a common example is a choice between periodic surveillance or aggressive treatment of patients at risk for a potential disease, such as women prone to breast cancer. While these choices make use of data analysis, the book demonstrates how statistical imprecision and identification problems often undermine clinical research and practice. Reviewing prevailing practices in contemporary medicine, the book discusses the controversy regarding whether clinicians should adhere to evidence-based guidelines or exercise their own judgment. It also critiques the wishful extrapolation of research findings from randomized trials to clinical practice. Exploring ways to make more sensible judgments with available data, to credibly use evidence, and to better train clinicians, the book helps practitioners and patients face uncertainties honestly. It concludes by examining patient care from a public health perspective and the management of uncertainty in drug approvals. The book explains why predictability in the field has been limited and furnishes criteria for more cogent steps forward.
Peter Keating and Alberto Cambrosio
- Published in print:
- 2012
- Published Online:
- September 2013
- ISBN:
- 9780226428918
- eISBN:
- 9780226428932
- Item type:
- chapter
- Publisher:
- University of Chicago Press
- DOI:
- 10.7208/chicago/9780226428932.003.0080
- Subject:
- History, History of Science, Technology, and Medicine
This chapter discusses how clinical cancer trials ceased to be seen as a mere extension of the Cancer Chemotherapy National Service Center (CCNSC) and became an autonomous form of clinical research. ...
More
This chapter discusses how clinical cancer trials ceased to be seen as a mere extension of the Cancer Chemotherapy National Service Center (CCNSC) and became an autonomous form of clinical research. First, it discusses the reorganization of screening and clinical trials in the United States. It also discusses the emergence of cooperative cancer research and then examines how surgery and radiotherapy participated in clinical cancer research.Less
This chapter discusses how clinical cancer trials ceased to be seen as a mere extension of the Cancer Chemotherapy National Service Center (CCNSC) and became an autonomous form of clinical research. First, it discusses the reorganization of screening and clinical trials in the United States. It also discusses the emergence of cooperative cancer research and then examines how surgery and radiotherapy participated in clinical cancer research.
Carol M. Ashton and Nelda P. Wray
- Published in print:
- 2013
- Published Online:
- September 2013
- ISBN:
- 9780199968565
- eISBN:
- 9780199346080
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780199968565.003.0012
- Subject:
- Public Health and Epidemiology, Public Health
Linking practice with evidence through payment policy will increase the value we get for the dollars we expend on medical care. But vast uncertainties exist in medicine. How should we proceed when ...
More
Linking practice with evidence through payment policy will increase the value we get for the dollars we expend on medical care. But vast uncertainties exist in medicine. How should we proceed when valid evidence about the benefits and harms of an intervention or course of action does not yet exist? Under conditions of uncertainty of the value of a health service, the best way to protect the interests of both payers as well as patients is to reduce the uncertainty. Payment models like Medicare’s coverage with evidence development incentivize the reduction of uncertainty in medicine through participation in research. These arrangements give the patient access to the item or service in return for contributing to an evidence base. Hearts, minds, and processes must be changed if we are to realize the vision of making evidence generation an inseparable part of the medical interactions that occur in routine clinical practice.Less
Linking practice with evidence through payment policy will increase the value we get for the dollars we expend on medical care. But vast uncertainties exist in medicine. How should we proceed when valid evidence about the benefits and harms of an intervention or course of action does not yet exist? Under conditions of uncertainty of the value of a health service, the best way to protect the interests of both payers as well as patients is to reduce the uncertainty. Payment models like Medicare’s coverage with evidence development incentivize the reduction of uncertainty in medicine through participation in research. These arrangements give the patient access to the item or service in return for contributing to an evidence base. Hearts, minds, and processes must be changed if we are to realize the vision of making evidence generation an inseparable part of the medical interactions that occur in routine clinical practice.
Søren Holm and Søren Madsen
- Published in print:
- 2009
- Published Online:
- September 2009
- ISBN:
- 9780199231461
- eISBN:
- 9780191723858
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780199231461.003.0001
- Subject:
- Public Health and Epidemiology, Public Health, Epidemiology
This chapter considers the question of whether the institutionalized and formalized practice of informed consent in the context of clinical research has been stretched beyond breaking point. It ...
More
This chapter considers the question of whether the institutionalized and formalized practice of informed consent in the context of clinical research has been stretched beyond breaking point. It focuses on the kinds of research where the potential participants are patients (i.e., not healthy volunteers) and where they have some important health interest at stake, usually because they have a serious illness and the research project is a trial of a new therapy. This kind of research includes the standard, double blind, randomized trial, as well as a range of other trial designs. The chapter begins with a brief account of the concept of informed consent and of its possible philosophical justifications. It then analyzes what is known about the way in which potential trial participants make their decisions concerning whether or not to participate and considers the implications of this knowledge for informed consent. Finally, the chapter provides a more theoretical discussion of whether informed consent is the right kind of transfer mechanism for rights to control health information or tissue samples.Less
This chapter considers the question of whether the institutionalized and formalized practice of informed consent in the context of clinical research has been stretched beyond breaking point. It focuses on the kinds of research where the potential participants are patients (i.e., not healthy volunteers) and where they have some important health interest at stake, usually because they have a serious illness and the research project is a trial of a new therapy. This kind of research includes the standard, double blind, randomized trial, as well as a range of other trial designs. The chapter begins with a brief account of the concept of informed consent and of its possible philosophical justifications. It then analyzes what is known about the way in which potential trial participants make their decisions concerning whether or not to participate and considers the implications of this knowledge for informed consent. Finally, the chapter provides a more theoretical discussion of whether informed consent is the right kind of transfer mechanism for rights to control health information or tissue samples.
Carol M. Ashton and Nelda P. Wray
- Published in print:
- 2013
- Published Online:
- September 2013
- ISBN:
- 9780199968565
- eISBN:
- 9780199346080
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780199968565.003.0001
- Subject:
- Public Health and Epidemiology, Public Health
Federal mandates for comparative effectiveness research enacted during the 2000’s are intended to increase the kind of high-quality evidence that doctors and patients need for optimal clinical ...
More
Federal mandates for comparative effectiveness research enacted during the 2000’s are intended to increase the kind of high-quality evidence that doctors and patients need for optimal clinical decision-making. Within the hierarchy of research designs, experimental designs—clinical trials— outweigh non-experimental designs in the ability to provide least-biased estimates that an intervention is likely to provide clinical benefit. Because of steady advances in the methods of clinical trials, we know how to generate high-quality evidence. Yet contemporary medical practice rests on a foundation of shaky scientific evidence. Many clinically-important questions go unstudied, and when they are addressed, research findings are often of dubious validity because weak study designs were used. The utility of syntheses of multiple studies addressing the same clinical question is undermined by variability in the methods and quality across individual studies. Additional funding for comparative effectiveness research will solve some of these problems, but not all.Less
Federal mandates for comparative effectiveness research enacted during the 2000’s are intended to increase the kind of high-quality evidence that doctors and patients need for optimal clinical decision-making. Within the hierarchy of research designs, experimental designs—clinical trials— outweigh non-experimental designs in the ability to provide least-biased estimates that an intervention is likely to provide clinical benefit. Because of steady advances in the methods of clinical trials, we know how to generate high-quality evidence. Yet contemporary medical practice rests on a foundation of shaky scientific evidence. Many clinically-important questions go unstudied, and when they are addressed, research findings are often of dubious validity because weak study designs were used. The utility of syntheses of multiple studies addressing the same clinical question is undermined by variability in the methods and quality across individual studies. Additional funding for comparative effectiveness research will solve some of these problems, but not all.
Carol M. Ashton and Nelda P. Wray
- Published in print:
- 2013
- Published Online:
- September 2013
- ISBN:
- 9780199968565
- eISBN:
- 9780199346080
- Item type:
- book
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780199968565.001.0001
- Subject:
- Public Health and Epidemiology, Public Health
Americans like to believe that the medical care we get from our doctors is based on solid scientific evidence. We hear often that American medical care and medical research are the best in the world. ...
More
Americans like to believe that the medical care we get from our doctors is based on solid scientific evidence. We hear often that American medical care and medical research are the best in the world. Yet between 2003 and 2010, three different laws were enacted, the most recent being the Affordable Care Act of 2010, that mandated new federal investments in a type of clinical research called comparative effectiveness research, research into what works best in medical care. In this book, we tell the story of how—and why—the federal government decided to make comparative effectiveness research an important feature of health reform. Despite significant legislative uptake of policy proposals on comparative effectiveness research, support for federal mandates took dramatic twists and turns as bipartisan alliances fell apart, special interests resisted, public opinion was mobilized, and compromises were reached. We examine where comparative effectiveness research fits in the production of scientific evidence about the benefits and harms of treatments for human diseases and conditions, and offer sobering confirmation that contemporary American medical care falls far short of the evidence-based ideal. While more research is needed, payment policy will be required in order to align medical practice with what the evidence shows works best in specific clinical scenarios, improving patients’ outcomes and enhancing the value of health care expenditures. Moreover, if we are to deal constructively with the vast uncertainties in medical care, policies are needed to make the generation of high-quality evidence an inseparable part of routine medical care.Less
Americans like to believe that the medical care we get from our doctors is based on solid scientific evidence. We hear often that American medical care and medical research are the best in the world. Yet between 2003 and 2010, three different laws were enacted, the most recent being the Affordable Care Act of 2010, that mandated new federal investments in a type of clinical research called comparative effectiveness research, research into what works best in medical care. In this book, we tell the story of how—and why—the federal government decided to make comparative effectiveness research an important feature of health reform. Despite significant legislative uptake of policy proposals on comparative effectiveness research, support for federal mandates took dramatic twists and turns as bipartisan alliances fell apart, special interests resisted, public opinion was mobilized, and compromises were reached. We examine where comparative effectiveness research fits in the production of scientific evidence about the benefits and harms of treatments for human diseases and conditions, and offer sobering confirmation that contemporary American medical care falls far short of the evidence-based ideal. While more research is needed, payment policy will be required in order to align medical practice with what the evidence shows works best in specific clinical scenarios, improving patients’ outcomes and enhancing the value of health care expenditures. Moreover, if we are to deal constructively with the vast uncertainties in medical care, policies are needed to make the generation of high-quality evidence an inseparable part of routine medical care.
Peter Keating and Alberto Cambrosio
- Published in print:
- 2012
- Published Online:
- September 2013
- ISBN:
- 9780226428918
- eISBN:
- 9780226428932
- Item type:
- chapter
- Publisher:
- University of Chicago Press
- DOI:
- 10.7208/chicago/9780226428932.003.0010
- Subject:
- History, History of Science, Technology, and Medicine
This chapter discusses the rise of cancer treatment research. It begins by discussing Dr. Pierre Band's career as a chemotherapist and a cancer clinical trial specialist. It then describes briefly ...
More
This chapter discusses the rise of cancer treatment research. It begins by discussing Dr. Pierre Band's career as a chemotherapist and a cancer clinical trial specialist. It then describes briefly the growth of clinical cancer research and the establishment of institutions such as the Eastern Cooperative Oncology Group (ECOG) and the European Organization for Research and Treatment of Cancer (EORTC). The chapter also provides a historical background of cancer clinical trials and the institutions that performed them. Finally, the chapter provides background information of the field of cancer therapy prior to the emergence of clinical cancer research.Less
This chapter discusses the rise of cancer treatment research. It begins by discussing Dr. Pierre Band's career as a chemotherapist and a cancer clinical trial specialist. It then describes briefly the growth of clinical cancer research and the establishment of institutions such as the Eastern Cooperative Oncology Group (ECOG) and the European Organization for Research and Treatment of Cancer (EORTC). The chapter also provides a historical background of cancer clinical trials and the institutions that performed them. Finally, the chapter provides background information of the field of cancer therapy prior to the emergence of clinical cancer research.
J. A. Muir Gray
- Published in print:
- 2011
- Published Online:
- May 2016
- ISBN:
- 9780262016032
- eISBN:
- 9780262298957
- Item type:
- chapter
- Publisher:
- The MIT Press
- DOI:
- 10.7551/mitpress/9780262016032.003.0007
- Subject:
- Psychology, Health Psychology
The quality of medical research depends on the use of structured protocols. Problems associated with poor quality research reports range from poor design to improper management or irrelevant ...
More
The quality of medical research depends on the use of structured protocols. Problems associated with poor quality research reports range from poor design to improper management or irrelevant research. Structured protocols have been shown to improve reporting, yet implementation and adherence remain major issues for those who fund research as well as for those who publish the results. In addition, the peer-review process used in research selection and publication contains flaws that must be addressed. Priority needs to be given to systematic reviews of randomized controlled trials, as these yield higher quality, stronger evidence than the report of any single controlled trial.Less
The quality of medical research depends on the use of structured protocols. Problems associated with poor quality research reports range from poor design to improper management or irrelevant research. Structured protocols have been shown to improve reporting, yet implementation and adherence remain major issues for those who fund research as well as for those who publish the results. In addition, the peer-review process used in research selection and publication contains flaws that must be addressed. Priority needs to be given to systematic reviews of randomized controlled trials, as these yield higher quality, stronger evidence than the report of any single controlled trial.
