Kirstin Borgerson | Dalhousie University (original) (raw)
Uploads
Papers by Kirstin Borgerson
IJFAB: International Journal of Feminist Approaches to Bioethics
The American Journal of Bioethics
The American Journal of Bioethics
The American Journal of Bioethics
The volume of clinical research is increasing exponentially—far beyond our ability to process and... more The volume of clinical research is increasing exponentially—far beyond our ability to process and absorb the results. Given this situation, it may be beneficial to consider reducing the flow at its source. In what follows, I will motivate and critically evaluate the following proposal: researchers should conduct fewer clinical trials. More specifically, I consider whether researchers should be permitted to conduct only clinical research of very high quality and, in turn, whether research ethics committees (RECs) should prohibit all other, lower-quality research, even when it might appear to meet some minimal ethical standard.1 Following a close analysis of the social-value requirement of ethical clinical research, I argue that this proposal is defensible.
(2016) Journal of Evaluation in Clinical Practice 22(4):459-465.
Clinical research has at least three problematic features: it tends to be redundant, secretive, a... more Clinical research has at least three problematic features: it tends to be redundant, secretive, and isolated. Research with these features not only wastes resources and causes harm, it also fails to meet a basic ethical requirement of research: scientific validity. According to a recent editorial in the BMJ, bioethicists and members of research ethics committees have been “notable by their absence” among those exposing persistent problems with clinical research and proposing solutions (Chalmers, Glasziou, and Godlee, BMJ 346, 2013, f105). In this paper I offer a theoretical diagnosis for the complicity of bioethicists and research ethics committees in these ongoing problems, as well as a partial solution in the form of a modified ethical requirement of scientific integrity.
Most phase III clinical trials today are explanatory. Because explanatory, or efficacy, trials te... more Most phase III clinical trials today are explanatory. Because explanatory, or efficacy, trials test hypotheses under ''ideal'' conditions, they are not well suited to providing guidance on decisions made in most clinical care contexts. Pragmatic trials, which test hypotheses under ''usual'' conditions, are often better suited to this task. Yet, pragmatic, or effectiveness, trials are infrequently carried out. This mismatch between the design of clinical trials and the needs of health care professionals is frustrating for everyone involved, and explains some of the challenges inherent in attempts to enhance knowledge translation and encourage evidence-based practice. The situation is more than simply frustrating, however; it is potentially unethical. Clinical trials must be socially valuable in order to (1) warrant the risks they impose on human research subjects and (2) fairly and efficiently assess new clinical interventions. Most bioethicists would agree that trials that have no social value, for instance, because their results do not have the potential to advance clinical care, should not be performed. What is less widely appreciated is that given limited research resources, trials that are more socially valuable should be preferred to trials that are less socially valuable when all else is equal. With respect to clinical trial design, I argue that while explanatory trials often have some social value, many have less social value than their pragmatic counterparts. On the basis of this general ethical assessment, I provide a preliminary defense of the position that clinical researchers should aim to conduct pragmatic trials, that is, that researchers face a burden of justification related to any idealizing elements added to trial designs.
Journal of Evaluation in Clinical Practice, 2015
Journal of Evaluation in Clinical Practice, 2013
Physicians do not always adjust their treatment recommendations in response to the latest researc... more Physicians do not always adjust their treatment recommendations in response to the latest research evidence, even when the research in question is judged to be methodologically rigorous. In his recent paper, 'Compellingness: assessing the practical relevance of clinical research results', Mark Tonelli identifies 12 features of clinical research that help to explain this resistance [1]. These features, which determine how compelling research results are to individual clinicians, are grouped into three categories: (1) epistemic factors; (2) fit with individualized care and patient values; and (3) considerations related to the stewardship of health care resources.
Journal of Evaluation in Clinical Practice, Mar 2013
Editors' introduction to 4th Philosophy of Medicine thematic issue of JECP
Reason and Value: Making Reasoning Fit for Practice, Oct 2012
Editors' introduction to third philosophy of medicine thematic issue of Journal of Evaluation in ... more Editors' introduction to third philosophy of medicine thematic issue of Journal of Evaluation in Clinical Practice
From the Handbook of the Philosophy of Science. Volume 16: Philosophy of Medicine. Volume editor:... more From the Handbook of the Philosophy of Science. Volume 16: Philosophy of Medicine. Volume editor: Fred Gifford. General editors: Dov M. Gabbay, Paul Thagard and John Woods. 2010 Elsevier BV.
… of Evaluation in …, Jan 1, 2011
Journal of Evaluation in Clinical Practice, Jan 1, 2010
Isis, Jan 1, 2011
JSTOR is a not-for-profit service that helps scholars, researchers, and students discover, use, a... more JSTOR is a not-for-profit service that helps scholars, researchers, and students discover, use, and build upon a wide range of content in a trusted digital archive. We use information technology and tools to increase productivity and facilitate new forms of scholarship. For more information about JSTOR, please contact support@jstor.org.
IJFAB: International Journal of Feminist Approaches to Bioethics
The American Journal of Bioethics
The American Journal of Bioethics
The American Journal of Bioethics
The volume of clinical research is increasing exponentially—far beyond our ability to process and... more The volume of clinical research is increasing exponentially—far beyond our ability to process and absorb the results. Given this situation, it may be beneficial to consider reducing the flow at its source. In what follows, I will motivate and critically evaluate the following proposal: researchers should conduct fewer clinical trials. More specifically, I consider whether researchers should be permitted to conduct only clinical research of very high quality and, in turn, whether research ethics committees (RECs) should prohibit all other, lower-quality research, even when it might appear to meet some minimal ethical standard.1 Following a close analysis of the social-value requirement of ethical clinical research, I argue that this proposal is defensible.
(2016) Journal of Evaluation in Clinical Practice 22(4):459-465.
Clinical research has at least three problematic features: it tends to be redundant, secretive, a... more Clinical research has at least three problematic features: it tends to be redundant, secretive, and isolated. Research with these features not only wastes resources and causes harm, it also fails to meet a basic ethical requirement of research: scientific validity. According to a recent editorial in the BMJ, bioethicists and members of research ethics committees have been “notable by their absence” among those exposing persistent problems with clinical research and proposing solutions (Chalmers, Glasziou, and Godlee, BMJ 346, 2013, f105). In this paper I offer a theoretical diagnosis for the complicity of bioethicists and research ethics committees in these ongoing problems, as well as a partial solution in the form of a modified ethical requirement of scientific integrity.
Most phase III clinical trials today are explanatory. Because explanatory, or efficacy, trials te... more Most phase III clinical trials today are explanatory. Because explanatory, or efficacy, trials test hypotheses under ''ideal'' conditions, they are not well suited to providing guidance on decisions made in most clinical care contexts. Pragmatic trials, which test hypotheses under ''usual'' conditions, are often better suited to this task. Yet, pragmatic, or effectiveness, trials are infrequently carried out. This mismatch between the design of clinical trials and the needs of health care professionals is frustrating for everyone involved, and explains some of the challenges inherent in attempts to enhance knowledge translation and encourage evidence-based practice. The situation is more than simply frustrating, however; it is potentially unethical. Clinical trials must be socially valuable in order to (1) warrant the risks they impose on human research subjects and (2) fairly and efficiently assess new clinical interventions. Most bioethicists would agree that trials that have no social value, for instance, because their results do not have the potential to advance clinical care, should not be performed. What is less widely appreciated is that given limited research resources, trials that are more socially valuable should be preferred to trials that are less socially valuable when all else is equal. With respect to clinical trial design, I argue that while explanatory trials often have some social value, many have less social value than their pragmatic counterparts. On the basis of this general ethical assessment, I provide a preliminary defense of the position that clinical researchers should aim to conduct pragmatic trials, that is, that researchers face a burden of justification related to any idealizing elements added to trial designs.
Journal of Evaluation in Clinical Practice, 2015
Journal of Evaluation in Clinical Practice, 2013
Physicians do not always adjust their treatment recommendations in response to the latest researc... more Physicians do not always adjust their treatment recommendations in response to the latest research evidence, even when the research in question is judged to be methodologically rigorous. In his recent paper, 'Compellingness: assessing the practical relevance of clinical research results', Mark Tonelli identifies 12 features of clinical research that help to explain this resistance [1]. These features, which determine how compelling research results are to individual clinicians, are grouped into three categories: (1) epistemic factors; (2) fit with individualized care and patient values; and (3) considerations related to the stewardship of health care resources.
Journal of Evaluation in Clinical Practice, Mar 2013
Editors' introduction to 4th Philosophy of Medicine thematic issue of JECP
Reason and Value: Making Reasoning Fit for Practice, Oct 2012
Editors' introduction to third philosophy of medicine thematic issue of Journal of Evaluation in ... more Editors' introduction to third philosophy of medicine thematic issue of Journal of Evaluation in Clinical Practice
From the Handbook of the Philosophy of Science. Volume 16: Philosophy of Medicine. Volume editor:... more From the Handbook of the Philosophy of Science. Volume 16: Philosophy of Medicine. Volume editor: Fred Gifford. General editors: Dov M. Gabbay, Paul Thagard and John Woods. 2010 Elsevier BV.
… of Evaluation in …, Jan 1, 2011
Journal of Evaluation in Clinical Practice, Jan 1, 2010
Isis, Jan 1, 2011
JSTOR is a not-for-profit service that helps scholars, researchers, and students discover, use, a... more JSTOR is a not-for-profit service that helps scholars, researchers, and students discover, use, and build upon a wide range of content in a trusted digital archive. We use information technology and tools to increase productivity and facilitate new forms of scholarship. For more information about JSTOR, please contact support@jstor.org.