Clinical research in context: The ethics and epistemology of clinical science.
Date
2007
Authors
Anderson, James A.
Journal Title
Journal ISSN
Volume Title
Publisher
Dalhousie University
Abstract
Description
In this essay I argue that the usual understanding of the field of research ethics is too narrowly focused on the protection of research participants. While protection of research participants is undoubtedly a desideratum, it is not the only matter of concern. Research ethics must also concern itself with the protection of patients, since the whole point of clinical research is to derive knowledge that will improve patient care. This second area of concern requires us to attend also to the research agenda itself.
There is, however, a conspicuous lack of serious critical work concerning the research agenda in the research ethics literature. No doubt there are historical and practical reasons for this state of affairs, but I believe the problem is primarily conceptual, and can be traced back to one of the foundational conceptual distinctions in research ethics: the distinction between research and practice.
At least since the seminal work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission) in the 1970's, a fundamental distinction between clinical research and clinical practice has underwritten both conceptual work in research ethics and regulations governing research involving human subjects. I believe that much contemporary interpretation of the distinction between research and practice as drawn by the National Commission in The Belmont Report is off the mark. It seems to me, however, that the distinction as found in The Belmont Report lends itself to such misinterpretation. If the distinction is to play the fundamental role in research ethics that is it supposed to, I believe it needs to be reworked in such a way that it wears its epistemological and metaphysical presuppositions on its shoulder, so to speak. That is my goal in this essay.
The central results of this work are twofold: (1) an enriched understanding of the epistemology of clinical research, a result of interest in its own right; and (2) insight into how to improve research ethics, facilitating both superior protections for research participants and the improvement of clinical practice.
Thesis (Ph.D.)--Dalhousie University (Canada), 2007.
There is, however, a conspicuous lack of serious critical work concerning the research agenda in the research ethics literature. No doubt there are historical and practical reasons for this state of affairs, but I believe the problem is primarily conceptual, and can be traced back to one of the foundational conceptual distinctions in research ethics: the distinction between research and practice.
At least since the seminal work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission) in the 1970's, a fundamental distinction between clinical research and clinical practice has underwritten both conceptual work in research ethics and regulations governing research involving human subjects. I believe that much contemporary interpretation of the distinction between research and practice as drawn by the National Commission in The Belmont Report is off the mark. It seems to me, however, that the distinction as found in The Belmont Report lends itself to such misinterpretation. If the distinction is to play the fundamental role in research ethics that is it supposed to, I believe it needs to be reworked in such a way that it wears its epistemological and metaphysical presuppositions on its shoulder, so to speak. That is my goal in this essay.
The central results of this work are twofold: (1) an enriched understanding of the epistemology of clinical research, a result of interest in its own right; and (2) insight into how to improve research ethics, facilitating both superior protections for research participants and the improvement of clinical practice.
Thesis (Ph.D.)--Dalhousie University (Canada), 2007.
Keywords
Philosophy.