Published in:
01-03-2005 | Clinical Commentary
Is it better to consent to an RCT or to care?
Μηδεν αγαν (“nothing in excess”)
Author:
Didier Dreyfuss
Published in:
Intensive Care Medicine
|
Issue 3/2005
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Excerpt
Twenty-five years ago the Belmont report [
1] established a formal distinction between care and research in order to protect patients. The legitimate fear that research might be conducted under the pretence of medical care regardless of whether this increased the risk to patients drove this effort toward clarification. A sound ethical foundation to medical research was deemed essential after the heinous Nazi experiments and the abhorrent 40-year-long Tuskegee syphilis study [
2]. At the time that the Belmont report was issued randomized clinical trials (RCTs) were coming into vogue. An RCT is not routine clinical care, even when the treatments in both study arms are consonant with standard practice. Thus both the ability of RCTs to produce high-quality medical knowledge and the distinction between care and research were considered of paramount importance at the time of the Belmont report [
1]. Whether research should be incorporated into medical care remains controversial, however, as reflected by several recent and conflicting statements of opinion [
3,
4,
5]. …