Clinical Pharmacology Conference
PAST AND PRESENT LESSONS IN THE ETHICS OF
CLINICAL
RESEARCH
The ethics of clinical research are longstanding. These issues have been
discussed since long before the advent of federal regulations, and
continue
to test our sense of morally acceptable research. This presentation will
discuss some of these issues in light of some recent findings. Many of
these issues will be familiar, but I hope to offer some new insights into
their origins approaches to their resolution.
I will focus on five overlapping and recurring issues: quality of
informed
consent, confusion between research and therapy, therapeutic
misconception,
blurring roles and potential for conflict of interest in some cases of
physicians who are also investigators, and overarching trust by subjects
in researchers, institutions and the research process.
New research on all of these issues from both a historical and
contemporary
perspective comes from the literature and recent federal efforts. Some
examples:
-
Interviews with researchers active during the Cold War indicated
that
consent was not obtained from sick hospitalized patients in research even
though consent was obtained from healthy subjects. The first formal
policy
requiring written informed consent was implemented at the NIH Clinical
Center in 1966.
- The US Department of Defense (DoD) had a policy requiring informed
consent and other safeguards for research subjects in DoD-sponsored
research as early as 1953, but it was largely ignored. In fact, part of
the problem may have been that this policy was classified Top Secret.
- A 1995 study of 125 IRB-approved and government funded research
protocols found that 14% of the proposals raised significant ethical
concerns. When only greater than minimal risk studies are considered,
almost 30 percent of the proposals reviewed raised significant ethical
concerns.
- Research subjects misinterpret the risk and benefit of research
participation, engaging in what has come to be called the "therapeutic
misconception." A 1994 study showed that even in Phase I trials, the vast
majority of subjects and a majority of referring physicians surveyed
stated
that they believed research would benefit subjects.
- A 1995 study showed that some proportion (less than 10%) of research
subjects believe they are not in research but are receiving therapy.
Conversely, a similar proportion of patients who are not in research
believe that they are. This points out the confusion between research and
therapy on the part of patient-subjects.
In spite of the above and other examples, research subjects still have
overarching trust in research and those who carry it out. They trust
researchers and the physicians who recommend participation; they trust
hospitals, in which research is carried out; and they trust the system of
rules and regulations, which protects their rights and interests.
This presentation will examine some of the historical and current evidence
and analysis around the five issues noted, and will conclude with what the
future holds in terms of the ethics of clinical research.
Co-sponsored by the UB Department
of Medicine, Divison of Clinical
Pharmacology, and Millard Fillmore Clinical
Pharmacokinetics Lab.
Return to Bioethics Events Page.