Biomedical Engineering Reference
In-Depth Information
that the responsibility for ensuring that the use of the device is ethically sound would fall
primarily to the IRB of the institution conducting the study.
The ethical concerns posed here can be best comprehended only with a clear understand-
ing of what justifies research in the first place. Ultimately, no matter how much basic
research and animal experimentation has been conducted on a given device, the risks and
benefits it poses for humans cannot be adequately determined until it is actually used on
humans. The benefit of research on humans lies primarily in the generalizable information
that is provided. This information is crucial to medical science's ability to generate new
modes of medical treatment that are both efficacious and safe. Therefore, one condition
for experimentation to be ethically sound is that it must be scientifically sound.
Although scientific soundness is a necessary condition of ethically sound research on
humans, it is not of and by itself sufficient. The human subjects of such research are at risk
of being mere research resources—that is, having value only for the ends of the research.
Human beings are not valuable wholly or solely for the uses to which they can be put. They
are valuable simply by being the kinds of entities they are. To treat them as such is to
respect them as people. Treating individuals as people means respecting their autonomy.
This requirement is met by ensuring that no competent person is subjected to any clinical
intervention without first giving voluntary and informed consent. Furthermore, respect
for people means that the physician will not subject a human to unnecessary risks and will
minimize the risks to patients in required procedures.
Much of the scrutiny that the FDA imposes upon use of unapproved medical devices in
the context of an IDE addresses two conditions of ethically sound research: Is the experi-
ment scientifically sound? and Does it respect the rights of the human subjects involved?
Medical ethicists argue that decreased FDA scrutiny will increase the likelihood that either
or both of these conditions will not be met. This possibility exists because many manufac-
turers of medical devices are, after all, commercial enterprises, companies that are moti-
vated to generate profit and thus to get their devices to market as soon as possible with
as little delay and cost as possible. These self-interest motives are likely, at times, to conflict
with the requirements of ethically sound research and thus to induce manufacturers to fail
to meet these requirements. Profit is not the only motive that might induce manufacturers
to contravene the requirements of ethically sound research on humans. A manufacturer
may sincerely believe that its product offers great benefit to many people and be prompted
to take shortcuts that compromise the quality of the research. Whether the consequences
being sought by the research are desired for reasons of self-interest, altruism, or both, the
ethical issue is the same. Research subjects may be placed at risk of being treated as mere
objects rather than as people.
What about the circumstances under which feasibility studies would take place? Are
these not sufficiently different from the “normal” circumstances of research to warrant
reduced FDA scrutiny? As just noted, manufacturers seek to engage in feasibility studies
in order to investigate new uses of existing devices, to investigate temporary or permanent
implants during the early developmental stages, and to investigate modifications to an
existing device. As also noted, a feasibility study would take place at only one institution
and would involve no more than ten human subjects. Given these circumstances, is the sort
of research that is likely to occur in a feasibility study less likely to be scientifically sound or
to fail to respect people than normal research upon humans in “normal” circumstances?
