Biomedical Engineering Reference
In-Depth Information
Research in feasibility studies would be done on a very small subject pool, and the harm
of any ethical lapses would likely affect fewer people than if such lapses occurred under
more usual research circumstances. Yet even if the harm done is limited to ten or fewer sub-
jects in a single feasibility study, the harm is still ethically wrong. To wrong ten or fewer
people is not as bad as to wrong in the same way more than ten people, but it is to engage
in wrongdoing nonetheless.
Are ethical lapses more likely to occur in feasibility studies than in studies that take place
within the requirements of an IDE? Although nothing in the preceding discussion provides
a definitive answer to this question, it is a question to which the FDA should give high
priority. The answer to this question might be quite different when the device at issue
is a temporary or permanent implant than when it is an already approved device being
put to new uses or modified in some way. Whatever the contemplated use under the
feasibility studies mechanism, the FDA would be ethically advised not to allow this kind
of exception to IDE use of an unapproved device without a reasonably high level of
certainty that research subjects would not be placed in greater jeopardy than in “normal”
research circumstances.
2.12 ETHICAL ISSUES IN EMERGENCY USE
What about the mechanism for avoiding the rigors of an IDE for emergency use? The
FDA has authorized emergency use in instances where an unapproved device offers the
only alternative for saving the life of a dying patient. However, what if an IDE has not
yet been approved for the device or its use, or an IDE has been approved but the physician
who wishes to use the device is not an investigator under the IDE?
The purpose of emergency use of an unapproved device is to attempt to save a dying
patient's life under circumstances where no other alternative is available. This sort of use
constitutes practice rather than research. Its aim is primary benefit to the patient rather than
provision of new and generalizable information. Because this sort of use occurs before the
completion of clinical investigation of the device, it constitutes a nonvalidated practice.
What does this mean?
First, it means that while the aim of the use is to save the life of the patient, the nature
and likelihood of the potential benefits and risks engendered by use of the device are far
more speculative than in the sort of clinical intervention that constitutes validated practice.
In validated practice, thorough investigation of a device, including preclinical studies,
animal studies, and studies on human subjects, has established its efficacy and safety. The
clinician thus has a well-founded basis upon which to judge the benefits and risks such an
intervention poses for the patient.
It is precisely this basis that is lacking in the case of a nonvalidated practice. Does this
mean that emergency use of an unapproved device should be regarded as immoral? This
conclusion would follow only if there were no basis upon which to make an assessment
of the risks and benefits of the use of the device. The FDA requires that a physician who
engages in emergency use of an unapproved device must have substantial reason to believe
that benefits will exist. This means that there should be a body of preclinical and animal
tests allowing a prediction of the benefit to a human patient.
