Biomedical Engineering Reference
In-Depth Information
Examples of the latter include various dental devices and contact lenses. Clinical research
involving a significant risk device cannot begin until an institutional review board (IRB)
has approved both the protocol and the informed consent form and the FDA itself has given
permission. This requirement to submit an IDE application to the FDA is waived in the case
of clinical research where the risk posed is insignificant. In this case, the FDA requires only
that approval from an IRB be obtained certifying that the device in question poses only
insignificant risk. In deciding whether to approve a proposed clinical investigation of a
new device, the IRB and the FDA must determine the following:
1.
That risk to subjects is minimized.
2.
That risks to subjects are reasonable in relation to anticipated benefit and knowledge to
be gained.
3.
That subject selection is equitable.
4.
That informed consent materials and procedures are adequate.
5.
That provisions for monitoring the study and protecting patient information are
acceptable.
The FDA allows unapproved medical devices to be used without an IDE in three types of
situations: feasibility studies, emergency use, and treatment use.
2.11 ETHICAL ISSUES IN FEASIBILITY STUDIE
S
In a feasibility study, or “limited investigation,” human research involving the use of a
new device would take place at a single institution and involve no more than ten human
subjects. The sponsor of a limited investigation is required to submit to the FDA a “Notice
of Limited Investigation,” which includes a description of the device, a summary of the
purpose of the investigation, the protocol, a sample of the informed consent form, and a
certification of approval by the responsible medical board. In certain circumstances, the
FDA could require additional information or require the submission of a full IDE applica-
tion or suspend the investigation.
Investigations of this kind are limited to (1) investigations of new uses for existing
devices, (2) investigations involving temporary or permanent implants during the early
developmental stages, and (3) investigations involving modification of an existing device.
To comprehend adequately the ethical issues posed by clinical use of unapproved medi-
cal devices outside the context of an IDE, it is necessary to use the distinctions among prac-
tice, nonvalidated practice, and research elaborated upon in the previous pages. How do
those definitions apply to feasibility studies?
Clearly, the goal of the feasibility study, which is a generalizable knowledge, makes it an
instance of research rather than practice. Manufacturers seek to determine the performance
of a device with respect to a particular patient population in an effort to gain information
about its efficacy and safety. Such information is important in order to determine whether
further studies (animal or human) need to be conducted, whether the device needs modifi-
cation before further use, and the like. The main difference between using an unapproved
device in a feasibility study and using it under the terms of an IDE is that the former would
be subject to significantly less intensive FDA review than the latter. This, in turn, means
