Biomedical Engineering Reference
In-Depth Information
1.
Are honestly informed about risks
2.
Are potentially benefited from the research, either personally or by bring-
ing about a more general good that gratifies them
3.
Are competent to weigh personal risks and benefits
4.
Are specially protected from exploitation if they belong to historically
vulnerable groups, and people with disabilities belong to one or more such
vulnerable groups.
These safeguards should be extrapolated to use contexts, as users may be
supposed to be exposed to some of the same risks (in order to achieve the
same personal benefits) as the test subjects. Currently, some assistive tech-
nology items are not submitted to human subjects testing, which is standard
for prescription drugs.
6
Their evaluation is more like that of bridges and lap-
tops, a combination of construction and product standards with marketing
research. Further, prospective users often are not accorded the opportunity
to be informed of the potential risks and benefits of using each assistive or
prosthetic device, and to consent, other than to be warned about (mis)uses
of devices in attempts to defend against product liability.
1.3.2 Medical Ethics
Many assistive and prosthetic devices are acquired through medical prescrip-
tion. As engineers move into designing devices that are distributed in this way,
6
See [
17
] for an easily understood description of the distinction between FDA require-
ments for Class 3 devices (usually invasive, such as implantable defibrillators) and Class 2
devices such as wheelchairs and communication devices. A review of FDA procedures by
the Institute of Medicine is due in Spring 2011.
For an account of lack of testing in, as an example, wheelchair design, and production
see [
2
]. Cooper writes here:
“Unfortunately, neither the VA nor FDA, or any other US-based agency made the
standards a requirement. This has resulted in a virtual flea market for testing, as
manufacturers and distributors pick and choose which tests to apply, create their
own tests, or even choose to ignore the issue altogether. In the end, wheelchair users,
their families, and their caregivers pay the price.”
See also Alberta Floyd, Individually and as Administrator of the Estate of Jacqueline
Ann Adams, Deceased, et al., Plaintiffs, v. Pride Mobility Products Corp., Defendant.
No. 1:05-CV-00389, United States District Court For The Southern District Of Ohio,
Western Division, 2007 US Dist. Lexis 91287 as an example of court assessments of the
nondispositive role of compliance with RESNA and ANSI standards in regard to wheelchair
design safety issues.
See also [
15
], a policy document that urges expansion of research on and manufacture
of assistive technology products but does not address testing.
Of course, the research of university-based assistive technology researchers and develop-
ers is monitored by institutional research and human subjects committees, but universities
are not central players in marketing assistive technology products.
