Page 57 - Biomedical Engineering and Design Handbook Volume 2, Applications

36 MEDICAL DEVICE DESIGN

2.13 TESTING MEDICAL DEVICES ON HUMAN SUBJECTS

The key issues in regulation of research involving human subjects are parallel to those in preclinical
studies: protecting the rights of subjects and assuring the integrity of the study data.
The current body of ethical standards for medical research on humans grew out of abuses rang-
ing from fiendishly evil to benevolent condescension. In all cases, however, the abuses resulted in an
international consensus that human subjects be given the free choice whether or not to participate in
a study and be fully aware of the risks and benefits of the research.
The most striking examples of neglect of these principles were experiments on prisoners during
World War II. For example, prisoners were submerged in icy water to determine how long they could
survive. This had a supposedly sound scientific purpose in that it determined how long downed
German pilots could survive in the North Sea. However, the cruelty to the prisoner/subjects so out-
raged humanity that a body of ethical thought and purpose developed from it. The Institute of
Medicine organized an international meeting on the topic, which resulted in the Declaration of
Helsinki, the touchstone of medical research ethics. The Declaration of Helsinki has been amended
over the years, but survives as a base level ethical guide for the treatment of human research subjects.
The United States does not have a unified regulatory scheme to cover all human research; rather
the control is segmented by functional purpose. For example, HHS has promulgated regulations gov-
erning human research conducted under government sponsorship, such as through NIH. This is
sometimes known as the Common Rule. Some academic research is not regulated at all on the fed-
eral level. The research of concern in this chapter is that which is directed to testing products for sub-
mission to FDA. This research is heavily regulated by FDA.
There are three sets of regulations encompassing the FDA control of clinical studies:
(1) The informed consent process ∗
(2) Institutional review boards (IRBs) †
(3) The conduct of clinical studies ‡

As discussed above, the process that distinguishes modern clinical research from its checkered
past is called informed consent. It is important to understand this as a process. Although we are
tempted to use the common shorthand and use the term informed consent to refer to a piece of paper
signed by a subject, this paper is not the essence of informed consent. The signed document is but a
record in which the subject recognizes that the process has occurred. FDA views the entire process
of screening and informing the subject to be informed consent.
The elements of informed consent, which are all normally included in a written document, are
(a) Basic elements of informed consent. In seeking informed consent, the following information shall be
provided to each subject:
(1) A statement that the study involves research, an explanation of the purposes of the research and
the expected duration of the subject’s participation, a description of the procedures to be fol-
lowed, and identification of any procedures which are experimental.
(2) A description of any reasonably foreseeable risks or discomforts to the subject.
(3) A description of any benefits to the subject or to others which may reasonably be expected from
the research.
(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be
advantageous to the subject.
(5) A statement describing the extent, if any, to which confidentiality of records identifying the sub-
ject will be maintained and that notes the possibility that the Food and Drug Administration may
inspect the records.
(6) For research involving more than minimal risk, an explanation as to whether any compensation
and an explanation as to whether any medical treatments are available if injury occurs and, if so,
what they consist of, or where further information may be obtained.
∗ Id. § 50.
† Id. pt. 56.
‡ Id. pt. 812.