Biomedical Engineering Reference
In-Depth Information
research, respect for people demands that participants enter into a research
program voluntarily and with good information about the research goals.
2.
Beneficence
is doing good to the individual. In
The Belmont Report
, benefi-
cence is understood in a sense to do no harm and to “maximize possible
benefits and minimize possible harms” to the individual research partici-
pant. “Do no harm” is a Hippocratic principle of medical ethics though
its extension into research implies that “one should not injure one person
regardless of the benefits that might come to others.” Sometimes investi-
gators cannot know that something is harmful until he or she tries it and
in the process of trying, or experimentation, people may be harmed. The
Hippocratic oath also requires that physicians help patients “according to
their best judgment,” but again learning what help may mean exposing a
person to risk. The principle of beneficence obligates both society and the
individual investigator. Society has to consider the long-term benefits and
risks that result from the development of novel devices or procedures that
are the outcome of research. Investigators and their institutions have to
plan to maximize benefits and minimize risks.
3.
Justice
refers to the benefits and harms to individual subjects of research
in
The Belmont Report
. In nineteenth and early twentieth century hospi-
tals, the burdens of experimentation fell upon the poor charity patients
while the rewards of the improved medical care went primarily to the rich
private patients. The Nazi researchers' experimentation on concentration
camp prisoners provides another example of injustice. The benefits and
burdens of research should be justly distributed. The selection of research
participants needs to be constantly monitored to determine whether some
pools of participants are being systematically selected from simply because
they are easily available, vulnerable, or easy to manipulate, rather than
chosen for reasons directly related to the research problem being studied.
Regulation and guidelines concerning the use of human research participants
in the United States and increasingly so in other countries, are based on
The Bel-
mont Report
. However, several philosophers articulated their thoughts on bioethi-
cal methods at around the same time as
The Belmont Report
. Tom Beauchamp and
James Childress published their textbook,
Principles of Biomedical Ethics
, which
was built upon the “four principles approach,” also known as principlism [4]. Ac-
cording to principlism, medical ethical issues should be decided by an appeal to the
four conditional principles; which principle prevails in conflict cases “depends on
the context.”
11.3.3 Institutional Review Board (IRB)
To enforce the protection of the rights and welfare of human subjects in research,
many government agencies have adapted the concept of reviewing the research at
the level of institutions where the work is carried out. An IRB is an independent
ethics committee within an institution (or entity) specially constituted to review
and monitor biomedical research involving human subjects conducted by faculty,
students, and staff at a facility belonging to that institution. IRB is constituted of
