In 1974, the passage of the National
Research Act (URL not responding as of 01-20-06) established the National
Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research. (URL not responding as of 01-20-06) The Commission published the Belmont
Report (URL not responding as of 01-20-06) which articulates the basic ethical principles
that guide the conduct of research with human subjects (Please
see Appendix 7
for more information) and form the foundation of 45 CFR 46. Three
principles were defined in the report as basic to the protection
of human subjects: 1) respect, 2) beneficence, and 3) justice.
The HSPCs are guided by the ethical principles set forth in the Belmont
Report. The Commission also published a report on IRBs and a
series of reports on research involving the human fetus,
children, prisoners, and mentally impaired individuals
("those institutionalized as mentally infirm").
Respect
In consideration of respect for persons, investigators are
required to seek voluntary, written informed consent from
potential subjects. Voluntary informed consent means that
subjects are given explicit assurances of the voluntary nature of
their participation in terms that are easy to understand and are
not under duress. The consent form also includes adequate
information about the study that will assist subjects in
intelligently deciding whether to participate in research. In
addition, respect means honoring the privacy of individuals and
maintaining their confidentiality. Respect for minors and
mentally disabled persons requires taking extra precautions to
protect those individuals who are immature or incapacitated,
perhaps even to the extent of excluding them from participation
in certain research. The extent of protection depends on the
risks and benefits of the research to the participants.
Beneficence
The principle of beneficence requires that researchers
maximize the potential benefits to the subjects and minimize the
potential risks of harm. Benefits to the subjects, or in the form
of generalized knowledge gained from the research, should always
outweigh the risks. Finally, if there are any risks resulting
from participation in the research, then there must be benefits,
either to the subject, or to humanity or society in general.
Justice
The principle of justice means that subjects are selected
fairly and that the risks and benefits of research are
distributed equitably. Investigators should take precautions not
to systematically select subjects simply because of the
subjects’ easy availability, their compromised position, or
because of social, racial,
sexual,
economic, or cultural biases institutionalized in society.
Investigators should base inclusion criteria on those factors
that most effectively and soundly address the research problem.
Contact OPRS
October 29, 2004
Contact Webmaster
|
