THE BELMONT

REPORT
When the National Research Act was signed into law on July 12, 1974, the
National Commission for the rotection of !uman "u#$ects of %iomedical and
%eha&ioural Research was created' (he Commission was charged with
identifying the #asic ethical )rinci)les that should underlie the condct of
#iomedical and #eha&ioural research in&ol&ing human su#$ects and to de&elo)
guidelines which should #e followed to assure that research is conducted in
accordance with those )rinci)les' *uring their discussions the Commission
considered the #oundaries #etween medical )ractice and research, the role of
assessment of ris+,#enefit in the determination of the a))ro)riateness of
research in&ol&ing human su#$ects, guidelines for the selection of human
su#$ects and the nature and definition of informed consent' (he %elmont
Re)ort thus attem)ts to summari-e the #asic ethical )rinci)les identified #y
the Commission in the course of its deli#erations in .e#ruary 197/' (he
re)ort itself does not ma+e s)ecific recommendations for administrati&e
action, #ut rather its o#$ecti&e is to )ro&ide an analytical framewor+ that will
guide the resolution of ethical )ro#lems arising during research in&ol&ing
human su#$ects'
BASIC ETHICAL PRINCIPLES
1' Respect for Persons ~ all &olunteers are treated as indi&iduals and are
entitled to )rotection'
0nformed Consent1 2'''each su#$ect to the degree they are ca)a#le, #e
gi&en the o))ortunity to choose what shall or shall not ha))en to
them'3
0nformation1 (he e4tent and nature of the information should #e
such that )ersons can decide
whether they wish to )artici)ate in the furthering
of +nowledge' (hat is to say,
consenting indi&iduals are aware that the
)rocedure is neither necessary for their care
nor )erha)s fully understood, and they
understand clearly the range of the ris+s'
Com)rehension1 (he a#ility of a su#$ect to understand is a function
of intelligence, rationality, maturity
and language and therefore it is necessary to
ada)t the )resentation of the
information to the su#$ect5s ca)acities'
0n&estigators are res)onsi#le for ascertaining
that the su#$ect has com)rehended the
information'
6oluntariness1 (he agreement to )artici)ate in research is
considered a &alid consent, if and only if
&oluntarily gi&en under conditions free of coercion
and undue influence'
2' Beneficence
*o not harm
7a4imi-e )ossi#le #enefits and minimi-e )ossi#le harms
Assessment of Ris+s and %enefits
8' Justice ~ 2fairness in distri#ution3
(o each )erson an e9ual share
(o each )erson according to indi&idual need
(o each )erson according to indi&idual effort
(o each )erson according to societal contri#ution
(o each )erson according to merit