Document ID: EPA-HQ-ORD-2006-0187-0058
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-03-31T05:00Z

Declaration
of
Helsinki
RECOMMENDATIONS
GUIDING
DOCTORS
IN
CLINICAL
RESEARCH
Adopted
by
the
18th
World
Medical
Assembly,
Helsinki,
Finland,
1964
INTRODUCTION
It
is
the
mission
of
the
doctor
to
safeguard
the
health
of
the
people.
His
knowledge
and
conscience
are
dedicated
to
the
fulfillment
of
this
mission.

The
Declaration
of
Geneva
of
The
World
Medical
Association
binds
the
doctor
with
the
words:
"
The
health
of
my
patient
will
be
my
first
consideration"
and
the
International
Code
of
Medical
Ethics
which
declares
that
"
Any
act
or
advice
which
could
weaken
physical
or
mental
resistance
of
a
human
being
may
be
used
only
in
his
interest."

Because
it
is
essential
that
the
results
of
laboratory
experiments
be
applied
to
human
beings
to
further
scientific
knowledge
and
to
help
suffering
humanity,
The
World
Medical
Association
has
prepared
the
following
recommendations
as
a
guide
to
each
doctor
in
clinical
research.
It
must
be
stressed
that
the
standards
as
drafted
are
only
a
guide
to
physicians
all
over
the
world.
Doctors
are
not
relieved
from
criminal,
civil
and
ethical
responsibilities
under
the
laws
of
their
own
countries.

In
the
field
of
clinical
research
a
fundamental
distinction
must
be
recognized
between
clinical
research
in
which
the
aim
is
essentially
therapeutic
for
a
patient,
and
the
clinical
research,
the
essential
object
of
which
is
purely
scientific
and
without
therapeutic
value
to
the
person
subjected
to
the
research.

II.
BASIC
PRINCIPLES
1.
Clinical
research
must
conform
to
the
moral
and
scientific
principles
that
justify
medical
research
and
should
be
based
on
laboratory
and
animal
experiments
or
other
scientifically
established
facts.
2
Clinical
research
should
be
conducted
only
by
scientifically
qualified
persons
and
under
the
supervision
of
a
qualified
medical
man.

3
Clinical
research
cannot
legitimately
be
carried
out
unless
the
importance
of
the
objective
is
in
proportion
to
the
inherent
risk
to
the
subject.

4
Every
clinical
research
project
should
be
preceded
by
careful
assessment
of
inherent
risks
in
comparison
to
foreseeable
benefits
to
the
subject
or
to
others.

5
Special
caution
should
be
exercised
by
the
doctor
in
performing
clinical
research
in
which
the
personality
of
the
subject
is
liable
to
be
altered
by
drugs
or
experimental
procedure.
II.
CLINICAL
RESEARCH
COMBINED
WITH
PROFESSIONAL
CARE
2.
In
the
treatment
of
a
sick
person,
the
doctor
must
be
free
to
use
a
new
therapeutic
measure,
if
in
his
judgment
it
offers
hope
of
saving
life,
reestablishing
health,
or
alleviating
suffering.

If
at
all
possible,
consistent
with
patient
psychology,
the
doctor
should
obtain
the
patient's
freely
given
consent
after
the
patient
has
been
given
a
full
explanation.
In
case
of
legal
incapacity,
consent
should
also
be
procured
from
the
legal
guardian;
in
case
of
physical
incapacity
the
permission
of
the
legal
guardian
replaces
that
of
the
patient.

3.
The
doctor
can
combine
clinical
research
with
professional
care,
the
objective
being
the
acquisition
of
new
medical
knowledge,
only
to
the
extent
that
clinical
research
is
justified
by
its
therapeutic
value
for
the
patient.

III.
NON­
THERAPEUTIC
CLINICAL
RESEARCH
4.
In
the
purely
scientific
application
of
clinical
research
carried
out
on
a
human
being,
it
is
the
duty
of
the
doctor
to
remain
the
protector
of
the
life
and
health
of
that
person
on
whom
clinical
research
is
being
carried
out.

5.
The
nature,
the
purpose
and
the
risk
of
clinical
research
must
be
explained
to
the
subject
by
the
doctor.

3a.
Clinical
research
on
a
human
being
cannot
be
undertaken
without
his
free
consent
after
he
has
been
informed;
if
he
is
legally
incompetent,
the
consent
of
the
legal
guardian
should
be
procured.

3b.
The
subject
of
clinical
research
should
be
in
such
a
mental,
physical
and
legal
state
as
to
be
able
to
exercise
fully
his
power
of
choice.

3c.
Consent
should,
as
a
rule,
be
obtained
in
writing.
However,
the
responsibility
for
clinical
research
always
remains
with
the
research
worker;
it
never
falls
on
the
subject
even
after
consent
is
obtained.

4a.
The
investigator
must
respect
the
right
of
each
individual
to
safeguard
his
personal
integrity,
especially
if
the
subject
is
in
a
dependent
relationship
to
the
investigator.

4b.
At
any
time
during
the
course
of
clinical
research
the
subject
or
his
guardian
should
be
free
to
withdraw
permission
for
research
to
be
continued.

The
investigator
or
the
investigating
team
should
discontinue
the
research
if
in
his
or
their
judgment,
it
may,
if
continued,
be
harmful
to
the
individual.

*