Document ID: EPA-HQ-OPP-2003-0132-0239
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-09-02T04:00Z

WORLD
MEDICAL
ASSOCIATION
DECLARATION
OF
HELSINKI
ETHICAL
PRINCIPLES
FOR
MEDICAL
RESEARCH
INVOLVING
HUMAN
SUBJECTS
Adopted
by
the
18th
WMA
General
Assembly
Helsinki,
Finland,
June
1964
and
amended
by
the
29th
WMA
General
Assembly,
Tokyo,
Japan,
October
1975
35th
WMA
General
Assembly,
Venice,
Italy,
October
1983
41st
WMA
General
Assembly,
Hong
Kong,
September
1989
48th
WMA
General
Assembly,
Somerset
West,
Republic
of
South
Africa,
October
1996
52nd
WMA
General
Assembly,
Edinburgh,
Scotland,
October
2000
INTRODUCTION
It
is
the
mission
of
the
physician
to
safeguard
the
health
of
the
people.
His
or
her
knowledge
and
conscience
are
dedicated
to
the
fulfillment
of
this
mission.

The
Declaration
of
Geneva
of
the
World
Medical
Assembly
binds
the
physician
with
the
words.
"
The
health
of
my
patient
will
be
my
first
consideration,"
and
the
International
Code
of
Medical
Ethics
declares
that,
"
A
physician
shall
act
only
in
the
patient s
interest
when
providing
medical
care
which
might
have
the
effect
of
weakening
the
physical
and
mental
condition
of
the
patient."

The
purpose
of
biomedical
research
involving
human
subjects
must
be
to
improve
diagnostic,
therapeutic
and
prophylactic
procedures
and
the
understanding
of
the
aetiology
and
pathogenesis
of
disease.

In
current
medical
practice
most
diagnostic,
therapeutic
or
prophylactic
procedures
involve
hazards.
This
applies
especially
to
biomedical
research.

Medical
progress
is
based
on
research
which
ultimately
must
rest
in
part
on
experimentation
involving
human
subjects.

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

Special
caution
must
be
exercised
in
the
conduct
of
research
which
may
affect
the
environment,
and
the
welfare
of
animals
used
for
research
must
be
respected.

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
every
physician
in
biomedical
research
involving
human
subjects.
They
should
be
kept
under
review
in
the
future.
It
must
be
stressed
that
the
standards
as
drafted
are
only
a
guide
to
physicians
all
over
the
world.
Physicians
are
not
relieved
from
criminal,
civil
and
ethical
responsibilities
under
the
laws
of
their
own
countries.

I.
BASIC
PRINCIPLES
1.
Biomedical
research
involving
human
subjects
must
conform
to
generally
accepted
scientific
principles
and
should
be
based
on
adequately
performed
laboratory
and
animal
experimentation
and
on
a
thorough
knowledge
of
the
scientific
literature.

2.
The
design
and
performance
of
each
experimental
procedure
involving
human
subjects
should
be
clearly
formulated
in
an
experimental
protocol
which
should
be
transmitted
for
consideration,
comment
and
guidance
to
a
specially
appointed
committee
independent
of
the
investigator
and
the
sponsor
provided
that
this
independent
committee
is
in
conformity
with
the
laws
and
regulations
of
the
country
in
which
the
research
experiment
is
performed.

3.
Biomedical
research
involving
human
subjects
should
be
conducted
only
by
scientifically
qualified
persons
and
under
the
supervision
of
a
clinically
competent
medical
person.
The
responsibility
for
the
human
subject
must
always
rest
with
a
medically
qualified
person
and
never
rest
on
the
subject
of
the
research,
even
though
the
subject
has
given
his
or
her
consent.

4.
Biomedical
research
involving
human
subjects
cannot
legitimately
be
carried
out
unless
the
importance
of
the
objective
is
in
proportion
to
the
inherent
risk
to
the
subject.

5.
Every
biomedical
research
project
involving
human
subjects
should
be
preceded
by
careful
assessment
of
predictable
risks
in
comparison
with
foreseeable
benefits
to
the
subject
or
to
others.
Concern
for
the
interests
of
the
subject
must
always
prevail
over
the
interests
of
science
and
society.

6.
The
right
of
the
research
subject
to
safeguard
his
or
her
integrity
must
always
be
respected.
Every
precaution
should
be
taken
to
respect
the
privacy
of
the
subject
and
to
minimize
the
impact
of
the
study
on
the
subject s
physical
and
mental
integrity
and
on
the
personality
of
the
subject.

7.
Physicians
should
abstain
from
engaging
in
research
projects
involving
human
subjects
unless
they
are
satisfied
that
the
hazards
involved
are
believed
to
be
predictable.
Physicians
should
cease
any
investigation
if
the
hazards
are
found
to
outweigh
the
potential
benefits.

8.
In
publication
of
the
results
of
his
or
her
research,
the
physician
is
obliged
to
preserve
the
accuracy
of
the
results.
Reports
of
experimentation
not
in
accordance
with
the
principles
laid
down
in
this
Declaration
should
not
be
accepted
for
publication.

9.
In
any
research
on
human
beings,
each
potential
subject
must
be
adequately
informed
of
the
aims,
methods,
anticipated
benefits
and
potential
hazards
of
the
study
and
the
discomfort
it
may
entail.
He
or
she
should
be
informed
that
he
or
she
is
at
liberty
to
abstain
from
participation
in
the
study
and
that
he
or
she
is
free
to
withdraw
his
or
her
consent
to
participation
at
any
time.

The
physician
should
then
obtain
the
subject s
freely­
given
informed
consent,
preferably
in
writing.

10.
When
obtaining
informed
consent
for
the
research
project
the
physician
should
be
particularly
cautious
if
the
subject
is
in
a
dependent
relationship
to
him
or
her
or
may
consent
under
duress.
In
that
case
the
informed
consent
should
be
obtained
by
a
physician
who
Is
not
engaged
in
the
investigation
and
who
is
completely
independent
of
this
official
relationship.

11.
In
case
of
legal
incompetence,
informed
consent
should
be
obtained
from
the
legal
guardian
in
accordance
with
national
legislation.
Where
physical
or
mental
incapacity
makes
it
impossible
to
obtain
informed
consent,
or
when
the
subject
is
a
minor,
permission
from
the
responsible
relative
replaces
that
of
the
subject
in
accordance
with
national
legislation.
Whenever
the
minor
child
is
in
fact
able
to
give
a
consent,
the
minor s
consent
must
be
obtained
in
addition
to
the
consent
of
the
minor s
legal
guardian.

12.
The
research
protocol
should
always
contain
a
statement
of
the
ethical
considerations
involved
and
should
indicate
that
the
principles
enunciated
in
the
present
Declaration
are
complied
with.

II.
MEDICAL
RESEARCH
COMBINED
WITH
CLINICAL
CARE
(
CLINICAL
RESEARCH)

1.
In
the
treatment
of
the
sick
person,
the
physician
must
be
free
to
use
a
new
diagnostic
and
therapeutic
measure,
if
in
his
or
her
judgement
it
offers
hope
of
saving
life,
reestablishing
health
or
alleviating
suffering.

2.
The
potential
benefits,
hazards
and
discomfort
of
a
new
method
should
be
weighed
against
the
advantages
of
the
best
current
diagnostic
and
therapeutic
methods.

3.
In
any
medical
study,
every
patient
­­
including
those
of
a
control
group,
if
any
­­
should
be
assured
of
the
best
proven
diagnostic
and
therapeutic
method.

4.
The
refusal
of
the
patient
to
participate
in
a
study
must
never
interfere
with
the
physicianpatient
relationship.

5.
If
the
physician
considers
it
essential
not
to
obtain
informed
consent,
the
specific
reasons
for
this
proposal
should
be
stated
in
the
experimental
protocol
for
transmission
to
the
independent
committee
(
I,
2).

6.
The
physician
can
combine
medical
research
with
professional
care,
the
objective
being
the
acquisition
of
new
medical
knowledge,
only
to
the
extent
that
medical
research
is
justified
by
its
potential
diagnostic
or
therapeutic
value
for
the
patient.

III.
NON­
THERAPEUTIC
BIOMEDICAL
RESEARCH
INVOLVING
HUMAN
SUBJECTS
(
NON­
CLINICAL
BIOMEDICAL
RESEARCH)

1.
In
the
purely
scientific
application
of
medical
research
carried
out
on
a
human
being,
it
is
the
duty
of
the
physician
to
remain
the
protector
of
the
life
and
health
of
that
person
on
whom
biomedical
research
is
being
carried
out.

2.
The
subjects
should
be
volunteers­­
either
healthy
persons
or
patients
for
whom
the
experimental
designed
is
not
related
to
the
patient s
illness.

3.
The
investigator
or
the
investigating
team
should
discontinue
the
research
if
in
his/
her
or
their
judgement
it
may,
if
continued,
be
harmful
to
the
individual.

4.
In
research
on
man,
the
interest
of
science
and
society
should
never
take
precedence
over
considerations
related
to
the
wellbeing
of
the
subject.