Document ID: EPA-HQ-OPP-2003-0132-0009
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-04-02T05:00Z

Initiated:
1964
17.
C
Original:
English
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
and
the
52nd
WMA
General
Assembly,
Edinburgh,
Scotland,
October
2000
Note
of
Clarification
on
Paragraph
29
added
by
the
WMA
General
Assembly,
Washington
2002
A.
INTRODUCTION
1.
The
World
Medical
Association
has
developed
the
Declaration
of
Helsinki
as
a
statement
of
ethical
principles
to
provide
guidance
to
physicians
and
other
participants
in
medical
research
involving
human
subjects.
Medical
research
involving
human
subjects
includes
research
on
identifiable
human
material
or
identifiable
data.

2.
It
is
the
duty
of
the
physician
to
promote
and
safeguard
the
health
of
the
people.
The
physician's
knowledge
and
conscience
are
dedicated
to
the
fulfillment
of
this
duty.

3.
The
Declaration
of
Geneva
of
the
World
Medical
Association
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."

4.
Medical
progress
is
based
on
research
which
ultimately
must
rest
in
part
on
experimentation
involving
human
subjects.

5.
In
medical
research
on
human
subjects,
considerations
related
to
the
well­
being
of
the
human
subject
should
take
precedence
over
the
interests
of
science
and
society.

6.
The
primary
purpose
of
medical
research
involving
human
subjects
is
to
improve
prophylactic,
diagnostic
and
therapeutic
procedures
and
the
understanding
of
the
aetiology
and
pathogenesis
of
disease.
Even
the
best
proven
prophylactic,
diagnostic,
and
therapeutic
methods
must
17.
C
The
Declaration
of
Helsinki
(
Document
17.
C)
is
an
official
policy
document
of
the
World
Medical
Association,
the
global
representative
body
for
physicians.
It
was
first
adopted
in
1964
(
Helsinki,
Finland)
and
revised
in
1975
(
Tokyo,
Japan),
1983
(
Venice,
Italy),
1989
(
Hong
Kong),
1996
(
Somerset­
West,
South
Africa)
and
2000
(
Edinburgh,
Scotland).
Note
of
clarification
on
Paragraph
29
added
by
the
WMA
General
Assembly,
Washington
2002.
2
continuously
be
challenged
through
research
for
their
effectiveness,
efficiency,
accessibility
and
quality.

7.
In
current
medical
practice
and
in
medical
research,
most
prophylactic,
diagnostic
and
therapeutic
procedures
involve
risks
and
burdens.

8.
Medical
research
is
subject
to
ethical
standards
that
promote
respect
for
all
human
beings
and
protect
their
health
and
rights.
Some
research
populations
are
vulnerable
and
need
special
protection.
The
particular
needs
of
the
economically
and
medically
disadvantaged
must
be
recognized.
Special
attention
is
also
required
for
those
who
cannot
give
or
refuse
consent
for
themselves,
for
those
who
may
be
subject
to
giving
consent
under
duress,
for
those
who
will
not
benefit
personally
from
the
research
and
for
those
for
whom
the
research
is
combined
with
care.

9.
Research
Investigators
should
be
aware
of
the
ethical,
legal
and
regulatory
requirements
for
research
on
human
subjects
in
their
own
countries
as
well
as
applicable
international
requirements.
No
national
ethical,
legal
or
regulatory
requirement
should
be
allowed
to
reduce
or
eliminate
any
of
the
protections
for
human
subjects
set
forth
in
this
Declaration.

B.
BASIC
PRINCIPLES
FOR
ALL
MEDICAL
RESEARCH
10.
It
is
the
duty
of
the
physician
in
medical
research
to
protect
the
life,
health,
privacy,
and
dignity
of
the
human
subject.

11.
Medical
research
involving
human
subjects
must
conform
to
generally
accepted
scientific
principles,
be
based
on
a
thorough
knowledge
of
the
scientific
literature,
other
relevant
sources
of
information,
and
on
adequate
laboratory
and,
where
appropriate,
animal
experimentation.

12.
Appropriate
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.

13.
The
design
and
performance
of
each
experimental
procedure
involving
human
subjects
should
be
clearly
formulated
in
an
experimental
protocol.
This
protocol
should
be
submitted
for
consideration,
comment,
guidance,
and
where
appropriate,
approval
to
a
specially
appointed
ethical
review
committee,
which
must
be
independent
of
the
investigator,
the
sponsor
or
any
other
kind
of
undue
influence.
This
independent
committee
should
be
in
conformity
with
the
laws
and
regulations
of
the
country
in
which
the
research
experiment
is
performed.
The
committee
has
the
right
to
monitor
ongoing
trials.
The
researcher
has
the
obligation
to
provide
monitoring
information
to
the
committee,
especially
any
serious
adverse
events.
The
researcher
should
also
submit
to
the
committee,
for
review,
information
regarding
funding,
sponsors,
institutional
affiliations,
other
potential
conflicts
of
interest
and
incentives
for
subjects.

14.
The
research
protocol
should
always
contain
a
statement
of
the
ethical
considerations
involved
and
should
indicate
that
there
is
compliance
with
the
principles
enunciated
in
this
Declaration.
17.
C
The
Declaration
of
Helsinki
(
Document
17.
C)
is
an
official
policy
document
of
the
World
Medical
Association,
the
global
representative
body
for
physicians.
It
was
first
adopted
in
1964
(
Helsinki,
Finland)
and
revised
in
1975
(
Tokyo,
Japan),
1983
(
Venice,
Italy),
1989
(
Hong
Kong),
1996
(
Somerset­
West,
South
Africa)
and
2000
(
Edinburgh,
Scotland).
Note
of
clarification
on
Paragraph
29
added
by
the
WMA
General
Assembly,
Washington
2002.
3
15.
Medical
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
consent.

16.
Every
medical
research
project
involving
human
subjects
should
be
preceded
by
careful
assessment
of
predictable
risks
and
burdens
in
comparison
with
foreseeable
benefits
to
the
subject
or
to
others.
This
does
not
preclude
the
participation
of
healthy
volunteers
in
medical
research.
The
design
of
all
studies
should
be
publicly
available.

17.
Physicians
should
abstain
from
engaging
in
research
projects
involving
human
subjects
unless
they
are
confident
that
the
risks
involved
have
been
adequately
assessed
and
can
be
satisfactorily
managed.
Physicians
should
cease
any
investigation
if
the
risks
are
found
to
outweigh
the
potential
benefits
or
if
there
is
conclusive
proof
of
positive
and
beneficial
results.

18.
Medical
research
involving
human
subjects
should
only
be
conducted
if
the
importance
of
the
objective
outweighs
the
inherent
risks
and
burdens
to
the
subject.
This
is
especially
important
when
the
human
subjects
are
healthy
volunteers.

19.
Medical
research
is
only
justified
if
there
is
a
reasonable
likelihood
that
the
populations
in
which
the
research
is
carried
out
stand
to
benefit
from
the
results
of
the
research.

20.
The
subjects
must
be
volunteers
and
informed
participants
in
the
research
project.

21.
The
right
of
research
subjects
to
safeguard
their
integrity
must
always
be
respected.
Every
precaution
should
be
taken
to
respect
the
privacy
of
the
subject,
the
confidentiality
of
the
patient's
information
and
to
minimize
the
impact
of
the
study
on
the
subject's
physical
and
mental
integrity
and
on
the
personality
of
the
subject.

22.
In
any
research
on
human
beings,
each
potential
subject
must
be
adequately
informed
of
the
aims,
methods,
sources
of
funding,
any
possible
conflicts
of
interest,
institutional
affiliations
of
the
researcher,
the
anticipated
benefits
and
potential
risks
of
the
study
and
the
discomfort
it
may
entail.
The
subject
should
be
informed
of
the
right
to
abstain
from
participation
in
the
study
or
to
withdraw
consent
to
participate
at
any
time
without
reprisal.
After
ensuring
that
the
subject
has
understood
the
information,
the
physician
should
then
obtain
the
subject's
freelygiven
informed
consent,
preferably
in
writing.
If
the
consent
cannot
be
obtained
in
writing,
the
non­
written
consent
must
be
formally
documented
and
witnessed.

23.
When
obtaining
informed
consent
for
the
research
project
the
physician
should
be
particularly
cautious
if
the
subject
is
in
a
dependent
relationship
with
the
physician
or
may
consent
under
duress.
In
that
case
the
informed
consent
should
be
obtained
by
a
well­
informed
physician
who
is
not
engaged
in
the
investigation
and
who
is
completely
independent
of
this
relationship.
17.
C
The
Declaration
of
Helsinki
(
Document
17.
C)
is
an
official
policy
document
of
the
World
Medical
Association,
the
global
representative
body
for
physicians.
It
was
first
adopted
in
1964
(
Helsinki,
Finland)
and
revised
in
1975
(
Tokyo,
Japan),
1983
(
Venice,
Italy),
1989
(
Hong
Kong),
1996
(
Somerset­
West,
South
Africa)
and
2000
(
Edinburgh,
Scotland).
Note
of
clarification
on
Paragraph
29
added
by
the
WMA
General
Assembly,
Washington
2002.
4
24.
For
a
research
subject
who
is
legally
incompetent,
physically
or
mentally
incapable
of
giving
consent
or
is
a
legally
incompetent
minor,
the
investigator
must
obtain
informed
consent
from
the
legally
authorized
representative
in
accordance
with
applicable
law.
These
groups
should
not
be
included
in
research
unless
the
research
is
necessary
to
promote
the
health
of
the
population
represented
and
this
research
cannot
instead
be
performed
on
legally
competent
persons.

25.
When
a
subject
deemed
legally
incompetent,
such
as
a
minor
child,
is
able
to
give
assent
to
decisions
about
participation
in
research,
the
investigator
must
obtain
that
assent
in
addition
to
the
consent
of
the
legally
authorized
representative.

26.
Research
on
individuals
from
whom
it
is
not
possible
to
obtain
consent,
including
proxy
or
advance
consent,
should
be
done
only
if
the
physical/
mental
condition
that
prevents
obtaining
informed
consent
is
a
necessary
characteristic
of
the
research
population.
The
specific
reasons
for
involving
research
subjects
with
a
condition
that
renders
them
unable
to
give
informed
consent
should
be
stated
in
the
experimental
protocol
for
consideration
and
approval
of
the
review
committee.
The
protocol
should
state
that
consent
to
remain
in
the
research
should
be
obtained
as
soon
as
possible
from
the
individual
or
a
legally
authorized
surrogate.

27.
Both
authors
and
publishers
have
ethical
obligations.
In
publication
of
the
results
of
research,
the
investigators
are
obliged
to
preserve
the
accuracy
of
the
results.
Negative
as
well
as
positive
results
should
be
published
or
otherwise
publicly
available.
Sources
of
funding,
institutional
affiliations
and
any
possible
conflicts
of
interest
should
be
declared
in
the
publication.
Reports
of
experimentation
not
in
accordance
with
the
principles
laid
down
in
this
Declaration
should
not
be
accepted
for
publication.

C.
ADDITIONAL
PRINCIPLES
FOR
MEDICAL
RESEARCH
COMBINED
WITH
MEDICAL
CARE
28.
The
physician
may
combine
medical
research
with
medical
care,
only
to
the
extent
that
the
research
is
justified
by
its
potential
prophylactic,
diagnostic
or
therapeutic
value.
When
medical
research
is
combined
with
medical
care,
additional
standards
apply
to
protect
the
patients
who
are
research
subjects.

29.
The
benefits,
risks,
burdens
and
effectiveness
of
a
new
method
should
be
tested
against
those
of
the
best
current
prophylactic,
diagnostic,
and
therapeutic
methods.
This
does
not
exclude
the
use
of
placebo,
or
no
treatment,
in
studies
where
no
proven
prophylactic,
diagnostic
or
therapeutic
method
exists.

30.
At
the
conclusion
of
the
study,
every
patient
entered
into
the
study
should
be
assured
of
access
to
the
best
proven
prophylactic,
diagnostic
and
therapeutic
methods
identified
by
the
study.
17.
C
The
Declaration
of
Helsinki
(
Document
17.
C)
is
an
official
policy
document
of
the
World
Medical
Association,
the
global
representative
body
for
physicians.
It
was
first
adopted
in
1964
(
Helsinki,
Finland)
and
revised
in
1975
(
Tokyo,
Japan),
1983
(
Venice,
Italy),
1989
(
Hong
Kong),
1996
(
Somerset­
West,
South
Africa)
and
2000
(
Edinburgh,
Scotland).
Note
of
clarification
on
Paragraph
29
added
by
the
WMA
General
Assembly,
Washington
2002.
5
31.
The
physician
should
fully
inform
the
patient
which
aspects
of
the
care
are
related
to
the
research.
The
refusal
of
a
patient
to
participate
in
a
study
must
never
interfere
with
the
patientphysician
relationship.

32.
In
the
treatment
of
a
patient,
where
proven
prophylactic,
diagnostic
and
therapeutic
methods
do
not
exist
or
have
been
ineffective,
the
physician,
with
informed
consent
from
the
patient,
must
be
free
to
use
unproven
or
new
prophylactic,
diagnostic
and
therapeutic
measures,
if
in
the
physician's
judgement
it
offers
hope
of
saving
life,
re­
establishing
health
or
alleviating
suffering.
Where
possible,
these
measures
should
be
made
the
object
of
research,
designed
to
evaluate
their
safety
and
efficacy.
In
all
cases,
new
information
should
be
recorded
and,
where
appropriate,
published.
The
other
relevant
guidelines
of
this
Declaration
should
be
followed.

FOOTNOTE:

Note
of
Clarification
on
Paragraph
29
of
the
WMA
Declaration
of
Helsinki
The
WMA
hereby
reaffirms
its
position
that
extreme
care
must
be
taken
in
making
use
of
a
placebocontrolled
trial
and
that
in
general
this
methodology
should
only
be
used
in
the
absence
of
existing
proven
therapy.
However,
a
placebo­
controlled
trial
may
be
ethically
acceptable,
even
if
proven
therapy
is
available,
under
the
following
circumstances:

­
Where
for
compelling
and
scientifically
sound
methodological
reasons
its
use
is
necessary
to
determine
the
efficacy
or
safety
of
a
prophylactic,
diagnostic
or
therapeutic
method;
or
­
Where
a
prophylactic,
diagnostic
or
therapeutic
method
is
being
investigated
for
a
minor
condition
and
the
patients
who
receive
placebo
will
not
be
subject
to
any
additional
risk
of
serious
or
irreversible
harm.

All
other
provisions
of
the
Declaration
of
Helsinki
must
be
adhered
to,
especially
the
need
for
appropriate
ethical
and
scientific
review.

§
§
§
6.10.2002