Document ID: EPA-HQ-ORD-2006-0384-0074
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-07-12T04:00Z

Science
Criteria
for
Review
of
Human
Studies
Protocols
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Human
Studies
Review
Board
June
28,
2006
General
Scientific
Criteria
(
1)

°
What
is
the
scientific
question
addressed
by
the
study?

°
Are
existing
data
adequate
to
answer
the
scientific
question?

°
Are
new
studies
involving
human
subjects
necessary
to
answer
the
question?
General
Scientific
Criteria
(
2)

°
What
are
the
potential
benefits
of
the
study?

°
What
is
the
likelihood
that
the
benefits
will
be
realized?

°
What
are
the
risks?

°
Is
potential
risk
serious
or
irreversible?
Study
Design
Criteria
(
1)

°
Is
the
purpose
of
the
study
clearly
defined?

°
Are
there
specific
objectives/

hypotheses?

°
Can
the
study
as
described
achieve
these
objectives
or
test
these
hypotheses?
Study
Design
Criteria
(
2)

°
What
is
the
sample
size
and
how
is
it
derived?

°
What
is
the
basis
for
the
proposed
dose
levels
and
formulations
in
the
study?

°
Is
there
a
plan
allocating
individuals
to
treatment?

°
Can
the
findings
from
this
study
be
generalized
beyond
the
study
sample?
Participation
Criteria
°
Is
there
a
justification
for
the
selection
of
target
population?

°
Are
participants
representative
of
the
population
of
concern?

°
If
not,
why
not?

°
Are
the
inclusion/
exclusion
criteria
appropriate?

°
Is
the
sample
a
vulnerable
group?
Measurement
Criteria
°
Will
the
measurements
be
accurate
and
reliable?

°
Are
measurements
appropriate
to
the
question
being
asked?

°
Are
adequate
quality
assurance
procedures
described?
Statistical
Analysis
Criteria
°
Can
data
be
statistically
analyzed?

°
Is
the
statistical
method
appropriate
to
answer
the
question?

°
Point
estimates
must
be
accompanied
by
measures
of
uncertainty?
Laboratory
and
Field
Conditions
°
Do
laboratory
conditions
simulate
realworld
conditions?

°
Are
the
field
conditions
representative
of
intended
use?

°
Does
the
protocol
include
a
stop
rule
plan,
medical
management
plan,
and
a
safety
monitor?
(
Risk
Section?)