EPA
Human
Studies
Review
Board
Chair's
Comments
April,
4
2006
Celia
B.
Fisher,
Ph.
D.

Fordham
University
Chair
HSRB
Responsibilities
°
The
Human
Studies
Review
Board
shall
comment
on
the
scientific
and
ethical
aspects
of
research
proposals
and
reports
of
completed
research
with
human
subjects
submitted
by
EPA
for
its
review
and,
on
request,
advise
EPA
on
ways
to
strengthen
its
programs
for
protection
of
human
subjects
of
research.
26.1603
(
b)
Charter
3.
Objectives
and
Scope
of
Activities
°
HSRB
will
provide
advice,
information
and
recommendations
on
issues
related
to
scientific
and
ethical
aspects
of
human
subjects
research.

°
The
major
objectives
are
to
provide
advice
and
recommendations
on:

 
Research
Proposals
and
Protocols
 
Reports
of
completed
research
with
human
subjects;
and
 
How
to
strengthen
EPA's
programs
for
protection
of
human
subjects
of
research.
Board
Process
Board
members
assigned
as
primary
and
secondary
discussants
will
begin
each
board
discussion
1.
Answer
questions
posed
by
EPA
2.
If
applicable
raise
significant
issues
that
were
not
posed
by
EPA
Board
Process
Science
Evaluation
followed
by
Ethics
Evaluation
Rationale:

°
To
be
of
benefit
a
study
must
be
scientifically
valid
(
Nuremberg
Code)

°
Risk­
benefit
ratio
can
only
be
calculated
if
there
is
benefit
Scientific
Aspects
of
Research
°
Did
the
research
design
and
implementation
meet
scientific
standards?

°
Do
the
data
generated
by
the
protocol
have
implications
for
the
Agency's
Weight
of
the
Evidence
(
WOE)
determination
and
when
applicable
aspects
of
the
risk
assessment.
Ethics
Evaluation
1.
Did
the
study
fail
to
fully
meet
specific
ethical
standards
prevalent
at
the
time
the
research
was
conducted?

Examples
°
FIFRA
Section
12(
a)
2(
P)

°
Declaration
of
Helsinki
or
other
International
Code
of
Conduct
for
Research
or
other
well­
established
International
Ethics
Code
°
1991
Common
Rule
40CFR26
(
after
1991
International
Codes
must
be
at
least
equivalent
to
Common
Rule
standards)
If
the
study
did
If
the
study
did
not
not
fully
meet
ethical
fully
meet
ethical
standards
prevalent
at
the
time:

standards
prevalent
at
the
time:
2.
Was
the
conduct
of
the
study
Fundamentally
Unethical?

There
is
clear
and
convincing
evidence
that
the
research
was
intended
to
seriously
harm
participants
or
failed
to
obtain
informed
consent
(
Final
Rule
26.104)
3.
Was
the
conduct
of
the
study
Significantly
Deficient
relative
to
the
ethical
standards
prevailing
at
the
time?

Is
there
is
clear
and
convincing
evidence
that:

a.
The
deficiencies
identified
could
have
resulted
in
serious
harm
(
based
on
knowledge
available
at
the
time
the
study
was
conducted);
or
b.
The
information
provided
to
participants
could
seriously
impair
informed
consent
