Regulatory
Basis
for
Regulatory
Basis
for
Protocol
Review
Protocol
Review
John
M.
Carley
Office
of
Pesticide
Programs
2
§
26.1125
Prior
submission
of
proposed
26.1125
Prior
submission
of
proposed
human
research
for
EPA
review
human
research
for
EPA
review
Any
person
or
institution
who
intends
to
conduct
or
sponsor
human
research
covered
by
§
26.1101(
a)

shall,
after
receiving
approval
from
all
appropriate
IRBs,
submit
to
EPA
prior
to
initiating
such
research

all
information
relevant
to
the
proposed
research
specified
by
§
26.1115(
a),
and

the
following
additional
information,
to
the
extent
not
already
included:
3
IRB
Records
specified
by
IRB
Records
specified
by
§
26.1115(
a)

26.1115(
a)

§
1115(
a)(
1):
Copies
of

all
research
proposals
reviewed,


scientific
evaluations,
if
any,
that
accompany
the
proposals,


approved
sample
consent
documents,


progress
reports
submitted
by
investigators,

and
reports
of
injuries
to
subjects.
4
IRB
Records
specified
by
IRB
Records
specified
by
§
26.1115(
a)

26.1115(
a)

§
1115(
a)(
2):
Minutes
of
IRB
meetings
which
shall
be
in
sufficient
detail
to
show

attendance
at
the
meetings;


actions
taken
by
the
IRB;


the
vote
on
these
actions
including
the
number
of

members
voting
for,
against,
and
abstaining;


the
basis
for
requiring
changes
in
or
disapproving
research;


a
written
summary
of
the
discussion
of
controverted
issues
and
their
resolution.
5
IRB
Records
specified
by
IRB
Records
specified
by
§
26.1115(
a)

26.1115(
a)

§
1115(
a)(
4):
Copies
of
all
correspondence
between
the
IRB
and
the
investigators.

§
1115(
a)(
5):


A
list
of
IRB
members
identified
by
name;
earned
degrees;

representative
capacity;
indications
of
experience
such
as
board
certifications,
licenses,
etc.,
sufficient
to
describe
each
member s
chief
anticipated
contributions
to
IRB
deliberations;


any
employment
or
other
relationship
between
each
member
and
the
institution,
for
example,
full­
time
employee,
a
member
of
governing
panel
or
board,
stockholder,
paid
or
unpaid
consultant.
6
IRB
Records
specified
by
IRB
Records
specified
by
§
26.1115(
a)

26.1115(
a)

§
1115(
a)(
6):
Written
procedures
for
the
IRB
in
the
same
detail
as
described
in
§
26.1108(
a)
and
§
26.1108(
b).
7
Additional
Information
Required
by
Additional
Information
Required
by
§
26.1125
26.1125
(
a)
A
discussion
of:

(
1)
The
potential
risks
to
human
subjects
(
2)
The
measures
proposed
to
minimize
risks
to
the
human
subjects
(
3)
The
nature
and
magnitude
of
all
expected
benefits
of
such
research,
and
to
whom
they
would
accrue
(
4)
Alternative
means
of
obtaining
information
comparable
to
what
would
be
collected
through
the
proposed
research
(
5)
The
balance
of
risks
and
benefits
of
the
proposed
research
8
Additional
Information
Required
by
Additional
Information
Required
by
§
26.1125
26.1125
(
b)
All
information
for
subjects
and
written
informed
consent
agreements
as
originally
provided
to
the
IRB,

and
as
approved
by
the
IRB
(
c)
Information
about
how
subjects
will
be
recruited,

including
any
advertisements
proposed
to
be
used
(
d)
A
description
of
the
circumstances
and
methods
proposed
for
presenting
information
to
potential
human
subjects
for
the
purpose
of
obtaining
their
informed
consent
9
Additional
Information
Required
by
Additional
Information
Required
by
§
26.1125
26.1125
(
e)
All
correspondence
between
the
IRB
and
the
investigators
or
sponsors
(
f)
Official
notification
to
the
sponsor
or
investigator,
in
accordance
with
the
requirements
of
this
subpart,
that
research
involving
human
subjects
has
been
reviewed
and
approved
by
an
IRB
10
§
26.1601
EPA
review
of
proposed
26.1601
EPA
review
of
proposed
human
research
human
research
(
a)
EPA
shall
review
all
protocols
submitted
under
§
26.1125
in
a
timely
manner.
With
respect
to
any
research
or
any
class
of
research,
the
Administrator
may
recommend
additional
conditions
which,
in
the
judgment
of
the
Administrator,
are
necessary
for
the
protection
of
human
subjects.
11
§
26.1601
EPA
review
of
proposed
26.1601
EPA
review
of
proposed
human
research
human
research
(
b)
In
reviewing
proposals
covered
by
this
subpart,
the
Administrator
may
take
into
account
[
the
past
record
of
the
investigator
with
respect
to
protection
of
human
subjects.]
12
§
26.1601
EPA
review
of
proposed
26.1601
EPA
review
of
proposed
human
research
human
research
(
c)
When
research
covered
by
subpart
K
takes
place
in
foreign
countries,
.
.
.
if
the
Administrator
determines
that
the
procedures
prescribed
by
the
institution
afford
protections
that
are
at
least
equivalent
to
those
provided
in
subpart
K,
the
Administrator
may
approve
the
substitution
of
the
foreign
procedures
.
.
.
.
13
§
26.1601
EPA
review
of
proposed
26.1601
EPA
review
of
proposed
human
research
human
research
(
d)
Following
initial
evaluation
of
the
protocol
by
Agency
staff,
EPA
shall
submit
the
protocol
and
all
supporting
materials,
together
with
the
staff
evaluation,
to
the
Human
Studies
Review
Board.

(
e)
EPA
shall
notify
the
submitter
of
the
proposal
of
the
results
of
the
EPA
and
Human
Studies
Review
Board
reviews
14
EPA
Completeness
Check:

EPA
Completeness
Check:

Carroll
Carroll­
Loye
Loye
Protocols
Protocols
15
EPA
Completeness
Check:

EPA
Completeness
Check:

Carroll
Carroll­
Loye
Loye
Protocols
Protocols

EPA
reviewed
initial
submission
against
requirements
of
§
1125

EPA
notified
Dr.
Carroll
of
deficiencies

Dr.
Carroll
resubmitted
protocols
with
more
extensive
supporting
materials

IIRB
refused
to
provide
to
Dr.
Carroll
records
of
IRB
membership,
procedures,
or
meeting
minutes
16
EPA
Completeness
Check:

EPA
Completeness
Check:

Carroll
Carroll­
Loye
Loye
Protocols
Protocols

EPA
contacted
IIRB
directly

IIRB
submitted
additional
materials
 
 
 

EPA
Assessment:


A
good
faith
effort
has
been
made
to
address
all
requirements
of
§
1125.


These
protocols
are
completely
enough
described
to
support
review
by
EPA
and
HSRB
