Protocol
CL
Protocol
CL­
001
001
Generic
Template
for
Generic
Template
for
Repellent
Efficacy
Repellent
Efficacy
Testing
Testing
Kevin
Sweeney
Clara
Fuentes
John
Carley
Roger
Gardner
2
Generic
Protocol
Generic
Protocol

Developed
to
submit
annually
to
the
California
Department
of
Pesticide
Regulation

Intended
to
cover
both
laboratory
and
field
studies
of
repellent
performance
against
mosquitoes,
biting
flies,
fleas,
and
ticks

Contains
general
background
information,

especially
concerning
recruiting
practices

Not
really
a
template
for
executable
studies;

cannot
support
full
review
3
CL
CL­
001
Framework
001
Framework
­
1
1.
Value

There
is
potential
societal
benefit
in
developing
additional
safe
and
effective
personal
repellents

Because
of
the
special
attraction
of
biting
arthropods
to
humans
and
their
role
in
disease
transmission,
EPA
requires
testing
with
human
subjects
to
establish
efficacy
2.
Scientific
Validity:
Defer
to
others
4
CL
CL­
001
Framework
001
Framework
­
2
3.
Subject
Selection

Recruiting
methods
are
well
described

No
indication
that
subjects
would
be
subject
to
any
coercion
or
undue
influence,
or
be
recruited
or
enrolled
for
reasons
inconsistent
with
the
goals
of
the
research

Exclusion
factors
ensure
exclusion
of
children
and
pregnant
or
lactating
women,
and
students
of
investigators
5
CL
CL­
001
Framework
001
Framework
­
3
4.
Risk­
Benefit
Ratio

Some
concern
evident
for
risk
reduction

Risk­
benefit
assessment
cannot
be
performed
in
the
generic
case
5.
Independent
Ethics
Review

Unanimously
approved
by
Independent
Investigational
Review
Board,
Inc.,
of
Plantation
FL
 
as
a
template
for
future
research. 


IIRB
is
registered
with
OHRP,
and
is
independent
of
the
investigators
6
CL
CL­
001
Framework
001
Framework
­
4
6.
Informed
Consent

Written
consent
from
all
subjects
promised

Procedures
for
consent
adequate

Promised
generic
consent
form
not
provided
7.
Respect
for
Subjects

Subject
privacy
would
not
be
compromised

Subjects
would
be
free
to
withdraw
7
Applicable
Standards
Applicable
Standards

This
is
a
generic
protocol
for
3rd­
party
intentional
exposure
studies
intended
for
submission
to
EPA
under
the
pesticide
laws.

The
applicable
standards
are:


40
CFR
26,
Subparts
K
and
L

FIFRA
§
12(
a)(
2)(
P)


If
conducted
in
California,
then
California
Code
of
Regulations
Title
3,
Section
6710
8
Deficiencies
Noted
Deficiencies
Noted
­
1
 
Section
4(
G)(
11)
states
that
subjects
"
are
orally
informed
of
the
risks
of
disease
contraction."
The
risk
of
contracting
disease 
and
the
treatment
available
should
it
happen 
should
also
be
discussed
in
writing
in
the
preconsent
information
package.
9
Deficiencies
Noted
Deficiencies
Noted
­
2
 
Section
4(
H)
states
that
"
there
is
no
plan
for
compensation
for
injury
due
to
the
low
levels
of
risk
involved.
.
.
."
The
risk
of
contracting
an
arthropod­
borne
disease
through
participation
in
a
field
test
may
be
low,
but
it
is
not
zero.

Planning
for
the
possibility
that
subjects
may
be
bitten
by
a
disease­
carrying
insect
is
essential
both
to
risk
minimization
and
to
fully
informing
potential
subjects.
10
Deficiencies
Noted
Deficiencies
Noted
­
3
 
The
generic
protocol
should
acknowledge
the
applicable
standards
of
ethical
conduct,
and
the
obligation
of
the
investigators
to
inform
the
cognizant
IRB
and,
if
a
study
is
conducted
in
California,
the
California
Department
of
Pesticide
Regulation,
of
any
amendments
to
or
deviations
from
the
approved
protocol.
