Document ID: EPA-HQ-ORD-2006-0384-0070
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-07-12T04:00Z

Carroll­
Loye
Protocols
EMD
003
(
Deer
ticks)

004
(
Mosquitoes)

Scott
Carroll,
Ph.
D.

Director
Carroll­
Loye
Biological
Research
Davis,
CA
TITLE:
TEST
OF
PERSONAL
INSECT
REPELLENTS
PROTOCOL
NUMBER:
C­
L 
001
TABLE
OF
CONTENTS
Protocol
(
as
required
by
California
EPA)
1
Experimental
Subject's
Bill
of
Rights
12
Concise
CV
of
Study
Director
13
Protocol
Approval
Signature
14
EFFICACY
TEST
PROTOCOL
PLEASE
NOTE:
This
protocol
is
privileged
and
confidential,
and
is
for
the
sole
use
of
Dr.
Scott
Carroll,
his
agents
and
associates.

TABLE
OF
CONTENTS
Protocol
1
Protocol
Approval
Signatures
12
Appendix:
Test
Material
Formulations
13
1
TITLE:
TEST
OF
PERSONAL
INSECT
REPELLENTS
History

US
EPA
protocol
review
a
courtesy

Cal
EPA
review
mandatory
­
discursive,
"
template"
protocol
required
(­
001)

­
EPA
personnel
as
co­
PI
­
approved
annually
­
approved
by
UCSF
Medical
School
IRB
Present

UCSF
bows
out

Cal
EPA
begins
by­
study
review

Cal­
EPA
suggests
FL­
based
`
IIRB'

SPC
divides
studies
by
target
pest
as
US
EPA
asks
for
protocols
for
HSRB

C­
L­
001
is
artifact 
C­
L 
001:
recruitment

Source(
s):
Participants
are
recruited
by
verbal
networking
through
our
academic
and
personal
communities
of
friends,
neighbors
and
scientists
in
Davis
California.
Individuals
are
recruited
from
the
community
specifically
for
each
study.
Studies
are
not
conducted
with
individuals
from
particular
employers
or
agencies.
Students
in
PI's
laboratory
who
depend
on
him
directly
for
employment
or
scholastically
are
not
eligible
to
participate.
C­
L 
001:
recruitment
2

Initial
Contact
Method:
Initial
contact
is
through
word­
of­
mouth
and
telephone
contact
of
individuals
in
our
Volunteer
Data
Base.

Follow
up
Contact
Method:
Telephone
interview,
personal
interview
with
the
Study
Director
conducted
at
the
Carroll­
Loye
Biological
Research
Offices.
C­
L 
001:
safety

18
point
explication
of
practices
that
promote
subject
comfort
and
safety
Informed
Consent
Form

Research
Related
Injuries

Nature
and
Purpose

Subject
Selection

Study
Duration

Study
Procedures

Study
Design

Screening
Visit

Procedures
ICF
2

Restrictions

Risk/
Discomforts

Measures
will
be
implemented
to
remove
mosquitoes
before
they
have
an
opportunity
to
bite.

Pregnancy
risks

Unknown
/
Unforeseeable
Risks
ICF
3

You
DO
NOT
waive
your
legal
rights
by
signing
this
form.

Right
to
Withdraw
or
Removal
from
the
Study

Treatment
Alternative

Benefits

Offer
to
any
Questions
about
this
Study

Costs
and
Reimbursement

Confidentiality
Inclusion

9.1.1
Inclusion
criteria:

9.1.1.1
Age:
At
least
18
yrs

9.1.1.2
Sex:
Male/
female

9.1.1.3
Race:
Any
race

9.1.1.4
Written
consent
(
see
9.4,
below)
Exclusion
1
9.1.2
Exclusion
criteria:

9.1.2.1
Known
to
be
to
be
hypersensitive
to
mosquito
bites.

9.1.2.2
Known
to
be
to
be
sensitive
to
any
of
the
test
product
ingredients.

9.1.2.3
Poor
physical
condition.

9.1.2.4
Unwilling
to
submit
to
brief
query
about
personal
condition.

9.1.2.5
Not
able
to
write,
and
speak
English
at
approximately
the
University
of
California
college
level.
Exclusion
2

9.1.2.6
Unwilling
to
refrain
from
use
of
perfumed
products,
alcoholic
beverages
or
smoking
after
9
PM
the
evening
preceding
the
test
and
throughout
the
test.

9.1.2.7
Known
to
be
pregnant
or
lactating.
Pregnancy
will
be
self­
checked
by
each
female
volunteer
on
the
morning
of
the
repellent
test
using
an
OTC
test
kit
provided
by
the
Study
Director.
Results
of
each
such
test
will
be
immediately
verified
by
direct
inspection
by
a
female
technician
trained
to
make
that
assessment.
Only
volunteers
scored
as
nonpregnant
will
be
allowed
to
participate.
Consenting
procedures
1

We
contact
subjects
who
participated
in
previous
Carroll­

Loye
repellent
efficacy
tests
by
selecting
them
from
our
Volunteer
Database.
At
that
time
interested
individuals
often
ask
if
one
or
more
of
their
lab
mates
or
acquaintances
can
participate
as
well.
All
such
potential
participants
are
screened
or
re­
screened
for
suitability
for
each
test
in
a
private,
one­
on­
one
conversation
held
at
the
office
of
the
Principal
Investigator
(
PI).
The
Exclusion
Criteria
(
section
9.1.2)
are
exercised
by
asking
each
candidate
to
address
them
in
the
interview
with
the
PI.
It
is
explained
that
pregnancy
will
be
assessed
directly
in
on
the
test
day.
The
PI
encourages
candidates
to
ask
questions
and
ask
for
clarification
at
any
time
during
the
interview
and
in
all
activities
that
follow.
Consenting
procedures
2

To
candidates
that
pass
screening
the
PI
describes
the
test
purpose
in
plain
language
(
in
English),
and
the
procedures
and
comportment
to
be
followed
are
described
in
detail.
Candidates
are
then
asked
if
they
would
like
to
retire
from
consideration
at
that
point.
If
they
wish
to
remain
in
consideration,
it
is
explained
and
emphasized
that
they
may
withdraw
from
the
test
at
any
time
during
the
test
without
penalty
to
their
compensation.
Candidates
are
given
copies
of
the
State
of
California
Department
of
Pesticide
Regulation
`
Experimental
Subjects'
Bill
of
Rights'
to
read
as
the
PI
reads
it
aloud.
They
are
also
given
a
copy
of
the
IRB­
approved
consent
form
to
read
as
the
PI
reads
it
aloud.
The
amount
and
form
of
compensation
is
described.
Consenting
procedures
3

They
are
again
encouraged
to
ask
any
questions
they
have
about
the
test,
which
may
include
understanding
its
purpose
more
fully,
understanding
risks
and
discomforts
more
fully,
and
understanding
treatment
and
compensation
for
injury
more
fully.

While
the
majority
of
our
subjects
have
worked
with
us
on
an
occasional
basis
for
a
number
of
years,
we
encourage
them
to
personally
evaluate
their
interests
and
concerns
about
participation
seriously
each
time.
Consenting
procedures
4

We
ask
them
not
to
sign
on
immediately
but
to
give
the
situation
due
consideration
(
normally
at
least
one
day,

sometimes
less
for
those
who
have
participated
in
multiple
prior
studies).
Because
most
of
the
volunteers
are
researchers
and/
or
have
advanced
degrees
in
life
sciences,
we
regard
their
motivations
and
decisions
to
participate
as
being
unusually
well
considered
and
well
informed.
Accordingly,
we
normally
accept
their
decisions
to
participate
if
they
so
choose
following
due
consideration.
Nonetheless,
the
PI
retains
the
final
right
to
refuse
participation
to
any
candidate.