Consent
Form Language and Readability
The following information
is provided to investigators
to assist in the preparation
of consent forms using language
that potential research subjects
can understand.
The University of Washington
Human Subjects Manual (Part
D.3.b.i., page 5,) states
that informed consent must
be written "in language
readily understandable to
potential subjects." The
language must be tailored
for the intended audience.
Potential subjects drawn
from a pool of university
students can be assumed to
have a reading ability at
grade level 12 or better.
But subjects recruited through
a city newspaper, for example,
cannot be assumed to have
such a high reading level.
The average reading level
in the city of Seattle is
reported to be at grade 6.
Some populations may have
a lower reading level or
may, in fact, be illiterate.
Illiterate subjects:
Subjects who cannot read
at a functional level,
but wish to participate
in research, may be consented
orally as long as the consent
process is witnessed and
they sign their name (or
make their mark) on the
consent form.
Subjects for whom English
is not a first spoken language:
Consent forms should be presented
to potential subjects in
their first language. If
this is not feasible, a competent
translator should be available
to translate the consent
form orally into the subject's
native language. It is the
responsibility of the investigator
to assure that the translator
can accurately translate
both the consent form and
questions and answers about
the research between the
subject and the investigator.
There are several tests
investigators can use, such
as the Frye test, while drafting
their consent forms to make
sure that the language is
not too complex.
Sample Consent Form
Statements -
Original and Revisions
PURPOSE
OF RESEARCH
Original: This
is an optional, volunteer
research study, the purpose
of which is to improve our
understanding of the risks
and mechanisms of transmission
of hepatitis C virus in patients
receiving hemodialysis for
chronic renal disease. [Grade
20]
Revised:
The purpose of this
research is to learn more
about how a disease called
Hepatitis C is spread. We
want to study people who
are on renal dialysis to
see if they have this disease.
We want to see if we can
figure out how they got it.
[Grade 6]
Original: Surgical
correction of a skeletal
disharmony with orthodontics
and orthognathic surgery
has become the standard
of care in certain malocclusions.
[ Grade 17]
Revised: Dentists
often use surgery to correct
bone structure in the mouth
and face. [ Grade 7]
Original: The
purpose of this project
is to study the safety
and effectiveness of an
investigational new X preparation
that has undergone heat
treatment to reduce the
likelihood of transmitting
viruses causing hepatitis
or other viral illnesses.
[Grade 22]
Revised: Sometimes medicines
can have viruses in them.
People who take the medicine
can then get the virus. For
example, sometimes people
who take X can get hepatitis.
The purpose of this study
is to test a new kind of
X. We have treated it with
heat to try to reduce the
chance that it will contain
hepatitis virus. We want
to see if the drug is safe
and effective. [Grade 7]
STUDY PROCEDURES
Original: The choice of
whether you receive the medication
or the placebo is made randomly
and neither you nor the investigator
will know the identity of
the solution used. [Grade
15]
Revised: Half of the people
in this study will get X.
Half will get "placebo" --
drops that look like X but
which have no active medicine
in them. We will make the
decision about who will get
X and who will get the placebo
by chance, like flipping
a coin. Neither you nor the
researcher will know which
one you get. [Grade 7]
Original: If you agree to
take part in this day-long
study, the physician investigator
will examine your throat
with a standard light to
see if it is normal and with
an ultraviolet light to make
sure there is no fluorescent
material present; and examine
your ears, and clear the
ear canal if necessary, to
determine if the tube is
open and there is no infection
in the ear. [Grade 14]
Revised: This study will
take one day. First, the
researcher will look at your
throat with a standard light
and with an ultraviolet light.
Then he will look into your
ears. He will clean your
ear canal, if necessary.
If you have an infection
in your ears, you will not
be able to take part in the
study. [Grade 4]
Original: One
venous blood draw of 49 ml
will be taken for the above
tests. The skin biopsy is
done by a physician who puts
the biopsy site under local
anesthesia (lidocaine) and
uses a 6 mm biopsy punch
(6 mm across, 2-3 mm deep)
to remove the skin sample.
The physician will close
the biopsy site with two
sutures (stitches). [Grade
9]
Revised: We will take about
10 teaspoons of blood from
a vein in your arm for tests.
We will also take a small
piece of skin (a biopsy)
from under your arm. First
we will numb the skin with
lidocaine. Then we will use
a punch machine to take a
piece of skin about the size
of a pea. We will close the
wound with two stitches.
[Grade 3]
CONFIDENTIALITY
Original: The patient's identity
will remain confidential
with respect to unauthorized
personnel. As with every
study involving an investigational
new drug, the FDA will have
access to study data which
may contain identifying information.
The manufacturer of the experimental
X preparation will have access
to the study data; the identifying
information provided will
contain only initials and
unidentifying numbers. [Grade
16]
Revised: Your identity will
remain private. Only the
researchers, the FDA, and
the company that makes X
will know that you took part
in this study. We will remove
your name from your study
records and replace your
name with a code number.
[Grade 7]
ADVERSE EVENTS
Original: If
you suffer an adverse event
as a result of study participation,
you will be treated by the
investigators or referred
for treatment. The costs
of this treatment will be
covered by X, the sponsor
of this study, if the investigator
has not deviated from the
protocol and if you have
been compliant with study
procedures. Payment will
be made over and beyond your
third party carrier or other
government or non-governmental
payer. No other compensation
is available. [Grade 12]
Revised: If you are hurt
as a result of taking part
in this study, we will treat
you or refer you for treatment.
We will not charge you for
this treatment. [Grade 4]
COMPENSATION
Original: As
a token of our appreciation,
we will give you a parking
voucher if you parked at
the University of Washington,
and your child will receive
a small toy and stickers.
Revised: If you park at
the University of Washington,
we will give you a parking
voucher. As a token of our
appreciation, we will give
your child a small toy and
some stickers.
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