Infant Vision Laboratory
Velma Dobson, PhD, Departments of Ophthalmology and Psychology
I am being asked to read the following
material to ensure that I am informed of the nature of this
research study and of how my child and I will participate
in it, if I consent to do so. Signing this form will indicate
that I have been so informed and that I give my consent.
Federal regulations require written informed consent prior
to participation in this research study so that I can know
the nature and risks of my child’s participation and can
decide to participate or not participate in a free and informed
I am being invited to allow my child to participate in a
research project investigating how well infants and young
children can see. The purpose of this project is to study
visual development in normal children and in children with
medical problems. The investigators are also trying to develop
better tests for measuring vision in infants and children.
My child and I are being invited to participate because
my child is healthy and can provide information on normal
visual development, or because my child is at risk for vision
problems and I, as a parent, have asked to have my child’s
vision tested. Approximately 200 subjects per year will
be enrolled in this study.
STANDARD ASSESSMENT TECHNIQUES
Visual development of infants and young children can be
evaluated by eye doctors (ophthalmologists and optometrists)
using procedures that are usually different from those used
in this research project.
If I agree to allow my child to participate, he/she will
be shown a series of patterns or lights. For some tests,
both eyes will be tested at the same time, and for other
tests, an eyepatch will be placed over one eye so each eye
can be tested separately. An observer will watch my child’s
face through a small hole to see which of the patterns or
lights my child looks at. In addition, some children will
be asked to look at a pattern of lights on an instrument
that measures whether the child is nearsighted, farsighted,
or has astigmatism. Testing takes 30 to 45 minutes. I will
be able to remain with my child during the test, and I will
be able to ask questions at any time.
There are no known risks of the vision testing procedures.
I may ask for testing to be stopped at any time.
I may receive useful information about my child’s eyes,
and I will be helping the investigator to gain more knowledge
about visual development in infants and young children.
All records will be coded by letters or numbers and will
remain confidential. Representatives of regulatory agencies
(including The University of Arizona Human Subjects Protection
Program) may access your records to ensure quality of study
data and conduct. If I would like, the investigator will
send the results of testing to my child’s medical provider.
I may indicate the person(s) to whom test results should
be sent at the end of this form.
PARTICIPATION COSTS AND SUBJECT COMPENSATION
There is no charge for my child’s participation, nor will
I be compensated financially.
I can obtain further information from the principal investigator
Velma Dobson, PhD at (520) 324-3160. If I have questions
concerning my rights as a research subject, I may call the
Human Subjects Committee office at (520) 626 6721. (If out
of state, use the toll-free number 1-866-278-1455.) If you
would like to contact the Human Subjects Protection Program
via the web, please visit the following website: http://www.irb.arizona.edu/contact/.
Before giving my consent by signing this form, the methods,
inconveniences, risks, and benefits have been explained
to me and my questions have been answered. I may ask questions
at any time and I am free to withdraw my child from the
project at any time without causing bad feelings. My participation
in this project may be ended by the investigator or by the
sponsor for reasons that would be explained. New information
developed during the course of this study which may affect
my willingness to continue in this research project will
be given to me as it becomes available. This consent form
will be filed in an area designated by the Human Subjects
Protection Program with access restricted to the principal
investigator, Velma Dobson, PhD, or authorized representative
of the Ophthalmology Department. I do not give up any of
my legal rights by signing this form. A copy of this signed
consent form will be given to me.
Parent/Legal Guardian's Name
Parent/Legal Guardian's Signature
Please send a report of the results of this test to the
following medical personnel:
Parent’s Initials: ______________ Witness:
I have carefully explained to the subject the nature of
the above project. I hereby certify that to the best of
my knowledge the person who is signing this consent form
understands clearly the nature, demands, benefits, and risks
involved in his/her participation and his/her signature
is legally valid. A medical problem or language or educational
barrier has not precluded this understanding.
Signature of Investigator
Version Date: 02/22/08