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INFANT VISION TESTING LABORATORY


The University of Arizona
Department of Ophthalmology and Vision Science

    
Infant Vision Testing Laboratory


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HIPPA


Authorization for Use and Disclosure of Protected Health Information for Research Parental Form
Vision Testing
Infant Vision Laboratory, Departments of Ophthalmology and Psychology, University of Arizona
Velma Dobson, PhD, Erin M. Harvey, PhD

The United States government has issued a new privacy rule to protect the privacy rights of individuals enrolled in research. The Privacy Rule is designed to protect the confidentiality of an individual’s health information. This document hereafter known as an “Authorization for Use and Disclosure of Protected Health Information for Research” describes my rights and explains how my health information will be used and disclosed for this study.

PURPOSE
My child is being invited to participate voluntarily in the above-titled research project. The purpose of this project is to study visual and motor development in normal children and in children with medical problems. The overall goal is to develop better methods for measuring vision in infants and children.

USE AND DISCLOSURE OF PROTECTED HEALTH INFORMATION
I will provide information about my child’s birth date, due date, and complications at birth. This information will be used to determine my child’s age, premature or full-term status, and whether my child is at risk for eye problems. If I would like a written copy of my child’s test results to be sent to my health care provider(s), I will initial the appropriate area on the “Parental Consent Form” for “Vision Testing” and will provide, on the consent form, the names and addresses of the individuals to which the information should be sent. I have the right to access my PHI that may be created during this study as it relates to my treatment or payment. 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.

CONTACTS
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 Protection Program office at (520) 626-6721.

AUTHORIZATION
I hereby authorize the use or disclosure of my individually identifiable health information. I may withdraw this authorization at any time by notifying the Principal Investigator in writing. The address for the Principal Investigator is Velma Dobson, PhD, The University of Arizona, Department of Ophthalmology, 655 N. Alvernon Way, Tucson, AZ 85711. If I do withdraw my authorization, any information previously disclosed cannot be withdrawn and may continue to be used. Once information about me is disclosed in accordance with this authorization, the individual or organization that receives this may redisclose it and my information may no longer be protected by Federal Privacy Regulations. I may refuse to sign this authorization form. If I choose not to sign this form, I cannot participate in the research study. Refusing to sign will not affect my present or future medical care and will not cause any loss of benefits to which I am otherwise entitled. This authorization will expire on the date the research study ends. I will be given a copy of this signed authorization form.

________________________________________________
Printed Name of Child

______________________________________________
Signature of Subject's Parent/Legal Representative

_______________
Date

______________________________________________
Printed Name of Subject’s Parent/Legal Representative

 

_______________________________
Relationship to the Subject

 


Version Date: 03/07/07

 

Consent Form

 

Parental Consent Form
Vision Testing
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 manner.

PURPOSE
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.

SELECTION CRITERIA
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.

PROCEDURE
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.

RISKS
There are no known risks of the vision testing procedures. I may ask for testing to be stopped at any time.

BENEFITS
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.

CONFIDENTIALITY
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.

CONTACTS
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/.

AUTHORIZATION
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.

________________________________
Child's Name

________________________________
Date

________________________________
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: _____________________


INVESTIGATOR'S AFFIDAVIT
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

________________________________
Date


Version Date: 02/22/08

 

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