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VIEWS: 22 PAGES: 8

									STEPHEN F. AUSTIN STATE UNIVERSITY                                                                         Form IRB-H
Nacogdoches, TX                                                                                 Revised September 2011
Page 1



          APPLICATION FOR APPROVAL OF RESEARCH INVOLVING THE USE OF HUMAN SUBJECTS
                                           (IRB-H)
Please provide one original to:

            DR. PAULINE SAMPSON, IRB CHAIR
            PO Box 13018
            Stephen F. Austin State University
            Nacogdoches, TX 75962

Date: January 26, 2012

1.    Faculty Researcher/Sponsor/Thesis or Dissertation Chair
Dixie Mercer                          Human Services          13019           1142       1342        dmercer@sfasu.edu
Printed Name(s)                       Department              Campus Box      Phone      Fax         E-mail

2.    Student Researcher (if applicable) Note: IRB feedback will be sent to faculty sponsor and student by e-mail.
Sheila Beasley                        Human Services          Distance
                                                              Education
Printed Name(s)                       Department              Campus Box      Phone      Fax         E-mail

          728 Benjamin Point Goldonna, LA 71031
Off-campus address (if appropriate)

3a.    Type of Research:                                         3b. Funding for Research (if applicable):

      x    Class Project (List Class): SPE 570                        Grant-funded?     Yes       x No

            Thesis                                                       If yes, specify funding source below:

            Dissertation

             Faculty Research

4.    Title of Project: Effectiveness of Blindfold Training During Orientation and Mobility Instruction

5.    Is this project a renewal or one that has previously been considered by the IRB? YES       or NO x
      Approximate dates of previous request: If the project had prior review by another IRB, attach a copy of
      approval and related correspondence. (Omit if not relevant)


6.    State the projected time period of the project. IRB approval is for a one-year period. A continuing project
      should reapply. Time period: 10 weeks


7.    Informed consent. Describe the consent process and attach consent forms/documents. The goal is to
      communicate clearly with the participants in simple, non-technical language.


8.    You must include copies of all other pertinent information, such as a copy of the questionnaires you will use or
      other survey instruments, letters of approval from cooperating institutions, etc.
STEPHEN F. AUSTIN STATE UNIVERSITY                                                                                 Form IRB-H
Nacogdoches, TX                                                                                         Revised September 2011
Page 2


9. Provide a research protocol following these steps:
       A. Describe the target population(s) and the selection criteria. What is the anticipated demographic
       profile: age, number, gender, ethnicity, etc? Describe the method of contact and recruitment. (Recruiting
       practices for children must be explained.) You must clearly include the anticipated number of participants.

          B. Identify the specific sites/agencies to be used as well as approval status. Include copies of approval
          letters from agencies to be used.

          C. Briefly describe the proposed research; include major research hypotheses or questions and the
          research design.

          D. Discuss the potential risks – physical, psychological, legal, or other – in relation to the anticipated
          benefits to the subjects and to society. None

          E. Discuss how confidentiality of the data or the participant’s identity will be maintained. Where will
          informed consent statements or other identifying information be stored? Researcher will maintain
          confidential files on each subject that will include demographics and data obtained. Access to any
          other individual will not be allowed without parent’s written permission.

          F. Briefly describe any compensation or reimbursement that will be provided to subjects for their
          participation. None


      Additions or changes in procedures involving human subjects, as well as any problems connected with the use
      of human subjects once the project has begun, must be brought to the attention of the IRB for human subjects.


10.    Signatures:

          A. Approval by faculty sponsor/thesis or dissertation chair (required of all students):
          I affirm the accuracy of this application, and accept the responsibility for the implementation and conduct
          of this research, supervision of the human subjects, the monitoring and maintenance of confidential data.



       ___________
___________________________________________________________________________
          Principal Investigator(s)                                                                   Date

          ___________________________________________________________________________________________________________________________
          Faculty Sponsor                                                                             Date


          B.   Approval by Department Chair (or Dean, if Chair is PI or faculty sponsor):

               I affirm the accuracy of the application and approve the document for submission to the IRB.

          ______________________________________________________________________________________
          Department Chair (or Dean, as applicable)                                                   Date
STEPHEN F. AUSTIN STATE UNIVERSITY                                                       Form IRB-H
Nacogdoches, TX                                                               Revised September 2011
Page 3




                                     Informed Consent Checklist

__x__ A statement that the study involves research

__x_ An explanation of the purposes of the research

__x__ The expected duration of the subject's participation

__x__ A description of the procedures to be followed

__x__ Identification of any procedures which are experimental

__x__ A description of any reasonably foreseeable risks of discomforts to the subject

__x__ A description of any benefits to the subject or to others which may reasonably be
      expected from the research

__x__ A disclosure of appropriate alternative procedures or courses of treatment, if any, that
      might be advantageous to the subject

___x_ A statement describing the extent, if any, to which confidentiality of records identifying
      the subject will be maintained

__x__ For research involving more than minimal risk, an explanation as to whether any
      compensation, and an explanation as to whether any medical treatments are available if
      injury occurs and, if so, what they consist of, or where further information may be
      obtained

__x__ An explanation of whom to contact for answers to pertinent questions about the research
      and research subjects' rights, including faculty sponsor's name and contact information if
      the investigator is a student

__x__ A statement that participation is voluntary, refusal to participate will involve no penalty
      or loss of benefits to which the subject is otherwise entitled, and the subject may
      discontinue participation at any time without penalty or loss of benefits to which the
      subject is otherwise entitled

__x__ A statement that the subject or the subject's legally authorized representative will receive
      a copy of the informed consent statement
STEPHEN F. AUSTIN STATE UNIVERSITY                                                                    Form IRB-H
Nacogdoches, TX                                                                            Revised September 2011
Page 4


                                                  Research Protocol


The focus of this research is to examine the techniques of O&M training for low vision students and the impact of

blindfold training as compared to training without the blindfold.




The subjects for this study are divided into three groups. The first group will consist of the older

subjects, ages eleven to sixteen. The second group will make up the youngest, ages five and six.

The third, middle group, will consist of nine to thirteen year olds.

Group 1

Subject #1. Age: 14
            Ethnicity: Hispanic
            Gender: Male
            Condition: End stage glaucoma, abnormal color vision, photophobic
            Placement: General Education
            O&M Experience: 2 years

Subject #4. Age: 13
            Ethnicity: Caucasian
            Gender: Female
            Condition: Coloboma
            Placement: General Education
            O&M Experience: Beginning


Subject #7. Age: 13
            Ethnicity: Caucasian
            Gender: Female
            Condition: Ocular albinism, Nystagmus, No binocular functioning, absence
                        of depth perception, reduced peripheral vision, risk for retinal
                        detachment
            Placement: General Education
            O&M Experience: 1 year
STEPHEN F. AUSTIN STATE UNIVERSITY                                               Form IRB-H
Nacogdoches, TX                                                       Revised September 2011
Page 5

Group 2.

Subject #3. Age: 5
            Ethnicity: African American
            Gender: Male
            Condition: Albinism, Nystagmus, Esophoria, Astigmatism, Hyperopia
            Placement: General Education
            O&M Experience: Beginning

Subject #5. Age: 6
            Ethnicity: Caucasian
            Gender: Male
            Condition: Oculocutaneous Albinism, Nystagmus
            Placement: General Education
            O&M Experience: 1 year

Subject #9. Age: 5
            Ethnicity: African American
            Gender: Male
            Condition: Septo-Optic Dysplasis
            Placement: General Education
            O&M Experience: 1 year



Group 3.

Subject #2. Age: 11
            Ethnicity: African American
            Gender: Male
            Condition: Retinal detachment
            Placement: General Education
            O&M Experience: 4 years

Subject #6. Age: 11
            Ethnicity: Caucasian
            Gender: Male
            Condition: Leber’s Syndrome
            Placement: General Education
            O&M Experience: 2 years
STEPHEN F. AUSTIN STATE UNIVERSITY                                                        Form IRB-H
Nacogdoches, TX                                                                Revised September 2011
Page 6

Subject #8. Age: 9
            Ethnicity: Caucasian
            Gender: Male
            Condition: Bilateral Microphthalmia with colobomatous optic nerves (left
                       eye), retinal detachment, high hyperopia
            Placement: General Education
            O&M Experience: 4 years

Subject #10. Age: 13
             Ethnicity: Caucasian
             Gender: Female
             Condition: Retinitis Pigmentosa
             Placement: General Education
             O&M Experience: Beginning

In this research project, students will be given five lessons using vision and five lessons under

blindfold using an AB design. They will be assessed for skills mastery at the first level. In

condition A, students will be allowed to use vision detecting drop-offs. In condition B, students

will be blindfolded detecting obstacles in his/her path.
STEPHEN F. AUSTIN STATE UNIVERSITY                                            Form IRB-H
Nacogdoches, TX                                                    Revised September 2011
Page 7


                                Informed Consent
      Effectiveness of Blindfold Training During Orientation and Mobility
                                   Instruction

I would like to request your permission to include your son/daughter in research
that I am doing as part of my work toward a Master’s degree in special education.
This study is designed to find out whether it is more effective to teach students
with low vision basic orientation and mobility skills using a blindfold or allowing
them to use their remaining vision. I expect that the research will last 12 weeks.
During this research period, I will be teaching your son/daughter two separate
basic skills. These are locating drop-offs using two point touch technique while
using residual vision and locating obstacles in path using constant contact
technique while under blindfold. During the instruction of one skill, I will ask your
child to wear a blindfold. During the instruction of the other skill, we will work
just as we always do with your child using their remaining vision.

No experimental techniques or procedures will be used during the study. I do not
anticipate that your son/daughter will be uncomfortable in any way during the
study. Training will take place just like it always does except for the use of the
blindfold.

I believe that studying whether or not using a blindfold is more effective for
teaching orientation and mobility skills to low vision students is very important.
What I learn in this study may influence how O&M is taught to low vision students
in other geographic areas. It is very important to teach these important skills as
efficiently and practically as possible and what I learn from your child will help us
understand more about how this is done.

For the purposes of the study, I will write a set of summaries about each student
including how old they are, the cause of their visual impairment, gender, ethnicity,
years of O & M experience and placement in school. This information will be
included in my study, but the student’s name will NEVER be used. While the
study is going on, I will keep records that show how your child learned to master
the specific skill that we are covering. These records will be strictly confidential
and no one else will be allowed to see this data connected to your child’s name
without your written permission.
STEPHEN F. AUSTIN STATE UNIVERSITY                                           Form IRB-H
Nacogdoches, TX                                                   Revised September 2011
Page 8
If you have questions about the study or anything that is related to it, please feel
free to contact me, Ms. Shelia Beasley at 318-471-5713. Also, my email address is
sbeasleyfam@hotmail.com. My degree will be awarded by Stephen F. Austin
State University in Nacogdoches, Texas and my faculty sponsor is Dr. Dixie
Mercer. She would be happy to visit with you concerning the study and you can
call her at either 936-468-1142 or on her cell phone at 936-558-8948. Her email
address is dmercer@sfasu.edu. Another person that you can contact is Dr. Pauline
Sampson who is the chairperson of the University committee that approves
research projects. Her phone number is 936-468-5496 or you can email her at
sampsonp@sfasu.edu.

The participation of your son/daughter is ABSOLUTELY voluntary. No penalty
 will happen if you decide that you do not want them to participate in the study and
 you can decide to stop their participation at any time. Nothing will be different.
 They will still receive the same services that they always have. All you need to do
 is let me know that you wish for them to be taken out of the study.

You will receive a copy of this consent form. Please feel free to contact me or Dr.
Mercer for more information at any time.



Parent/guardian                                                         date



Researcher                                                              date


Faculty Sponsor                                                         date

								
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