Application for Approval of Research Involving the Use of Human Subjects

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 [email protected] 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. Human Services Distance Education Printed Name(s) Department Campus Box Phone Fax E-mail

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:

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:

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. STEPHEN F. AUSTIN STATE UNIVERSITY Form IRB-H Nacogdoches, TX Revised September 2011 Page 2 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.

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 STEPHEN F. AUSTIN STATE UNIVERSITY Form IRB-H Nacogdoches, TX Revised September 2011 Page 4 __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 5

Informed Consent Project Name

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 XXX weeks. During this research period, I will be teaching your son/daughter two separate basic skills. These are XXX and XXX. 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, XXXXX. 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.

If you have questions about the study or anything that is related to it, please feel free to contact me, STUDENT DOING RESEARCH at CELL PHONE. Also, my email address is XXXXX. 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 your can call her at STEPHEN F. AUSTIN STATE UNIVERSITY Form IRB-H Nacogdoches, TX Revised September 2011 Page 6 either 936-468-1142 or on her cell phone at 936-558-8948. Her email address is [email protected]. You may also contact the Chairperson of the IRB Committee for Stephen F. Austin State University. Her name is Dr. Pauline Sampson and she can be contacted at [email protected] or 936-468-2908.

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