This section for use by IRB Office only
Log Number: Date Received: Date Approved:

TEXAS A&M UNIVERSITY-SAN ANTONIO

APPLICATION FOR APPROVAL OF INVESTIGATION INVOLVING THE USE OF HUMAN SUBJECTS

PLEASE TYPE

1. Principal Investigator's Name:
Department & Campus Address:
Campus Phone No.:
Alternate No.:
Associates:
2. If you are a student, provide the following:
Faculty sponsor:
Ext.:
For the following questions with check boxes: simply double click the box to check it, if applicable
Faculty, whether principal investigator/sponsor: have you completed ethics training with CITI? Yes No
Faculty, Students, staff who are doing research with human subjects must have completed CITI training
before commencing research. Click on the link below, choose Texas A&M University-San Antonio as the participating institution, and then create your username and password. Follow the rest of the instructions. Once you complete the training, retain the certificate for your records. Upon successful completion of the training your status will automatically be updated in the Office of Graduate Studies.
The Collaborative Institutional Training Initiative (CITI)Human Subjects Research Training.
Please check the status of this project:
Dissertation / Thesis / Faculty Project / Graduate Research Project / Class Project
Please check your academic status:
Faculty / Doctoral / Masters / Undergraduate

Staff

3. a) Project Title:
b) Project Time Line / From: / Date of approval by IRB / To:
4. Has this project previously been considered by the IRB? / Yes / No
5. Is a proposal for external support being submitted? / Yes / No
If “no,” please go directly to number 6.
If "yes," submit one complete copy of that proposal as soon as it is available and complete the following:
a) Is notification of Human Subjects approval required? / Yes / No
b) Is this a renewal application? / Yes / No
c) Sponsor's name and identification number:
d) Total Project Period / From: / To:
6. Please check the category of review for this study as listed in Section VI of the IRB guidelines:
Full / Expedited / Exempt
If expedited or exempt, indicate below the category number and page in the manual of the review category (expedited categories begin on page 15 and exempt categories begin on page 17):
Number(s): / Page(s):
7. I have included copies of all pertinent attachments including, but not limited to: questionnaire instruments, informed consent(s), letters of approval from cooperating institutions, copy of external support proposal of application, etc.
Yes / No
If no, please explain:
8. Description of human subjects:
Approximate Number: / Approximate Age Range:
Sex: / F / M / Both Male and Female
Will this study be using a vulnerable population (minors, elderly, uneducated, imprisoned, etc)?
Yes / No / If yes, please explain:
9. Please thoroughly describe 1) the source(s) of subjects and 2) the selection criteria. Specifically, where did you obtain the names of potential subjects (i.e. agency files, hospital records, local organizations, etc.)? Where and how will you contact them?
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10. Please provide a brief description of proposed research: include 1) major hypotheses and 2) research design.
11. Procedures: Please provide a clear step-by-step description of each procedure, including the frequency, duration and location of each procedure.
12. Informed consent: Describe the consent process; in other words how you will obtain consent from the subjects. Be sure to attach all consent documents.
13. Benefits: Describe the anticipated benefits to subjects, and the importance of the knowledge that may reasonably be expected to result.
14. Risks: Describe the risks involved with these procedures (physical, psychological and/or social) and the precautions you have taken to minimize these risks.

15. Addition to 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 as soon as possible. I agree to provide whatever surveillance is necessary to ensure that the rights and welfare of the human subjects are properly protected. I understand that I cannot initiate any contact with human subjects before I have received approval and/or complied with all contingencies made in connection with that approval.

Signature of Principal Investigator / Date

16. Approval by Faculty Sponsor (required for all students): I affirm the accuracy of this application, and I accept the responsibility for the conduct of this research and the supervision of human subjects as required by law

Signature of Faculty Sponsor / Date

17. Approval by College/Department IRB Representative (required for Expedited and Exempt Reviews).

I have reviewed and approve of the procedures that involve research with human subjects.

______

Signature of College/Department IRB Representative Date

18. Approval by Department Chair/Dean/Director (not required for applications for Expedited and Exempt Review): I confirm the accuracy of the information stated in this application. I am familiar with, and approve of the procedures that involve research with human subjects.

Name of College/Department
Signature of Department Chair / Date
Signature of College Dean / Date

For all proposals: Please email a Word version of this completed application to .

Concurrently, deliver or send a signed hardcopy to: Office of Graduate Studies, Brooks City Base Campus, Room 189 or to the Main Campus, Room 312b.

Required Signatures
Exempt & Expedited Review / Signatures are required in Items 15 & 17.
Also, signature is required in Item 16 if student is doing research.
Full Board Review / Signatures are required in Items 15, 17, 18.
Also, signature is required in Item 16 if student is doing research.

Revised June 2013