SECTION 1:

The number below is your APPLICATION REFERENCE NUMBER. You must do two things with this number:

1. First, cut and paste the number into the field below it.   (Question #1) You must manually enter the number in the field.

2. Second, write down the number and save it.

This Application Reference Number must be used when you complete the second step of the application, which is emailing your supporting documentation.  

Make sure the number is in the subject line of the email that contains your supporting documentation, as well as any subsequent emails regarding this application.

*Please enter the application reference number (above) in this field:

* Are you: a student a faculty/staff member?

* Have you taken the required CITI Course in the Protection of Human Subjects? Yes  No

NOTE:  If you have not taken the CITI Course in the Protection of Human Subjects, you must complete it before your application can be processed.

If you have taken a comparable course elsewhere, send documentation of your training to the IRB administrator at ospirb@txstate.edu

* Title of project:

* Project type:

Academic/Class
Funded Research
Non-Funded Research
Institutional/Admin.

If Academic/Class, Course #:

* If funded research, complete name of funder:

*You will be informed of the IRB's decision via email. Do you require a signed hard copy of the IRB's decision for your records? Yes No

SECTION 2:

This section requires brief answers on topics that should be covered in more detail in your synopsis, consent forms, survey instruments, and other required documents accompanying your application. Please do not assume that your answer below relieves you of the responsibility to cover these issues in detail in your supporting documentation.

* Does your project involve the use of the following as research subjects:

Children under the age of 18 Yes No
Nursing home patients Yes No
Prisoners Yes No
Pregnant women or fetuses Yes No
Persons with a physical illness, injury , or disability Yes No
Mentally or psychologically impaired persons Yes No

* Are you offering any incentives to subjects in return for participation? Yes No

* Will you be asking subjects to provide:

Name
Social Security #
Phone #
Address
Medical/health info
I will NOT be asking subjects to provide their Name, Social Security #, Phone #, Address, or Medical/health info

Risk: The probability of harm or injury -physical, psychological, social, or economic -occurring as a result of participation in a research study.
* On a scale of 1-10, with 1 being no risk and 10 being significant risk, rate the overall risk to subjects in your project.

Benefit: A valued or desired outcome; an advantage.
* On a scale of 1-10, with 1 being no benefit and 10 being significant benefit, rate the overall benefits to subjects in your project.

* In the space below, briefly describe the method you used to assess risks and benefits associated with your research project.

SECTION 3:

* Will you be using an informed consent document? Yes No

If  you answered ‘no” above, please explain here:

If you are using an informed consent document, answer the following questions about your informed consent document(s): Note: if you answered "No" above, then you may leave all of the below Yes / No questions blank.

* Is the language in the document appropriately matched to the comprehension level of your intended subject pool? Yes No
* Will the document be provided in language(s) other than English? Yes No
* Will you arrange in advance for translators for non-English speakers? Yes No
* Are you 100% sure that these translators fully understand the exact meaning of the consent document? Yes No
* Will you be obtaining the subject's signature? Yes No
* Will you be providing subjects a copy of their consent document? Yes No
* Does your document in any way ask or imply that subjects are waiving any right or releasing you from any liability? Yes No

If you are using an informed consent document, does your informed consent document contain:

* A statement that the study involves research? Yes No
* An explanation of the purposes of the research? Yes No
* The expected duration of the subject's participation? Yes No
* Identification of any procedures which are experimental? Yes No
* A description of any reasonably foreseeable risks or discomforts to the subject? Yes No
* A description of any benefits to the subject or to others which may reasonably be expected from the research? Yes No
* A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject? Yes No

* 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? Yes No

* An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject? Yes No

* 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? Yes No