Submission, Renewal, Closeout, and Other Forms

STEP 1: Does my Research need IRB oversight?

Step 1: Does my research need IRB oversight or not?

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Start by completing the IRB Online Form

IRB Online Form

If the answer is "no": STOP at STEP 1.
If the answer is "yes": GO to STEP 2.

STEP 2: Do you have your forms ready?

Step 2: Do you have the needed forms ready to be uploaded?

If the answer is "yes": GO to STEP 3.

If the answer is "no": PREPARE your consent form or information sheet (use templates below), and prepare your survey. Then GO to Step 3.

TEMPLATES:

General Information Sheet Template (English)

General Information Sheet Template (Spanish)

General Consent Form Template (English)

General Consent Form Template (Spanish)

NOTE: If project will require Parental Consent and/or Minor Assent, contact irb@tamiu.edu to discuss project first before submitting any IRB forms (electronic or in hard copy). Parental Consent and Minor Assent template forms available in both English and Spanish upon request.

STEP 3: Does research fit IRB Exempt Category 2?

Step 3: Does my research fit IRB exempt category 2?

CATEGORY 2: Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met [45 CFR 46.104(d)(2)]:

The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).

If the answer is "no": Complete the IRB Protocol for Human Subjects in Research Form and submit protocol in hard copy to KL426.

If the answer is "yes": Complete the Category 2 online form, upload your consent form/information sheet and survey into the online form and submit it. After you submit, you will see a confirmation screen, which tells you that your protocol has been received by the IRB, and that you will receive a determination letter from the IRB after your protocol has been reviewed.

IRB Protocol Application for Human Subjects Research

CATEGORY 2 Online Form

STEP 4: RENEWAL AND CLOSE-OUT

Step 4: IRB renewal and closeout

Do you want to keep the IRB protocol active for more than a year?

Starting January 21, 2019, for new protocols submitted following instructions in STEP 3, nine months after you receive your determination letter, the IRB will start emailing the principal investigator listed on the protocol to request a status update on whether the protocol will remain active beyond the initial year.

No paperwork will be required to keep protocols active for more than 1 year of use, excepting those protocols that were reviewed at the Full Review level. For those studies, a Continuing Review Form will still need to be submitted.

If the answer is "no" the investigator needs to respond to IRB status check email and tell IRB protocol can be closed. No additional paperwork is required unless the status check email includes a Completion Report Form, which is required for expedited and full review protocols only (see STEP 5).

If the answer is "yes" the investigator needs to respond to IRB status check email and tell IRB that the protocol needs to remain active for another year of use.

Continuing Review Form

Completion Report Form

STEP 5: Completion Report

Step 5: Completion report

Do I need to submit a completion report to formally close my protocol?

Only expedited and full review protocols must submit the Completion Report Form to formally close the protocol. When you are contacted by the IRB for the annual status check, if this is required, a copy of this report form and submission instructions are included with that status check email.

Completion Report Form