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Protocol SUBMISSION, Renewal and other forms

 

no NEW protocols will be accepted on pre-2019 forms - effective 1/21/2019

 

Must use Firefox or Chrome for Wufoo forms to work

 

STEP 1:  Click here to see - Does my research need IRB oversight or not?

If answer is "no", stop at STEP 1. 

If answer is "yes", go to STEP 2.

 

STEP 2:  Do you have a consent form or information sheet (see templates below) AND a survey or list of topics ready to be uploaded?

If answer is "yes", continue to STEP 3.

If answer is "no", then prepare your consent form or information sheet, using one of these templates below, and prepare your survey, then go to Step 3

1.  General Information Sheet Template
 
2.  General Consent Form Template
 
3.  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.
 

STEP 3:  Does research fit ONLY ONE of the exempt categories below?

If answer is "no", then you must use the following IRB protocol form and submit protocol in hard copy to KL326 - Protocol for Human Subjects in Research - (new 2019 form must be used)   

If answer is "yes", click then link for category your research fits, fill out the online form, upload your consent form/information sheet and survey into the online form and submit it.  You will receive an automatic confirmation email that the protocol has been received by the IRB, and then you will receive a determination letter from the IRB after your protocol has been reviewed.

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Category 1

Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods [45 CFR 46.104(d)(1)].

 To determine if your project meets category 1 criteria - click here

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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)]:

  1. 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;

  2. 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

  3. 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).

 To determine if your project meets category 2 criteria - click here

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Category 3

i.  Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

  1. 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;

  2. 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

  3. 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).

ii.  For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

iii.  If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

 To determine if your project meets category 3 criteria [45 CFR 46.104(d)(3)] -  click here

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IRB RenewaL and closeout

 

STEP 4:  If I want to keep the protocol active for more than a year, what do I need to do?

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, the following Continuing Review form will still need to be submitted - Continuing Review Form.

For protocols submitted before January 21, 2019, when the protocol, nine months after the principal investigator received the 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. 

If answer is "no", then investigator will closeout the pre-2019 protocol, and for expedited and full review protocols only, a Completion Report form must be submitted (see STEP 5).

 If answer is "yes", then investigator will be given detailed instructions at that time for the procedure to keep protocol active for another year of use.

STEP 5:  Do I need to submit a completion report to formally close my protocol?

When you are contacted by the IRB for the annual status check, you will be given instructions on what you need to do to keep a protocol active and on what you need to do to close the protocol if you are ready to do so. 

Submission of the following completion report form is only required for pre-2019 protocols that were determined to require expedited or full review.  Completion Report

For protocols received on or after 1/21/2019, the Completion Report will only be required for protocols requiring full review. 

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 Other forms

IRB-02 Continuing Review Form - only for full review protocols

IRB-04 Completion Report Form - only for expedited and full review protocols

Unanticipated Events/Adverse Events Report Form - Any adverse reactions and any research related problems or complaints must be reported immediately and in writing to the IRB chair.

 

Research in school districts

        UISD Research Agreement - UISD - Liz Raymond, Coordinator of Family Services,  473-8772, eraymond@uisd.net

        LISD form - Gerardo G. Cruz, Assistant Superintendent for Human Resources, 273-1001, gcruz@Laredoisd.org

 

If you have questions please contact the IRB Chair, Jennifer Coronado, (irb@tamiu.edu or 326-3060).

 

  1. Guide to the IRB Application Process
  2. IRB Members