What qualifies as exempt? Click to view exempt categories of research . The principal investigator may make an initial determination and request for study exemption under federal guidelines. The IRB Chair (or designee) will make the final determination for exemption status. Submit a completed Form 1A bearing the original signatures and indicating exempt review, a narrative, and any applicable attachments from the list on Form 1A (e.g., if conducting a survey, submit a copy of the survey instrument). Submit only one (original) packet. No additional copies are required. Refer also to Additional Attachments. There is no submission deadline. Submit at will.

Request for Expedited Review

What qualifies for expedited review? Click to view the list of approved expedited review categories. Submit a completed Form 1 bearing the original signatures and indicating expedited review, a narrative, and any applicable attachments (e.g., if conducting a survey, submit a copy of the survey instrument, advertisements to recruit subjects, testing forms, etc.). Submit also an Informed Consent Document (ICD) [unless you are applying for a waiver]. Submit one (original) packet plus one copy. Refer also to the Additional Attachments section of Form 1. There is no submission deadline. Submit at will.

Request for Full Review

If the level of risk embodied within the research is above minimal risk, then by default, it must be reviewed at the level of Full Review. Submit a completed Form 1 bearing the original signatures and indicating full review, a narrative, and any applicable attachments from the list (e.g., if conducting a survey, submit a copy of the survey instrument, advertisements to recruit subjects, testing forms, etc.). Submit also an Informed Consent Document (ICD) [unless you are applying for a waiver]. Submit 1 (original) packet. Submit a Curriculum Vitae or other statements of the investigator's qualification to conduct research at this level. (For Industrial or Clinical Trials: If available from the sponsor, submit one copy each of the research Protocol (with the cover sheet showing the amendment # and version date) and Investigator Brochure. Refer also to Additional Attachments. Submission deadlines apply. Return to IRB Home. Click on the appropriate IRB to view the meeting dates and submission deadlines.

Request for Waiver Approval

The waiver provisions [45 CFR 46.116(c)(1) and (2), §46.116(d)(1)-(4) and §46.117(c)(1)or(2)] allow the IRB to approve a consent procedure which does not include, or which alters, some or all of the elements of the informed consent. The IRB may, under certain conditions, even waive the requirement for the investigator to obtain a signed consent form for some or all of the subjects. To see if the research qualifies for a waiver, go to the WAIVER CHECKLIST.

Submitting a Waiver Approval for Expedited Review

Submitting a Waiver Approval for Full Review

Request for Continuing Review

The regulations at 45 CFR 46.109(e) require continuing (annual) review of human subjects research by an Institutional Review Board (IRB) at intervals appropriate to the degree of risk, but not less than once per year. The UTA policy is to provide approvals based on risks for periods not to exceed twelve months. The ORI&C, serving as the administration for the IRB will forward, to the attention of the PI, an email announcing the continuation review at least six weeks ahead of the continuing review due date. A hyperlink to the Form 7 will be provided that will request the information necessary for the IRB to conduct its substantive, annual review of the ongoing research. Unless the research has been completed or closed, the completed Form #7, along with 2 clean copies of the most recent ICD (without the stamps affixed by the IRB Administration during the previous review period) must be returned as indicated by the deadline. Please note that this includes research that is currently closed to subject accrual. If an amendment or revision is being submitted at the time of continuing review, the Form #7 should indicate a status changed to "continuing / revised." All revisions must be clearly indicated (use yellow highlighter or type changes in BOLD print). Submission deadlines will be strictly enforced.

IMPORTANT NOTE: Failure to respond by the published deadline may cause the research to exceed the approval period. IRB approval cannot exceed 365 calendar days. Should expiration occur, IRB approval is withdrawn and the research must cease. No further accrual may take place and data collection must cease. Any data collected after the period of approval cannot be used in the research. Institutional and federal officials and department heads are notified of the research closure. If the research was funded, sponsors are also notified.

Request for Modification Approval

Once research has been approved by the IRB, no changes, modifications or revisions can be made prior to IRB approval [§46.103(b)(4)(iii)] except where necessary to eliminate apparent immediate hazards to the subject. Requests that are minor in nature (e.g., title change, telephone number correction) can be reviewed by expedited review procedures (reviewed and approved by the Chair or designee) with the written approval released usually within just a couple of days. Modifications submitted for approval that are determined to be "non-minor" in nature must be presented to the IRB at a convened meeting. Non-minor modifications are changes that manipulate the risk (increase or decrease) or would serve to cause a potential subject to reconsider whether or not they would want to remain in the study (e.g., adding on 10 more needle sticks). Submit one original copy of the Request for Modification Approval Form 4 along with any applicable attachments. Additional instructions on completing Form 4 are available on the electronic forms page.