Human Research Forms – Exempt Application Checklist Submission Instructions Always download the forms from the IRB website to ensure you are using the most current versions. All submissions to the IRB should be sent via the IRBmail@uthscsa.edu mailbox. Original Signed documents are to be scanned and attached to the email. Label the subject of the email with: NS, PI name (Exempt). Hard copy submissions are not accepted. Items in the blue section are required. Items in the orange sections should be submitted if applicable to your research. Depending on the nature of your research, some sections of the application will apply to your research, some will not. Please review each section to determine applicability to your research, and include the forms appropriate for your study in your IRB application submission. This checklist document should not be submitted to the IRB. It is intended to assist the study team in preparing the submission packet. Mark the boxes to designate forms applicable to your study. X Required Forms for Initial Submission X Research Common Application Step 1 Form *Required X Research Common Application Step 2 Institutional Form *Required X Inst-M – Personnel Form *Required X Form B-3 - Exempt Research Request - General Information Sheet *Required X Form A - Signature Assurance Sheet *Required Billing / Payment Forms - Submit as applicable Billing Grid Submit if applicable Participant Payment Form Submit if applicable Study Budget Submit if applicable Clinical Trial Agreement Submit if applicable Consent Forms - Submit as applicable Form D-IS (Information Sheet) Submit if applicable Telephone Script Submit if applicable HIPAA (Health Insurance Portability and Accountability) - Submit as applicable Form J - HIPAA Waiver of Authorization Submit if applicable Collaboration - Submit as applicable Form K-1 - UT System Centralized IRB Review Submit if applicable Form K-2 - Intent to Rely on UTHSCSA for IRB Review Submit if applicable Advertisements & Data Collection Instruments - Submit as applicable Form L - Proposed advertisement(s) of any type for recruiting Submit if applicable Form L-1 - Find a Study Recruitment Website Submit if applicable Page 1 of 2 Form M - Proposed data collection instrument(s) (i.e., survey(s), questionnaire(s)) Submit if applicable Schedule of Events Submit if applicable Other Materials - Submit as applicable Form AA - Grant Application Submit if applicable Form BB - Sponsor's protocol Submit if applicable Form BC – Protocol Template Form Submit if applicable Form HH - CTRC Review Committee Submit if applicable Form X - Protocol Related Conflict of Interest (COI) Report Submit if applicable Letters of Support or Memorandum of Understanding for Off-site Research Submit if applicable Page 2 of 2