Human Research Forms – Full Board Review 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 (Full Board). 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 that are 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 Research Common Application Step 2 Continuation UTHSCSA IRB Application *Required X Form BB - Sponsor's protocol OR Form BC – Protocol Template *Required Form X Form A - Signature Assurance Sheet *Required Form C-1 - Local Repository Description *Required for repository 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 - Research Consent Submit if applicable Form D-1 - VA Research Consent Submit if applicable Form D-2 - Spanish Research Consent Submit if applicable Form D-PP – Pregnant Consent and Authorization Submit if applicable Form D Withdrawal Submit if applicable Page 1 of 3 Form D-IS (Information Sheet) Submit if applicable Telephone Script Submit if applicable Form E - Repository Consent Submit if applicable Form E-1 - VA Repository Consent Submit if applicable Form E-2 -Spanish Repository Consent Submit if applicable Form F - BLANK Template Submit if applicable Form F - SAMPLE waiver of consent for Chart Review study Submit if applicable Form F - SAMPLE waiver of consent for Recruitment Submit if applicable Form F - SAMPLE Alteration and waiver of documentation of consent for research procedures prior to full consent Submit if applicable Form G - Model Consent Form Submit if applicable Form H-1 - Translation Certification Form Submit if applicable HIPAA (Health Insurance Portability and Accountability) - Submit as applicable Form I - HIPAA De-identification Agreement Form Submit if applicable Form J - HIPAA Waiver of Authorization Submit if applicable Form J-1 - Assurance for Research on Decedent's Information Submit if applicable Form H-UT - UT HIPAA Authorization [Use with Form D-1 for non-VA sites.] Submit if applicable Form H-VA - VA HIPAA Authorization [Use with Form D-1 for VA sites.] 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 Form M - Proposed data collection instrument(s) (i.e., survey(s), questionnaire(s)) Submit if applicable Schedule of Events Submit if applicable Use of Drugs and/or Devices - Submit as applicable Form O - Use of a Drug in Research Submit if applicable Form O-2 - Use of a Placebo in Place of Standard Therapy Submit if applicable Form P - Use of Investigational Device Form (May be Exempt from IDE) Submit if applicable Form Inst-H - Local Sponsor-Investigator Monitoring Plan Submit if applicable Page 2 of 3 Form Inst-F - Investigational Drug Information Record Form Submit if applicable Form Inst-G - Pharmacy LOU Submit if applicable Form S - Copy of package insert or FDA approved label (PDR reference) Submit if applicable Use of Radiation / Use of Gene Transfer - Submit as applicable Form Q - Use of Radiation in Human Research (Radiation Exposure Worksheet) Submit if applicable Form GG - Radiation Safety Committee Submit if applicable Form II - Radioactive Drug Research Committee Submit if applicable Form Q-1 - Gene Transfer Therapy in Human Research Studies Submit if applicable Form EE - Institutional Biosafety Committee Submit if applicable Vulnerable Populations - Submit as applicable Form T - Research Involving the Decisionally Impaired Submit if applicable Form U - Research Involving Pregnant Women, Fetuses, &/or Neonates Submit if applicable Form U - Prefilled for Pregnant Partners Form D-PP Pregnant Partner Consent and Authorization Form V - Research Involving Prisoners Submit if applicable Submit if applicable Submit if applicable Form W - Research Involving Children, Healthy Neonates, and/or Submit if applicable Neonates (Viability not in question) Form Inst-J - Texas Department of Family and Protective Services Request for Approval Submit if applicable Other Materials - Submit as applicable Form AA - Grant Application Submit if applicable Form CC - Investigator Brochure Submit if applicable Form HH - CTRC Review Committee Submit if applicable Form R - Monitoring Participant Safety and Data Integrity Submit if applicable Form X - Protocol Related Conflict of Interest (COI) Report Submit if applicable Form Y - Monitoring Plan - Coordinating Center and/or Lead PI Letters of Support or Memorandum of Understanding for Off-site Research Page 3 of 3 Submit if applicable Submit if applicable