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 ailbox.
  • 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.

X

Mark the boxes to designate forms that are applicable to your study.

/ Required Forms for Initial Submission
X / Institutional Research Application / *Required
X / Inst-M – Personnel Form / *Required
X
/ UTHSCSA IRB Application / *Required
X / Form BB - Sponsor's protocol OR Form BC – Protocol Template Form / *Required
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
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 to VA R&D 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
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 / Submit if applicable
Form D-PP Pregnant Partner Consent and Authorization / Submit if applicable
Form V - Research Involving Prisoners / Submit if applicable
Form W - Research Involving Children, Healthy Neonates, and/or Neonates (Viability not in question) / Submit if applicable
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 / Submit if applicable
Letters of Support or Memorandum of Understanding for Off-site Research / Submit if applicable

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