All (A - Z) Forms
Note: These forms are best downloaded using Internet Explorer (IE) as your web browser but then click "Save" because they are best opened in Microsoft Word from after being saved to your computer (Click the picture for an example). If you are experiencing problems downloading a form from our page, and using an alternate browser has not helped (i.e., Netscape Navigator, Internet Explorer), please call the Office of the IRB at 210-567-2351.
Instructions:
Always return to this webpage to create new submissions for continuing review, amendments, reports of possible UPIRSO, etc. to ensure you are using the most current forms.
| Form | Instructions | MS Word | rtf for Apple |
Adverse Device Effect - Possible UADE |
Used to report Unanticipated Adverse Device Effects (UADE) not meeting criteria as UPIRSO (Otherwise report on UPIRSO form) Typically this is the case when an adverse device effect is not unexpected when considering the subjects underlying condition or known circumstances (does not meet UPIRSO criteria) but is unexpected based on protocol documents and meets other criteria as a UADE. |  |
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Adverse Event Tracking Form |
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Agreement for Investigators Who are Not Affiliated with One of the Institutions Subject to UTHSCSA IRBs for All Research |
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Alteration to Consent |
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Amendment to Human Use Protocol |
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Amendment to Human Use Protocol Checklist |
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Application for Access to De-identified Data (or Specimens) |
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Checklist-Amendment to Human Use Protocol |
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Checklist-Exempt |
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Checklist-Expedited |
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Checklist-Full Review |
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Children (Request for Research Involving) |
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Children (Request for Research Involving) |
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Conflict of Interest (COI) |
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Consent |
Form D |
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Consent Template for Emergency Treatment Use of Investigational Drugs Biologics or Devices |
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Copy of package insert or FDA approved label (PDR reference) |
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Decisionally Impaired (Request for Research Involving) |
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De-identified Data (or Specimens) |
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Description of Use of the HUD |
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Drug - Emergency use |
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Durable Power of Attorney for Health Care sample forms: |
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Emergency Consent Template |
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Emergency ID Card (Sample) |
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Emergency Treatment Use of Investigational Drugs Biologics or Devices-Consent Template |
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Exempt Certificate |
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Exempt Research Request - General Information Sheet |
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Exempt Submission Checklist |
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Expedited Certification Form |
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Expedited Checklist |
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Expedited Repository Certification Form (Under construction) |
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Form A Signature Assurance Sheet |
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Form AA Grant Application |
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Form B General Information sheet |
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Form B-1 Expedited Certification Form |
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Form B-2 Study Personnel List |
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Form B-2 Study Personnel List |
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Form B-3 Exempt Research Request - General Information Sheet |
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Form B-4 Exempt Certificate |
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Form BB Sponsor’s detailed drug protocol |
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Form C Research Description |
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Form C-1 Local Repository Description |
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Form CC Investigator Brochure |
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Form D Research Consent |
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Form D-1 VA Research Consent |
This is an easy to edit version without VA required formatting intended for use until ICD language is approved. Then the ICD may be converted to the Official VA Consent Template. Only place IRB approved language into the Official VA Consent Template after IRB approval of Form D-1. Blank VA Template |
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Form D-2 Spanish Research Consent |
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Form D-3 VA Spanish Research Consent |
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Form DD Device proposal and/or the sponsor’s contract |
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Form E Repository Consent |
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Form E-1 VA Repository Consent |
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Form E-2 Spanish Repository Consent (Under Construction) |
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Form E-3 VA Spanish Repository Consent (Under Construction) |
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Form EE Institutional Biosafety Committee (IBC) |
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Form F Alteration to Consent |
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Form F Waiver of Documentation of Informed Consent Process |
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Form F Waiver of Informed Consent Process |
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Form FF University Radiation Safety Committee |
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Form G NIH model Consent Form |
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Form GG Applicable Radiation Safety Committee |
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Form H translated consent document |
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Form H-1 Translation Certification form |
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Form HH CTRC (Formerly SACI) Review Committee |
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Form I HIPAA De-identification Certification Form |
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Form II Radioactive Drug Research Committee |
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Form J HIPAA Waiver of Authorization |
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Form JJ For VA studies: 10-1086; 10-1223 Report of Subcommittee on Human Studies; and 10-9012 Investigational Drug Information Record |
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Form L Proposed advertisement(s) of any type for recruiting |
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Form M Proposed data collection instrument(s) (i.e. survey(s) questionnaire(s)) |
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Form N Off-site research |
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Form O Use of a Drug in Research |
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Form O-1 Use of Approved Drug(s) for Unapproved Use |
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Form O-2 Use of A Placebo In Place of Standard Therapy |
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Form P Humanitarian Use Device |
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Form P Use of New Device Form (including Humanitarian Use Device) |
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Form Q Use of Radiation in Human Research (Radiation Exposure Worksheet) |
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Form R Monitoring Participant Safety and Data Integrity |
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Form S Copy of package insert or FDA approved label (PDR reference) |
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Form T Decisionally Impaired (Request for Research Involving) |
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Form U Research Involving Pregnant Women Fetuses &/or Neonates |
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Form V Prisoners (Request for Research Involving) |
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Form V Request for Research Involving Prisoners |
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Form W Children (Request for Research Involving) |
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Form W Research Involving Children |
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Form X Protocol Related Conflict of Interest (COI) |
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Form Y Scientific/Ethical Pre-review email from IRB |
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Full Review Application Checklist |
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HDE Progress Report Form |
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HIPAA De-identification Certification Form |
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HIPAA Waiver of Authorization |
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Humanitarian Use Device |
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Humanitarian Use Device - Report of Emergency Use (HUD used without IRB approval) |
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Information Sheet / Letter |
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IRB Authorization Agreement Form |
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Letters of Support or Memorandum of Understanding for Off-site Research |
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Local Repository Description |
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Local Repository Description |
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Log for Tracking Adverse Events |
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Modification to Human Use Protocol |
Amendment to Human Use Protocol Amendment Checklist |
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Non-Human Research Request |
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Non-Research OR Research not Involving Human Subjects |
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Non-Research Request |
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Notification of Adverse Device Effect - Possible UADE |
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Off-site research |
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Other Committee Approvals Information Sheet |
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Package insert or FDA approved label (PDR reference) (Copy) |
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Prisoners (Request for Research Involving) |
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Progress Report Form |
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Progress Report Form-HDE |
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Radiation in Human Research (Radiation Exposure Worksheet) |
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Repository Consent |
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Repository Progress Report Form |
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Repository VA Consent |
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Request for Inactivation (Formerly "Final Report") |
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Request for Review of Project not Involving Research OR Research not Involving Human Subjects |
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Research Consent |
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Research Involving Pregnant Women Fetuses &/or Neonates |
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Research Involving the Decisionally Impaired |
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Signature Assurance Sheet |
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Telephone Script |
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Tracking Log for Events and Problems Not Requiring Prompt Reporting |
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Translation Certification for Consent forms requiring translation |
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UADE Report |
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UPIRSO Reporting Form / Adverse Event |
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UPIRSO Reporting Form / Adverse Event (Resuled in physical or psychological harm) |
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UPIRSO Reporting Form / Non-Adverse Event |
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UPIRSO Reporting Form / Non-Adverse Event (Medical or nonmedical but no physical or psychological harm resulted) |
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Use of a Drug in Research |
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Use of A Placebo In Place of Standard Therapy |
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Use of Approved Drug(s) for Unapproved Use |
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Use of New Device Form (including Humanitarian Use Device) |
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Use of Radiation in Human Research (Radiation Exposure Worksheet) (AKA Form Q) |
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UTHSCSA UPIRSO Policy |
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VA Repository Consent |
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VA Research Consent |
Form D-1. This is an easy to edit version without VA required formatting intended for use until ICD language is approved. Then the ICD may be converted to the Official VA Consent Template. Only place IRB approved language into the Official VA Consent Template after IRB approval of Form D-1. Blank VA Template |
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Waiver of Documentation of Informed Consent Process |
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Waiver of Informed Consent Process |
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