Office of the Institutional Review Board

Miscellaneous Forms

  • 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.
  • Hard copy submissions are not accepted.

Agreement Forms

Agreement for Investigators Who are Not Affiliated with One of the Institutions Subject to UTHSCSA IRBs for All Research
     (One Non-Affiliated Investigator, One Study)

  One Non-Affiliated Investigator, One Study Agreement Form (pdf)

Agreement for Investigators Who are Not Affiliated with One of the Institutions Subject to UTHSCSA IRBs for All Research
    (Multiple Non-Affiliated Investigators, One Study)

  • Submit:
    • Signed Part A for each unaffiliated investigator
    • Signed Part B for each study listing all unaffiliated investigators

Part A (PDF)

Part B (PDF)

IRB Authorization Agreement Form

Contact the IRB Director if you need to negotiate an agreement.

 

Assurance Letter

Assurance Letter

A letter containing the UTHSCSA FWA number, numbers of the IRBs listed under this FWA and a list of affiliated institutions covered by the IRB under general IRB Authorization Agreements.

pdf for PC

Disclosure of PHI of Decedents

Form J-1 - Assurance for Research on Decedent's Information

Form J-1 - This document is used to notify the IRB that an investigator plans to use or disclosure PHI of decedents (deceased persons); to assure the IRB that it is being requested solely for the purpose of research on the PHI of decedents for the Research Project described; and to assure the IRB that it is necessary for conduct of this Research Project. The researcher agrees that upon request by UTHSCSA or affiliated institution’s Covered Component from whom the PHI is sought, he/she will provide documentation establishing that the Individual’s(s’) whose PHI is/are being requested is/are deceased.

doc for PC

Documents Related to Consent

CONSENT- SHORT FORM - SPANISH

Submit an amendment to request IRB approval to utilize a SHORT FORM consent process for potential subjects or LARs that are non-English speaking and there is not enough time to obtain a translation. This is the Spanish version.

doc for PC

CONSENT- SHORT FORM - ENGLISH

Submit an amendment to request IRB approval to utilize a SHORT FORM consent process for potential subjects or LARs that are non-English speaking and there is not enough time to obtain a translation (the English version is provided here to be translated in the appropriate language).

doc for PC

Form D-2 - Spanish Research Consent

Use only after IRB approval to add the consent process for potential subjects or LARs that are unable to speak or understand English.

doc for PC
Form D-PP - Pregnant Consent and Authorization For studies collecting pregnancy outcomes of participants who inadvertently become pregnant or the participant’s partner who becomes pregnant. doc for PC
Form D Withdrawal Use this form for continued follow-up after withdrawal from interventions. doc for PC

Form E - 2 - Spanish Repository Consent

Use only after IRB approval to add the consent process for potential subjects or LARs that are unable to speak or understand English. doc for PC

Form H-1 - Translation Certification Form (turned in with translated consent form)

Pertains to subjects from any foreign culture

doc for PC

Forms & Documents Related to Pregnant Women, Neonates, Fetuses

Example Form U - PregWomen Neonates Fetuses- describing Follow up only

  doc for PC

FDA Guidance for Industry: Establishing Pregnancy Exposure Registries

  Webpage
Form D-PP - Pregnant Consent and Authorization For studies collecting pregnancy outcomes of participants who inadvertently become pregnant or the participant’s partner who becomes pregnant. doc for PC

Transfer Research Data When Leaving the University

Request to Transfer Research Data, Tangible Research Property or Equipment When Leaving the University   pdf for PC

Medical Directive & Power of Attorney Samples

Advance Medical Directive sample forms

Internet Legal Research Group - Forms

Webpage

Durable Power of Attorney for Health Care sample forms

Patient-Centered Guides: Durable Power of Attorney

Webpage

Durable Power of Attorney for Health Care sample forms

Internet Legal Research Group

Webpage

Optional Forms / Samples / Documents To Be Used By The Study Team

Emergency ID Card (Sample)

  doc for PC

PI-SA Survey for website

PI Self Assessment Survey with Corrective Actions-EXAMPLE

doc for PC

Protocol Deviations Tracking Log

 

doc for PC

Tracking Log for Events and Problems (Track both UPIRSO and Events and Problems Not Requiring Prompt Reporting)

Option form. For use when no pre-existing tracking system capable of producing reports is available.

doc for PC

 

Example
Note: These forms are to be downloaded and saved to your computer and then opened in Microsoft Word (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., Chrome, Firefox, Internet Explorer), please call the Office of the IRB at 210-567-8250.