Investigators may not initiate any minor or major changes in research protocol , procedures or consent form(s) without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subject.
Amendment to the UT Health IRB:
Submit to IRBmail@uthscsa.edu with revised IRB approved forms (using tracked changes in the most current IRB-approved forms [which were emailed to you with the approval letter]) or new forms as applicable. The PI may be copied on the submission in lieu of the Form A-1.
Required Forms | |
|---|---|
| Amendment Form to Human Use Protocol | *Required |
| Form A - 1 Multipurpose Signature Assurance Sheet | *Required Signed by the Principal Investigator . How to digitally sign Adobe forms. |
Other Forms - Submit if applicable to the amendment | |
| Use the most current IRB-approved forms (which were emailed to you with the approval letter) - Make necessary changes to existing IRB approved forms using tracked changes. | Submit if applicable. Go to the appropriate protocol type and download the needed form(s). |
| If applicable, complete new forms related to the amendment. | Submit if applicable |
| Documents related to Consent | Submit as applicable. Go to Documents Related to Consent page - the page includes Informed Consent Documents, Concise Summary Templates and Tools, and Documents Related to Consent to be used after approval. |
Collaboration - Submit if applicable to the amendment | |
| Form K-2 - Intent to Rely Form | Submit this form if applicable. This form should be completed to document centralized IRB review under a Broad or Reciprocal agreement. This form helps to ensure any outstanding concerns or requirements by the Deferring Site are addressed before the study is approved by the Reviewing IRB . |
| Greater Plains Collaborative Reliance Checklist | Submit this form if applicable to your research. Use this form when you are collaborating with researchers from an Institution that is part of the Greater Plains Collaborative Reciprocity Agreement. This form will need to be completed by the relying institution. |
NOTE: Institutional Review is conducted concurrently by UT Health San Antonio through the Office of Clinical Research (OCR) for submissions that do not strictly require IRB regulatory review. An institutional activation letter from UTHSA is required prior to beginning your research. Does not apply if UT Health San Antonio is not engaged in research activities.