Each Institutional Review Board (IRB) overseeing clinical trials must be current with required reporting to the TMB. The annual report shall not include any patient identifying information and the report shall cover the time-period beginning September 1 and ending on August 31. The report must be submitted to the Medical Board before the end of the calendar year in which the reporting time-period ends.

Reporting Criteria

The reporting criteria below has been adopted by the Texas Medical Board in accordance with the requirements of Chapter 1003 of the Texas Health and Safety Code, and 22 Texas Administrative Code §170.6.

 

An Investigational Review Board (IRB) overseeing clinical trials of investigational stem cell treatments shall submit an annual report to the Texas Medical Board that:

  (1) sets forth the study's current findings;

  (2) specifies the number of patients participating in the stem cell clinical trial(s);

  (3) documents the treatment results for patients, as applicable;

  (4) generally describes the effects of the treatments including all adverse events;

  (5) outlines the study's findings to date;

  (6) identifies the medical school or hospital the IRB is affiliated with;

  (7) provides the location where the patients' treatments were provided in accordance with §1003.055 of the Texas Health and Safety Code; and

  (8) includes the names of all physicians certified by the IRB or the affiliated entity and the time-period of that certification.

Reporting Forms

Please submit completed forms electronically (PDF format) to the Registration Department. Please include the e-mail subject line: "IRB Annual Report [Year of Report] – [Name of IRB]"

Important: If the file size of the completed forms is 30MB or more, please mail a thumb drive with the PDF file to the following address:

 

Texas Medical Board
ATTN: IRB Annual Report [Year of Report] – [Name of IRB]
P.O. Box 2018 
Austin, TX 78768-2018

 

Helpful Documents

IRB Reports

Completed IRB reports will be made available in March each year. Please check back for updates. 

 

2019 Reports

2024 Reports 

 

Note that there are no reports from 2020 through 2023.