22 Tex. Admin. Code § 170.6 - Annual Reporting of Clinical Trial of Investigational Stem Cell Treatments

(a) In accordance with Chapter 1003 of the Texas Health and Safety Code, each IRB overseeing clinical trials of investigational stem cell treatments must submit an annual report to the board that:

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

(2) specifies the number of patients participating in the 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.

(b) The annual report shall not include any patient identifying information.

(c) The annual report shall cover the time period beginning September 1 and ending on August 31.

(d) The report must be submitted to the board before the end of the calendar year in which the reporting time period ends.

Notes

22 Tex. Admin. Code § 170.6

Adopted by Texas Register, Volume 43, Number 26, June 29, 2018, TexReg 4454, eff. 7/8/2018; Adopted by Texas Register, Volume 50, Number 02, January 10, 2025, TexReg 0351, eff. 1/9/2025