Texas Administrative Code
Title 22 - EXAMINING BOARDS
Part 9 - TEXAS MEDICAL BOARD
Chapter 170 - STANDARDS FOR USE OF INVESTIGATIONAL AGENTS
Subchapter B - INVESTIGATIONAL STEM CELL TREATMENTS FOR PATIENTS WITH CERTAIN SEVERE CHRONIC DISEASES OR TERMINAL ILLNESSES
Section 170.6 - Annual Reporting of Clinical Trial of Investigational Stem Cell Treatments
Universal Citation: 22 TX Admin Code § 170.6
Current through Reg. 50, No. 13; March 28, 2025
(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.
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