Section 198.6 - Process and Procedures for IRBs Engaged in the Use of Investigational Stem Cell Treatments for Patients with Certain Severe Chronic Diseases or Terminal Illnesses(a) In accordance with Chapter 1003 of the Texas Health and Safety Code, each IRB overseeing clinical trials of investigational stem cell treatments shall 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 stem cell clinical trial(s);(3) includes the treatment results of all patients treated with investigational stem cell treatments;(4) generally describes the effects of the treatments and study's findings to date, including all adverse events;(5) includes the medical school or hospital the IRB is affiliated with in accordance with § 1003.055 of the Texas Health and Safety Code;(6) includes the location where the patients' treatments were provided in accordance with § 1003.055 of the Texas Health and Safety Code;(7) includes the names of all physicians certified by the IRB or the affiliated entity to administer or provide investigational stem cell treatments and the time-period of that certification; and(8) shall not include any patient identifying information, as the report will be made available to the public upon request.(b) Each IRB overseeing clinical trials must be current with required reporting to the TMB. The annual 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.22 Tex. Admin. Code § 198.6
Adopted by Texas Register, Volume 43, Number 28, July 13, 2018, TexReg 4757, eff. 7/19/2018