| (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.
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