Sec. 1003.055. TREATMENT REQUIREMENTS; TEXAS MEDICAL BOARD RULES. (a) Treatment provided under this subchapter must be:

(1) administered directly by a physician certified under Subsection (c);

(2) overseen by an institutional review board described by Subsection (d); and

(3) provided at:

(A) a hospital licensed under Chapter 241;

(B) an ambulatory surgical center licensed under Chapter 243; or

(C) a medical school, as defined by Section 61.501, Education Code.

(b) A physician administering an investigational stem cell treatment under this subchapter shall comply with all applicable Texas Medical Board rules.

(c) An institutional review board described by Subsection (d) may certify a physician to provide an investigational stem cell treatment under this subchapter.

(d) An institutional review board that oversees investigational stem cell treatments administered under this subchapter must meet one of the following conditions:

(1) be affiliated with a medical school, as defined by Section 61.501, Education Code;

(2) be affiliated with a hospital licensed under Chapter 241 that has at least 150 beds;

(3) be accredited by the Association for the Accreditation of Human Research Protection Programs;

(4) be registered by the United States Department of Health and Human Services, Office for Human Research Protections, in accordance with 21 C.F.R. Part 56; or

(5) be accredited by a national accreditation organization acceptable to the Texas Medical Board.

(e) The Texas Medical Board may adopt rules regarding institutional review boards as necessary to implement this section.

Added by Acts 2017, 85th Leg., R.S., Ch. 697 (H.B. 810), Sec. 3, eff. September 1, 2017.

Amended by:

Acts 2019, 86th Leg., R.S., Ch. 1158 (H.B. 3148), Sec. 3, eff. September 1, 2019.