22 Tex. Admin. Code § 170.1 - General Standards for Use of Investigational Agents

(a) Pursuant to Chapter 489 of the Texas Health and Safety Code, a physician who administers or provides for the use of investigational drugs, biological products, or devices must:

(1) comply with all applicable state and federal laws and rules;

(2) meet the standard of care;

(3) comply with ethical standards including Declaration of Helsinki and the Belmont Report;

(4) maintain adequate medical records; and

(5) document the proposed investigational agent to be used:

(A) is included in an FDA/NIH approved protocol or study; or

(B) is approved by an Institutional Review Board (IRB) meeting standards under subsection (b) of this section.

(b) The approving IRB must be:

(1) affiliated with an academic setting or a Texas-licensed hospital;

(2) accredited by the Association for the Accreditation of Human Research Protection Programs, Inc.

(3) registered by the U.S. Department of Health and Human Services Office for Human Research Protection, pursuant to 21 CFR Part 56; or

(4) accredited by a national accrediting organization recognized by the board.

Notes

22 Tex. Admin. Code § 170.1

The provisions of this §170.1 adopted to be effective January 4, 2007, 31 TexReg 10798; amended to be effective January 20, 2014, 39 TexReg 279; Amended by Texas Register, Volume 40, Number 31, July 31, 2015, TexReg 4898, eff. 8/4/2015; Adopted by Texas Register, Volume 50, Number 02, January 10, 2025, TexReg 0350, eff. 1/9/2025