1. (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. (1) comply with all applicable state and federal laws and rules;
   2. (2) meet the standard of care;
   3. (3) comply with ethical standards including Declaration of Helsinki and the Belmont Report;
   4. (4) maintain adequate medical records; and

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

      1. (A) is included in an FDA/NIH approved protocol or study; or
      2. (B) is approved by an Institutional Review Board (IRB) meeting standards under subsection (b) of this section.

2. (b) The approving IRB must be:

   1. (1) affiliated with an academic setting or a Texas-licensed hospital;
   2. (2) accredited by the Association for the Accreditation of Human Research Protection Programs, Inc.
   3. (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. (4) accredited by a national accrediting organization recognized by the board.

Source Note:The provisions of this §170.1 adopted to be effective January 9, 2025, 50 TexReg 349.